Full-scale Randomized Controlled Trial Research Articles

ABSTRACT 24

Background and aims: Approximately 25% of children demonstrate negative psychological outcomes following pediatric intensive care unit (PICU) hospitalization, yet few interventions target those outcomes. Aims: This pilot randomized controlled trial (RCT) tested the feasibility and acceptability of a nursing-directed intervention promoting child comfort and psychological well-being associated with PICU hospitalization. Methods: Children aged 2 to 14 years admitted to PICU were randomized to intervention (IG: n=10) or control (CG: n=10) groups following Institutional Review Board approval. The comfort intervention consisted of: (1) parental soothing (touch and reading), and (2) earmuff application with music to reduce auditory stimulation. Comfort was assessed: (a) in PICU (Comfort scale, pain, sleep diaries), (b) on the wards (sleep actigraphy), and (c) 3 months post-discharge (anxiety, distress, sleep actigraphy). Intervention and methodological acceptability and feasibility were assessed via observation, measurement completion rates, semi-structured interviews, and telephone calls. Results: The intervention was acceptable to 100% of nurses. While 49% of parents approached agreed to participate, 70% and 100% of IG parents responded positively to the intervention’s soothing and music components, respectively. Most IG parents (70%) and all nurses felt children responded positively to the intervention; all nurses felt it was feasible. Measurement response rates ranged from 85% to 100%. Pilot data suggest lower IG child anxiety scores, better sleep quality on wards and at home, and larger decreases in IG parent anxiety onwards. Conclusions: Methods: were acceptable and feasible, and children responded positively to the intervention. Results: support the development of a full-scale RCT to evaluate the effectiveness of the comfort intervention.

Multimodal group rehabilitation compared to usual care for patients with chronic neck pain: A pilot study

The aim of this pilot randomised controlled trial (RCT) was to compare multimodal group rehabilitation to usual care physiotherapy for patients with chronic neck pain (CNP). Participants ( n = 14) were randomly assigned to one of two interventions, multimodal group rehabilitation or usual care physiotherapy. Multimodal group rehabilitation involved stability, strengthening and proprioceptive exercises along with an educational programme. Patients attended for 1 h, once a week for six weeks. The usual care group was treated as deemed appropriate by their physiotherapist. A blinded assessor recorded baseline and post-intervention scores of disability and pain using the neck disability index (NDI) and the 0–10 pain numerical rating scale (NRS), respectively. One participant from each group dropped out before receiving any intervention. Post-intervention both groups significantly improved in both function and pain scores ( p ≤ 0.01). The mean change in the NDI scores for the multimodal group versus the usual care group were 12.3 ± 5.3% and 7.4 ± 4.8%, and pain NRS score changes were 4.6 ± 2.3 and 4.5 ± 2.2, respectively. There was no significant difference in improvements in disability ( p = 0.84) or pain ( p = 0.67) between groups. These results warrant further investigation of multimodal group rehabilitation for CNP, and provide data to inform an appropriately powered full-scale RCT with long-term follow-up.

Pilot Randomized Controlled Trial of Interpersonal Counseling for Subsyndromal Depression Following Miscarriage

Miscarriage, which occurs in 10% to 20% of clinically recognized pregnancies, is associated with an increased risk for subsyndromal depression. We examined whether Interpersonal Counseling (IPC) was superior to treatment as usual (TAU) in reducing subsyndromal depression among miscarrying women and, secondarily, superior to TAU in improving role functioning. Nineteen of 20 eligible women participated in a randomized controlled trial of 1 to 6 weekly telephone sessions of IPC versus TAU, which consisted of whatever lay counseling or professional care women sought on their own initiative, from October 2001 to April 2002. The 2 trial arms were compared on mean within-subject change in Hamilton Rating Scale for Depression-17-item (HAM-D-17) scores and in role functioning scale scores (a 5-item modification of the 36-item Medical Outcomes Study questionnaire) from baseline to post-intervention. In the primary intent-to-treat analysis, the baseline mean HAM-D-17 scores were 18.0 (SD +/- 8.4) and 14.8 (SD +/- 6.6) in the IPC (N = 10) and TAU (N = 9) arms, respectively; post-intervention, the corresponding means were 11.6 (SD +/- 8.2) and 12.9 (SD +/- 8.3). The mean within-subject decline in HAM-D-17 scores was significantly greater in the IPC (6.4) than in the TAU (1.9) arm (difference in mean within-subject score decline, adjusted for design features, baseline HAM-D-17 scores and for baseline ethnic imbalance between study arms, 6.2 [95% CI = 0.4 to 12.0]). In a subordinate completers' analysis (N = 15), the corresponding mean decline and difference in adjusted mean decline were 8.0, 2.4, and 6.7 (95% CI = 0.4 to 13.1), respectively. Treatment was unrelated to improved role functioning. The efficacy of telephone-administered IPC for subsyndromal depression after miscarriage warrants testing in a full-scale randomized controlled trial.