Patient Self-evaluation Research Articles

Patient self-evaluation of side-effects related to adjuvant chemotherapy in breast cancer: A prospective study.

9606 Background: There is a growing interest in patient-reported outcomes (PRO) in cancer treatment. We evaluated a Common-toxicity criteria (CTC) v4.02-based, self-administered questionnaire to co...

Multidimensional Analysis on the Effect of Vocal Function Exercises on Aged Vocal Fold Atrophy

Age-related voice change is characterized as weak, harsh, and breathy. These changes are caused by histologic alteration of the lamina propria of the vocal fold mucosa as well as atrophy of the thyroarytenoid muscle. Several therapeutic strategies involving laryngeal framework surgery and injection laryngoplasty have been tried, but effects have been limited. Vocal function exercises (VFE) have been used to treat age-related vocal fold atrophy although the effectiveness has been shown with limited analysis. The present study aims to determine the effectiveness of VFE for the treatment of aged atrophy using multidimensional analysis. This is a retrospective study. Sixteen patients with vocal fold atrophy aged 65-81 years underwent voice therapy using VFE. Six patients with vocal fold atrophy aged 65-85 years were involved as a historical control group. The grade, roughness, breathiness, asthenia, strain (GRBAS) scale, stroboscopic examinations, aerodynamic assessment, acoustic analysis, and Voice Handicap Index-10 (VHI-10) were performed before and after VFE. Normalized mucosal wave amplitude (NMWA), normalized glottal gap (NGG), and bowing index (BI) were measured by image analysis during stroboscopic examinations. After VFE, significant improvements were shown in GRBAS, maximum phonation time, jitter, NMWA, NGG, and VHI-10 although BI has not changed significantly. There were no significant improvements in the historical control. The data suggest that VFE produces significant improvement in subjective, objective, and patient self-evaluation and deserves further attention as a treatment for aged atrophy of the vocal fold. It was also suggested that VFE does not improve the vocal fold bowing but may improve muscular function during voicing.

Autobiographical memory and electroconvulsive therapy: do not throw out the baby.

Retrograde amnesia for autobiographical information is the most critical adverse effect of electroconvulsive therapy (ECT). Much, if not most, modern research demonstrating long-term autobiographical amnesia after ECT has used either the Columbia University Autobiographical Memory Interview (CUAMI) or the short form of this scale (CUAMI-SF). Semkovska and McLoughlin claimed that studies using these instruments should be dismissed and the findings ignored owing to a lack of normative data, as well as concerns about the reliability and validity of these instruments. In this commentary, the development and use of these scales is reviewed. It is shown that Semkovska and McLoughlin's critique is factually incorrect, as normative data were simultaneously collected in virtually all studies using these instruments. Furthermore, there is substantial evidence supporting the reliability and validity of these scales. Indeed, these instruments are the only neuropsychological tests repeatedly shown to covary with patient self-evaluations of ECT's effects on memory and have repeatedly demonstrated long-term differences in the magnitude of amnesia as a function of ECT technique. Findings with the CUAMI and CUAMI-SF provide key evidence regarding ECT's adverse cognitive effect profile. It is inaccurate and inadvisable to continue to deny that ECT can exert long-term adverse effects in this domain.

SAT0380 Do Patients Know Best? Reliability of Electronic Patient Self-Evaluation of Swollen and Tender Joints in Psoriatic Arthritis: A Comparison Study with B-Mode Ultrasonography, Physician and Nurse Assessments

Background68 tender (TJC) and 66 swollen joint counts (SJC) are recommended for disease activity assessment in psoriatic arthritis (PsA). However there are time constraints and these counts may not be...

Results of the treatment of the open femoral shaft fractures in children

BackgroundIntramedullary nailing has become the treatment of choice for closed femoral shaft fractures in children and adolescents. Immediate intramedullary nailing of open fractures of femur in children remains controversial, with most surgeons preferring to treat grade II or III open fractures either by debridement and traction or external fixation. The aimsThe aim of this study is to evaluate the results of intramedullary nailing of open femoral fractures in children. Methods172 children were treated for femoral shaft fracture in our department. 19 fractures were opened in 18 patients. ResultsIn children with polytrauma, multiple fractures, head injuries and other conditions which necessitate intensive nursing care, intramedullary nailing of opens femoral shaft fractures (type I, II, IIIA, IIIB) should be preferred. ConclusionSatisfactory results were obtained in all patients in terms of self evaluation of patients, radiological and clinical evaluation. The infection rate was much lower for patients who had been given a cephalosporin than for patient who had been given a penicillin or had been given no antibiotic.

