- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07436832
Emotional Freedom Technique (EFT)
The Effect of Emotional Freedom Technique Applied to High-Risk Pregnant Women on Anxiety and Postpartum Depression: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mersin, Turkey (Türkiye)
- Mersin University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Participants meeting the following criteria will be included in the study:
Identified as at-risk pregnancies according to the Ministry of Health Risk Assessment Form,
Able to speak and understand Turkish,
Aged between 18 and 45 years,
Have a planned cesarean delivery decision,
Have a gestational age of 36 weeks or more,
Have a State Anxiety Inventory (STAI-State) mean score of 37 or higher,
Voluntarily agree to participate in the study.
Exclusion Criteria
Participants meeting any of the following criteria will be excluded from the study:
Pregnant women evaluated between March 1, 2024 and September 30, 2024 at Ankara Etlik City Hospital, Perinatology Clinic, who decline voluntary participation,
Pregnant women classified as low-risk according to the Ministry of Health Risk Assessment Form,
Younger than 18 years or older than 45 years,
Those who undergo vaginal delivery,
Pregnant women with a gestational age of 35 weeks or less,
Those with a State Anxiety Inventory (STAI-State) mean score of 36 or lower,
Pregnant women with any psychiatric disorder or diagnosis,
Those unable to speak or understand Turkish,
Participants who withdraw from the study at any stage at their own request.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: emotional freedom technique group
A pregnant woman, who was scheduled for a high-risk cesarean section in the perinatology ward due to a high-risk pregnancy, was initially evaluated using the pregnancy information form and the scores obtained from the SSI.
The woman's emotional score was assessed using the SSI scale: The researcher showed her the points to tap before the session.
Then, a round of SSI was administered by the researcher and the woman.
After the application, the woman was asked to evaluate her emotions on the SSI scale.
The session ended if the scale score exceeded +7.
For pregnant women who could not reach +7, the SSI round continued by creating new suggestion sentences according to their needs (until it reached +7).
The SSI was administered to the woman in the last hour of the preoperative period.
Postpartum, the woman was informed that she could perform the SSI she had been taught if she desired, and that if she did, she would inform the researcher of the number of times she had performed it.
On the 2
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Emotional Freedom Technique application to high-risk pregnant women
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No Intervention: standard care group
The researcher performing the intervention assigned the individuals to the groups, ensuring a safe randomization process by blinding them to their group.
The researcher met with the women upon their admission to the Perinatology Unit, provided information about the study, and obtained their verbal consent.
After the hospital preoperative preparations were completed, the researcher opened the envelope and acted according to the group information.
Information was provided about the purpose, scope, and duration of the study, and informed consent forms were signed by the volunteer participants (Appendix 6).
No other interventions were performed on the women in this group other than the consent forms and assessment tools.
In the last hour before the surgery, the researcher again asked the women the questions on the SAC.
On the 21st day following her delivery, the women were contacted by phone and asked the EPAD questions, and the study concluded.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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State Anxiety Scale mean score
Time Frame: Before intervention (baseline) and immediately after intervention (post-test)
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Mean change in State Anxiety Scorefrom baseline to post-intervention (immediately after treatment), Minimum score: 20, Maximum score: 80, Higher scores indicate higher levels of state (situational) anxiety, Lower scores indicate lower levels of state anxiety.
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Before intervention (baseline) and immediately after intervention (post-test)
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Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- 2024/299
- Mersin University (Other Identifier: Mersin University)
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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