Effect of Continuous Midwifery Support on Comfort, Sleep Quality, and Breastfeeding Self-Efficacy in Primiparous Women: A Follow-Up Study From Pregnancy to Motherhood

NCT07165288 | Completed

• 1 other identifier: Palu Devlet Hastanesi
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Effect of Continuous Midwifery Support on Comfort, Sleep, and Breastfeeding Self-Efficacy in Primiparous Women: A Follow-Up From Pregnancy to Motherhood

Keywords

Breastfeeding self-efficacy; Comfort; Continuous midwifery support; Primiparity; Sleep quality

Outcome Measures

Primary Outcomes (3)

• 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),

  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.

  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.

  8 weeks

Study Arms (2)

Continuous midwife support care

ACTIVE COMPARATOR

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

NO INTERVENTION

Control Group First Interview (36th week of pregnancy - first encounter) Second Interview (5-7th day after birth):

Interventions

Continuous midwife support care OTHER

Primiparous pregnant women are provided with continuous and individual midwife support starting from the 36th week until the postpartum period.

Continuous midwife support care

Pilates ball usage OTHER

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.

Continuous midwife support care

warm shower OTHER

It was generally applied to the majority of our pregnant women within the scope of training.

Continuous midwife support care

Eligibility Criteria

• Age: 18 Years - 36 Years
• Gender Eligibility Details: Since the study will be conducted with pregnant women, only female individuals are eligible to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All pregnant women who communicate verbally and do not have a reading or writing disability,
• Having a singleton healthy pregnancy,
• Having a primiparous pregnancy in the 36th week of pregnancy,
• Not a midwife by profession,
• Not having any diagnosed psychiatric problems were included.

You may not qualify if:

• Women who developed an indication for cesarean section were excluded.
• For postpartum women;
• Those who developed a condition requiring separation from their babies,
• Those who wanted to leave the study during the follow-ups,
• Those who filled out the data collection forms incompletely,
• Those who gave birth before the third interview were excluded.

Sponsors & Collaborators

• Palu Devlet Hastanesi: lead

Study Sites (1)

Palu Devlet Hastanesi

Elâzığ, 23000, Turkey (Türkiye)

Location

Related Links

• Qualitative study in a maternity unit in Norway, where approximately 4000 births take place each year. In-depth interviews were conducted with ten midwives working in two different maternity units. Qualitative data were analysed using systematic text con

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Sümeyye ŞİMŞEK, MSC student

  İnönü Üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Midwife / MSC Student

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: September 10, 2025
• Study Start: January 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: December 20, 2024
• Last Updated: September 10, 2025

Record last verified: 2025-03

Locations

TU (1)