A Pilot Randomized Controlled Trial of an Intervention to Promote Psychological Well-Being in Critically Ill Children: Soothing Through Touch, Reading, and Music

Objectives: To examine the feasibility and acceptability of a PICU Soothing intervention using touch, reading, and music. Design: Nonblinded, pilot randomized controlled trial. Setting: The PICU and medical-surgical wards of one Canadian pediatric hospital. Patients: Twenty PICU patients age 2–14 years old and their parents, randomized to an intervention group (n = 10) or control group (n = 10). Intervention: PICU Soothing consisted of: 1) parental comforting (touch and reading), followed by 2) a quiet period with music via soft headbands, administered once daily throughout hospitalization. Measurements and Main Results: Acceptability and feasibility of the intervention and methods were assessed via participation rates, observation, measurement completion rates, semistructured interviews, and telephone calls. Psychological well-being was assessed using measures of distress, sleep, and child and parent anxiety in the PICU, on the wards and 3 months post discharge. Forty-four percent of parents agreed to participate. Seventy percent and 100% of intervention group parents responded positively to comforting and music, respectively. Most intervention group parents (70%) and all nurses felt children responded positively. All nurses found the intervention acceptable and feasible. Measurement completion rates ranged from 70% to 100%. Pilot data suggested lower intervention group child and parent anxiety after transfer to hospital wards. Conclusions: PICU Soothing is acceptable and feasible to conduct. Results support the implementation of a full-scale randomized controlled trial to evaluate intervention effectiveness. ClinicalTrials.gov Identifier: NCT01176188; Unique Protocol identifier: 09-069-PED. This research was funded by the Quebec Interuniversity Nursing Intervention Research Group (GRIISIQ; now the Quebec Nursing Intervention Research Network [RRISIQ]), and the Canadian Nurses Foundation. Dr. Rennick holds a Fonds de recherche du Québec – Santé (FRQ-S) Clinical Research Scholar Award. During the study, Dr. Stremler held a Canadian Institutes of Health Research (CIHR) New Investigator Award and an Ontario Ministry of Research and Innovation Early Researcher Award. Dr. Aita held a CIHR RCT Mentoring Program Award; and Dr. Constantin held an FRQ-S Clinical Scholar Award. Drs. Rennick, Constantin, and Majnemer are members of the Research Institute of the McGill University Health Centre, which is funded by the FRQ-S. The authors have disclosed that they do not have any potential conflicts of interest. For information regarding this article, E-mail: janet.rennick@muhc.mcgill.ca ©2018The Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies

from Emergency Medicine via xlomafota13 on Inoreader https://ift.tt/2qu7iAf