Effects of Biofeedback-based Music Program Using a Smart Device Application on Perioperative Sleep Quality

Not Applicable

Recruiting

• Conditions: Sleep Quality
• Interventions: Device: biofeedback-based music program; Other: Control

• Registration Number: NCT05726162
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to investigate whether the effects of biofeedback-based music programs using a smart device application can improve perioperative sleep quality in patients undergoing breast cancer surgery.

Detailed Description

In a biofeedback-based music group, the patient performs an active respiratory intervention session, which induces a slow breathing pattern. If breathing has been slow enough, the automatic mode is activated to provide music based on the patient's own breathing pattern. The investigators will provide biofeedback-based music, which incorporates the patient's respiratory information, while no intervention will be performed in the control group.

Study Timeline

• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-02-13
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-20
• Study Start: 2023-08-21
• Last Update Posted: 2023-08-23
• Primary Completion: 2023-12-30
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

• Patients undergoing elective breast cancer surgery

Exclusion Criteria

• Patients' refusal
• Day surgery or urgent surgery
• BMI ≥35
• Neurocognitive impairment, hearing disorder (ex : (dementia, impaired cognitive dysfunction, cerebral infarction, transient cerebral ischemic attack))
• Patients with psychiatric diseases, psychological drug intake
• Pre-existing conditions associated with sleep disorders or drug intake related to sleep

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofeedback-based music	biofeedback-based music program	Patient is provided with a biofeedback-based music program using a smart device application for sleep.
Control	Control	Patients sleep as usual with noise-canceling earplugs

Primary Outcome Measures

Name	Time	Method
The Richards-Campbell Sleep Questionnaire on the day of the surgery	The daytime after the surgery (POD1)	sleep quality questionnaires that are most commonly used in the ICU setting, RCSQ 1-5 (0-100), Average RCSQ (0-100), higher scores mean a better outcome

Secondary Outcome Measures

Name	Time	Method
The reasons of sleep disturbance	The daytime after the surgery (POD1)	Ask the patients who answered "yes" to the question of whether there was a disturbance during sleep.
Quality of recovery score 15 (QoR 15)	after the surgery (POD1; Postoperative 24 hours)	Korean version of quality of recovery-15 (0-150), higher scores mean a better outcome
Pittsburgh Sleep Quality Index	on the day before the surgery	A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. C1-7 (0-3), total (0-21), higher scores mean a worse outcome
Hospital Anxiety and Depression scale	on the day before the surgery	Method to measure anxiety and depression in a general medical population of patient, total (0-42), K-HADS depression subscale(0-21), K-HADS anxiety (0-21), higher scores mean a worse outcome
Postoperative Pain	after the surgery (POD1; Postoperative 24 hours)	NRS score (0-11) of pain, higher scores mean a worse outcome
Time to fall asleep (minutes)	The daytime after the surgery (POD1)	The time to sleep from intervention
Sleep disturbance	The daytime after the surgery (POD1)	Awakened from sleep (yes/no)
The Richards-Campbell Sleep Questionnaire on the day before the surgery	on the day of the surgery before surgery	sleep quality questionnaires that are most commonly used in the ICU setting, RCSQ 1-5 (0-100), Average RCSQ (0-100), higher scores mean a better outcome
The incidence of postoperative nausea and vomiting	after the surgery (POD1; Postoperative 24 hours)	Postoperative nausea and vomiting
Total sleep time (hours)	The daytime after the surgery (POD1)	Duration of sleep
The Richards-Campbell Sleep Questionnaire (baseline, usual patients' pattern)	on the day before the surgery	sleep quality questionnaires that are most commonly used in the ICU setting, RCSQ 1-5 (0-100), Average RCSQ (0-100), higher scores mean a better outcome
Analgesics requirement	after the surgery (POD1; Postoperative 24 hours)	Analgesics other than opioid requirement
Sleep quality (0-100)	The daytime after the surgery (POD1)	VAS score for sleep quality (0-100), higher scores mean a better outcome
Postoperative opioid consumption	after the surgery (POD1; Postoperative 24 hours)	Postoperative opioid requirement

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of