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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep Quality
- Sponsor
- Seoul National University Hospital
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- The Richards-Campbell Sleep Questionnaire on the day of the surgery
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Hojin Lee, MD
Professor
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing elective breast cancer surgery
Exclusion Criteria
- •Patients' refusal
- •Day surgery or urgent surgery
- •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
Outcomes
Primary Outcomes
The Richards-Campbell Sleep Questionnaire on the day of the surgery
Time Frame: The daytime after the surgery (POD1)
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
Secondary Outcomes
- Quality of recovery score 15 (QoR 15)(after the surgery (POD1; Postoperative 24 hours))
- Pittsburgh Sleep Quality Index(on the day before the surgery)
- Hospital Anxiety and Depression scale(on the day before the surgery)
- Postoperative Pain(after the surgery (POD1; Postoperative 24 hours))
- Time to fall asleep (minutes)(The daytime after the surgery (POD1))
- Sleep disturbance(The daytime after the surgery (POD1))
- The Richards-Campbell Sleep Questionnaire on the day before the surgery(on the day of the surgery before surgery)
- The incidence of postoperative nausea and vomiting(after the surgery (POD1; Postoperative 24 hours))
- Total sleep time (hours)(The daytime after the surgery (POD1))
- The Richards-Campbell Sleep Questionnaire (baseline, usual patients' pattern)(on the day before the surgery)
- Analgesics requirement(after the surgery (POD1; Postoperative 24 hours))
- Sleep quality (0-100)(The daytime after the surgery (POD1))
- The reasons of sleep disturbance(The daytime after the surgery (POD1))
- Postoperative opioid consumption(after the surgery (POD1; Postoperative 24 hours))