- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07522814
"Educational Intervention for Tokophobia in Pregnant Women" (TOKO-EDU)
"Effectiveness of Educational Sessions in Reducing Tokophobia and Improving Quality of Life Among Pregnant Women: A Quasi-Experimental Study"
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Tokophobia is a severe and persistent fear of pregnancy and childbirth that can negatively affect maternal mental health, coping abilities, and overall quality of life. It is associated with increased anxiety, avoidance behaviors, and preference for unnecessary medical interventions such as cesarean delivery. Lack of knowledge and inadequate psychological support during pregnancy may exacerbate this condition.
Educational interventions have been identified as effective strategies to enhance awareness, reduce fear, and improve psychological outcomes among pregnant women. Providing structured information and coping strategies may empower women, increase their sense of control, and promote positive pregnancy experiences.
This study adopts a quasi-experimental one-group pretest-posttest design to evaluate the effectiveness of structured educational sessions on tokophobia among pregnant women attending antenatal clinics at Soad Kafafi Hospital, October City, Egypt. A purposive sample of 50 pregnant women aged 18 years and above is included in the study.
The intervention consists of five structured educational sessions, including three theoretical sessions and two practical sessions. The sessions focus on increasing awareness about tokophobia, identifying its causes and symptoms, and introducing psychological coping strategies such as relaxation techniques and stress management. Additionally, lifestyle modifications and supportive practices to enhance maternal well-being are addressed.
Data are collected before and after the intervention using validated tools, including the Tokophobia Awareness Questionnaire, Tokophobia Assessment Scale (TAS), Jalowiec Coping Scale (JCS), and WHOQOL-BREF.
The primary objective is to assess the effectiveness of the educational intervention in improving awareness and reducing tokophobia severity. Secondary outcomes include improvement in coping strategies and enhancement of quality of life.
The findings of this study may contribute to improving antenatal care practices by integrating structured educational programs targeting tokophobia, thereby supporting maternal psychological well-being and promoting positive pregnancy outcomes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Giza Governorate
-
Cairo, Giza Governorate, Egypt, 12566
- Soad Kafafi Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Pregnant women attending antenatal clinics Age 18 years and above Willing to participate and provide informed consent
Exclusion Criteria:
Pregnant women with diagnosed acute psychological disorders Pregnant women who are unable to participate in educational sessions Refusal to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Educational Intervention Group
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Tokophobia Severity Score Measured by Tokophobia Assessment Scale (TAS)
Time Frame: Baseline and immediately after completion of the intervention (approximately 2.5 months)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Tokophobia Awareness Score Measured by Tokophobia Awareness Questionnaire
Time Frame: Baseline and immediately after intervention
|
Change in awareness scores measured using the Tokophobia Awareness Questionnaire.
The total score ranges from [ zero] to [23], with higher scores indicating better awareness of tokophobia.
|
Baseline and immediately after intervention
|
|
Change in Coping Strategies Score Measured by Jalowiec Coping Scale (JCS)
Time Frame: Baseline and immediately after intervention
|
Change in coping strategies measured using the Jalowiec Coping Scale (JCS).
The total score ranges from [MIN] to [MAX], with higher scores indicating more effective coping strategies.
|
Baseline and immediately after intervention
|
|
Change in Quality of Life Score Measured by WHOQOL-BREF
Time Frame: Baseline and immediately after completion of the educational sessions
|
Change in quality of life measured using the WHOQOL-BREF questionnaire.
The total score ranges from 0 to 100, with higher scores indicating better quality of life.
|
Baseline and immediately after completion of the educational sessions
|
Collaborators and Investigators
Investigators
- Principal Investigator: Basma W Elrefay, phd, Delta University for Science and Technology, Egypt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DU-TOKO-2025-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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