An interventional study of Standardized Maternal Heartbeat Sound Application in Sleep, Circadian Rhythm and Pregnancy, sponsored by Hakan Avan. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Hakan Avan · Not applicable, Interventional, and Supportive care
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.
804 studies on the registry are indexed under Sleep Wake Disorders; 188 are open to participants now.
This study's planned enrollment of 80 is above the median of 62 across 556 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →Hakan Avan is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
Exclusion Criteria:
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).
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.
Behavioral: Standardized Maternal Heartbeat Sound Application
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.
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.
Perceived Stress Level
Measured using the Perceived Stress Scale (PSS).
Time frame: 7 day Baseline (Pre-test) and Day 7 (Post-test)
Breastfeeding Self-Efficacy
Measured using the Breastfeeding Self-Efficacy Scale - Short Form.
Time frame: 7 day Baseline (Pre-test) and Day 7 (Post-test)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2026, 1 month later.
Of 229 non-industry interventional studies with no phase under Sleep Wake Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 1 month is below that.
Counting every sponsor, half of 266 studies reached it within 17 months; a quarter within 6 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Hakan Avan