Sleep QualityNCT05726162
Effects of Biofeedback-based Music Program Using a Smart Device Application on Perioperative Sleep Quality
A study testing biofeedback-based music program in people with Sleep Quality, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 69 years, women only
- Conditions the study is for
- Sleep Quality
- What is being tested?
- biofeedback-based music program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Aug 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective breast cancer surgery
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, KS013
Hojin Lee, MD, PhD, 82-2-2072-2467, zenerdiode03@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Quality
- Being tested
- biofeedback-based music program, Control
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biofeedback-based music programDevice
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.
ControlOther
The investigators will provide noise-canceling earplugs to minimize bias from noise in the ward.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients sleep as usual with noise-canceling earplugs Receives: Other: Control |
| Biofeedback-based music | Experimental | Patient is provided with a biofeedback-based music program using a smart device application for sleep. Receives: Device: biofeedback-based music program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Richards-Campbell Sleep Questionnaire on the day of 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
Measured: The daytime after the surgery (POD1)
Secondary outcomes (15)
The Richards-Campbell Sleep Questionnaire 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
Measured: on the day of the surgery before surgery
Pittsburgh Sleep Quality Index
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
Measured: on the day before the surgery
Quality of recovery score 15 (QoR 15)
Korean version of quality of recovery-15 (0-150), higher scores mean a better outcome
Measured: on the day before the surgery
Hospital Anxiety and Depression scale
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
Measured: on the day before the surgery
The Richards-Campbell Sleep Questionnaire (baseline, usual patients' pattern)
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
Measured: on the day before the surgery
Quality of recovery score 15 (QoR 15)
Korean version of quality of recovery-15 (0-150), higher scores mean a better outcome
Measured: after the surgery (POD1; Postoperative 24 hours)
Postoperative Pain
NRS score (0-11) of pain, higher scores mean a worse outcome
Measured: after the surgery (POD1; Postoperative 24 hours)
The incidence of postoperative nausea and vomiting
Postoperative nausea and vomiting
Measured: after the surgery (POD1; Postoperative 24 hours)
Postoperative opioid consumption
Postoperative opioid requirement
Measured: after the surgery (POD1; Postoperative 24 hours)
Analgesics requirement
Analgesics other than opioid requirement
Measured: after the surgery (POD1; Postoperative 24 hours)
Total sleep time (hours)
Duration of sleep
Measured: The daytime after the surgery (POD1)
Time to fall asleep (minutes)
The time to sleep from intervention
Measured: The daytime after the surgery (POD1)
Sleep quality (0-100)
VAS score for sleep quality (0-100), higher scores mean a better outcome
Measured: The daytime after the surgery (POD1)
Sleep disturbance
Awakened from sleep (yes/no)
Measured: The daytime after the surgery (POD1)
The reasons of sleep disturbance
Ask the patients who answered "yes" to the question of whether there was a disturbance during sleep.
Measured: The daytime after the surgery (POD1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start21 Aug 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hojin Lee, MD, Seoul National University Hospital
- Investigators
- Seohee Lee, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726162
- Sponsor's protocol ID
- Biofeedback_based_music
- Status last verified
- Aug 2023
- First submitted
- 30 Jan 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05726162
- Acronym / sponsor ID
- Biofeedback_based_music
- Conditions
- Sleep Quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlPatients sleep as usual with noise-canceling earplugs |
| Biofeedback-based music | Experimental | Device: biofeedback-based music programPatient is provided with a biofeedback-based music program using a smart device application for sleep. |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective breast cancer surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biofeedback-based music programThe 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. | Device | Biofeedback-based music |
| ControlThe investigators will provide noise-canceling earplugs to minimize bias from noise in the ward. | Other | Control |
Primary outcome
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
15 secondary outcomes
The Richards-Campbell Sleep Questionnaire on the day before the surgery
Time frame: on the day of the surgery before surgery
Pittsburgh Sleep Quality Index
Time frame: on the day before the surgery
Quality of recovery score 15 (QoR 15)
Time frame: on the day before the surgery
Hospital Anxiety and Depression scale
Time frame: on the day before the surgery
The Richards-Campbell Sleep Questionnaire (baseline, usual patients' pattern)
Time frame: on the day before the surgery
Quality of recovery score 15 (QoR 15)
Time frame: after the surgery (POD1; Postoperative 24 hours)
Postoperative Pain
Time frame: after the surgery (POD1; Postoperative 24 hours)
The incidence of postoperative nausea and vomiting
Time frame: after the surgery (POD1; Postoperative 24 hours)
Postoperative opioid consumption
Time frame: after the surgery (POD1; Postoperative 24 hours)
Analgesics requirement
Time frame: after the surgery (POD1; Postoperative 24 hours)
Total sleep time (hours)
Time frame: The daytime after the surgery (POD1)
Time to fall asleep (minutes)
Time frame: The daytime after the surgery (POD1)
Sleep quality (0-100)
Time frame: The daytime after the surgery (POD1)
Sleep disturbance
Time frame: The daytime after the surgery (POD1)
The reasons of sleep disturbance
Time frame: The daytime after the surgery (POD1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
Related trials for Sleep Quality
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruiting
HALO Clarity™ Cranial Alternating Current Stimulation Therapy for Adults With Moderate-to-Severe Insomnia
Moderate to Severe Insomnia
Enrolling by invitation
Recreational Badminton, Sleep and Melatonin
Sedentary Behavior
Not yet recruiting
CannaRiver CBD Calm for Anxiety, Sleep, and Well-Being in Adults With Generalized Anxiety Disorder
Generalized Anxiety Disorder
Recruiting
Hemodynamics After Resistance Training
Perimenopause
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seohee Lee, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biofeedback-based music program in people with Sleep Quality, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hojin Lee, MD, PhD (+82-2-2072-2467, zenerdiode03@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Richards-Campbell Sleep Questionnaire on the day of the surgery (time frame: The daytime after the surgery (POD1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.