Using music and biofeedback to improve sleep quality before breast cancer surgery
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
NA · Seoul National University Hospital · NCT05726162
This study is testing if a special music program that helps with breathing can improve sleep quality for patients before breast cancer surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 19 Years to 69 Years |
| Sex | Female |
| Sponsor | Seoul National University Hospital (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05726162 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a biofeedback-based music program delivered through a smart device application on the sleep quality of patients undergoing breast cancer surgery. Participants in the intervention group will engage in a respiratory intervention that promotes slow breathing, which will then trigger music tailored to their breathing patterns. The control group will not receive any intervention, allowing for a comparison of outcomes between the two groups. The goal is to determine if this innovative approach can enhance perioperative sleep quality.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for elective breast cancer surgery.
Not a fit: Patients who may not benefit include those with neurocognitive impairments, severe obesity, or pre-existing sleep disorders.
Why it matters
Potential benefit: If successful, this approach could significantly improve sleep quality for patients undergoing breast cancer surgery, potentially leading to better surgical outcomes.
How similar studies have performed: While the use of biofeedback and music therapy is gaining interest, this specific approach has not been widely tested in the context of perioperative sleep quality, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Principal investigator: Seohee Lee, MD, PhD — Seoul National University Hospital
- Study coordinator: Hojin Lee, MD, PhD
- Email: zenerdiode03@gmail.com
- Phone: +82-2-2072-2467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Quality