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Trial Title:
Effects of Biofeedback-based Music Program Using a Smart Device Application on Perioperative Sleep Quality
NCT ID:
NCT05726162
Condition:
Sleep Quality
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
biofeedback-based music program
Description:
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.
Arm group label:
Biofeedback-based music
Intervention type:
Other
Intervention name:
Control
Description:
The investigators will provide noise-canceling earplugs to minimize bias from noise in
the ward.
Arm group label:
Control
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.
Criteria for 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
Gender:
Female
Minimum age:
19 Years
Maximum age:
69 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
KS013
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hojin Lee, MD, PhD
Phone:
82-2-2072-2467
Email:
zenerdiode03@gmail.com
Start date:
August 21, 2023
Completion date:
January 30, 2024
Lead sponsor:
Agency:
Seoul National University Hospital
Agency class:
Other
Source:
Seoul National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05726162
