Mean Discomfort Score Research Articles

Sexual Function and Discomfort in Women After Midurethral Sling Surgery.

The purpose of this study was to evaluate medium-term sexual function following midurethral sling (MUS) surgery. This was an ambidirectional observational study with a nested matched case-control study performed in a tertiary urogynecology referral center. We assessed sexual discomfort and function using the Pelvi-Perineal Surgery Sexuality Questionnaire (PPSSQ), pre- and postoperatively, in a patient cohort that comprised patients who underwent an MUS procedure between January 2014 and December 2019. We recruited a group of volunteers without a previous history of MUS surgery. The nested case-control study comprised a subgroup of cases from the patients' cohort matched to controls from the volunteer's cohort. Cases and controls were matched for age and menopausal status at a 1:1 ratio. A total of 118 patients and 128 volunteers were recruited. Of these, 105 cases and 105 controls comprised the nested case-control study. There was no statistically significant difference in the mean discomfort and pain scores between cases and controls (19.8 ± 21.2 vs 15.4 ± 15.7 respectively; p = 0.19 primary outcome). Similarly, there was no difference in mean sexual health scores. However, the rate of reported sensation of an obstruction in the vagina was significantly more in cases (16%) than in controls (2.6%; p = 0.001). There were no significant differences between patient-reported sexual function at follow-up compared with their recollection before surgery. Midurethral sling surgery does not seem to impair the quality of sexual life in the medium term.

Efficiency of clear aligners with nickel titanium wires for treating mandibular incisor crowding.

Patients who are allergic to nickel, which is present in stainless steel brackets and wires, commonly utilise clear aligners. The objective of this research was to compare the management of mandibular incisor crowding with nickel titanium (NiTi) wires and clear aligners. A random division of forty participants into two groups of twenty samples each was made. Participants in group B received transparent aligners, whereas those in group A received NiTi arch wires. We assessed malocclusion using Little's irregularity index. A survey instrument was utilised to document the degree of discomfort. Patients were routinely recalled every one, two, and three months. The mean score for groups A and B was 2.86 mm and 2.88 mm at baseline, 1.71 mm and 1.52 mm at one month, 1.02 mm and 1.23 mm at two months, and 0.72 mm and 0.48 mm at three months, respectively. The difference wasn't that big (p > 0.05). In groups A and B, the mean change in Little's irregularity index score was 1.19 mm and 1.21 mm at one month, 0.55 mm and 0.51 mm at two months, and 0.26 mm and 0.45 mm at three months, respectively. The difference wasn't that big (p > 0.05). For groups A and B, the corresponding mean discomfort scores were 2.6 and 2.3 at baseline, 2.2 and 1.8 after one month, 1.6 and 1.5 at two months, and 1.1 and 0.9 at three months. Since p > 0.05, the difference was not significant. The results of this study showed that NiTi wires and clear aligners worked just as well to treat cases of mandibular anterior crowding.

Use of Esmarch bandage does not increase peripheral vein size in healthy volunteers: A randomized clinical trial

IntroductionUltrasound is used for peripheral intravenous (PIV) cannulation in patients with difficult landmark-guided IV access in the Emergency Department. Distal-to-proximal application of an Esmarch bandage on the target limb has been suggested as a method for increasing vein size and ease of cannulation. MethodsThis study was a single-blinded crossover randomized controlled trial comparing basilic vein size under ultrasound with use of an Esmarch bandage in addition to standard IV tourniquet (“tourniquet + Esmarch”) compared to use of a standard IV tourniquet alone. Participant discomfort with the tourniquet + Esmarch was also compared to that with standard IV tourniquet alone. ResultsTwenty-two healthy volunteers were used to measure basilic vein size with and without the Esmarch bandage. There was no difference in basilic vein size between the two groups, with a mean diameter of 6.0 ± 1.5 mm in the tourniquet + Esmarch group and 6.0 ± 1.4 mm in the control group, p = 0.89. Discomfort score (from 0 to 10) was different between the groups, with a mean discomfort score of 2.1 in the tourniquet + Esmarch group and 1.1 in the standard IV tourniquet alone group (p < 0.001). ConclusionsThis study showed that the use of an Esmarch bandage does not increase basilic vein size in healthy volunteers but is associated with a mild increase in discomfort.

