An interventional study of Continuous midwife support care and Pilates ball usage in Effect of Continuous Midwifery Support on Comfort, Sleep, and Breastfeeding Self-Efficacy in Primiparous Women: A Follow-Up From Pregnancy to Motherhood, sponsored by Palu Devlet Hastanesi. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 36 Years. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Palu Devlet Hastanesi · Not applicable, Interventional, and Supportive care
The study was conducted to determine the effect of continuous midwife support provided to primiparous pregnant women until the postpartum period on comfort, sleep quality and breastfeeding self-sufficiency.
The study was conducted to determine the effect of continuous midwifery support provided to primiparous pregnant women until the postpartum period on comfort, sleep quality, and breastfeeding self-efficacy.
Materials and Methods: This randomized controlled trial included a total of 128 pregnant women-64 in the experimental group and 64 in the control group-who were in the 36th week of pregnancy and applied to the Elazığ Palu State Hospital Gynecology and Obstetrics Outpatient Clinic. During the first interview (36th week), pre-test data were collected in the NST room using the "Personal Information Form", "General Comfort Questionnaire", "Pittsburgh Sleep Quality Index", and the "Antenatal Breastfeeding Self-Efficacy Scale-Short Form".
In the second (37th week of pregnancy), third (38th week of pregnancy), and fifth interviews (within the first 4-8 hours postpartum), participants in the experimental group received training in line with educational booklets prepared by the researcher. Since the fourth interview was scheduled during the labor process, continuous support was provided to the pregnant women during childbirth. The sixth interview was conducted between the 5th and 7th days postpartum, during which post-test data were collected using the "General Comfort Questionnaire", "Pittsburgh Sleep Quality Index", and the "Postnatal Breastfeeding Self-Efficacy Scale-Short Form".
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 128 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →This is the only study on the registry with Palu Devlet Hastanesi as lead sponsor.
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All pregnant women who communicate verbally and do not have a reading or writing disability,
Exclusion Criteria:
For postpartum women;
Experimental Group First Interview (36th week of pregnancy - first encounter) Second Interview (37th week of pregnancy) Third Interview (38th week of pregnancy) Fourth Observation (Hospital follow-up covering the labor process and the first day after birth) Fifth Interview (5-7th day after birth):
Other: Continuous midwife support care · Other: Pilates ball usage · Other: warm shower
Control Group First Interview (36th week of pregnancy - first encounter) Second Interview (5-7th day after birth):
Primiparous pregnant women are provided with continuous and individual midwife support starting from the 36th week until the postpartum period.
Primiparous pregnant women were provided with educational support starting from the prenatal period to the postnatal period. In addition, depending on the preferences of the pregnant woman, at least one of the above-mentioned practices was chosen with the accompaniment of a midwife at the time of birth.
It was generally applied to the majority of our pregnant women within the scope of training.
It was determined that continuous midwife support provided to primiparous pregnant women until the postpartum period increased women's comfort, sleep quality and breastfeeding self-sufficiency.
Outcome Measure Title: General Comfort Level Description: General comfort level is assessed using the General Comfort Scale developed by Kolcaba (1992) and validated in Turkish by Kuğuoğlu and Karabacak (2008). This 48-item Likert-type scale includes four subdimensions: Physical Comfort (12 items), Psychospiritual Comfort (13 items), Environmental Comfort (13 items), and Sociocultural Comfort (10 items). Scores are calculated by reverse coding negative items, summing with positive items, and dividing by the number of items to yield an average score ranging from 1 (low comfort) to 4 (high comfort). Reliability coefficients (Cronbach's alpha) in this study were 0.773 (experimental group) and 0.905 (control group). Measurement Unit: Mean score (1-4),
Time frame: 8 weeks
It was determined that continuous midwife support provided to primiparous pregnant women until the postpartum period increased women's comfort, sleep quality and breastfeeding self-sufficiency.
Title: Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI) Description: Sleep quality was assessed using the PSQI, a validated questionnaire measuring sleep quality over the past month. The scale consists of 19 self-reported items scored from 0 to 3, with total scores ranging from 0 to 21. Scores above 5 indicate poor sleep quality. The study measured the change in PSQI total scores from baseline (pre-intervention) to post-intervention between the experimental and control groups.
Time frame: 8 weeks
It was determined that continuous midwife support provided to primiparous pregnant women until the postpartum period increased women's comfort, sleep quality and breastfeeding self-sufficiency.
Title: Breastfeeding Self-Efficacy Measured by the Antenatal Breastfeeding Self-Efficacy Scale - Short Form (AEBS-SF) Description: Breastfeeding self-efficacy was evaluated using the AEBS-SF, a validated 14-item questionnaire with a 5-point Likert scale (1 = Not confident at all, 5 = Always confident). Scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy. The study assessed changes in breastfeeding self-efficacy scores from baseline to post-intervention in the experimental group.
Time frame: 8 weeks
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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