NCT06999564

Brief Summary

This study is a parallel randomized controlled trial on 60 primiparous women with cesarean section pain, randomly divided into EFT and control groups. The study was approved by KTO Karatay University Faculty of Medicine Ethics Committee. Women will be included in the study according to the following criteria: at least primary school graduate, primiparous, planned cesarean section and 4 or more postoperative pain according to VAS. Women with chronic diseases such as heart disease, high blood pressure and diabetes, history of miscarriage, placenta previa, mental illness in the past year, psychoactive drug use, drug addiction, smoking, and pregnancy complications such as pre-eclampsia, bleeding, intrauterine death and preterm delivery will be excluded. Data collection will start in June 2025 and will be completed in August 2025.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

June 2, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2025

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

April 13, 2025

Last Update Submit

December 12, 2025

Conditions

Keywords

caesarean sectionanxietysense of course

Outcome Measures

Primary Outcomes (2)

  • EFT for women who had a planned caesarean section

    Face-to-face EFT will be applied to mothers in the period after cesarean delivery in order to examine the effect of EFT application between 0-24 hours on womens pain level.

    0-24 hour

  • 2. EFT for women with a planned cesarean section

    Description: By applying EFT face-to-face to mothers in the period after cesarean delivery, the effect of EFT application between 0-24 hours on women's anxiety levels will be examined.

    0-24 hour

Secondary Outcomes (1)

  • 3.EFT for women with a planned cesarean section

    0-24 hour

Study Arms (2)

EFT

EXPERIMENTAL

Three sessions of face-to-face EFT will be applied to mothers who will have a planned cesarean section three days before delivery. In order to examine the effect of EFT on women's feelings of security, anxiety and pain levels after childbirth, face-to-face EFT will be applied to mothers in the postpartum period after cesarean section.

Behavioral: EFT

CONTROL

NO INTERVENTION

No application was made to the control group. Following the pre-test application, VAS, SUI and STAI-I-SATAI-II post-test data will be applied before and after cesarean delivery. After the data were reported, EFT was applied to the women in the control group individually by the researchers.

Interventions

EFTBEHAVIORAL

EFT involves the following steps: 1. Identification of the problem that is causing the person distress (e.g., fear of childbirth) and scoring or measuring the severity of this problem. 2. Tapping with the fingertips on certain points of the face and body, known as correction (i.e., regulation of the energy system), as well as the expression of an emphatic phrase (related to the person\'s problem and self-acceptance).

EFT

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswill be performed with women who have had a planned caesarean section
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • primary school graduate
  • primiparous
  • planned cesarean section
  • Postoperative pain of 4 or more according to VAS.

You may not qualify if:

  • Heart disease
  • high blood pressure
  • chronic diseases such as diabetes
  • history of miscarriage
  • placenta previa
  • mental illness in the last year
  • use of psychoactive drugs
  • drug addiction
  • cigarette smoking
  • preeclampsia
  • bleeding
  • intrauterine death
  • premature birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hafize Dağ Tüzmen

Konya, 4200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AgnosiaAnxiety Disorders

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
While the pre-tests and post-tests of the study will be administered by a researcher who does not know which groups the participants are assigned to, they will be administered by the lead researcher who is an expert in EFT and the results will be reported by a blind statistician.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study is a parallel randomized controlled trial on 60 primiparous women with cesarean section pain randomly allocated to EFT and control groups. The study was approved by the Ethics Committee of KTO Karatay University Faculty of Medicine. In addition, the protocol of this study was registered in the Clinical Trials Register. All participants gave written informed consent before data collection. Women were included according to the following criteria: at least primary school graduate, primiparous, planned cesarean section, and postoperative pain of 4 or more according to VAS. Women with chronic diseases such as heart disease, high blood pressure and diabetes, history of miscarriage, placenta previa, mental illness in the past year, use of psychoactive drugs, drug addiction, smoking, and pregnancy complications such as pre-eclampsia, bleeding, intrauterine death and preterm delivery were excluded.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.

Study Record Dates

First Submitted

April 13, 2025

First Posted

May 31, 2025

Study Start

June 2, 2025

Primary Completion

December 1, 2025

Study Completion

December 13, 2025

Last Updated

December 16, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

YES

Shared Documents
STUDY PROTOCOL
Time Frame
June and was completed in August 2025

Locations