NCT07436832

Brief Summary

This study was conducted as a randomized controlled trial to examine the effect of the Emotional Freedom Technique on preoperative anxiety and postpartum depression in high-risk pregnant women who had decided to undergo planned cesarean delivery. Data were collected from women diagnosed with high-risk pregnancy who had made the decision for planned cesarean delivery in the last trimester of pregnancy. In the Emotional Freedom Technique group, the technique was applied during the preoperative period, while the standard care group received only standard care. The study was completed with 30 women in the Emotional Freedom Technique group and 32 women in the standard care group. The "Pregnant Introductory Information Form," the "State-Trait Anxiety Inventory," and the "Edinburgh Postnatal Depression Scale" were used as data collection tools. Pre-test and post-test applications of the scales were performed, and on the 21st day postpartum, the Edinburgh Postnatal Depression Scale was administered. For data analysis, descriptive statistics, independent samples t-test, paired samples t-test, ANOVA, and Pearson correlation analyses were used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

February 13, 2026

Last Update Submit

February 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • State Anxiety Scale mean score

    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.

    Before intervention (baseline) and immediately after intervention (post-test)

Study Arms (2)

emotional freedom technique group

EXPERIMENTAL

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

Other: Emotional Freedom Tecnic

standard care group

NO INTERVENTION

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.

Interventions

Emotional Freedom Technique application to high-risk pregnant women

emotional freedom technique group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnancy
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

mersin University

Mersin, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 13, 2026

First Posted

February 27, 2026

Study Start

March 1, 2024

Primary Completion

September 30, 2024

Study Completion

October 30, 2024

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because of institutional data protection policies and participant privacy concerns.

Locations