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

NCT ID: NCT05726162

Last Updated: 2023-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-21

Study Completion Date

2024-01-30

Brief Summary

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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

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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

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Sleep Quality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

Patients sleep as usual with noise-canceling earplugs

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

The investigators will provide noise-canceling earplugs to minimize bias from noise in the ward.

Biofeedback-based music

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

Group Type EXPERIMENTAL

biofeedback-based music program

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Control

The investigators will provide noise-canceling earplugs to minimize bias from noise in the ward.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hojin Lee, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seohee Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hojin Lee, MD, PhD

Role: CONTACT

+82-2-2072-2467

Facility Contacts

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Hojin Lee, MD, PhD

Role: primary

82-2-2072-2467

Other Identifiers

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Biofeedback_based_music

Identifier Type: -

Identifier Source: org_study_id

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