The Effect of Spouse Participation Childbirth Preparation Program on Birth Outcomes

NCT06453811 | Completed DMC

• 1 other identifier: LHU_FND1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The research is designed as a pre-test, post-test, parallel-group, randomized controlled study to examine the effect of a spouse-participated childbirth preparation program based on self-efficacy theory on fear of childbirth, self-efficacy, mode of delivery and outcomes. Participants will be allocated to experimental and control groups through block randomization. Participants in the experimental group will be enrolled in a two-session spouse-participated childbirth preparation program based on self-efficacy theory once a week, in addition to receiving routine care at the hospital. Participants in the control group will not receive any intervention, only routine care provided at the hospital.

Conditions

Fear of Childbirth; Childbirth Self-Efficacy; Mode of Delivery; Childbirth Preparation Program

Keywords

Self-Efficacy; Childbirth Preparation; Fear of Childbirth; Mode of Delivery; Spousal Support; Nursing

Outcome Measures

Primary Outcomes (2)

• The Childbirth Self-Efficacy Inventory Short Form

  Measures the level of self-efficacy of expectant mothers in childbirth. The lowest score that can be obtained from the overall scale is 32 and the highest score is 320. The highest score obtained from the overall scale means that women's self-efficacy levels in childbirth are high (Ersoy \& Kukulu, 2011).

  The pre-test will be administered before randomisation and the post-test will be administered 15 minutes after the training is completed (on the same day).

• Birth Process Information Form

  This form inquires about the mode of delivery and intervention at birth. One of the primary outcomes of the research is mode of delivery.

  It will be applied two hours after the expectant mother gives birth.

Secondary Outcomes (3)

• The Fathers' Fear of Childbirth Scale

  The pre-test will be administered before randomisation and the post-test will be administered 15 minutes after the training is completed (on the same day).

• The Wijma Delivery Expectancy/Experience Questionnaire Version A-B

  The pre-test will be administered before randomisation and the post-test 2 hours after the delivery.

• The Perception of Spousal Support in Pregnancy Scale

  The pre-test will be administered before randomisation and the post-test will be administered 15 minutes after the training is completed (on the same day).

Study Arms (2)

Experimental Group

EXPERIMENTAL

According to the block randomisation method, the couples who are included in the experimental group by applying the pre-test will be included in the programme in groups of 3-4 couples by planning the day and time they can participate in the programme. At the end of the sessions, the training guide reflecting the training content will be given to the couples and they will be asked to read it at home and do their homework by using the relevant parts of the guide. At the same time, these couples will continue their routine pregnancy controls in the hospital. It is planned to complete the trainings once a week, twice in total and for two weeks. After the trainings are completed, it is planned to send at least three reminders by text message until the calculated delivery date. Brochures and text message content related to the training content will be used in the reminder.

Other: Self-efficacy Theory-based Childbirth Preparation Program

Control Group

NO INTERVENTION

No additional intervention will be provided to couples in the control group, and they will receive the routine care provided at the hospital. This routine care includes standard antenatal follow-ups, during which pregnant women and their spouses receive information about pregnancy and childbirth only during physician examinations.

Interventions

Self-efficacy Theory-based Childbirth Preparation Program OTHER

According to the block randomisation method, the couples who are included in the experimental group by applying the pre-test will be included in the programme in groups of 3-4 couples by planning the day and time they can participate in the programme. At the end of the sessions, the training guide reflecting the training content will be given to the couples and they will be asked to read it at home and do their homework by using the relevant parts of the guide. At the same time, these couples will continue their routine pregnancy controls in the hospital. It is planned to complete the trainings once a week, twice in total and for two weeks. After the trainings are completed, it is planned to send at least three reminders by text message until the calculated delivery date. Brochures and text message content related to the training content will be used in the reminder.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Couples must be 18 years of age or older,
• Couples should be able to read and write Turkish,
• The pregnant woman has never given birth before,
• The pregnant woman is at 28-30 weeks of gestation,
• The pregnancy is viable and singular,
• The pregnant woman does not have an established indication for caesarean section,
• Routine controls during pregnancy are carried out in the hospital where the study is conducted.

You may not qualify if:

• Pregnancy achieved by assisted reproductive techniques,
• Participating in a birth preparation programme other than the routine pregnancy check-ups at the hospital,
• Failure to attend any of the sessions in the childbirth preparation programme,
• Failure to communicate in the postnatal period (no response to at least 3 telephone calls)
• Development of any indication for caesarean section during pregnancy,
• The birth takes place in a health institution different from the hospital where the research will be conducted.

Sponsors & Collaborators

• Lokman Hekim University: lead

Study Sites (1)

Lokman Hekim University

Ankara, Söğütözü Mahallesi, 06510, Turkey (Türkiye)

Location

Related Publications (5)

• Calpbinici P, Uzunkaya Oztoprak P, Terzioglu F, Ustun Y. The Fathers' Fear of Childbirth Scale: a Turkish validity and reliability study. J Reprod Infant Psychol. 2024 Jun;42(3):424-438. doi: 10.1080/02646838.2023.2225084. Epub 2023 Jun 13.

  PMID: 37309993 BACKGROUND

• Korukcu O, Kukulu K, Firat MZ. The reliability and validity of the Turkish version of the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) with pregnant women. J Psychiatr Ment Health Nurs. 2012 Apr;19(3):193-202. doi: 10.1111/j.1365-2850.2011.01694.x. Epub 2012 Jan 20.

  PMID: 22260727 BACKGROUND

• Korukcu O, Bulut O, Kukulu K. Psychometric Evaluation of the Wijma Delivery Expectancy/Experience Questionnaire Version B. Health Care Women Int. 2016;37(5):550-67. doi: 10.1080/07399332.2014.943838. Epub 2014 Oct 8.

  PMID: 25119342 BACKGROUND

• Yurdakul M, Beşen MA, Alıcı, D. Development of the Perception of Spousal Support in Pregnancy Scale (PSSPS): Reliability and Validity Studies. Journal of Education and Research in Nursing. 2020; 17(1): 258-266.

  BACKGROUND

• Ersoy Y, Kukulu K. Validity and Reliability Study of Self-Efficacy in Labour and Delivery Scale [Master's Thesis]. Akdeniz University. 2011.

  BACKGROUND

Study Officials

• Zehra Gölbaşı, Ph.D.

  Lokman Hekim University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: After meeting the couples, their eligibility for inclusion in the study will be assessed. Subsequently, couples who meet the inclusion criteria will be asked to read the informed consent form and provide verbal and written consent. Pre-tests will be administered to eligible couples, who will then be assigned to either the experimental group (Self-Efficacy Theory-Based Spouse Participation Childbirth Preparation Program) or the control group according to the block randomization list.

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 12, 2024
• Study Start: January 9, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)