Functional Health Status in Oropharyngeal Dysphagia

Patient self-evaluations on Functional Health Status (FHS) questionnaires are considered to be part of the assessment of oropharyngeal dysphagia. FHS questionnaires capture the unique personal perception of someone’s health, taking into account social, functional and psychological factors. Many FHS questionnaires have been reported on in literature. This paper describes a selection of FHS questionnaires in more detail; issues concerning the inclusion of Health Related Quality of Life (HRQOL) items, choices in target populations and the distinction between oropharyngeal versus esophageal dysphagia will be discussed. Recommendations are made about the evaluation and use of FHS questionnaires in daily clinical practice. In particular the psychometric properties of FHS questionnaires should be evaluated to determine if they meet quality criteria for measurement properties of health status questionnaires in order to guarantee valid and reliable outcome measurements.

Combination ALA‐PDT and ablative fractional Er:YAG laser (2,940 nm) on the treatment of severe acne

Scarring is a very common complication of severe acne and is difficult to treat by conventional methods. 5-Aminolevulinic acid (ALA) photodynamic therapy (PDT) is a novel treatment for improving acne lesions. Fractional laser resurfacing is a promising treatment for scar treatment because of its unique ability to stimulate the wound healing response and its depth of penetration. To evaluate the efficacy of combination therapies of ALA-PDT and ablative fractional Er:YAG laser (2,940 nm) for scarring lesions in severe acne patients. A prospective, single-arm, pilot study. Forty subjects with severe acne were treated with 15% ALA-PDT for four times at 10-day intervals. They then received ablative fractional Er:YAG laser treatment five times at 4-week intervals. Three independent investigators evaluated subject outcomes at 1, 3, 6, and 12 months post-treatment (primary outcome); patients also provided self-assessments of improvement (secondary outcome). Significant reductions in acne score (P < 0.01) were obtained at follow-up visits after 1, 3, 6, and 12 months. After 6 month, the lesions showed overall improvement in all of subjects (good to excellent in acne inflammatory lesions), 80% overall improvement in acne scars. After 12 months, most of subjects had improved hypertrophic/atrophic scars (good to excellent in 85%) and no one had recurrent acne inflammatory lesions. Patient self-evaluation also revealed good to excellent improvements (on average) in acne lesions and scarring, with significant improvements in self-esteem after 6 months post-treatment. PDT can control the inflammation and improve the severity of acne lesions. Fractional resurfacing is a promising new treatment modality for scars by stimulating wound healing and remodeling. The combination therapy is a promising option for severe acne to prevent and improve car formation.

Body self-evaluation and physical scars in patients with borderline personality disorder: an observational study.

BackgroundData from general psychology suggest that body self-evaluation is linked to self-esteem and social emotions. Although these emotions are fragile in individuals with borderline personality disorder (BPD), body self-evaluation is clearly understudied in BPD research.MethodsA total of 200 women took part in the study: 80 female BPD patients, and 47 healthy and 73 clinical controls including post-traumatic stress disorder (PTSD) after childhood sexual abuse (CSA). Diagnoses were established through standardised interviews conducted by experienced psychologists. The participants used the Survey of Body Areas to indicate which areas of their own bodies they liked or disliked and to mark the locations of physical scars.ResultsCompared to healthy controls, both BPD patients and patients with PTSD after CSA had a predominantly negative body self-evaluation (Cohen’s d = 1.42 and 1.38, respectively). As indicated by multilevel analyses, scars were related to a negative evaluation of the affected areas in BPD patients, but not in the control groups. Subgroup analyses revealed that the negative body self-evaluation applies to both BPD patients with and without PTSD or reported CSA.ConclusionsBPD patients show a negative body self-evaluation which is associated with the presence of scars but not with CSA.