Binaural hearing in monaural conductive or mixed hearing loss fitted with unilateral Bonebridge.

To determine the benefits of binaural hearing rehabilitation in patients with monaural conductive or mixed hearing loss treated with a unilateral bone conduction implant (BCI). This monocentric study includes 7 patients with monaural conductive or mixed hearing loss who underwent surgical implantation of a unilateral BCI (Bonebridge, Med-El). An ITA Matrix test was performed by each patient included in the study - without and with the BCI and in three different settings - to determine the summation effect, squelch effect and head shadow effect. Subjective hearing benefits were assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. The difference in signal to noise ratio of patients without and with BCI was 0.79 dB in the summation setting (p < 0.05), 4.62 dB in the head shadow setting (p < 0.05) and 1.53 dB (p = 0.063) in the squelch setting. The APHAB questionnaire revealed a subjective discomfort in the presence of unexpected sounds in patients using a unilateral BCI (aversiveness score) compared to the same environmental situations without BCI, with a mean discomfort score of 69.00% (SD ± 21.24%) with monaural BCI versus 25.67% (SD ± 16.70%) without BCI (difference: -43.33%, p < 0.05). In terms of global score, patients wearing a unilateral Bonebridge implant did not show any significant differences compared to those without hearing aid (difference: -4.00%, p = 0.310). Our study shows that the use of a unilateral BCI in patients affected by monaural conductive or mixed hearing loss can improve speech perception under noise conditions due to the summation effect and to the decrease of the head shadow effect. However, since monaural BCIs might lead to discomfort under noise conditions in some subjects, a pre-operative assessment of the possible individual benefit of a monaural BCI should be carried out in patients affected by unilateral conductive or mixed hearing loss in order to investigate the possible additional effect of the fitting of hearing aids.

A brief mind-body intervention to reduce pain and anxiety during prostate needle biopsy: a clinically integrated randomized controlled trial with 2-staged consent

ObjectivesMany patients experience pain, anxiety, and discomfort with prostate biopsy, which may discourage enrollment in active surveillance programs or follow-up biopsy. Guided meditation can significantly reduce pain and anxiety during percutaneous biopsy. We sought to evaluate the effectiveness of a brief mind-body intervention on patient-reported outcomes after prostate biopsy. Methods and materialsWe performed a clinically-integrated randomized controlled trial of a brief mind-body intervention during biopsy compared to usual care at a single tertiary care center from 2018 to 2022. All patients offered transrectal ultrasound-guided prostate biopsy in the clinic with local anesthesia were eligible for enrollment. This clinically integrated trial was conducted simultaneously with a randomized controlled trial of 1-stage and 2-stage consent. The primary outcome was patient-reported pain, anxiety, discomfort, and tolerability on a visual-analog scale (0–10). A 15% improvement was prespecified as clinically relevant. We compared the proportion of men in each arm reporting a severe score (7–10) on any of the 4 scales using Fisher's exact test and then compared means for each scale separately using ANCOVA with randomization stratum (first vs. prior biopsy) as a covariate. ResultsOf 263 eligible patients, 238 enrolled (119 per arm). One hundred seventy-two (72%) enrolled with 2-stage consent. A total of 37/94 (39%) and 38/102 (37%) patients randomized to usual care and intervention, respectively, reported severe scores in any of the 4 domains, a difference of 2.1% (95% confidence interval [CI] -13, 17%, P = 0.8). There was no evidence of a difference in mean postbiopsy anxiety (P = 0.3), discomfort (P = 0.09), pain (P = 0.4) or tolerability scores (P = 0.2). ConclusionsA clinically meaningful benefit for this brief mind-body intervention during prostate biopsy is unlikely. Robust patient enrollment is feasible using 2-stage consent.

Functional and sexual outcomes following surgical vaginal introital reduction.

