Clinical trial NCT06181903: The Effect of Emotional Freedom Technique on Mental Well-Being and Stress Level in Pregnant Women
Official title: The Effect of Emotional Freedom Technique Applied to Women With Risky Pregnancy on Mental Well-Being and Stress Level
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnant at Risk
Keywords: Pregnant
Well-being
Mental health
Stress
Emotional Freedom Technique
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of the level of Mental Well-Being
timeFrame: The Warwick-Edinburgh Mental Well-Being Scale will be administered to two groups of pregnant women on day one (first interview)
measure: Assessment of the level of Mental Well-Being
timeFrame: 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).
measure: Assessment of prenatal distress level
timeFrame: The Prenatal Distress Scale - Revised Version will be administered to two groups of pregnant women on day one (first interview)
measure: Assessment of prenatal distress level
timeFrame: 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).
measure: Determining the level of anxiety
timeFrame: The Subjective Units of Experience (SUE) scale will be administered to two groups of pregnant women on day one (first interview)
measure: Determining the level of anxiety
timeFrame: One hour after the first interview, all pregnant women in all two groups will be administered the SUE (second measure)
measure: Determining the level of anxiety
timeFrame: Seven days after the first interview, all pregnant women in all two groups will be administered the SUE (third measurement)
measure: Determining the level of anxiety
timeFrame: One hour after the third measurement, all pregnant women in all two groups will be administered the SUE (fourth measurement)
measure: Determining the level of anxiety
timeFrame: Seven days after the fourth measurement, all pregnant women in all two groups will be administered the SUE (fifth measurement)
measure: Determining the level of anxiety
timeFrame: : One hour after the fifth measurement, all pregnant women in all two groups will be administered the SUE (sixth measurement)
measure: Determining the level of anxiety
timeFrame: Seven days after the sixth measurement, all pregnant women in all two groups will undergo the SUE (seventh measurement).
measure: Determining the level of anxiety
timeFrame: One hour after the seventh measurement, all pregnant women in all two groups will be administered the SUE (eighth measurement)
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaras Sutcu Imam University
state: Onikişubat
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: Eda SEVER
role: STUDY_DIRECTOR
affiliation: Inonu University
name: Esra GÜNEY, PhD
role: STUDY_DIRECTOR
affiliation: Kahramanmaras Sutcu Imam University
name: Esra KARATAŞ OKYAY, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.