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

Sleep Quality Clinical Trial

Official title:

Effects of Biofeedback-based Music Program Using a Smart Device Application on Perioperative Sleep Quality in Patients Undergoing Breast Cancer Surgery: an Open-labeled Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05726162
• Other study ID #: Biofeedback_based_music
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: August 2023
• Source: Seoul National University Hospital
• Contact: Hojin Lee, MD, PhD
• Phone: +82-2-2072-2467
• Email: zenerdiode03[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: January 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Quality

Intervention

Device:
• biofeedback-based music program
The investigators will provide biofeedback-based music, which incorporates the patient's respiratory information. 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 patient's own breathing pattern. It automatically will be terminated 30 minutes after intervention.

Other:
• Control
The investigators will provide noise-canceling earplugs to minimize bias from noise in the ward.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Richards-Campbell Sleep Questionnaire on the day of 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	The daytime after the surgery (POD1)
Secondary	The Richards-Campbell Sleep Questionnaire 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	on the day of the surgery before surgery
Secondary	Pittsburgh Sleep Quality Index	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	on the day before the surgery
Secondary	Quality of recovery score 15 (QoR 15)	Korean version of quality of recovery-15 (0-150), higher scores mean a better outcome	on the day before the surgery
Secondary	Hospital Anxiety and Depression scale	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	on the day before the surgery
Secondary	The Richards-Campbell Sleep Questionnaire (baseline, usual patients' pattern)	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	on the day before the surgery
Secondary	Quality of recovery score 15 (QoR 15)	Korean version of quality of recovery-15 (0-150), higher scores mean a better outcome	after the surgery (POD1; Postoperative 24 hours)
Secondary	Postoperative Pain	NRS score (0-11) of pain, higher scores mean a worse outcome	after the surgery (POD1; Postoperative 24 hours)
Secondary	The incidence of postoperative nausea and vomiting	Postoperative nausea and vomiting	after the surgery (POD1; Postoperative 24 hours)
Secondary	Postoperative opioid consumption	Postoperative opioid requirement	after the surgery (POD1; Postoperative 24 hours)
Secondary	Analgesics requirement	Analgesics other than opioid requirement	after the surgery (POD1; Postoperative 24 hours)
Secondary	Total sleep time (hours)	Duration of sleep	The daytime after the surgery (POD1)
Secondary	Time to fall asleep (minutes)	The time to sleep from intervention	The daytime after the surgery (POD1)
Secondary	Sleep quality (0-100)	VAS score for sleep quality (0-100), higher scores mean a better outcome	The daytime after the surgery (POD1)
Secondary	Sleep disturbance	Awakened from sleep (yes/no)	The daytime after the surgery (POD1)
Secondary	The reasons of sleep disturbance	Ask the patients who answered "yes" to the question of whether there was a disturbance during sleep.	The daytime after the surgery (POD1)