Clinical trial · Interventional
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
NCT05726162CI-TRIAL-00069033unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sleep Quality | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biofeedback-based music program | Device | — | UNRESOLVED |
| Control | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Patients sleep as usual with noise-canceling earplugs
- interventionNames
- Other: Control
- type
- EXPERIMENTAL
- label
- Biofeedback-based music
- description
- Patient is provided with a biofeedback-based music program using a smart device application for sleep.
- interventionNames
- Device: biofeedback-based music program
Primary outcomes (1)
- measure
- The Richards-Campbell Sleep Questionnaire on the day of the surgery
- timeFrame
- The daytime after the surgery (POD1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.