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

NCT05344144 | Completed

• 1 other identifier: KSUESRAKARATASOKYAY001
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Loss; Anxiety

Keywords

Emotional Freedom Technique; Midwifery; Well-Being Status; Cortisol; Music; Prenatal loss; Psychological Development

Outcome Measures

Primary Outcomes (10)

• 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.

Study Arms (3)

Emotional freedom technique group

EXPERIMENTAL

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

Music group

EXPERIMENTAL

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

Control

NO INTERVENTION

control group standard care group

Interventions

Emotional Freedom Technique OTHER

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.

Emotional freedom technique group

Music OTHER

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.

Music group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Anxiety level is 1 and above when measured with the subjective discomfort unit scale (Appendix 3),
• years old and over,
• There are no conditions such as infection, wound, scar in the tapping areas,
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

Location

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 RESULT

Related Links

• Description citation link

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Esra Karataş Okyay, Phd

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

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: April 1, 2022
• First Posted: April 25, 2022
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: October 6, 2021
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)