Surgical introital reduction procedures are commonly performed for the treatment of vaginal laxity (VL), yet poorly studied. The aim of this study was to assess clinical outcomes following surgical vaginal introital reduction for VL. This was an ambidirectional cohort study conducted in a single urogynecology center. All sexually active women who had vaginal introital surgical reduction for VL between March 2015 and September 2020 were included in this study. VL was defined as a genital hiatus distance ≥4cm according to the POP-Q classification, associated with symptoms of laxity. The primary endpoint was sexual health assessed by the Pelvi-Perineal Surgery Sexuality Questionnaire (PPSSQ), while the secondary endpoints included postoperative pain, perioperative complications, rate of dyspareunia, patient satisfaction and success rate based on the Patient Global Improvement Index (PGI-I) and Vaginal Laxity Questionnaire (VLQ). Of the 27 patients sent the questionnaires, 23 sexually active patients returned the completed ones and were included in the study. Participants had a mean age and BMI of 41 years (range 24-74) and 21.3 (range 17.6-31.9) respectively. The most prevalent preoperative symptom was feeling of VL in 82.6% followed by bulging sensation in 47.8%. Preoperative dyspareunia was reported in 8/23 (34.8%). Surgical interventions involved perineorrhaphy with (n=14) or without (n=9) levator ani plication. The PPSSQ mean sexual health score was 86.7/100 (SD 5.8; range 16.7-93.3) and the mean discomfort and pain score was 27.5/100 (SD 26.0; range 0-80). Postoperative sexuality was reported to better, identical or worse in 16 (69.6%), 2 (8.7%) and 5 (21.7%) patients respectively. On PGI-I, patients reported feeling much better, better, slightly better and no change in 10 (43.5%), 5 (21.7%), 5 (21.7%) and 3 (13.0%) respectively. None of the women reported feeling worse. The overall post-operative complication rate was 3/23 (13.0%), including a perineal hematoma, and two cases of reoperation for narrow introitus. De novo dyspareunia was reported by 11/18 (61.1%) patients, occurring often or more in 4/18 (22.2%) patients, due to narrow introitus (n=2), enlarge introitus (n=1) and vaginal dryness (n=1). Vaginal introital reduction surgery is a viable treatment option for symptoms of vaginal laxity after failure of conservative measures. However, patients should be made aware of the risk of de novo dyspareunia.

A brief mind-body intervention to reduce pain and anxiety during prostate needle biopsy: A randomized, controlled trial with two-staged consent.

e17092 Background: Prostate biopsy is among the most common oncologic procedures performed annually. A substantial proportion of patients experience significant morbidity related to biopsy, including pain, anxiety, and discomfort which may discourage follow-up biopsy crucial for identifying progression or discourage enrollment in active surveillance programs that require serial biopsy. Guided meditation significantly reduces pain and anxiety during breast biopsy. We developed a brief mind-body intervention that could easily integrate into general practice for patients during prostate biopsy and compared patient-reported outcomes after biopsy with and without this intervention. Methods: We conducted a clinically-integrated randomized controlled trial (MSK IRB 18-089) of a brief mind-body intervention during prostate biopsy compared to usual care. All adult patients offered biopsy were eligible. Patients randomized to the intervention were offered both a pre-biopsy mind-body exercise and guided mindfulness meditation during biopsy via headphones. The primary outcome of interest was any severe patient-reported pain, anxiety, discomfort, or tolerability on a visual-analog scale (0-10). We compared the proportion of men in each arm reporting a severe score (7-10) on any of the four scales using Fisher’s exact test. The pre-specified clinically relevant improvement justifying integration into clinical practice was 15%. We compared means separately using ANCOVA with randomization stratum (first vs. prior biopsy) as a covariate. Results: 238 patients (119 per arm) enrolled. 102 in the intervention arm and 94 in the usual care arm proceeded to biopsy and completed the questionnaire. A total of 37/94 (39%) and 38/102 (37%) patients in the usual care and the intervention arms, respectively, reported severe scores in any of the four domains, a difference of 2.1% (95% confidence interval -13, 17%, p = 0.8). The upper bound of the confidence interval includes the pre-specified clinically relevant difference. There was no evidence of a difference in mean post-biopsy anxiety (p = 0.3), discomfort (p = 0.09), pain (p = 0.4) or tolerability scores (p = 0.2), Table. Conclusions: There was no difference in patient reported outcomes between a mind-body intervention and usual care for prostate biopsy. Though the upper bound of the 95% confidence interval included the clinically relevant difference in severe scores, the difference in means for each outcome suggests a clinically meaningful benefit for this brief mindfulness intervention is unlikely. [Table: see text]

