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

August 20, 2023 updated by: Hojin Lee, MD, Seoul National University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control
Patients sleep as usual with noise-canceling earplugs
Other: Control
The investigators will provide noise-canceling earplugs to minimize bias from noise in the ward.
Experimental: Biofeedback-based music
Patient is provided with a biofeedback-based music program using a smart device application for sleep.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Richards-Campbell Sleep Questionnaire on the day of the surgery
Time Frame: The daytime after the surgery (POD1)
sleep quality questionnaires that are most commonly used in the ICU setting, RCSQ 1-5 (0-100), Average RCSQ (0-100), higher scores mean a better outcome
The daytime after the surgery (POD1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence of postoperative nausea and vomiting
Time Frame: after the surgery (POD1; Postoperative 24 hours)
Postoperative nausea and vomiting
after the surgery (POD1; Postoperative 24 hours)
Postoperative opioid consumption
Time Frame: after the surgery (POD1; Postoperative 24 hours)
Postoperative opioid requirement
after the surgery (POD1; Postoperative 24 hours)
Analgesics requirement
Time Frame: after the surgery (POD1; Postoperative 24 hours)
Analgesics other than opioid requirement
after the surgery (POD1; Postoperative 24 hours)
Total sleep time (hours)
Time Frame: The daytime after the surgery (POD1)
Duration of sleep
The daytime after the surgery (POD1)
Time to fall asleep (minutes)
Time Frame: The daytime after the surgery (POD1)
The time to sleep from intervention
The daytime after the surgery (POD1)
Sleep disturbance
Time Frame: The daytime after the surgery (POD1)
Awakened from sleep (yes/no)
The daytime after the surgery (POD1)
The reasons of sleep disturbance
Time Frame: The daytime after the surgery (POD1)
Ask the patients who answered "yes" to the question of whether there was a disturbance during sleep.
The daytime after the surgery (POD1)
The Richards-Campbell Sleep Questionnaire on the day before the surgery
Time Frame: on the day of the surgery before surgery
sleep quality questionnaires that are most commonly used in the ICU setting, RCSQ 1-5 (0-100), Average RCSQ (0-100), higher scores mean a better outcome
on the day of the surgery before surgery
Pittsburgh Sleep Quality Index
Time Frame: on the day before the surgery
A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. C1-7 (0-3), total (0-21), higher scores mean a worse outcome
on the day before the surgery
Quality of recovery score 15 (QoR 15)
Time Frame: on the day before the surgery
Korean version of quality of recovery-15 (0-150), higher scores mean a better outcome
on the day before the surgery
Hospital Anxiety and Depression scale
Time Frame: on the day before the surgery
Method to measure anxiety and depression in a general medical population of patient, total (0-42), K-HADS depression subscale(0-21), K-HADS anxiety (0-21), higher scores mean a worse outcome
on the day before the surgery
The Richards-Campbell Sleep Questionnaire (baseline, usual patients' pattern)
Time Frame: on the day before the surgery
sleep quality questionnaires that are most commonly used in the ICU setting, RCSQ 1-5 (0-100), Average RCSQ (0-100), higher scores mean a better outcome
on the day before the surgery
Quality of recovery score 15 (QoR 15)
Time Frame: after the surgery (POD1; Postoperative 24 hours)
Korean version of quality of recovery-15 (0-150), higher scores mean a better outcome
after the surgery (POD1; Postoperative 24 hours)
Postoperative Pain
Time Frame: after the surgery (POD1; Postoperative 24 hours)
NRS score (0-11) of pain, higher scores mean a worse outcome
after the surgery (POD1; Postoperative 24 hours)
Sleep quality (0-100)
Time Frame: The daytime after the surgery (POD1)
VAS score for sleep quality (0-100), higher scores mean a better outcome
The daytime after the surgery (POD1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seohee Lee, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Biofeedback_based_music

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings