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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Quality
• Intervention / Treatment: Other: Control; Device: biofeedback-based music program

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 Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hojin Lee, MD, PhD; Phone Number: +82-2-2072-2467; Email: zenerdiode03@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, KS013
    • Recruiting
    • Seoul National University Hospital
    • Contact: Hojin Lee, MD, PhD; Phone Number: 82-2-2072-2467; Email: zenerdiode03@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Patients sleep as usual with noise-canceling earplugs	Other: Control; The investigators will provide noise-canceling earplugs to minimize bias from noise in the ward.
Experimental: Biofeedback-based music; Patient is provided with a biofeedback-based music program using a smart device application for sleep.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of postoperative nausea and vomiting	Postoperative nausea and vomiting	after the surgery (POD1; Postoperative 24 hours)
Postoperative opioid consumption	Postoperative opioid requirement	after the surgery (POD1; Postoperative 24 hours)
Analgesics requirement	Analgesics other than opioid requirement	after the surgery (POD1; Postoperative 24 hours)
Total sleep time (hours)	Duration of sleep	The daytime after the surgery (POD1)
Time to fall asleep (minutes)	The time to sleep from intervention	The daytime after the surgery (POD1)
Sleep disturbance	Awakened from sleep (yes/no)	The daytime after the surgery (POD1)
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)
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
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
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
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
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
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)
Postoperative Pain	NRS score (0-11) of pain, higher scores mean a worse outcome	after the surgery (POD1; Postoperative 24 hours)
Sleep quality (0-100)	VAS score for sleep quality (0-100), higher scores mean a better outcome	The daytime after the surgery (POD1)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Seohee Lee, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 20, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Biofeedback_based_music

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No