The Effect of Emotional Freedom Technique on Mental Well-Being and Stress Level in Pregnant Women

July 7, 2024 updated by: Esra KARATAŞ OKYAY, Kahramanmaras Sutcu Imam University

The Effect of Emotional Freedom Technique Applied to Women With Risky Pregnancy on Mental Well-Being and Stress Level

Emotional freedom technique will be applied to women with risky pregnancy. Emotional freedom technique group and control groups each consisted of 60 pregnant women.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objective In this experimental study, it was aimed to examine the effect of emotional freedom technique applied to women with risky pregnancy on mental well-being and stress levels.

Materials and Methods: This randomized controlled study will be conducted between February 2024 and August 2024 in Kahramanmaraş Necip Fazıl City Hospital Obstetrics and Gynecology Annex Building Obstetrics Outpatient Clinics with a total of 120 risk pregnant women (60 EFT, 60 control). EFT will be applied in the study. Women in the EFT group will receive EFT four times at one-week intervals. Pretest data will be obtained by filling out the Personal Information Form, Warwick-Edinburgh Mental Well-Being Scale (WEMWB), Prenatal Distress Scale - Revised Version before the Emotional Freedom Technique application. After the interventions, post-test data will be obtained by completing the Warwick-Edinburgh Mental Well-Being Scale (WEMWB), Prenatal Distress Scale - Revised Version. In addition, the Subjective Units of Experience (SUE) scale will be administered before and after each EFT intervention.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Onikişubat
      • Kahramanmaraş, Onikişubat, Turkey, 46050
        • Recruiting
        • Kahramanmaraş Sütçü İmam University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age or older,
  • Graduated from at least primary school
  • Volunteering to participate in the research,
  • Primiparous,
  • Pregnant women who do not have conditions such as infection, wound, scar in the tapping areas.
  • Pregnant women who meet any of the criteria in the Ministry of Health Risk Assessment Form for Pregnancy.

Exclusion Criteria:

