NCT06199245

Brief Summary

This study was planned to determine the effect of emotional freedom technique (EFT) on breastfeeding success and self-efficacy in primiparous women in the early postpartum period who had a cesarean delivery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

December 27, 2023

Last Update Submit

January 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Bristol Breastfeeding Rating Scale

    This scale measures breastfeeding success. The scale is a Likert-type scale consisting of 4 items: "positioning", "holding", "sucking" and "swallowing". Each item is scored between 0-2 points. The lowest score from the scale is 0, the highest score is 8. Low scores indicate that breastfeeding is not effective, while high scores indicate that breastfeeding is effective.

    one day

Secondary Outcomes (2)

  • breastfeeding self-efficacy scale

    one day

  • Subjective Units of Disturbance Scala

    one day

Study Arms (2)

emotional freedom technique experimental group

EXPERIMENTAL

Emotional Freedom Technique was applied to the participants in the experimental group, who had a cesarean section on the first postpartum day and agreed to participate in the study, and their breastfeeding self-efficacy and breastfeeding success were evaluated.

Other: emotional freedom technique experimental group

control group

NO INTERVENTION

Participants in the control group were selected from the same sample group, but no intervention was applied. Breastfeeding self-efficacy and breastfeeding success were evaluated after a routine hospital procedure.

Interventions

Participants in the experimental group, who had a cesarean delivery on the first postpartum day, filled out the sociodemographic and obstetric information form and the Breastfeeding Self-Efficacy Scale, and then were asked to breastfeed their babies and their breastfeeding was evaluated with the Bristol Breastfeeding Evaluation Scale. The participant was then asked to score her breastfeeding between 0 and 10 to evaluate her Subjective Units of Disturbance Scala (SUD) score. The next evaluation was made 2 hours after the participant received breastfeeding training, the Bristol Breastfeeding Rating Scale score was obtained, and the SUD was scored again after 2 rounds of Emotional Freedom Techniques (EFT) application. Finally, at the end of the day, 2 rounds of EFT application were performed by taking the SUD score before the EFT session, and after the application, the participant's Breastfeeding Self-Efficacy Scale, Bristol Breastfeeding Evaluation Scale and SUD scores were recorded.

emotional freedom technique experimental group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study is conducted with women who have given birth by cesarean section.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 18-35,
  • Primiparous and giving birth by cesarean section,
  • Having a spontaneous pregnancy,
  • Wound, scar, infection etc. in the tapping area. without conditions,
  • Women who do not have verbal communication problems

You may not qualify if:

  • Being outside the age range of 18-35
  • Has any problem that prevents communication,
  • Those who gave birth normally
  • Having had a high-risk pregnancy,
  • Women who want to leave the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol Mega University Hospital

Istanbul, 34214, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Pınar IRMAK VURAL, Asst. Prof.

    thesis advisor

    STUDY DIRECTOR

Central Study Contacts

Eda Yüzügüler, student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The researcher knows the distribution of the groups, but the participants do not know whether they are in the experimental or control group.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: An experimental group in which EFT was applied and a control group in which the routine procedure was applied.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc student

Study Record Dates

First Submitted

December 27, 2023

First Posted

January 10, 2024

Study Start

November 1, 2023

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations