Maternal voice intervention effects on sleep in children with congenital heart disease undergoing open-heart surgery remain unreported in this protocol.
Photo by Elisha Oyeleru / Unsplash
Key Takeaway
Note that primary results and safety data for this maternal voice intervention protocol are not yet reported.
The study design is a randomized controlled trial protocol focusing on children with congenital heart disease scheduled for open-heart surgery. The intervention involves a maternal voice-based auditory stimulus, while the comparator is a standard control group. The primary outcome measures overall sleep efficiency during the night of surgery, postoperative Day 1, and postoperative Day 2. Secondary outcomes include additional sleep parameters, pain and sedation scores, delirium scores, biomarker levels (BNP, cTnI), medication dosages, length of stay in the CICU and hospital, and parental satisfaction.
The sample size is projected at 132 participants. The setting and follow-up duration are not reported in this protocol. No adverse events, serious adverse events, discontinuations, or specific tolerability data are available at this stage, as the study has not yet been conducted or reported with results. Funding sources and potential conflicts of interest are not reported.
Key limitations include the absence of reported main results, safety data, and certainty notes. Causality cannot be established from a protocol. The practice relevance remains uncertain until the trial is completed and results are published. Clinicians should interpret this document as a study plan rather than evidence of efficacy or safety.
More on Congenital Heart Disease
Feedback-regulated background infusion reduces postoperative nausea and vomiting in laparoscopic myomectomy patients.
Smart pump cuts nausea after surgery without hurting pain control
This randomized controlled trial enrolled 132 patients undergoing laparoscopic myomectomy. Feedback-regulated background infusion significan…
A new smart pain pump adjusts medicine automatically to cut nausea after surgery while keeping pain relief strong for patients who need it m…
Intranasal Dexmedetomidine Plus Midazolam Improves Sedation Success Versus Chloral Hydrate in Children
Dexmedetomidine Plus Midazolam Works Better for Kids
This randomized controlled trial enrolled 180 children aged 1–6 years undergoing outpatient procedural sedation. The dexmedetomidine plus mi…
A common sedation combo for children fails more often and causes more side effects than a better alternative most clinics already use.
Systematic review suggests dexmedetomidine may improve tolerance and reduce agitation in pediatric and adult non-invasive respiratory support.
Calm Kids Need Breathing Help
This systematic review and meta-analysis evaluates dexmedetomidine use in pediatric and adult patients receiving non-invasive respiratory su…
Imagine a child struggling to breathe. They are scared, agitated, and fighting the mask that saves their life.
Retrospective cohort study links congenital heart surgery with CPB to early postoperative cerebral desaturation events in infants.
New Tool Predicts Brain Risk in Babies After Heart Surgery
This retrospective cohort study evaluated 397 infants aged >1 month and ≤1 year undergoing elective congenital heart surgery with cardiopulm…
This new chart could help doctors spot babies at risk for brain oxygen drops after heart surgery, allowing them to act faster to protect the…
View Original Abstract ↓
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.
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.
This trial aims to provide high-quality evidence on maternal voice to improve postoperative sleep quality in children with CHD.
Chinese Clinical Trial Registry (https://www.chictr.org.cn) ChiCTR2500111004.
Evolocumab reduces cardiovascular events in diabetes without known atherosclerosis
Evolocumab cuts heart events in high-risk diabetes patients
Related in Cardiology
Cryoballoon ablation reduces PV automaticity retention compared to radiofrequency ablation in PAF
Ablation times differ but rhythm return looks the same for both methods
This RCT in 100 patients with paroxysmal atrial fibrillation undergoing initial catheter ablation found that cryoballoon ablation (CBA) resu…
Two common heart rhythm procedures show similar success rates for stopping fast beats, even though one takes longer and uses more X-ray time…
Structured Exercise Training Improves LVEF and LDL-C in HFmrEF Patients After PCI
Heart function improved more with exercise than medicine alone in stable heart disease patients
This single-center randomized trial of 120 stable CAD patients with HFmrEF (LVEF 40-49%) post-PCI found that adding a 52-week structured exe…
A 52-week program of structured exercise plus standard heart medicines helped heart function recover better than medicines alone in patients…
Vericiguat showed no significant effect on flow-mediated dilation in a small pilot trial of 26 heart failure patients.
Pilot trial shows vericiguat may lower heart failure blood pressure markers
This pilot, randomized, double-blind, placebo-controlled trial enrolled 26 patients with heart failure with reduced ejection fraction (HFrEF…
A small pilot trial found vericiguat reduced a heart failure blood pressure marker, though the study was too small to confirm this benefit.
Nurse-led care coordination fails to improve medication adherence in high-need patients
Nurse-led care coordination did not improve medication adherence for most common chronic conditions.
This pragmatic randomized controlled trial tested nurse-led care coordination versus usual care in high-need, high-cost commercially insured…
A large trial found that nurse-led care coordination did not improve how often people took their diabetes, heart, or thyroid medications com…
From Other Specialties
Late-onset rheumatoid arthritis shows higher DAS28 scores and lower remission rates compared to young-onset disease in a meta-analysis.
Meta-analysis compares treatment outcomes in older versus younger rheumatoid arthritis patients
This meta-analysis reviewed data from over 5000 patients with late-onset rheumatoid arthritis (LORA) and young-onset rheumatoid arthritis (Y…
A large review found older patients with rheumatoid arthritis had higher disease activity and lower remission rates on biologics compared to…
Systematic review and meta-analysis of supervised exercise for foot pain in rheumatoid arthritis
Exercise reduces foot pain and improves function in rheumatoid arthritis
This systematic review and meta-analysis evaluated supervised exercise programs in adults with rheumatoid arthritis and foot involvement. Th…
Supervised exercise programs significantly reduce foot pain and improve physical function in adults with rheumatoid arthritis.
Vitamin D supplementation may reduce disease activity in SLE: a systematic review and meta-analysis
Vitamin D supplements may calm lupus activity, study finds
This systematic review and meta-analysis of 847 patients with systemic lupus erythematosus found that vitamin D supplementation significantl…
A new analysis of 847 lupus patients suggests vitamin D supplements may reduce disease activity and improve immune markers.
Observational study assesses MiniDock MTB diagnostic accuracy against Xpert in Indonesian TB patients
New TB test shows promise in Indonesia trial
This observational study evaluated the diagnostic accuracy of MiniDock MTB on sputum swabs compared to Xpert MTB/RIF Ultra and liquid cultur…
A new TB test called MiniDock MTB accurately detected TB in adults, but sensitivity dropped in children and low-burden cases.