Effect of visual distraction on discomfort score during flexible fiberoptic direct laryngoscopy: a randomized control trial

BackgroundFlexible fiberoptic direct laryngoscopy is the standard technique for evaluating the larynx and hypopharynx and is a routine outpatient procedure performed in ENT. This study aims to find the effect of patients’ own procedure video as a distractor over the discomfort score, during flexible fiberoptic direct laryngoscopy. It can be a cost-effective alternative to local anesthetics and should be included in our routine practice.ResultsThe study included 60 patients undergoing flexible laryngoscopy at a tertiary care hospital. Patients were divided into two groups: group A (those patients who had visualized their procedure video while performing FFODL) and group B (those patients who had not visualized their procedure video while performing FFODL). Visual distraction was involving patients to see their own video while FFODL was being performed. After, the procedure discomfort score was assessed using a visual analog scale. In our study, both groups were comparable in terms of age and gender. The mean discomfort score was significantly reduced in group A as compared to group B (p value 0.003).ConclusionThis study has shown that visual distraction significantly reduced the procedure-specific mean discomfort scores and that it should be practiced routinely to alleviate patient’s anxiousness and fear to go through this procedure and to gain the confidence of patients.

A comparative evaluation of nickel-titanium wires and clear aligners in the management of mandibular incisor crowding

To compare nickel-titanium (NiTi) wires and clear aligners in the management of mandibular incisor crowding.Seventy-two participants were arbitrarily alienated into two groups with 36 samples in each. Group I participants were treated with NiTi arch wires and group II participants with clear aligners. Malocclusion was evaluated using Little's irregularity index. A questionnaire was applied to record the discomfort levels. Patients were recalled regularly at four weeks, eight weeks, and twelve weeks.At baseline, the mean score was 2.91 mm and 2.72 mm; at 4 weeks, it was 1.64 mm and1.48 mm; at 8 weeks, it was 0.98 mm and1.0 mm; and at 12 weeks, it was 0.68 mm and 0.52 mm in groups I and II, respectively. The mean change in Little's irregularity index score at 4 weeks was 1.27 mm and 1.24 mm; at 8 weeks, it was 0.66 mm and 0.48 mm; and at 12 weeks, it was 0.30 mm and 0.48 mm in groups I and II, respectively. The disparity was not-considerable (p > 0.05). The mean discomfort score at baseline was 2.8 and 2.5; at 4 weeks, it was 2.4 and 2.0; at 8 weeks, it was 1.8 and 1.4; and at 12 weeks, it was 1.3 and 1.0 for groups I and II correspondingly. The disparity was non-significant (p > 0.05).From the present study, it was found that both NiTi wires and clear aligners were equally effective in managing mandibular anterior crowding cases.

Development and validation of a patient-reported scale for tolerability of endoscopic procedures using conscious sedation

Patient-reported experience measures (PREMs) assessing the tolerability of endoscopic procedures are scarce. In this study, we designed and validated a PREM to assess tolerability of endoscopy using conscious sedation. The patient-reported scale for tolerability of endoscopic procedures (PRO-STEP) consists of questions within 2 domains and is administered to outpatients at discharge from the endoscopy unit. Domain 1 (intraprocedural) consists of 2 questions regarding discomfort/pain and awareness, whereas domain 2 (postprocedural) consists of 4 questions on pain, nausea, distention, and either throat or anal pain. All questions are scored on a Likert scale from 0 to 10. Cronbach's alpha was used to measure internal consistency of the questions. Multivariable logistic regression was performed to assess predictors of higher scores, reported using adjusted odds ratios and confidence intervals. Two hundred fifty-five patients (91 colonoscopy, 73 gastroscopy, and 91 ERCP) were included. Colonoscopy was the least tolerable procedure by recall, with mean intraprocedural awareness and discomfort scores of 5.1 ± 3.8, and 2.6 ± 2.7, respectively. Consistency between intraprocedural awareness and discomfort/pain yielded an acceptable Cronbach's alpha of .71 (95% confidence interval, .62-.78). Higher use of midazolam during colonoscopy was inversely associated with an intraprocedural awareness score of 7 or higher (per additional mg: adjusted odds ratio, .23; 95% confidence interval, .09-.54). PRO-STEP is a simple PREM that can be administered after multiple endoscopic procedures using conscious sedation. Future work should focus on its performance characteristics in adverse event prediction.

