SleepNCT07881484
HEARTBEAT SOUND FOR BREASTFEEDİNG DİFFİCULTİES: A RANDOMİZED CONTROLLED TRİAL
A study testing Standardized Maternal Heartbeat Sound Application in people with Sleep and Circadian Rhythm, run by Hakan Avan.
Trial summary
This randomized controlled trial aims to evaluate the effect of listening to a pre-recorded, standardized maternal heartbeat sound on perceived stress levels and breastfeeding self-efficacy in mothers experiencing early breastfeeding difficulties. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sleep, Circadian Rhythm, Pregnancy
- What is being tested?
- Standardized Maternal Heartbeat Sound Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2026to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For Mothers:
- Being a mother who has completed the 24th postpartum hour and is being followed up to 72 hours.
- Having had a first pregnancy or first live birth.
- Being identified as experiencing early breastfeeding difficulties.
- Volunteering to participate in the study.
- Being 18 years of age or older.
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- Not having a psychiatric disorder or serious chronic illness.
- For Infants:
- Born from a singleton pregnancy.
- Gestational age ≥ 37 weeks (term infant).
- Postnatal health status must be stable and not require intensive care.
- No congenital anomalies or serious congenital diseases.
Who cannot join
- For Mothers:
- Mothers with serious medical problems or contraindications related to breastfeeding (e.g., severe wound or infection after breast surgery).
- Mothers who experienced severe complications during childbirth (e.g., hemorrhage, sepsis, conditions requiring emergency surgery).
- Mothers who do not agree to participate or do not sign the form.
- For Infants:
- Serious physiological problems that would prevent receiving the heartbeat sound (e.g., severe hearing problems, severe respiratory problems).
About this study
Official title: THE EFFECT OF A SENSORY-BASED INTERVENTİON (STANDARDİZED HEARTBEAT SOUND) ON PERCEİVED STRESS AND BREASTFEEDİNG SELF-EFFİCACY İN MOTHER-INFANT DYADS WİTH EARLY BREASTFEEDİNG DİFFİCULTİES: A RANDOMİZED CONTROLLED TRİAL
This randomized controlled trial aims to evaluate the effect of listening to a pre-recorded, standardized maternal heartbeat sound on perceived stress levels and breastfeeding self-efficacy in mothers experiencing early breastfeeding difficulties. The study will be conducted in the postpartum service of a tertiary hospital. The results are expected to contribute to easily applicable, non-invasive, and supportive care approaches for breastfeeding support.
- Conditions
- Sleep, Circadian Rhythm, Pregnancy, Newborn, Sleep Disorders, Healthy
- Being tested
- Standardized Maternal Heartbeat Sound Application
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Maternal Heartbeat Sound ApplicationBehavioural
A pre-recorded, standardized maternal heartbeat sound will be played to the infant via an environmental speaker for 7 days, starting after the 24th postpartum hour, twice a day for approximately 10 minutes per session. The sound level will be kept in the safe range of 40-60 dB. The application is non-invasive, non-pharmacological, and contains no medical procedure beyond routine care.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | A pre-recorded, standardized maternal heartbeat sound will be played to the infant via an environmental speaker for 7 days, starting after the 24th postpartum hour, twice a day for approximately 10 minutes per session. The sound level will be kept in the safe range of 40-60 dB. The application is non-invasive, non-pharmacological, and contains no medical procedure beyond routine care. Receives: Behavioral: Standardized Maternal Heartbeat Sound Application |
| Control Group | No intervention | Only routine care services will be provided to the mothers in the control group. No additional intervention will be applied to participants in this group within the scope of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Level
Measured using the Perceived Stress Scale (PSS).
Measured: 7 day Baseline (Pre-test) and Day 7 (Post-test)
Breastfeeding Self-Efficacy
Measured using the Breastfeeding Self-Efficacy Scale - Short Form.
Measured: 7 day Baseline (Pre-test) and Day 7 (Post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start25 Oct 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hakan Avan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hakan Avan, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881484
- Sponsor's protocol ID
- hakanavan-0005
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF A SENSORY-BASED INTERVENTİON (STANDARDİZED HEARTBEAT SOUND) ON PERCEİVED STRESS AND BREASTFEEDİNG SELF-EFFİCACY İN MOTHER-INFANT DYADS WİTH EARLY BREASTFEEDİNG DİFFİCULTİES: A RANDOMİZED CONTROLLED TRİAL
- ClinicalTrials.gov ID
- NCT07881484
- Acronym / sponsor ID
- hakanavan-0005
- Conditions
- Sleep, Circadian Rhythm, Pregnancy, Newborn, Sleep Disorders, Healthy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hakan AvanUniversity, hospital or other
- Study start
- 25 Oct 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 19 Oct 2026 (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.
This randomized controlled trial aims to evaluate the effect of listening to a pre-recorded, standardized maternal heartbeat sound on perceived stress levels and breastfeeding self-efficacy in mothers experiencing early breastfeeding difficulties. The study will be conducted in the postpartum service of a tertiary hospital. The results are expected to contribute to easily applicable, non-invasive, and supportive care approaches for breastfeeding support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Standardized Maternal Heartbeat Sound ApplicationA pre-recorded, standardized maternal heartbeat sound will be played to the infant via an environmental speaker for 7 days, starting after the 24th postpartum hour, twice a day for approximately 10 minutes per session. The sound level will be kept in the safe range of 40-60 dB. The application is non-invasive, non-pharmacological, and contains no medical procedure beyond routine care. |
| Control Group | No intervention | –Only routine care services will be provided to the mothers in the control group. No additional intervention will be applied to participants in this group within the scope of the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- For Mothers:
- Being a mother who has completed the 24th postpartum hour and is being followed up to 72 hours.
- Having had a first pregnancy or first live birth.
- Being identified as experiencing early breastfeeding difficulties.
- Volunteering to participate in the study.
Key exclusion criteria (6 listed)
- For Mothers:
- Mothers with serious medical problems or contraindications related to breastfeeding (e.g., severe wound or infection after breast surgery).
- Mothers who experienced severe complications during childbirth (e.g., hemorrhage, sepsis, conditions requiring emergency surgery).
- Mothers who do not agree to participate or do not sign the form.
- Serious physiological problems that would prevent receiving the heartbeat sound (e.g., severe hearing problems, severe respiratory problems).
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 |
|---|---|---|
| Standardized Maternal Heartbeat Sound ApplicationA pre-recorded, standardized maternal heartbeat sound will be played to the infant via an environmental speaker for 7 days, starting after the 24th postpartum hour, twice a day for approximately 10 minutes per session. The sound level will be kept in the safe range of 40-60 dB. The application is non-invasive, non-pharmacological, and contains no medical procedure beyond routine care. | Behavioural | Experimental Group |
Primary outcome
Perceived Stress Level
Time frame: 7 day Baseline (Pre-test) and Day 7 (Post-test)
Measured using the Perceived Stress Scale (PSS).
Breastfeeding Self-Efficacy
Time frame: 7 day Baseline (Pre-test) and Day 7 (Post-test)
Measured using the Breastfeeding Self-Efficacy Scale - Short Form.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Maternal Heartbeat Sound Application in people with Sleep and Circadian Rhythm, run by Hakan Avan.
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 12 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: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Level (time frame: 7 day Baseline (Pre-test) and Day 7 (Post-test)). The study lists 2 primary outcomes in all. 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 19 Oct 2026.