EPA-0083 - Psychotic symptoms are linked to movement patterns

Disordered communication is a core problem in schizophrenia patients' everyday functioning. Our research group has worked on measures of nonverbal behavior that can be used to evaluate social interaction. We conducted projects with this embodiment background addressing nonverbal behavior in role plays with schizophrenia patients (378 role-play scenes involving 27 outpatients), in actigraphic data (100 schizophrenia spectrum patients), and also in psychotherapy sessions and healthy dyads in conversation. In schizophrenia research, we found that the amount of movement during social interaction and the structure of actigraphic timeseries of patients' everyday behavior were linked to symptom profiles of patients. In healthy dyads, synchrony was related to interaction type and predicted the affective pleasantness of conversations. In psychotherapy, relationship quality was embodied in nonverbal synchrony between therapist and patient. This suggested that beyond the mere amount of movement, the degree of synchrony between patients and others varies with patients' symptoms and social cognition. Nonverbal synchrony was assessed objectively using a video-based algorithm (Motion Energy Analysis, MEA) developed in our group. In schizophrenia, lower nonverbal synchrony was associated with symptoms (negative symptoms, conceptual disorganization, lack of insight), patients' verbal memory and self-evaluation of competence. Results suggested that synchrony is an objective and sensitive indicator of the severity of patients' problems. Social synchronization is viewed as an important, usually unconscious, capacity that regulates social interaction and expresses the satisfaction with social exchange. Its analysis provides insights in the relationships between symptoms and social cognition and offers promising targets for psychotherapeutic interventions.

Me, myself and I: temporal dysfunctions during self-evaluation in patients with schizophrenia

Self-concept is deeply affected in schizophrenia. Positive symptoms in particular are related to disturbed self/other distinctions. The neural networks underlying self-evaluation in schizophrenia have barely been investigated. The study reported here involved 13 patients with schizophrenia and 13 matched controls. During functional MRI, participants decided in three conditions whether the presented positive and negative personality traits characterized themselves, an intimate person, or included a certain letter. Based on the responses, each experimental condition was designed using a flexible factorial model. Controls and patients showed a similar behavioral pattern during self-evaluation, with group comparison revealing decreased activation in patients in the left inferior temporal gyrus and both temporal poles during self-ascription of traits, and in the anterior medial prefrontal cortex during evaluation of an intimate person. In patients, positive symptoms correlated positively with brain activation in the left parahippocampus during trait self-ascription. Hence, while evaluating themselves, schizophrenia patients revealed decreased activation in areas related to self-awareness overlapping with networks involved in theory of mind, empathy and social knowledge. Moreover, patients' brain activation during self-reflection was affected by the current positive symptomatology. The close interaction between self and other highlights the clinical and social relevance of self-processing deficits in schizophrenia.

The Efficacy of Combined Herbal Extracts Gel in Reducing Scar Development at a Split-Thickness Skin Graft Donor Site

The aim of this study was to evaluate the efficacy of combined herbal extracts in a gel preparation (Cybele(®) Scagel) in reducing scar development at a split-thickness skin graft donor site. A prospective, randomized, double-blind control study was performed to evaluate the efficacy of Scagel in 15 patients who underwent a split-thickness skin graft operation. Both Scagel and placebo were applied equally to the donor site within 1month after complete epithelialization. Scar assessments using the Vancouver Scar Scale (VSS) and patient self-evaluation were taken at 2, 4, 8, and 12weeks. Of the 15 patients, 10 were enrolled and evaluated in this study. There was no significant difference in each parameter of the VSS. The total VSS was significantly lower in the Scagel group compared to the placebo group after 4weeks (p=0.003, 0.003, and <0.001 at 4, 8, and 12weeks, respectively). The patient satisfaction score in the Cybele(®) Scagel group was significantly higher (p=0.002) at the 12-week evaluation. Application of combined herbal extracts in gel preparation might reduce scar development at split-thickness skin graft donor sites. There was a positive trend in the reduction of postinflammatory hyperpigmentation. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Tracking the implicit self using event-related potentials

Negative biases in implicit self-evaluation are thought to be detrimental to subjective well-being and have been linked to various psychological disorders, including depression. An understanding of the neural processes underlying implicit self-evaluation in healthy subjects could provide a basis for the investigation of negative biases in depressed patients, the development of differential psychotherapeutic interventions, and the estimation of relapse risk in remitted patients. We thus studied the brain processes linked to implicit self-evaluation in 25 healthy subjects using event-related potential (ERP) recording during a self-relevant Implicit Association Test (sIAT). Consistent with a positive implicit self-evaluation in healthy subjects, they responded significantly faster to the congruent (self-positive mapping) than to the incongruent sIAT condition (self-negative mapping). Our main finding was a topographical ERP difference in a time window between 600 and 700 ms, whereas no significant differences between congruent and incongruent conditions were observed in earlier time windows. This suggests that biases in implicit self-evaluation are reflected only indirectly, in the additional recruitment of control processes needed to override the positive implicit self-evaluation of healthy subjects in the incongruent sIAT condition. Brain activations linked to these control processes can thus serve as an indirect measure for estimating biases in implicit self-evaluation. The sIAT paradigm, combined with ERP, could therefore permit the tracking of the neural processes underlying implicit self-evaluation in depressed patients during psychotherapy.

