Clinical trial NCT06453811: The Effect of Spouse Participation Childbirth Preparation Program on Birth Outcomes
Official title: The Effect of a Self-Efficacy Theory-Based Spouse Participation Childbirth Preparation Program on Fear of Childbirth, Self-Efficacy, Mode of Delivery and Birth Outcomes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Lokman Hekim Üniversitesi
Sponsor class: OTHER_GOV
First posted: 2024-06-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Nulliparous pregnant women and their spouses who apply to the obstetrics and gynecology clinic and outpatient clinic of the hospital where the research will be conducted will be assessed for eligibility according to the inclusion criteria, and informed consent will be obtained. Subsequently, prospective fathers will be given a Personal Information Form and the Fathers' Fear of Childbirth Scale; prospective mothers will be given a Personal Information Form, the Wijma Delivery Expectancy/Experience Questionnaire Version A, the Childbirth Self-Efficacy Inventory Short Form, and the Perception of Spousal Support in Pregnancy Scale as pre-tests. Couples will be allocated to the experimental or control group according to a block randomization list. Couples assigned to the experimental group will be included in a three-week program, attending a self-efficacy theory-based childbirth preparation program in groups of 3-4 couples, scheduled according to their availability. At the end of the sessions, the training guide reflecting the content of the training 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 routine pregnancy controls in the hospital. Routine pregnancy check-ups at the hospital include standard antenatal follow-ups, and pregnant women and their partners receive information about the pregnancy and labour process only during the medical examination. 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 contents related to the training content will be used in the reminder. After completing the training, the Fathers' Fear of Childbirth Scale, the Childbirth Self-Efficacy Inventory Short Form, and the Perception of Spousal Support in Pregnancy Scale will be administered again. Following childbirth, the Wijma Delivery Expectancy/Experience Questionnaire Version B will be completed by the mothers, and the birth process information form will be filled out by the researcher. Couples in the control group will undergo the same pre-test and post-test assessments as the experimental group. However, no additional intervention will be provided to these couples, and they will receive the same routine care as the experimental group.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The Childbirth Self-Efficacy Inventory Short Form
timeFrame: 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).
measure: Birth Process Information Form
timeFrame: It will be applied two hours after the expectant mother gives birth.
Secondary outcomes:
measure: The Fathers' Fear of Childbirth Scale
timeFrame: 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).
measure: The Wijma Delivery Expectancy/Experience Questionnaire Version A-B
timeFrame: The pre-test will be administered before randomisation and the post-test 2 hours after the delivery.
measure: The Perception of Spousal Support in Pregnancy Scale
timeFrame: 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).
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Lokman Hekim University
state: Söğütözü Mahallesi
Study officials:
affiliation: Lokman Hekim Üniversitesi
name: Zehra Gölbaşı, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Ersoy Y, Kukulu K. Validity and Reliability Study of Self-Efficacy in Labour and Delivery Scale [Master's Thesis]. Akdeniz University. 2011.