Fear of ChildbirthTOKO-EDUNCT07522814
"Educational Intervention for Tokophobia in Pregnant Women"
A study testing Educational Sessions on Tokophobia in people with Fear of Childbirth and Anxiety Disorders, run by Delta University for Science and Technology at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth, Anxiety Disorders, Pregnancy-Related Anxiety
- What is being tested?
- Educational Sessions on Tokophobia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2025to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women attending antenatal clinics Age 18 years and above Willing to participate and provide informed consent
Who cannot join
- Pregnant women with diagnosed acute psychological disorders Pregnant women who are unable to participate in educational sessions Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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.
Read more
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.
Read the 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.
- Being tested
- Educational Sessions on Tokophobia
- Keywords
- Tokophobia, Maternal Mental Health, Quality of Life Coping Strategies, Pregnant Women, Educational Intervention
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Sessions on TokophobiaBehavioural
Also called Tokophobia Education Program
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Educational Sessions on Tokophobia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline and immediately after intervention
Change in Coping Strategies Score Measured by Jalowiec Coping Scale (JCS)
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.
Measured: Baseline and immediately after intervention
Change in Quality of Life Score Measured by WHOQOL-BREF
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.
Measured: Baseline and immediately after completion of the educational sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start20 Feb 2025
- Primary completion10 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-group quasi-experimental pretest-posttest design was used to evaluate the effect of educational sessions on tokophobia among pregnant women.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Basma W Elrefay, phd, Principal investigator, Delta University for Science and Technology, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522814
- Sponsor's protocol ID
- DU-TOKO-2025-01
- Acronym
- TOKO-EDU
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made publicly available due to privacy, confidentiality, and ethical restrictions related to the study participants.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effectiveness of Educational Sessions in Reducing Tokophobia and Improving Quality of Life Among Pregnant Women: A Quasi-Experimental Study"
- ClinicalTrials.gov ID
- NCT07522814
- Acronym / sponsor ID
- TOKO-EDU / DU-TOKO-2025-01
- Keywords
- Tokophobia, Maternal Mental Health, Quality of Life Coping Strategies, Pregnant Women, Educational Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-group quasi-experimental pretest-posttest design was used to evaluate the effect of educational sessions on tokophobia among pregnant women.
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention Group | Experimental | Behavioral: Educational Sessions on TokophobiaPregnant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women attending antenatal clinics Age 18 years and above Willing to participate and provide informed consent
Key exclusion criteria (1 listed)
- Pregnant women with diagnosed acute psychological disorders Pregnant women who are unable to participate in educational sessions Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Sessions on TokophobiaAlso: Tokophobia Education ProgramA 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. | Behavioural | Educational Intervention Group |
Primary outcome
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.
3 secondary outcomes
Change in Tokophobia Awareness Score Measured by Tokophobia Awareness Questionnaire
Time frame: 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 Quality of Life Score Measured by WHOQOL-BREF
Time frame: Baseline and immediately after completion of the educational sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made publicly available due to privacy, confidentiality, and ethical restrictions related to the study participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Basma W Elrefay, phd principal investigator
Delta University for Science and Technology, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Sessions on Tokophobia in people with Fear of Childbirth and Anxiety Disorders, run by Delta University for Science and Technology at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.