Clinical trial NCT05726162: Effects of Biofeedback-based Music Program Using a Smart Device Application on Perioperative Sleep Quality
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Quality
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 68
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Richards-Campbell Sleep Questionnaire on the day of the surgery
timeFrame: The daytime after the surgery (POD1)
Secondary outcomes:
measure: The Richards-Campbell Sleep Questionnaire on the day before the surgery
timeFrame: on the day of the surgery before surgery
measure: Pittsburgh Sleep Quality Index
timeFrame: on the day before the surgery
measure: Quality of recovery score 15 (QoR 15)
timeFrame: on the day before the surgery
measure: Hospital Anxiety and Depression scale
timeFrame: on the day before the surgery
measure: The Richards-Campbell Sleep Questionnaire (baseline, usual patients' pattern)
timeFrame: on the day before the surgery
measure: Quality of recovery score 15 (QoR 15)
timeFrame: after the surgery (POD1; Postoperative 24 hours)
measure: Postoperative Pain
timeFrame: after the surgery (POD1; Postoperative 24 hours)
measure: The incidence of postoperative nausea and vomiting
timeFrame: after the surgery (POD1; Postoperative 24 hours)
measure: Postoperative opioid consumption
timeFrame: after the surgery (POD1; Postoperative 24 hours)
measure: Analgesics requirement
timeFrame: after the surgery (POD1; Postoperative 24 hours)
measure: Total sleep time (hours)
timeFrame: The daytime after the surgery (POD1)
measure: Time to fall asleep (minutes)
timeFrame: The daytime after the surgery (POD1)
measure: Sleep quality (0-100)
timeFrame: The daytime after the surgery (POD1)
measure: Sleep disturbance
timeFrame: The daytime after the surgery (POD1)
measure: The reasons of sleep disturbance
timeFrame: The daytime after the surgery (POD1)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Seohee Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: