Effect of maternal voice on sleep quality in children following cardiac surgery: protocol for a randomized controlled trial
Abstract
Background Children with congenital heart disease (CHD) frequently experience postoperative sleep disturbances, which can adversely affect recovery and overall postoperative outcomes. Maternal voice has been suggested as a soothing auditory stimulus with the potential to improve sleep quality in children. This study aims to evaluate the effect of auditory intervention centered on the maternal voice on sleep quality in children undergoing cardiac surgery. Methods This prospective, randomized controlled trial will enroll 132 children with CHD undergoing open-heart surgery. Participants will be randomly assigned to either the control group or the maternal voice–based intervention group. The primary outcome is the overall sleep efficiency across the night of surgery, postoperative Day 1, and postoperative Day 2. Secondary outcomes include additional sleep parameters, pain scores, sedation scores, delirium scores, B-type natriuretic peptide (BNP) levels, cardiac troponin I (cTnI) levels, dosages of dexmedetomidine and sufentanil, cardiac intensive care unit (CICU) length of stay, total hospital length of stay, and parental satisfaction. Discussion This trial aims to provide high-quality evidence on maternal voice to improve postoperative sleep quality in children with CHD. Trial registration numbers Chinese Clinical Trial Registry (https://www.chictr.org.cn) ChiCTR2500111004.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 132 participants or records.
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