Effects of Biofeedback-based Music Program Using a Smart Device Application on Perioperative Sleep Quality

Seoul National University

Status: Enrolling

Conditions: Sleep Quality

Treatments: Device: biofeedback-based music program; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05726162

Biofeedback_based_music

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 estimated patients

Sex: Female

Ages: 19 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Control

Active Comparator group

Description:

Patients sleep as usual with noise-canceling earplugs

Treatment:

Other: Control

Biofeedback-based music

Experimental group

Description:

Patient is provided with a biofeedback-based music program using a smart device application for sleep.

Treatment:

Device: biofeedback-based music program