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

NCT06181903 | Recruiting

• 1 other identifier: KSUESRAKARATASOKYAY005
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnant at Risk

Keywords

Pregnant; Well-being; Mental health; Stress; Emotional Freedom Technique

Outcome Measures

Primary Outcomes (12)

• Assessment of the level of Mental Well-Being

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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)

Study Arms (2)

Emotional freedom technique group

EXPERIMENTAL

Emotional freedom technique will be applied to risky pregnant women in the emotional freedom technique group.

Behavioral: Emotional freedom technique group

Control group

NO INTERVENTION

Pregnant women in the control group will not receive any intervention other than routine hospital care.

Interventions

Emotional freedom technique group BEHAVIORAL

Control group

Also known as: No Intervention

Emotional freedom technique group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Onikişubat, 46050, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Irmak Vural P, Aslan E. Emotional freedom techniques and breathing awareness to reduce childbirth fear: A randomized controlled study. Complement Ther Clin Pract. 2019 May;35:224-231. doi: 10.1016/j.ctcp.2019.02.011. Epub 2019 Feb 15.

  PMID: 31003663 BACKGROUND

Related Links

• Description citation link

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Eda SEVER

  Kahramanmaras Sutcu Imam University

  STUDY DIRECTOR

• Esra GÜNEY, PhD

  Inonu University

  STUDY DIRECTOR

• Esra KARATAŞ OKYAY, PhD

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esra KARATAŞ OKYAY, PhD

CONTACT

05432125225; esrakaratas44@hotmail.com

Esra GÜNEY, PhD

CONTACT

05432064063; esra.guney@inonu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: February 28, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)