Trials / Unknown
UnknownNCT05726162
Effects of Biofeedback-based Music Program Using a Smart Device Application on Perioperative Sleep Quality
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- Female
- Age
- 19 Years – 69 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | biofeedback-based music program | 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. |
| OTHER | Control | The investigators will provide noise-canceling earplugs to minimize bias from noise in the ward. |
Timeline
- Start date
- 2023-08-21
- Primary completion
- 2023-12-30
- Completion
- 2024-01-30
- First posted
- 2023-02-13
- Last updated
- 2023-08-23
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05726162. Inclusion in this directory is not an endorsement.