NCT07522814

Brief Summary

This quasi-experimental study aims to evaluate the effectiveness of structured educational sessions on tokophobia among pregnant women. Tokophobia, defined as an intense fear of pregnancy and childbirth, can negatively affect maternal psychological well-being, coping abilities, and overall quality of life. A purposive sample of 50 pregnant women attending antenatal clinics at Soad Kafafi Hospital, October City, Egypt, participated in the study. Participants received a structured educational intervention consisting of five sessions addressing knowledge about tokophobia, psychological coping strategies, and lifestyle modifications to enhance well-being during pregnancy. Data were collected before and after the intervention using validated tools, including the Tokophobia Awareness Questionnaire, Tokophobia Assessment Scale, Jalowiec Coping Scale, and WHOQOL-BREF. The study evaluates changes in awareness levels, severity of tokophobia, coping strategies, and quality of life following the intervention. The findings are expected to provide evidence on the role of educational interventions in reducing fear of childbirth and improving maternal psychological outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 4, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

TokophobiaMaternal Mental HealthQuality of Life Coping StrategiesPregnant WomenEducational Intervention

Outcome Measures

Primary Outcomes (1)

  • Change in Tokophobia Severity Score Measured by Tokophobia Assessment Scale (TAS)

    Change in tokophobia severity scores measured using the Tokophobia Assessment Scale (TAS). The total score ranges from \[MIN\] to \[MAX\], with higher scores indicating greater severity of fear of childbirth.

    Baseline and immediately after completion of the intervention (approximately 2.5 months)

Secondary Outcomes (3)

  • Change in Tokophobia Awareness Score Measured by Tokophobia Awareness Questionnaire

    Baseline and immediately after intervention

  • Change in Coping Strategies Score Measured by Jalowiec Coping Scale (JCS)

    Baseline and immediately after intervention

  • Change in Quality of Life Score Measured by WHOQOL-BREF

    Baseline and immediately after completion of the educational sessions

Study Arms (1)

Educational Intervention Group

EXPERIMENTAL

Pregnant women who received a structured educational intervention consisting of five sessions (three theoretical and two practical) focusing on increasing awareness of tokophobia, reducing fear of childbirth, and improving coping strategies and psychological well-being.

Behavioral: Educational Sessions on Tokophobia

Interventions

A structured educational program designed to provide information about tokophobia, its causes, symptoms, and management, along with training on psychological coping strategies and supportive techniques to enhance maternal well-being.

Also known as: Tokophobia Education Program
Educational Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women attending antenatal clinics Age 18 years and above Willing to participate and provide informed consent

You may not qualify if:

  • Pregnant women with diagnosed acute psychological disorders Pregnant women who are unable to participate in educational sessions Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soad Kafafi Hospital

Cairo, Giza Governorate, 12566, Egypt

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Basma W Elrefay, phd

    Delta University for Science and Technology, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking was applied in this study due to the nature of the educational intervention
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: A single-group quasi-experimental pretest-posttest design was used to evaluate the effect of educational sessions on tokophobia among pregnant women.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2026

First Posted

April 13, 2026

Study Start

February 20, 2025

Primary Completion

May 10, 2025

Study Completion

May 15, 2025

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be made publicly available due to privacy, confidentiality, and ethical restrictions related to the study participants.

Locations