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

Seoul National University Hospital68 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Sleep Quality

Interventions

biofeedback-based music programDEVICE

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.

ControlOTHER

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

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: The daytime after the surgery (POD1)

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: on the day before the surgery

Central Contacts

Hojin Lee, MD, PhD

CONTACT

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

Data from ClinicalTrials.gov

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