Viewing Study NCT06453811



Ignite Creation Date: 2024-06-16 @ 11:52 AM
Last Modification Date: 2024-10-26 @ 3:31 PM
Study NCT ID: NCT06453811
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-12
First Post: 2024-06-01

Brief Title: The Effect of Spouse Participation Childbirth Preparation Program on Birth Outcomes
Sponsor: Lokman Hekim Üniversitesi
Organization: Lokman Hekim Üniversitesi

Study Overview

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
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 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
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 ExpectancyExperience 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 ExpectancyExperience 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None