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NCT07925606
Effect of Sufi Music on Sleep, Cardiac Symptoms and Vital Signs in Open-Heart Surgery Patients
Conditions: Sleep, Cardiac Symptoms, Vital Signs
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: Yeliz Ciğerci
Summary
The aim of this randomised, double-blind, controlled experimental study is to investigate the effect of Sufi music delivered via a bone-conduction pillow speaker on sleep quality, cardiac symptoms and vital signs in open-heart surgery patients. The study will be conducted with three groups, each comprising 30 patients (90 in total): an intervention group, a sham group and a routine care control group. Participants in the intervention group will listen to relaxing Sufi music without percussion for 15-20 minutes, starting at 21:30, through a bone-conduction pillow speaker placed under the pillow. Participants in the sham group will have an identical-looking pillow speaker placed under their pillow for the same duration, but no sound will be transmitted. Participants in the control group will receive only the hospital's standard night-care protocol, with no device or music intervention. Vital signs (blood pressure, pulse, respiratory rate and oxygen saturation) will be measured immediately before and after the application period in all groups, and sleep quality will be assessed the following morning between 08:00 and 09:00 using the Richards-Campbell Sleep Questionnaire. Cardiac symptoms will be assessed in all groups with a Cardiac Symptom Survey before discharge.
Eligibility Criteria
Inclusion Criteria:
* Aged 18 years or older,
* Literate in Turkish (able to read and write),
* Having undergone elective open-heart surgery (coronary artery bypass graft surgery) and extubated after the operation,
* Fully oriented to place, time and person and fully cooperative,
* Able to complete the cognitive function assessment scales,
* Planned to receive inpatient treatment in the clinical setting for at least two days and receiving inpatient treatment in the ward at the time of the study (21:30),
* Without severe hearing loss that would impair bone-conduction sound transmission or the perception of verbal instructions,
* Patients who voluntarily agree to participate and sign the Informed Voluntary Consent Form will be included in the study.
Exclusion Criteria:
* Undergoing emergency surgery, Having a severe neurological deficit (e.g., cerebrovascular event) or a diagnosed psychiatric disorder, Requiring mechanical ventilator support for longer than 24 hours in the postoperative period, Having persistent haemodynamic instability, requiring an intra-aortic balloon pump, or receiving high-dose inotropic support, Having a history of diagnosed sleep apnoea or chronic insomnia, Having received sedative, hypnotic, anxiolytic or strong analgesic (e.g., opioid) medication within 4-6 hours before the intervention time, Having severe pain (VAS \>4) requiring analgesic treatment before the intervention, Having an open wound, lesion, burn or acute surgical incision in the temporal/mastoid region or the cranial bones where the bone-conduction pillow speaker will make contact, and patients using a cochlear implant whose device cannot be removed in the evening hours.
Source: ClinicalTrials.gov (NCT07925606). StuddyBuddy aggregates publicly available trial information.