Clinical trial NCT05344144: EFT and Music on Psychological Development, Well-Being Status and Cortisol Level in Pregnant Women
Official title: The Effect of Emotional Freedom Technique and Music, Applied to Pregnant Women Having Experienced Prenatal Loss on Psychological Development, Well-Being Status and Cortisol Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Loss
Anxiety
Keywords: Emotional Freedom Technique
Midwifery
Well-Being Status
Cortisol
Music
Prenatal loss
Psychological Development
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 159
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Emotional freedom technique and music were applied to pregnant women who experienced prenatal loss. Emotional freedom technique group, music group and control groups each consisted of 53 pregnant women.

Detailed description: Aim: The research is conducted to determine for the purpose of the effect of emotional freedom technique and music applied to pregnant women having experienced prenatal loss on psychological development, well-being status, and cortisol level.

Material and Method: The research is conducted in a randomized controlled manner with a total of 159 pregnant women who applied to the gynecology outpatient clinics of Elazig Fethi Sekin City Hospital between October 2020 and April 2021 (53 EFT, 53 music, 53 control). In the research, EFT was applied to the pregnant women in the EFT group twice, with an interval of one week; pregnant women in the music group were listened to music twice, with a one-week interval. Pregnant women continued the attempts for one week after the first attempt. SUDS, SUE Scale, PTGI, WHO-5 WellBeing Index were used to collect data, and a saliva sample was taken.

Eligibility criteria: Inclusion Criteria:

1. Anxiety level is 1 and above when measured with the subjective discomfort unit scale (Appendix 3),
2. 18 years old and over,
3. There are no conditions such as infection, wound, scar in the tapping areas,
4. All pregnant women who did not have any health problems (such as preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios, fetal anomaly) during pregnancy and baby were included in the sample.

Exclusion Criteria:

1. Having any problem that prevents communication (such as not knowing Turkish, having hearing, speaking and understanding abilities),
2. Contaminated salivary cortisol,
3. Those with psychiatric health problems according to their medical records were excluded from the study.

Primary outcomes:
measure: Determining the level of anxiety
timeFrame: In the first interview, SUE was applied to all pregnant women in all three groups as a pre-test at any time of pregnancy.
measure: Determining the level of anxiety
timeFrame: One hour after the first interview, SUE was applied to all pregnant women in all three groups.
measure: Determining the level of anxiety
timeFrame: Seven day after the first interview, SUE was applied to all pregnant women in all three groups.
measure: Determining the level of anxiety
timeFrame: One hour after the third measurement, SUE was applied to all pregnant women in all three groups.
measure: Evaluation of the level of psychological development
timeFrame: In the first interview, PTGI was applied to all pregnant women in all three groups as a pre-test at any time of pregnancy.
measure: Evaluation of the level of psychological development
timeFrame: Seven day after the first interview, PTGI was applied to all pregnant women in all three groups as a post-test.
measure: Evaluation of the level of well-being
timeFrame: In the first interview, WHO-5 well-being ındex was applied to all pregnant women in all three groups as a pre-test at any time of pregnancy.
measure: Evaluation of the level of well-being
timeFrame: Seven day after the first interview, WHO-5 Well-Being IndexI was applied to all pregnant women in all three groups as a post-test.
measure: Evaluation of the level of cortisol
timeFrame: At the first interview, saliva samples were taken from all pregnant women in all three groups as a pre-test at any time of pregnancy.
measure: Evaluation of the level of cortisol
timeFrame: Seven day after the first interview, saliva samples were taken from all pregnant women in all three groups as a post-test.
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaras Sutcu Imam University
Study officials:
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.