The Effect of Spouse Participation Childbirth Preparation Program on Birth Outcomes

Fear of Childbirth Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06453811
• Other study ID #: LHU_FND1
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Lokman Hekim Üniversitesi
• Contact: Fatma Nur Duman, M.Sc.
• Phone: +0903124448548
• Email: fatmanurduman8[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 three-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.

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 4-5 couples, scheduled according to their availability. At the end of the sessions, brochures reflecting the educational content will be given to the couples to read at home. These couples will also receive routine care provided at the hospital, which includes standard antenatal follow-up and information about pregnancy and childbirth during physician visits. After the completion of the training, couples will receive weekly phone calls until their estimated due date to reinforce the educational content. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Volunteering to participate in the study

• Both members of the couple being 18 years of age or older

• Both members of the couple having the ability to read and write in Turkish

• The pregnant woman having no prior history of childbirth

• The pregnant woman being in the 30-33rd week of pregnancy

• The pregnancy being singleton and viable

• The pregnant woman having no known obstacles to vaginal delivery

• The pregnant woman not having any specified indication for cesarean section

• Routine pregnancy check-ups being conducted at the hospital where the research is being carried out

• The pregnant woman not meeting any of the criteria listed in the "Republic of Turkey Ministry of Health Pregnancy Risk Assessment Form"

Exclusion Criteria:

• Voluntarily withdrawing from the study

• Non-attendance to any session of the childbirth preparation program

• Failure to maintain communication in the postpartum period

• Development of any risk factor related to pregnancy

• Delivery occurring at a healthcare institution other than the one where the research is being conducted

• Emergency cesarean section

• Conception occurring through assisted reproductive techniques

• Participating in another childbirth preparation program outside of the prenatal care received at the hospital

Related Conditions & MeSH terms

• Childbirth Self-Efficacy
• Fear of Childbirth
• Mode of Delivery

Intervention

Other:
• Self-efficacy Theory-based Childbirth Preparation Program
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 4-5 couples, scheduled according to their availability. At the end of the sessions, brochures reflecting the educational content will be given to the couples to read at home. These couples will also receive routine care provided at the hospital, which includes standard antenatal follow-up and information about pregnancy and childbirth during physician visits. After the completion of the training, couples will receive weekly phone calls until their estimated due date to reinforce the educational content.

Locations

Country	Name	City	State
Turkey	Lokman Hekim University	Ankara	Sögütözü Mahallesi

Sponsors (1)

Lead Sponsor	Collaborator
Lokman Hekim Üniversitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Fathers' Fear of Childbirth Scale	Measures the level of fear of childbirth in expectant fathers. The minimum score that can be obtained from the scale is 17 and the maximum score is 85. As the score increases, the level of fear of birth experienced by fathers also increases.	The pre-test will be administered before randomization, and the post-test will be administered fifteen minutes after the training is completed.
Primary	The Wijma Delivery Expectancy/Experience Questionnaire Version A-B	Measures the level of fear of childbirth in expectant mothers. The minimum score that can be obtained from the scale is 0 and the maximum score is 165. As the score obtained from the scale increases, women's fear of childbirth also increases.	The pre-test will be administered before randomization, and the post-test will be administered fifteen minutes after the training is completed.
Primary	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.	The pre-test will be administered before randomization, and the post-test will be administered fifteen minutes after the training is completed.
Primary	The Perception of Spousal Support in Pregnancy Scale	Measures pregnant women's perceived partner support. A minimum of 16 and a maximum of 80 points can be obtained from the scale. A higher score means higher perceived spousal support.	The pre-test will be administered before randomization, and the post-test will be administered fifteen minutes after the training is completed.
Primary	Birth Process Information Form	It asks about the gestational week at birth and the mode of delivery.	It will be applied two hours after the expectant mother gives birth.