Voice and Speech Changes in Various Phases of Menstrual Cycle

The reproductive system in females undergoes a regular cyclic change known as the menstrual cycle. Laryngeal changes are evident and fluctuate systematically during the reproductive years with the menstrual cycle. The impact of estrogens in concert with progesterone produces the characteristics of the female voice, with a fundamental frequency (F(0)) higher than that of male. To characterize changes in voice and speech in adolescent females in different phases of the menstrual cycle--during menstruation, after menstruation, mid-menstrual cycle, and premenstruation. Sixteen adult females who were nonusers of oral contraceptives participated in a cross-sectional study of menstrual cycle influences on voicing and speaking tasks. Acoustic analysis (F(0), intensity, perturbation measurements [jitter and shimmer], and harmonic-to-noise ratio), maximum phonation time (MPT), s/z ratio, and perceptual assessments (grade [G], roughness [R], breathiness [B], asthenia [A], and strain [S] [GRBAS] and Voice Handicap Index-10 [VHI-10]) scales were performed during all phases. None of the acoustic analysis parameters and MPT and s/z ratio measurements revealed statistically significant difference (P > 0.05). Perceptual voice assessment scales either clinician based or patients self-evaluated showed significant differences among phases (P < 0.05). The objective voice analysis methods, such as acoustic analysis, MPT, and s/z ratio, determined no difference; however, the subjective voice analysis methods, such as clinician-based perceptual assessment (GRBAS) and patients self-evaluation (VHI-10) scales, demonstrated significant changes during different phases of menstrual cycle.

Predetermined Energy Delivery as an Endpoint for Radiofrequency Skin Tightening

Introduction: Clinicians have been advised to perform radiofrequency (RF) skin tightening by observing subjective parameters such as the number of passes or superficial edema or tissue elevation to determine endpoints in treatment. Common to these techniques is the difficulty in reproducing the endpoint and the lack of consistency both during treatment and with subsequent treatments. This study was initiated to investigate whether total delivered energy to a given cosmetic unit is a reliable parameter for reproducing treatments in the same individual and whether it could be used as a parameter to predict results. Materials and Methods: Five patients who desired skin tightening of cosmetic units involving the face and body were treated with a novel RF delivery device in which the endpoint of treatment was predetermined at a given energy level measured in kilojoules. At the end of 5 treatments, a comparison of treatment endpoints and patient self-evaluation, as well as evaluation of photographic results by a nontreating physician were correlated. Results: Using a preselected delivery of total energy per cosmetic unit, 5 patients received a total of 5 treatment sessions each. When clinical results did not meet expectations, the total energy levels were increased at the next treatment session. All patients reported relative comfort during the treatments. No topical or regional anesthesia was used. Patient satisfaction was reported at 80%. Patients evaluated their own outcomes at slightly less than 50% improvement, and a nontreating physician evaluated outcome based on clinical photography at 50%. Conclusions: A system of quantitation for the delivery of RF to promote skin tightening is presented. Predetermined energy delivery is a reproducible variable with which to compare subsequent treatments as well as a method for adjusting RF delivery in subsequent treatment sessions in an attempt to produce optimal results. Patient impressions as well as evaluation by a nontreating physician were recorded and found to be in agreement concerning the efficacy of treatment.