The Role of Combination Calcipotriol plus Betamethasone Dipropionate Gel in the Treatment of Moderate-to-Severe Scalp Seborrhoeic Dermatitis.

This study aimed to investigate the off-label use of a combination calcipotriol plus betamethasone dipropionate (CBD) gel in the treatment of moderate-to-severe scalp seborrhoeic dermatitis (SSD). This retrospective study involved 32 patients with SSD who were prescribed CBD gel at the Subang Jaya Medical Centre, Selangor, Malaysia, between January 2016 and December 2017. The Physician Global Assessment Scale was used to assess disease severity. Itching/discomfort was evaluated using a visual analogue scale. The mean age was 35.8 ± 6.9 years. Severe disease was seen in 53.1%. Complete clearance was recorded in 15.6%, 40.6% and 59.4% of patients at weeks two, six and 10, respectively. By week 10, 87.5% had achieved marked improvement. Both mean itching and discomfort scores significantly improved at weeks two, six and 10 (P <0.001). Better outcomes were significantly associated with disease duration and itching intensity and discomfort at presentation (P <0.050). CBD gel should be considered as an option for SSD cases not adequately controlled by prior conventional treatment.

A Simplified Single-Penetration Technique of IANB (MK Technique) for Mandibular Anesthesia.

Owing to the anatomical basis established on the detailed course, distribution and innervations of buccal nerve in the literature, we believe that an effective and extensive buccal nerve block could be achieved when the nerve is anesthetized proximal to its branching point which relates to anteromedial aspect of ramus (retromolar fossa). Though several techniques of inferior alveolar nerve block (IANB) including few single-penetration approaches were already well reviewed and practiced, pitfalls remained in terms of achieving adequate retromolar soft tissue anesthesia, as well as undermining the very importance of contacting the bone and the orientation of the bevel. We propose a simplified single-penetration technique aligning almost similar to conventional technique and its well-adopted landmarks, but still obviating the need for a separate penetration for long buccal nerve anesthesia. To study the efficacy of a simplified single-penetration technique for mandibular anesthesia. To study the adequacy of the simplified IANB technique in minimizing the number of penetrations required to achieve buccal nerve anesthesia decreasing patient's pain and discomfort when IANB is performed and the ease of adaptability across the operators. A 25-gauge 42-mm needle, local anesthesia with adrenaline-2% lignocaine HCl (1:80,000), 2.5-ml syringe, observation form. Study 1-A sample size of 120 cases, in oral surgery department of our college, with 60 patients in Group I (control) where patients received anesthesia through conventional IANB and 60 patients in Group II (experimental) where patients received anesthesia through simplified IANB. Both the groups are again subdivided into group A (single operator) and group B (multiple operators). Study 2-20 bilateral mandibular impacted third molar in oral surgery department of our college, with right side (control-conventional technique) and left side (experimental-simplified single-penetration technique). VAS data are recorded in the excel sheet. The success rate of the simplified technique is quite comparable to the conventional groups. The mean pain and discomfort score in simplified technique was 3.08 which is relatively lower when compared to mean value in conventional technique which was 6.88. The difference was statistically significant. Simplified technique minimizes the number of penetrations, which substantially decreases patient's pain and discomfort levels not only during injection, but also during surgical procedures on mandibular posterior region because of extensive and profound buccal nerve territorial anesthesia.

A comfort assessment of existing cervical orthoses

Purpose: Identify location and intensity of discomfort experienced by healthy participants wearing cervical orthoses.Method: Convenience sample of 34 healthy participants wore Stro II, Philadelphia, Headmaster, and AspenVista® cervical orthoses for four-hour periods. Participants reported discomfort level (scale 0–6) and location.Results: Participants reported mean discomfort for all orthoses over the four-hour test between ‘a little discomfort’ and ‘very uncomfortable’ (mean discomfort score = 1.64, SD = 1.50). Seven participants prematurely stopped tests due to pain and six reported maximum discomfort scores. Significant linear increase in discomfort with duration of wear was found for all orthoses. Significantly less discomfort was reported with Stro II than Headmaster and Philadelphia. Age correlated with greater perceived discomfort. Orthoses differed in the location discomfort was experienced.Conclusion: Existing cervical orthoses cause discomfort influenced by design and duration of wear with orthoses’ design the more significant factor. This work informed the design of a new orthosis and future orthoses developments.Practitioner Summary: The purpose of this study was to gain greater knowledge about the discomfort caused by wearing of existing neck orthoses in order to inform the design and development of a new neck orthosis. This study gathers empirical data from a surrogate population and concludes that orthosis design is more influential than the duration of wear.

