Companions Who Support the Pregnant Woman During the Birth Process

NCT06624748 | Completed

• 1 other identifier: 2023/1021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

In our country, although there is currently an emphasis on companion support within the scope of mother-friendly hospitals, there is no guide for companions. This study was planned to determine the effect of women who have companion support during labor on birth satisfaction, birth comfort, postpartum comfort level and positive birth outcomes, as well as the opinions of the people who provide support. Based on the results obtained and the positive contributions to maternal satisfaction during the labor process, birth and postpartum comfort process, mother-baby health, as well as the opinions of the companions, a 'Pregnant Support Guide in Labor' will be created and the companions will be enabled to support the pregnant woman in line with this guide. In addition, based on the opinions of the attendants, the researchers plan to develop the 'Birth Support Satisfaction Scale'.

Conditions

Childbirth Problems; Support, Family

Keywords

Pregnancy; Midwife

Outcome Measures

Primary Outcomes (1)

• Birth Comfort Scale Score

  The Birth Comfort Scale is a tool designed to evaluate the level of comfort experienced by women during labor and delivery. The scale measures the influence of physical, psychological, and environmental factors on comfort during childbirth. It allows women to assess aspects such as physical ease, pain management, a sense of security, and environmental support during labor. Typically, the scale follows a 5-point Likert format, with each item scored from 1 to 5 (1: Strongly disagree, 5: Strongly agree). The total comfort score can range from a minimum of 10 to a maximum of 50. The scale demonstrates high internal consistency as measured by Cronbach's Alpha, with values typically ranging between 0.80 and 0.90, indicating that it is a reliable tool for assessing birth comfort.

  At the time of cervical dilatation reaching 8 cm during the intrapartum period

Secondary Outcomes (1)

• Postpartum Comfort Scale

  Two hours postpartum

Study Arms (2)

emotional and physical support to the pregnant woman provided by attendant

EXPERIMENTAL

Following the information, the attendant will provide emotional and physical support to the pregnant woman (such as massage, supporting the pregnant woman while moving, giving the pregnant woman a warm shower), and all interventions made by the companion and their duration will be recorded by the researcher in the 'Birth Process Support Form'. When the cervical dilatation is 8 cm, the Birth Comfort Scale will be applied to the pregnant woman, and two hours after the birth, the Birth Satisfaction Scale and the Postpartum Comfort Scale will be applied. Information about the birth process will be recorded in the Birth Information Form. In addition, semi-structured questions in the 'Companion Interview Form' will be asked to the companions selected for qualitative interviews and voice recording will be recorded.

Behavioral: emotional and physical support to the pregnant woman provided by attendant

Standard of care

NO INTERVENTION

Women who are informed about the purpose and practices of the research and who agree to participate in the study voluntarily will not be deviated from routine practices in the hospital. Women who are followed and delivered by the same midwife will be included in the study to ensure that there is no difference between the groups in terms of episiotomy application and birth techniques. When the cervical dilatation is 8 cm, the Birth Comfort Scale will be applied to the pregnant woman, and two hours after the birth, the Birth Satisfaction Scale and the Postpartum Comfort Scale will be applied. Information about the birth process will be recorded in the Birth Information Form.

Interventions

emotional and physical support to the pregnant woman provided by attendant BEHAVIORAL

The companion will provide emotional and physical support to the pregnant woman (such as massage, supporting the pregnant woman while moving, taking a warm shower, etc.), and all interventions made by the companion and their duration will be recorded by the researcher in the 'Birth Process Support Form'. When the cervical dilatation is 8 cm, the Birth Comfort Scale will be applied to the pregnant woman, and two hours after the birth, the Birth Satisfaction Scale and the Postpartum Comfort Scale will be applied. Information about the birth process will be recorded in the Birth Information Form. In addition, semi-structured questions in the 'Companion Interview Form' will be asked to the companions selected for qualitative interviews and voice recording will be recorded.

emotional and physical support to the pregnant woman provided by attendant

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged 37-42.
• Women who are planning to give birth vaginally during their first week of pregnancy.
• First-time pregnant women.
• Women with no vision, hearing, or communication problems.
• Women who can speak and express themselves in Turkish.
• Women who are willing to participate voluntarily in the study.

You may not qualify if:

• Pregnant women with multiple pregnancies.
• Women who are planned to give birth by cesarean section.
• Women with any complications during pregnancy.
• Women with chronic diseases.
• Pregnant women with verbal, mental, or other communication disabilities.
• Among the pregnant women included in the control or intervention group, those who:
• Received epidural analgesia.
• Experienced instrumental delivery (with vacuum or forceps).
• Had postnatal complications in the newborn.
• Had complications related to episiotomy (such as 3rd and 4th degree laceration, hematoma).

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (2)

Bihter Akın

Selçuklu, Konya, 42060, Turkey (Türkiye)

Location

Selcuk University

Konya, 42100, Turkey (Türkiye)

Location

Related Publications (1)

• Balcik Colak M, Akin B, Kalkan SC, Uslu Yuvaci H. Effects of labor support on pregnant women's childbirth comfort, satisfaction and postpartum comfort levels: a randomized controlled trial. BMC Pregnancy Childbirth. 2025 Jul 24;25(1):789. doi: 10.1186/s12884-025-07904-6.

  PMID: 40707892 DERIVED

Study Officials

• Bihter Akın

  Selcuk University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assos. Prof.

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: October 3, 2024
• Study Start: March 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)