High Prevalence and Impact on the Quality of Life of Facial Lipoatrophy and Other Abnormalities in Fat Tissue Distribution in HIV-Infected Patients Treated with Antiretroviral Therapy

Few data report the prevalence in actual clinical settings of lipodystrophy (LD), and in particular of facial lipoatrophy (LA), in HIV-infected patients treated with long-term antiretroviral therapy (ART). A French, multicenter, cross-sectional, observational study was conducted in HIV-infected patients on continuous ART for more than 12 months. The main objective was to assess the prevalence of facial LA in this population. Additional objectives were to make the same assessments for nonfacial LA and lipohypertrophy. The presence of LD signs, type, and severity was assessed by clinicians and compared with patient self-evaluations through two questionnaires. A total of 2,131 assessable patients had a median age of 46 years and a median time on ART of 10 years. Physicians diagnosed facial LA in 54% of patients and these subjects had received ART for a longer duration than those without LA. Thymidine analog usage was associated with an increased likelihood of facial LA, but 28% of patients recently treatment-initiated (1-5 years) were also affected. At other sites, LA and lipohypertrophy were diagnosed in 59% and 57% of cases, respectively. The concordance between physician and patient assessments was good for facial and buttocks LA. In this study, facial LA affects more than half of the subjects and is frequent even among the most recently treated patients. The prevalence of facial LA significantly increases with the duration of ART, with male gender, hepatitis C virus (HCV) coinfection, and non-African origin being independent risk factors. Lipohypertrophy is frequent and appears early after ART initiation.

Development of a nursing model for life adjustment in patients with lung cancer inJapan

The aim of this study was to obtain basic data about the support for life adjustment in lung cancer patients in Japan. We identified factors that affect life adjustment in people with lung cancer, developed a model for life adjustment support of lung cancer patients, and investigated its validity. A survey was conducted using self-completed questionnaires, and responses were received by 203 individuals. Analysis of the responses revealed that life adjustment was regulated by six factors associated with positive self-evaluation: stress dissipation, fighting spirit, helplessness/hopelessness, full discussion with doctor about treatment, clarity of thought, and support network size. A model search with covariance structure analysis was conducted. The resulting model was revealed to have a goodness-of-fit index of 0.963, an adjusted goodness-of-fit index of 0.930, a comparative fit index of 0.974, and a root mean square error of approximation of 0.040. The findings suggest that improvements in quality of life can be expected by combining a positive self-evaluation in lung cancer patients and interventions to raise self-adjustment ability with the use of this Model, although it requires further testing.

Can treatment with Cocculine improve the control of chemotherapy-induced emesis in early breast cancer patients? A randomized, multi-centered, double-blind, placebo-controlled Phase III trial

BackgroundChemotherapy induced nausea and vomiting (CINV) remains a major problem that seriously impairs the quality of life (QoL) in cancer patients receiving chemotherapy regimens. Complementary medicines, including homeopathy, are used by many patients with cancer, usually alongside with conventional treatment. A randomized, placebo-controlled Phase III study was conducted to evaluate the efficacy of a complex homeopathic medicine, Cocculine, in the control of CINV in non-metastatic breast cancer patients treated by standard chemotherapy regimens.MethodsChemotherapy-naïve patients with non-metastatic breast cancer scheduled to receive 6 cycles of chemotherapy including at least three initial cycles of FAC 50, FEC 100 or TAC were randomized to receive standard anti-emetic treatment plus either a complex homeopathic remedy (Cocculine, registered in France for treatment of nausea and travel sickness) or the matching placebo (NCT00409071 clinicaltrials.gov). The primary endpoint was nausea score measured after the 1st chemotherapy course using the FLIE questionnaire (Functional Living Index for Emesis) with 5-day recall. Secondary endpoints were: vomiting measured by the FLIE score, nausea and vomiting measured by patient self-evaluation (EVA) and investigator recording (NCI-CTC AE V3.0) and treatment compliance.ResultsFrom September 2005 to January 2008, 431 patients were randomized: 214 to Cocculine (C) and 217 to placebo (P). Patient characteristics were well-balanced between the 2 arms. Overall, compliance to study treatments was excellent and similar between the 2 arms. A total of 205 patients (50.9%; 103 patients in the placebo and 102 in the homeopathy arms) had nausea FLIE scores > 6 indicative of no impact of nausea on quality of life during the 1st chemotherapy course. There was no difference between the 2 arms when primary endpoint analysis was performed by chemotherapy stratum; or in the subgroup of patients with susceptibility to nausea and vomiting before inclusion. In addition, nausea, vomiting and global emesis FLIE scores were not statistically different at any time between the two study arms. The frequencies of severe (Grade ≥ 2) nausea and vomiting were low in our study (nausea: P: 17.6% vs C: 15.7%, p=0.62; vomiting: P: 10.8% vs C: 12.0%, p=0.72 during the first course).ConclusionThis double-blinded, placebo-controlled, randomised Phase III study showed that adding a complex homeopathic medicine (Cocculine) to standard anti-emetic prophylaxis does not improve the control of CINV in early breast cancer patients.

