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

NCT05726162 | Unknown DMC

• 1 other identifier: Biofeedback_based_music
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Quality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• The Richards-Campbell Sleep Questionnaire on the day before the surgery

  on the day of the surgery before surgery

• Pittsburgh Sleep Quality Index

  on the day before the surgery

• Quality of recovery score 15 (QoR 15)

  on the day before the surgery

• Hospital Anxiety and Depression scale

  on the day before the surgery

• The Richards-Campbell Sleep Questionnaire (baseline, usual patients' pattern)

  on the day before the surgery

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients sleep as usual with noise-canceling earplugs

Other: Control

Biofeedback-based music

EXPERIMENTAL

Patient is provided with a biofeedback-based music program using a smart device application for sleep.

Device: biofeedback-based music program

Interventions

biofeedback-based music program DEVICE

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.

Biofeedback-based music

Control OTHER

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

Control

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective breast cancer surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, KS013, South Korea

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Seohee Lee, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hojin Lee, MD, PhD

CONTACT

+82-2-2072-2467; zenerdiode03@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 13, 2023
• Study Start: August 21, 2023
• Primary Completion: December 30, 2023
• Study Completion: January 30, 2024
• Last Updated: August 23, 2023

Record last verified: 2023-08

Locations

KR (1)