- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07413185
Relationship Between the Severity of Sleep Deprivation in the First 48 Hours Postpartum, Breastfeeding Motivation, and Breastfeeding Success
The postpartum period is a critical time marked by significant physiological and psychosocial changes that can affect sleep, emotional well-being, and breastfeeding behaviors. Previous studies indicate that mode of delivery and sleep quality are closely associated with breastfeeding outcomes, with cesarean birth often linked to poorer sleep and lower breastfeeding success. Evidence also suggests that postpartum sleep disturbances are related to reduced breastfeeding self-efficacy, lower motivation, fatigue, depressive symptoms, and shorter breastfeeding duration.
However, the literature lacks studies that evaluate insomnia severity, breastfeeding motivation, and breastfeeding success simultaneously-particularly during the first 48 hours after birth. This analytical study aims to assess insomnia severity, breastfeeding motivation, and breastfeeding success (LATCH) within the first 48 postpartum hours and to examine the relationships among these variables. Findings are expected to support early postpartum clinical interventions to improve maternal and infant health outcomes.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Güzin Ünlü Suvari, M.Sc.
- Phone Number: +902165004429
- Email: guzin.unlu@acibadem.edu.tr
Study Locations
-
-
Altunizade
-
Istanbul, Altunizade, Turkey (Türkiye)
- Recruiting
- Acibadem Health Group
-
Principal Investigator:
- Merve Coşkun, Ph.D.
-
Contact:
- Güzin Ünlü Suvari, M.Sc.
- Phone Number: 2165004429 +90
- Email: guzinnunlu@gmail.com
-
Principal Investigator:
- Şevval Çilekci, B.Sc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Primiparous or multiparous women aged 18 years and older
- Having a healthy term delivery
- Infant not admitted to the neonatal intensive care unit (NICU)
- Initiated breastfeeding within the first 48 hours postpartum
Exclusion Criteria:
- Complications requiring sedation
- Severe postpartum hemorrhage
- Severe postoperative pain or need for narcotic analgesics
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Success (LATCH Score)
Time Frame: Within the first 48 hours postpartum (one-time assessment at enrollment)
|
Breastfeeding success will be assessed using the LATCH Breastfeeding Assessment Tool, which evaluates five domains: latch, audible swallowing, type of nipple, maternal comfort (breast/nipple), and holding/positioning.
Each item is scored from 0 to 2, with a total score ranging from 0 to 10. Higher scores indicate greater breastfeeding success.
|
Within the first 48 hours postpartum (one-time assessment at enrollment)
|
|
Insomnia Severity (Insomnia Severity Index, ISI)
Time Frame: Within the first 48 hours postpartum (one-time assessment at enrollment)
|
Insomnia severity will be measured using the Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing difficulty initiating sleep, difficulty maintaining sleep, early morning awakening, satisfaction with sleep, interference with daytime functioning, noticeability of impairment, and distress caused by sleep problems.
Each item is scored from 0 to 4, yielding a total score of 0-28.
Higher scores indicate more severe insomnia.
|
Within the first 48 hours postpartum (one-time assessment at enrollment)
|
|
Breastfeeding Motivation (Breastfeeding Motivation Scale Subscale Scores)
Time Frame: Within the first 48 hours postpartum (one-time assessment at enrollment)
|
Breastfeeding motivation will be evaluated using the Breastfeeding Motivation Scale based on Self-Determination Theory.
The scale includes 24 items rated on a 4-point Likert scale and provides scores for five subdomains: integrated regulation, intrinsic motivation/identified regulation, introjected regulation (social approval), introjected regulation (social pressure), and external regulation (secondary benefits).
Subscale scores are calculated as the mean of items within each subdomain; higher scores indicate stronger motivation of that type.
|
Within the first 48 hours postpartum (one-time assessment at enrollment)
|
|
Maternal and Neonatal Characteristics (Descriptive Data Form)
Time Frame: Within the first 48 hours postpartum (one-time assessment at enrollment)
|
Participant demographic, obstetric, delivery-related, neonatal, breastfeeding history, breastfeeding-related characteristics, and sleep habit information will be collected using a structured descriptive information form developed by the researchers based on the literature.
|
Within the first 48 hours postpartum (one-time assessment at enrollment)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Altıparmak, S., & Yılmaz, A. N. (2021). The effect of birth type on breastfeeding success and insomnia severity in puerperant women. Samsun Sağlık Bilimleri Dergisi, 6(1), 119-127.
- Witkowska-Zimny, M., Zhyvotovska, A., Isakov, R., Boiko, D. I., & Nieradko-Iwanicka, B. (2024). Maternal sleeping problems before and after childbirth-A systematic review. International journal of women's health, 345-371.
- Khadka, R., Hong, S. A., & Chang, Y. S. (2020). Prevalence and determinants of poor sleep quality and depression among postpartum women: a community-based study in Ramechhap district, Nepal. International health, 12(2), 125-131. https://doi.org/10.1093/inthealth/ihz032
- Jensen, D., Wallace, S., & Kelsay, P. (1994). LATCH: a breastfeeding charting system and documentation tool. Journal of Obstetric, Gynecologic, & Neonatal Nursing, 23(1), 27-32.
- Boysan, M., Güleç, M., Besiroglu, L., & Kalafat, T. (2010). Uykusuzluk Siddeti Indeksi'nin Türk örneklemindeki psikometrik özellikleri. Anadolu Psikiyatri Dergisi, 11(3), 248.
- Kestler-Peleg, M., Shamir-Dardikman, M., Hermoni, D., & Ginzburg, K. (2015). Breastfeeding motivation and Self-Determination Theory. Social Science & Medicine, 144, 19-27. doi:10.1016/j.socscimed.2015.09.006
- Ruan, H., Zhang, Y., Tang, Q., Zhao, X., Zhao, X., Xiang, Y., Geng, W., Feng, Y., & Cai, W. (2022). Sleep duration of lactating mothers and its relationship with feeding pattern, milk macronutrients and related serum factors: A combined longitudinal cohort and cross-sectional study. Frontiers in nutrition, 9, 973291. https://doi.org/10.3389/fnut.2022.973291
- Kayahan, C., & Ozturk, C. S. (2025). Antenatal and postnatal breastfeeding motivation and self-efficacy in primiparous women: a prospective observational study. European Journal of Pediatrics, 184(10), 631.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-20-750
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Sleep
-
University of Wisconsin, MadisonPhilips HealthcareCompletedSleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
-
Brain Electrophysiology Laboratory CompanyRecruiting
-
University GhentEuropean CommissionCompleted
-
Mahidol UniversityRamathibodi HospitalNot yet recruitingSleep Inertia | Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization | Night Shift WorkThailand
-
Northumbria UniversityCompletedSleep | Mood | Poor Quality Sleep | Good Sleep HabitUnited Kingdom
-
Universidade Federal de PernambucoEnrolling by invitationSleep | Obstructive Sleep Apnea (OSA)Brazil
-
Atlas UniversityCompletedSleep | Surgery | Sleep QualityTurkey (Türkiye)
-
Mersin UniversityCompletedSleep Quality | Sleep PerceptionTurkey (Türkiye)
-
Brigham and Women's HospitalNot yet recruitingObstructive Sleep Apnea | Sleep-disordered BreathingUnited States
-
Institute of Nutrition, Slovenia (Nutris)Valens Int. d.o.o., Slovenija; Faculty of Pharmacy, University of Ljubljana... and other collaboratorsNot yet recruitingSleep Quality | Sleep Onset LatencySlovenia