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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Sleep Quality

Intervention / Treatment
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* Device: biofeedback-based music program
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 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) | 
| 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 quality (0-100) | VAS score for sleep quality (0-100), higher scores mean a better outcome | 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) |