Effects of Biofeedback-based Music Program Using a Smart Device Application on Perioperative Sleep Quality.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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. We will provide biofeedback-based music, which incorporates the patient's respiratory information, while no intervention will be performed in the control group.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Control Patients sleep as usual with noise-canceling earplugs |
Other: Control
We will provide noise-canceling earplugs to minimize bias from noise in the ward.
|
| Experimental: Biofeedback-based music Patient is povided with a biofeedback-based music program using a smart device application for sleep. |
Device: biofeedback-based music program
We 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.
|
Outcome Measures
Primary Outcome Measures
- The Richards-Campbell Sleep Questionnaire on the day of the surgery [The daytime after the surgery (POD1)]
sleep quality questionnaires that are most commonly used in the ICU setting
Secondary Outcome Measures
- The Richards-Campbell Sleep Questionnaire on the day before the surgery [on the day of the surgery before surgery]
sleep quality questionnaires that are most commonly used in the ICU setting
- Pittsburgh Sleep Quality Index [on the day before the surgery]
A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
- Quality of recovery score 15 (QoR 15) [on the day before the surgery]
Korean version of quality of recovery-15
- Hospital Anxiety and Depression scale [on the day before the surgery]
Method to measure anxiety and depression in a general medical population of patient
- The Richards-Campbell Sleep Questionnaire (baseline, usual patients' pattern) [on the day before the surgery]
sleep quality questionnaires that are most commonly used in the ICU setting
- Quality of recovery score 15 (QoR 15) [after the surgery (POD1; Postoperative 24 hours)]
Korean version of quality of recovery-15
- Postoperative Pain [after the surgery (POD1; Postoperative 24 hours)]
NRS score (0-11) of pain
- The incidence of postoperative nausea and vomiting [after the surgery (POD1; Postoperative 24 hours)]
Postoperative nausea and vomiting
- Postoperative opioid consumption [after the surgery (POD1; Postoperative 24 hours)]
Postoperative opioid requirement
- Analgesics requirement [after the surgery (POD1; Postoperative 24 hours)]
Analgesics other than opioid requirement
- Total sleep time (hours) [The daytime after the surgery (POD1)]
Duration of sleep
- Time to fall asleep (minutes) [The daytime after the surgery (POD1)]
The time to sleep from intervention
- Sleep quality (0-100) [The daytime after the surgery (POD1)]
VAS score for sleep quality (0-100) 100mm),
- Sleep disturbance [The daytime after the surgery (POD1)]
Awakened from sleep (yes/no)
- The reasons of sleep disturbance [The daytime after the surgery (POD1)]
Ask the patients who answered "yes" to the question of whether there was a disturbance during sleep.
Eligibility Criteria
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))
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Patients with psychiatric diseases, psychological drug intake
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Pre-existing conditions associated with sleep disorders or drug intake related to sleep
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Seoul National University Hospital
Investigators
- Principal Investigator: Seohee Lee, MD, PhD, Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Biofeedback_based_music