NCT06947369

Brief Summary

The research is planned as a randomised controlled experimental study. Research data will be collected between March-July 2025. The population of the study will consist of all pregnant women who come to Kilis Prof.Dr.Alaeddin Yavaşca State Hospital Gynaecology and Obstetrics Polyclinics. The sample of the study will consist of primiparous pregnant women who meet the research criteria and accept to participate in the study among the pregnant women who come to Kilis Prof.Dr.Alaeddin Yavaşca State Hospital Gynaecology and Obstetrics Polyclinics. Data will be collected from primiparous pregnant women who meet the inclusion criteria and accept the study after being informed about the study by meeting the pregnant women who come to Kilis Prof.Dr.Alaeddin Yavaşca State Hospital Gynaecology and Obstetrics Outpatient Clinic before or after their outpatient examinations. Data Collection Tools Personal Information Form, Wijma Birth Anticipation / Experience Scale A Version scale and Prenatal Self-Assessment Scale Dependent variables of the study: Wijma Birth Expectancy / Experience Questionnaire (W-DEQ) A Version and Prenatal Self-Assessment Scale subscales of acceptance of maternal role and readiness for childbirth scales. Independent variables of the study: Socio-demographic and obstetric characteristics of primiparous pregnant women

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 3, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

April 20, 2025

Last Update Submit

April 25, 2025

Conditions

Keywords

Primiparous pregnant, fear of childbirth,role of motherhood, Joyce Travelbee, childbirth readiness

Outcome Measures

Primary Outcomes (1)

  • Information about the physiology of pregnancy and the pregnancy process

    * Briefly introducing herself * How she felt when she learned she was pregnant * How she perceived and adapted to pregnancy * Questioning the pregnancy process and providing information on the subject

    1 week after the pretest was administered

Study Arms (2)

Experimental group

EXPERIMENTAL

Within the scope of the research, the pregnant women in the experimental group will be given a training program based on Joyce Travelbee's human-to-human relations theory, one session per week for 30-45 minutes, for a total of five sessions.

Other: Experimental Group

Control group

NO INTERVENTION

Within the scope of the research, no training will be given to the control group after the pretest is applied.

Interventions

Within the scope of the research, the pregnant women in the experimental group will be given a training program based on Joyce Travelbee's human-to-human relations theory, one session per week for 30-45 minutes, for a total of five sessions, while the control group will continue their routine follow-up.

Experimental group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPrimiparous pregnant women
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. The pregnant woman is between 28-40 weeks of gestation (third trimester). 4. The pregnant woman does not have a chronic health problem. 5. The pregnant woman has a single fetus. 6. The pregnant woman has not received infertility treatment. 7. The pregnant woman has not received a psychiatric diagnosis. 8. The pregnant woman does not have a high-risk pregnancy. 9. The pregnant woman's acceptance to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kilis Prof.Dr.Alaeddin Yavaşca State Hospital

Kilis, Merkez, 79000, Turkey (Türkiye)

RECRUITING

Study Officials

  • Prof.Dr.Ümran SEVİL

    Hasan Kalyoncu University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

April 20, 2025

First Posted

April 27, 2025

Study Start

March 3, 2025

Primary Completion

June 1, 2025

Study Completion

July 31, 2025

Last Updated

April 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations