EFT and Music on Psychological Development, Well-Being Status and Cortisol Level in Pregnant Women (EFT)

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Pregnancy Loss
• Intervention / Treatment: Other: Emotional Freedom Technique; Other: Music

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.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kahramanmaraş, Turkey
    • Kahramanmaras Sutcu Imam University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Emotional freedom technique group; Emotional freedom technique group pregnant women who have experienced prenatal loss, who were included in the emotional freedom technique group with randomization method, will be given a counseling program including psychosocial care and emotional freedom technique application in addition to the routine.	Other: Emotional Freedom Technique; EFT was applied to pregnant women with a history of prenatal loss twice, one week apart, by the researcher. Between the two treatments, they were given personalized homework (on waking up in the morning and before going to sleep at night) for self-administration.
EXPERIMENTAL: Music group; Music group pregnant women who have experienced prenatal loss, who were included in the music group with randomization method, will be given a counseling program including music application in addition to the routine.	Other: Music; Music practice was applied to the pregnant women with a history of prenatal loss twice, one week apart, by the researcher. For one week after the first application, the music application was applied by the pregnant woman once a day/for 30 minutes, and the researcher was reminded by phone message.
NO_INTERVENTION: Control; control group standard care group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determining the level of anxiety	In order to determine the anxiety level of the pregnant women, SUE (Subjective Units of Experience) was applied. SUE is used to determine the intensity of the person's emotion at the beginning and end of therapy. The scale is scored between -10 and +10, with negative numbers for negative/unpleasant experiences and positive numbers for positive/pleasant experiences.	In the first interview, SUE was applied to all pregnant women in all three groups as a pre-test at any time of pregnancy.
Determining the level of anxiety	In order to determine the anxiety level of the pregnant women, SUE was applied. SUE is used to determine the intensity of the person's emotion at the beginning and end of therapy. The scale is scored between -10 and +10, with negative numbers for negative/unpleasant experiences and positive numbers for positive/pleasant experiences.	One hour after the first interview, SUE was applied to all pregnant women in all three groups.
Determining the level of anxiety	In order to determine the anxiety level of the pregnant women, SUE was applied. SUE is used to determine the intensity of the person's emotion at the beginning and end of therapy. The scale is scored between -10 and +10, with negative numbers for negative/unpleasant experiences and positive numbers for positive/pleasant experiences.	Seven day after the first interview, SUE was applied to all pregnant women in all three groups.
Determining the level of anxiety	In order to determine the anxiety level of the pregnant women, SUE was applied. SUE is used to determine the intensity of the person's emotion at the beginning and end of therapy. The scale is scored between -10 and +10, with negative numbers for negative/unpleasant experiences and positive numbers for positive/pleasant experiences.	One hour after the third measurement, SUE was applied to all pregnant women in all three groups.
Evaluation of the level of psychological development	PTGI (Post Traumatic Growth Inventory) was applied to determine the psychological development level of the pregnant women. PTGI is a 21-item Likert-type scale developed to evaluate positive changes after trauma and is scored between 0 and 5. The lowest score that can be obtained from the scale is 0, and the highest score is 105. A high score indicates that the person has experienced a high level of growth after the traumatic experience.	In the first interview, PTGI was applied to all pregnant women in all three groups as a pre-test at any time of pregnancy.
Evaluation of the level of psychological development	PTGI (Post Traumatic Growth Inventory) was applied to determine the psychological development level of the pregnant women. PTGI is a 21-item Likert-type scale developed to evaluate positive changes after trauma and is scored between 0 and 5. The lowest score that can be obtained from the scale is 0, and the highest score is 105. A high score indicates that the person has experienced a high level of growth after the traumatic experience.	Seven day after the first interview, PTGI was applied to all pregnant women in all three groups as a post-test.
Evaluation of the level of well-being	WHO-5 Well-Being Index was applied to determine the pwell-being level of the pregnant women. In order to determine mental well-being, the scale, which consists of 5 questions in total, is of 6-point Likert type, varying between "never", "sometimes", "less than half of the time", "more than half of the time" and "always". The raw score is calculated by adding the numbers of the five answers, and the resulting score ranges from zero to 25. Zero represents the worst possible quality of life and 25 the best possible quality of life.	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.
Evaluation of the level of well-being	WHO-5 Well-Being Index was applied to determine the pwell-being level of the pregnant women. In order to determine mental well-being, the scale, which consists of 5 questions in total, is of 6-point Likert type, varying between "never", "sometimes", "less than half of the time", "more than half of the time" and "always". The raw score is calculated by adding the numbers of the five answers, and the resulting score ranges from zero to 25. Zero represents the worst possible quality of life and 25 the best possible quality of life.	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.
Evaluation of the level of cortisol	Saliva samples were taken from pregnant women to determine the cortisol level. Saliva sample collection materials consist of 1.5 ml saliva collection tube (ependorf tube) and sips to facilitate the salivation process. The pregnant women were informed about the procedure to be followed and the saliva collection process was explained by the researcher. For salivary cortisol analysis, 96-well microplates were covered with cortisol-BSA at +4 C overnight and blocked with 200 µl BSA (1%) at 37 °C for 2 hours. Saliva samples were thawed before adding to microplates and centrifuged at 4000g for 10 minutes. The plates were incubated for 45 minutes at 37 °C and washed 5 times with washing solution. When the blue color occurred, the plates were read by the plate-reader spectrophotometer. Calibration curves were created using 4-parameter logistic regression curves and cortisol levels were measured using this curve.	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.
Evaluation of the level of cortisol	Saliva samples were taken from pregnant women to determine the cortisol level. Saliva sample collection materials consist of 1.5 ml saliva collection tube (ependorf tube) and sips to facilitate the salivation process. The pregnant women were informed about the procedure to be followed and the saliva collection process was explained by the researcher. For salivary cortisol analysis, 96-well microplates were covered with cortisol-BSA at +4 C overnight and blocked with 200 µl BSA (1%) at 37 °C for 2 hours. Saliva samples were thawed before adding to microplates and centrifuged at 4000g for 10 minutes. The plates were incubated for 45 minutes at 37 °C and washed 5 times with washing solution. When the blue color occurred, the plates were read by the plate-reader spectrophotometer. Calibration curves were created using 4-parameter logistic regression curves and cortisol levels were measured using this curve.	Seven day after the first interview, saliva samples were taken from all pregnant women in all three groups as a post-test.

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University
• Investigators: Principal Investigator: Esra KARATAŞ OKYAY, PhD, Kahramanmaras Sutcu Imam University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Description citation link

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ACTUAL): June 1, 2021
• Study Completion (ACTUAL): October 6, 2021

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (ACTUAL): April 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Cortisol; Emotional Freedom Technique; Music; Midwifery; Well-Being Status; Prenatal loss; Psychological Development
• Other Study ID Numbers: KSUESRAKARATASOKYAY001

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