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Completed

NCT Number: NCT07165288

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

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.

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Key information

Conditions

Effect of Continuous Midwifery Support on Comfort, Sleep, and Breastfeeding Self-Efficacy in Primiparous Women: A Follow-Up From Pregnancy to Motherhood Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Palu Devlet Hastanesi

Elâzığ, 23000, Turkey (Türkiye)

About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

warm shower

Other

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

Primary outcomes

  1. 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.

    Time frame: 8 weeks

    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),

  2. 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.

    Time frame: 8 weeks

    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.

  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.

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Palu Devlet Hastanesi

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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