Can Listening to Music Decrease Pain, Anxiety, and Stress During a Urodynamic Study? A Randomized Prospective Trial Focusing on Gender Differences

To evaluate the effect of listening to music on pain, anxiety, or stress during a urodynamic study (UDS). A total of 74 female and 74 male patients who underwent UDS between March 2013 and October 2013 were prospectively randomized. The patients were divided into 2 groups according to gender (female, n = 74 vs male, n = 74) and into 2 subgroups according to whether they listened to music or not. Music group subjects played their preferred music during UDS. Before and after UDS, all subjects completed the State-Trait Anxiety Inventory (STAI) form and their degree of pain, anxiety, and satisfaction during examination were assessed by the visual analog scale (VAS, 0-10). Basic vital signs were also checked before and after the procedure. In the analysis of anxiety, pain, and stress scores, the mean shame, discomfort, and satisfaction scores (VAS) were significantly higher in female patients, whereas the mean score of willingness to retry the procedure was higher in male patients whether listening to music or not (P < .001). In the analysis of differences of STAI total, state anxiety, and trait anxiety, there were no statistical significances between the music group and the no-music group in either gender. In our study, music during UDS did not reduce anxiety, pain, and stress in either gender. In the analysis focusing on gender difference, female patients showed statistically higher levels of pain, anxiety, and stress scores than male patients whether listening to music or not.

Measurement of body temperature in 300 dogs with a novel noncontact infrared thermometer on the cornea in comparison to a standard rectal digital thermometer.

To assess the accuracy of obtaining body temperatures in dogs with a noncontact infrared thermometer (NCIT) on the cornea compared with a rectal digital thermometer (RDT). Prospective single center study. University teaching hospital. Three hundred dogs presented with low, normal, or high body temperatures. Three body temperature readings were measured by an RDT and by an NCIT on the cornea of the left eye by 2 investigators (experienced and inexperienced). Results obtained by the 2 methods were compared. Median body temperature measured by the experienced investigator with the RDT and the NCIT were 38.3°C (range 35.5°C-41.1°C; 95% CI: 38.2-38.4°C) and 37.7°C (35.9°C-40.1°C; 95% CI: 37.7°C-37.9°C), respectively. Measurement of RDT as well as of NCIT correlated well between both investigators (rRDT = 0.94; rNCIT = 0.82; respectively, P < 0.001 for both methods). Mean RDT and NCIT-temperature correlated poorly (r = 0.43; P < 0.001) when taken by the experienced investigator and even less by the nonexperienced investigator (r = 0.38; P < 0.001). Repeatability of the NCIT revealed an unsatisfactory value (0.24°C) compared to RDT measurement (0.12°C). Agreement between both devices in measuring low, normal, and high values, calculated by Cohens-Kappa, was unsatisfactory (к = 0.201; P < 0.001). Calculating the receiver operating characteristic curve to determine the best threshold for fever (defined as RDT temperature >39.0°C) showed an area under the curve of 0.76. Mean discomfort score was significantly lower using NCIT compared to RDT measurement (P < 0.001). There was poor agreement between body temperatures obtained by RDT and NCIT. The corneal NCIT measurement tends to underrecognize hypothermic and hyperthermic conditions. Although the use of the NCIT yields faster results and is significantly more comfortable for the dog than the RDT measurement, it cannot be recommended in dogs at this time.

Does anxiety or waiting time influence patients' tolerance of upper endoscopy?

Background/Aims:Endoscopy is an essential and very commonly used procedure for the evaluation of a multitude of gastrointestinal symptoms. Although it is increasingly required, patients often wait on arrival at the endoscopy unit until they are called for the procedure. It is not clear whether or not this waiting time may have an impact on patient's tolerance during upper endoscopy. Our study attempts to address this.Patients and Methods:We studied consecutive outpatients who underwent endoscopy from September to December, 2013. Gender, age, body mass index (BMI), previous endoscopic experiences, antidepressant therapy, and the time interval between arrival at the endoscopy unit and the onset of examination was recorded. Anxiety before the procedure, pain, and discomfort were rated by a numeric rating scale (0 = no pain/discomfort encountered to 10 = extremely painful/uncomfortable).Results:One hundred and five consecutive outpatients (male = 52; mean age = 45.3 years; age range = 20–86 years) were included in the study. The mean BMI was 25 ± 4.8; mean waiting time from registration to the procedure was 172 min (time range = 30 - 375 mins). Mean patients' pre-examination anxiety level was 3 ± 3.84, mean discomfort score was 4.3 ± 3.09 and mean pain score was 3.4 ± 3.03. The level of pain and discomfort was significantly higher in patients with higher levels of pre-procedure anxiety. No differences were found in terms of anxiety, pain and discomfort among patients divided according to waiting time.Conclusions:According to our data, waiting time does not have a significant impact on the perception of pain and discomfort related to the endoscopic procedure. On the other hand, high pre-procedural levels of anxiety were associated with a low tolerance. Further multicenter randomized trials are needed to clarify the impact of waiting time.

The Effect of the Duration of Merocel in a Glove Finger on Postoperative Morbidity

We examined the effects of the duration of keeping a Merocel nasal packing in the nose and the application technique (packing applied either directly or inside a glove finger) on postoperative morbidity and complications. The study included 129 patients (67 males and 62 females; age range 18 to 56 years) undergoing nasal septoplasty without turbinate intervention. The patients were randomly assigned into 4 groups. In group 1 and group 2, Merocel was directly applied in the nasal cavity for 24 hours and 48 hours, respectively; in group 3 and group 4, Merocel was kept in the nasal cavity in a powder-free glove finger for 24 hours and for 48 hours, respectively. Pain and discomfort scores were evaluated by a visual analog scale. The time taken between removal of the tampon and when the patients began to breathe comfortably was called the nasal obstruction time. The differences in mean discomfort score between the groups were not statistically significant (P > 0.05), while the mean pain scores were statistically higher in groups 1 and 2 than in groups 3 and 4 (P < 0.05). The nasal obstruction time was statistically shorter in groups 2 and 4 than in groups 1 and 3 (P < 0.05). Therefore, keeping Merocel inside a glove finger in place for 48 hours notably reduces the pain occurring during the removal of the nasal tampon. It also reduces nasal obstruction time and prevents synechia, leakage, bleeding, and septal hematoma, without compromising patient comfort.

Differences in Pain Perceptions between Automated Breast Ultrasound and Digital Screening Mammography

A prospective single-site survey was performed to gauge perceived pain during automated breast ultrasound (ABUS) and digital x-ray mammography (XRM). Patients also described differences in duration of the exams, provided their bra size, and indicated whether they would recommend ABUS to a friend. Pain was measured on a Likert-type visual analog scale (1–10). Participants were 199 female volunteers who also participated in the prospective, multicenter, nationwide clinical research study SOMO•INSIGHT. There was a mean pain and/or discomfort score of 6.41 (± 2.41) for XRM and a mean score of 1.86 (± 1.24) for ABUS ( P = .001). Bra size and perceived examination duration played no role in determining patient pain and/or discomfort. One hundred percent of patients who participated said that they would recommend ABUS to a friend. These data suggest that if ABUS is proven to be a valuable adjunctive screening test for breast cancer among women with dense breast tissue, its routine use will be well tolerated by patients.