  • Pregnant women who participated in EFT or other antenatal classes/programs during the study period.
  • Those who did not want to continue participating in the study,
  • Those with a psychological problem according to the pregnant women's statements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Emotional freedom technique group
Emotional freedom technique will be applied to risky pregnant women in the emotional freedom technique group.
Behavioral: Emotional freedom technique group
Control group
Other Names:
  • No Intervention
No Intervention: Control group
Pregnant women in the control group will not receive any intervention other than routine hospital care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the level of Mental Well-Being
Time Frame: The Warwick-Edinburgh Mental Well-Being Scale will be administered to two groups of pregnant women on day one (first interview)
The scale is a 14-item, self-report style scale. The scale consists of positive items including hedonic and eudaimonic dimensions of mental well-being, optimism, feeling useful, relaxation, interest in other people, being energetic and lively, coping with problems, clear thinking, feeling good, feeling close to other people, self-confidence, decision-making, love, interest in new things and being cheerful. The scale covers psychological well-being and subjective well-being and deals with the positive mental health of individuals. The scale is a five-point Likert scale with a minimum score of 14 and a maximum score of 70. Scoring of the scale is as follows: strongly disagree (1), disagree (2), somewhat agree (3), agree (4), strongly agree (5). All items of the scale are positive. High scores on the scale indicate high mental well-being.
The Warwick-Edinburgh Mental Well-Being Scale will be administered to two groups of pregnant women on day one (first interview)
Assessment of the level of Mental Well-Being
Time Frame: The Warwick-Edinburgh Mental Well-Being Scale will be administered to three groups of menopausal women at the last interview (after the 4th intervention at one week interval).
The scale is a 14-item, self-report style scale. The scale consists of positive items including hedonic and eudaimonic dimensions of mental well-being, optimism, feeling useful, relaxation, interest in other people, being energetic and lively, coping with problems, clear thinking, feeling good, feeling close to other people, self-confidence, decision-making, love, interest in new things and being cheerful. The scale covers psychological well-being and subjective well-being and deals with the positive mental health of individuals. The scale is a five-point Likert scale with a minimum score of 14 and a maximum score of 70. Scoring of the scale is as follows: strongly disagree (1), disagree (2), somewhat agree (3), agree (4), strongly agree (5). All items of the scale are positive. High scores on the scale indicate high mental well-being.
The Warwick-Edinburgh Mental Well-Being Scale will be administered to three groups of menopausal women at the last interview (after the 4th intervention at one week interval).
Assessment of prenatal distress level
Time Frame: The Prenatal Distress Scale - Revised Version will be administered to two groups of pregnant women on day one (first interview)
The scale determines pregnant women's social relationships, their physical and emotional symptoms during pregnancy, and their level of anxiety about themselves and their babies. The scale items have options ranging from "Not at all" (0), "A little" (1) and "Very much" (2), and the total score is obtained by summing the scores of the answers given to the scale items. A minimum score of 0 and a maximum score of 34 points are obtained from the scale. An increase in the total score obtained from the scale indicates an increase in the level of prenatal distress perceived by pregnant women.
The Prenatal Distress Scale - Revised Version will be administered to two groups of pregnant women on day one (first interview)
Assessment of prenatal distress level
Time Frame: The Prenatal Distress Scale - Revised Version will be administered to three groups of menopausal women at the last interview (after the 4th intervention at one week interval).
The scale determines pregnant women's social relationships, their physical and emotional symptoms during pregnancy, and their level of anxiety about themselves and their babies. The scale items have options ranging from "Not at all" (0), "A little" (1) and "Very much" (2), and the total score is obtained by summing the scores of the answers given to the scale items. A minimum score of 0 and a maximum score of 34 points are obtained from the scale. An increase in the total score obtained from the scale indicates an increase in the level of prenatal distress perceived by pregnant women.
The Prenatal Distress Scale - Revised Version will be administered to three groups of menopausal women at the last interview (after the 4th intervention at one week interval).
Determining the level of anxiety
Time Frame: The Subjective Units of Experience (SUE) scale will be administered to two groups of pregnant women on day one (first interview)
Subjective Units of Experience (SUE) will be applied to determine the anxiety level of pregnant women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.
The Subjective Units of Experience (SUE) scale will be administered to two groups of pregnant women on day one (first interview)
Determining the level of anxiety
Time Frame: One hour after the first interview, all pregnant women in all two groups will be administered the SUE (second measure)
Subjective Units of Experience (SUE) will be applied to determine the anxiety level of pregnant women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.
One hour after the first interview, all pregnant women in all two groups will be administered the SUE (second measure)
Determining the level of anxiety
Time Frame: Seven days after the first interview, all pregnant women in all two groups will be administered the SUE (third measurement)
Subjective Units of Experience (SUE) will be applied to determine the anxiety level of pregnant women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.
Seven days after the first interview, all pregnant women in all two groups will be administered the SUE (third measurement)
Determining the level of anxiety
Time Frame: One hour after the third measurement, all pregnant women in all two groups will be administered the SUE (fourth measurement)
Subjective Units of Experience (SUE) will be applied to determine the anxiety level of pregnant women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.
One hour after the third measurement, all pregnant women in all two groups will be administered the SUE (fourth measurement)
Determining the level of anxiety
Time Frame: Seven days after the fourth measurement, all pregnant women in all two groups will be administered the SUE (fifth measurement)
Subjective Units of Experience (SUE) will be applied to determine the anxiety level of pregnant women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.
Seven days after the fourth measurement, all pregnant women in all two groups will be administered the SUE (fifth measurement)
Determining the level of anxiety
Time Frame: : One hour after the fifth measurement, all pregnant women in all two groups will be administered the SUE (sixth measurement)
Subjective Units of Experience (SUE) will be applied to determine the anxiety level of pregnant women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.
: One hour after the fifth measurement, all pregnant women in all two groups will be administered the SUE (sixth measurement)
Determining the level of anxiety
Time Frame: Seven days after the sixth measurement, all pregnant women in all two groups will undergo the SUE (seventh measurement).
Subjective Units of Experience (SUE) will be applied to determine the anxiety level of pregnant women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.
Seven days after the sixth measurement, all pregnant women in all two groups will undergo the SUE (seventh measurement).
Determining the level of anxiety
Time Frame: One hour after the seventh measurement, all pregnant women in all two groups will be administered the SUE (eighth measurement)
Subjective Units of Experience (SUE) will be applied to determine the anxiety level of pregnant women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.
One hour after the seventh measurement, all pregnant women in all two groups will be administered the SUE (eighth measurement)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kahramanmaras Sutcu Imam University

Investigators

  • Principal Investigator: Esra KARATAŞ OKYAY, PhD, Kahramanmaraş Sütçü İmam University
  • Study Director: Eda SEVER, Kahramanmaraş Sütçü İmam University
  • Study Director: Esra GÜNEY, PhD, Inonu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Actual)

July 9, 2024

Last Update Submitted That Met QC Criteria

July 7, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KSUESRAKARATASOKYAY005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We don't share individual participant data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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