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

NCT ID: NCT07165288

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-12-20

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.

Detailed Description

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".

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Continuous midwife support care

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):

Group Type: ACTIVE_COMPARATOR

Continuous midwife support care

Intervention Type: OTHER

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

Pilates ball usage

Intervention Type: 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

Intervention Type: OTHER

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

Control Group

Control Group First Interview (36th week of pregnancy - first encounter)

Second Interview (5-7th day after birth):

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Continuous midwife support care

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

Intervention Type: OTHER

Pilates ball usage

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.

Intervention Type: OTHER

warm shower

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Palu Devlet Hastanesi

OTHER

Sponsor Role: lead

Responsible Party

Sümeyye ŞİMŞEK

Midwife / MSC Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sümeyye ŞİMŞEK, MSC student

Role: PRINCIPAL_INVESTIGATOR

İnönü Üniversitesi

Locations

Palu Devlet Hastanesi

Elâzığ, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Study Documents

Document Type: Study Protocol

Our study found that the support provided had a significant impact on primiparous mothers.

View Document

Related Links

https://pubmed.ncbi.nlm.nih.gov/26370160/

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

Other Identifiers

Palu Devlet Hastanesi

Identifier Type: -

Identifier Source: org_study_id