Randomised clinical trials: linaclotide phase 3 studies in IBS‐C – a prespecified further analysis based on European Medicines Agency‐specified endpoints

Treatment options that improve overall symptoms of irritable bowel syndrome with constipation (IBS-C) are lacking. A prespecified further analysis to evaluate the efficacy and safety of linaclotide, a guanylate cyclase C agonist, in patients with IBS-C, based on efficacy parameters prespecified for European Medicines Agency (EMA) submission. Two randomised, double-blind, multicentre Phase 3 trials investigated once-daily linaclotide (290 μg) for 12 weeks (Trial 31) or 26 weeks (Trial 302) in patients with IBS-C. Prespecified primary endpoints were the EMA-recommended co-primary endpoints: (i) 12-week abdominal pain/discomfort responders [≥30% reduction in mean abdominal pain and/or discomfort score (11-point scales), with neither worsening from baseline, for ≥6 weeks] and (ii) 12-week IBS degree-of-relief responders (symptoms 'considerably' or 'completely' relieved for ≥6 weeks). Overall, 803 (Trial 31) and 805 patients (Trial 302) were randomised. A significantly greater proportion of linaclotide-treated vs. placebo-treated patients were 12-week abdominal pain/discomfort responders (Trial 31: 54.8% vs. 41.8%; Trial 302: 54.1% vs. 38.5%; P < 0.001) and IBS degree-of-relief responders (Trial 31: 37.0% vs. 18.5%; Trial 302: 39.4% vs. 16.6%; P < 0.0001). Similarly, significantly more linaclotide- vs. placebo-treated patients were responders for ≥13 weeks in Trial 302 (abdominal pain/discomfort: 53.6% vs. 36.0%; IBS degree-of-relief: 37.2% vs. 16.9%; P < 0.0001). The proportion of sustained responders (co-primary endpoint responders plus responders for ≥2 of the last 4 weeks of treatment) was also significantly greater with linaclotide vs. placebo in both trials (P < 0.001). Linaclotide treatment significantly improved abdominal pain/discomfort and degree-of-relief of IBS-C symptoms compared with placebo over 12 and 26 weeks. ClinicalTrials.gov (identifiers: NCT00948818 and NCT00938717).

The Water-Aided Method in Routine Unsedated Colonoscopy: A Randomized Controlled Trial (RCT) in Diagnostic Cases in Indonesian Patients: Presidential Poster

Purpose: Background: A proof-of-principle randomized controlled trial by a U.S. colonoscopist with limited experience in scheduled unsedated colonoscopy showed that the water-aided method (water exchange) produced significant patient-centered benefits (significantly reduced discomfort score and increased willingness to repeat) at the expense of prolonged procedural times (GIE 2010;72:693-700). To determine if a colonoscopist experienced in scheduled unsedated colonoscopy in Indonesia can reproduce the beneficial effects without negative procedural outcomes. Methods: Design: Prospective, RCT (NCT01341847). Settings: Single center, in and outpatients of Sardjito General Hospital. Patients: 110 consecutive symptomatic patients meeting inclusion criteria. Single Colonoscopist: With experience in performing over 700 scheduled unsedated colonoscopy. Interventions: In the water-aided study method group (combining water immersion and water exchange) the air pump was turned off; water at room temperature was infused to aid colonoscope advancement; residual colonic air was bypassed and infused water was removed by suction predominantly during withdrawal (water immersion). When blurred viewed was encountered dirty water was removed by suction and clean water was infused to clear the view (water exchange). In the air control method group air insufflation was used during insertion. Main Outcome Measurements: The discomfort during insertion (primary outcome) was scored by the patient (visual analog scale: 0=none, 10=most severe) shortly after completion of colonoscopy. Secondary outcomes included patient and procedural measures. Results: 53 and 57 patients were randomized to the study or control method, respectively. Water-aided vs air method comparisons revealed: mean discomfort score (±SD), 4.1±2.6 vs 6.4±2.4 (p<0.001, t-test); willingness to repeat, 83.7% vs 62.7% (p=0.024, Fisher's exact test); cecal intubation time 11.9±5.5 vs 12.9±7.1 minutes (p=0.38); cecal intubation rate, 92.4% vs 89.5% (p=0.74). Discomfort score was not correlated with duration of examination. Limitations: Unblinded study. Conclusion: Water immersion combined with suction of feces obscuring the view replicated patient-centered benefits (significant reduction of discomfort and increase in willingness to repeat) of water-aided method in Indonesian patients. Extensive experience in scheduled unsedated colonoscopy obviated adverse impacts on colonoscopist-centered procedural outcomes (cecal intubation time and rate). Whether full water exchange by adding suction removal of residual air and aspiration of the infused water predominantly during insertion will further enhance these benefits among Indonesian patients remain to be determined.Table 1: Demographic variablesTable 2: Primary and secondary outcomes