NCT06082895

Brief Summary

Birth enables women to assume the role of parent, but experiencing labor pain is seen as a very stressful event. Birth pain is described as one of the most severe pains women experience throughout their lives. Different pharmacological and non-pharmacological methods are used to cope with labor pain. Non-pharmacological coping includes physiological coping (such as breathing techniques, relaxation, postural changes, and movement during labor), psychological coping (including social support, increasing self-efficacy, and increasing self-confidence), and cognitive coping (including distraction, illustration). , and focus). Birth self-efficacy refers to the mother's confidence or perception in her own ability to give birth, which may influence her future birth choices. Women with high efficacy expectations (i.e., high confidence regarding childbirth) may use cognitive coping behaviors to cope with labor pain and therefore reduce the likelihood of medical intervention.It has been found that a woman's confidence in her ability to cope with childbirth contributes significantly to her perception of pain during labor and can foster a positive perception of birth. Pregnant women with low self-efficacy also have low self-confidence during birth, which negatively affects their ability to take an active role during birth and causes an increase in cesarean delivery rates. Various approaches such as antenatal training, cognitive behavioral approach, and psychoeducation program are used to reduce the negative consequences that fear of birth may cause and to help pregnant women cope with the fear of birth and increase birth self-efficacy. One of the approaches that include these strategies is seen as the motivational interviewing method. The motivational interviewing method is a goal-oriented and more participant-centered counseling approach that aims to facilitate and activate participants' intrinsic motivation to change their behavior. Motivational interviewing is a method that encourages the participant to think about changes that can be made, rather than the counselor offering suggestions. The basic concepts of motivational interviewing are that the participant recognizes and accepts the need to make changes in their lives; This approach encourages participants to consider whether they are ready to change their behavior.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

October 9, 2023

Last Update Submit

April 15, 2024

Conditions

Keywords

birth self-efficacymotivational interviewpregnancy

Outcome Measures

Primary Outcomes (1)

  • The Childbirth Self-Efficacy Scale-Short Form (CBSEI-SF)

    The short version of the Birth Self-Efficacy Scale consists of 32 items. This scale was developed to measure the self-efficacy level of pregnant women in labor. The validity and reliability of the scale in Turkish was conducted. The scale consists of two sub-dimensions: outcome expectation and competence expectation. Each sub-dimension of the scale consists of 16 items. A high score from each subscale indicates that pregnant women have high expectations of adequacy and outcome regarding labor. High scores from the scale indicate that pregnant women have high self-efficacy levels in labor.

    each participant pregnant will be evaluated for outcome measure for four weeks

Study Arms (2)

intervention group

EXPERIMENTAL

This group will consist of 45 pregnant women. The training program based on the motivational interviewing method will continue once a week for a total of 4 weeks.

Behavioral: Birth self-efficacy enhancement training based on motivational interviewing method

control group

NO INTERVENTION

This group will consist of 45 pregnant women. This group will not be given any training program and routine pregnancy follow-ups will continue.

Interventions

Birth self-efficacy enhancement training based on motivational interviewing method

intervention group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince there is a training program on pregnant women, female gender was preferred.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years or older,
  • Being at least a primary school graduate,
  • Being between 20-34 weeks in the calculations made according to the last menstrual date or with USG data for pregnant women who do not know the last menstrual date,
  • Having a fear of birth,
  • Having a single and live pregnancy,
  • Agreeing to participate in the research,
  • Having no difficulty in communicating,
  • Without infertility treatment,
  • No contraindications for vaginal birth

You may not qualify if:

  • Pregnant women with medical indications,
  • Those with risky pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yozgat City Hospital

Yozgat, 66000, Turkey (Türkiye)

Location

Study Officials

  • Tuğba Sarı, Nurse

    Yozgat City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Two groups, intervention and control groups, will be created by randomization method for pregnant women who have fear of birth and are determined to have low birth self-efficacy. Pregnant women in the intervention group will be given a 4-session motivational interview program. The control group will continue routine monitoring. After the training, birth self-efficacy levels will be compared between the two groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
sponsor-investigator

Study Record Dates

First Submitted

October 9, 2023

First Posted

October 13, 2023

Study Start

October 5, 2023

Primary Completion

March 6, 2024

Study Completion

March 10, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

All IPD collected and affecting the outcome of the study will be published

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
starting 6 months after publication
Access Criteria
Only the collected data will be shared for analysis.

Locations