Noncompliance with glaucoma medication in Korean patients: a multicenter qualitative study

To investigate the common side effects of topical antiglaucoma medication, factors affecting compliance, and the utilization of herbal medicine for glaucoma treatment in South Korea. A cross-sectional multicenter hospital-based study. In-depth interviews using a structured questionnaire were conducted with 581 individuals diagnosed with glaucoma. Additional eligibility requirements were: all participants were diagnosed with glaucoma in one or both eyes and prescribed eye drops at least one month before the start of the study, and were in a suitable condition for an interview. The frequency of response for each category in the interview questionnaire was analyzed. Conjunctival injection, a stinging sensation, and blurred vision were the most frequently reported side effects, among which blurred vision was the most unbearable. Patient knowledge of glaucoma was the only factor associated with the patient's self-evaluation of compliance. Forgetfulness was the most common reason for nonadherence. Only 2.9 % of patients were taking herbal medicine. Physicians should address a patient's complaint of blurred vision resulting from medication. Complete initial explanation of the consequences of nonadherence and of the potential vision loss from glaucoma are critical elements in improving patient adherence in Asian populations.

Assessing Relapses and Response to Relapse Treatment in Patients with Multiple Sclerosis

There are currently no assessment tools that focus on evaluating patients with multiple sclerosis (MS) who are experiencing a relapse or that evaluate patients' response to acute relapse treatment. In practice, assessments are often subjective, potentially resulting in overlooked symptoms, unaddressed patient concerns, unnoticed or underrecognized side effects of therapies (both disease modifying and symptomatic), and suboptimal therapeutic response. Systematic evaluation of specific symptoms and potential side effects can minimize the likelihood of overlooking important information. However, given the number of potential symptoms and adverse events that patients may experience, an exhaustive evaluation can be time-consuming. Clinicians are thus challenged to balance thoroughness with brevity. A need exists for a brief but comprehensive objective assessment tool that can be used in practice to 1) help clinicians assess patients when they present with symptoms of a relapse, and 2) evaluate outcomes of acute management. A working group of expert nurses convened to discuss recognition and management of relapses. In this article, we review data related to recognition and management of relapses, discuss practical challenges, and describe the development of an assessment questionnaire that evaluates relapse symptoms, the impact of symptoms on the patient, and the effectiveness and tolerability of acute treatment. The questionnaire is designed to be appropriate for use in MS specialty clinics, general neurology practices, or other practice settings and can be administered by nurses, physicians, other clinicians, or patients (self-evaluation). The relapse assessment questionnaire is currently being piloted in a number of practice settings.

Acute Pain Therapy in Postanesthesia Care Unit Directed by Skin Conductance: A Randomized Controlled Trial

BackgroundAfter surgery, effective and well-directed acute pain therapy is a necessary and integral part of the overall treatment plan. Generally, the assessment of pain intensity depends on a patient’s self-evaluation using scoring systems such as numeric rating scales (NRS, 0 to 10). Recently, a “Pain Monitor” was commercially provided which is based on measurements of fluctuations of skin conductance (NFSC). In this randomized, controlled, single-blind trial, possible benefits of this certain device were studied.MethodsPostoperative patients (n = 44) were randomly assigned to a test or a control group during their stay in the postanesthesia care unit (PACU). All patients were treated and monitored according to internal hospital standards. Whereas all patients systematically evaluated their pain each 15 min, test group patients were additionally addressed when NFSC exceeded a predefined level. In cases of NRS≥5 during a routine elevation or in between, pain relief was achieved by standard procedures irrespective of group allocation.ResultsDuring their stay in PACU, both test and control groups experienced a significant decrease in NRS as a consequence of pain therapy. No significant differences in mean NRS or in NFSC values were found between the test and control groups. No correlation was observed between NRS and NFSC.ConclusionPostoperative patients experience diverse stressors, such as anxiety, disorientation, shivering, sickness and pain. Although the application of continuous pain monitoring would be meaningful in this clinical setting, the tested device failed to distinguish pain from other stressors in postoperative adult patients.Trial RegistrationGerman Clinical Trials Register DRKS00000755.