Pregnancy LossEFTNCT05344144
EFT and Music on Psychological Development, Well-Being Status and Cortisol Level in Pregnant Women
A study testing Emotional Freedom Technique and Music in people with Pregnancy Loss and Anxiety, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Loss, Anxiety
- What is being tested?
- Emotional Freedom Technique and Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 6 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Anxiety level is 1 and above when measured with the subjective discomfort unit scale (Appendix 3),
- 18 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University
Kahramanmaraş
About this study
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
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.
Read the 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.
- Conditions
- Pregnancy Loss, Anxiety
- Being tested
- Emotional Freedom Technique, Music
- Keywords
- Emotional Freedom Technique, Midwifery, Well-Being Status, Cortisol, Music, Prenatal loss, Psychological Development
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Freedom TechniqueOther
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.
MusicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Music |
| Control | No intervention | control group standard care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Seven day after the first interview, saliva samples were taken from all pregnant women in all three groups as a post-test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Jun 2020
- Primary completion1 Jun 2021
- Study completion6 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra KARATAŞ OKYAY, Kahramanmaras Sutcu Imam University
- Investigators
- Esra Karataş Okyay, Phd, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344144
- Sponsor's protocol ID
- KSUESRAKARATASOKYAY001
- Acronym
- EFT
- Status last verified
- Jul 2024
- First submitted
- 1 Apr 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we don't share individual participant data with other researchers
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.
PubMed 31003663
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05344144
- Acronym / sponsor ID
- EFT / KSUESRAKARATASOKYAY001
- Conditions
- Pregnancy Loss, Anxiety
- Keywords
- Emotional Freedom Technique, Midwifery, Well-Being Status, Cortisol, Music, Prenatal loss, Psychological Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Emotional freedom technique group | Experimental | Other: Emotional Freedom TechniqueEmotional 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. |
| Music group | Experimental | Other: MusicMusic 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. |
| Control | No intervention | –control group standard care group |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Anxiety level is 1 and above when measured with the subjective discomfort unit scale (Appendix 3),
- 18 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Freedom TechniqueEFT 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. | Other | Emotional freedom technique group |
| MusicMusic 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. | Other | Music group |
Primary outcome
Determining the level of anxiety
Time frame: In the first interview, SUE was applied to all pregnant women in all three groups as a pre-test at any time of pregnancy.
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.
Determining the level of anxiety
Time frame: One hour after the first interview, SUE was applied to all pregnant women in all three groups.
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.
Determining the level of anxiety
Time frame: Seven day after the first interview, SUE was applied to all pregnant women in all three groups.
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.
Determining the level of anxiety
Time frame: One hour after the third measurement, SUE was applied to all pregnant women in all three groups.
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.
Evaluation of the level of psychological development
Time frame: In the first interview, PTGI was applied to all pregnant women in all three groups as a pre-test at any time of pregnancy.
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.
Evaluation of the level of psychological development
Time frame: Seven day after the first interview, PTGI was applied to all pregnant women in all three groups as a post-test.
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.
Evaluation of the level of well-being
Time frame: 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.
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.
Evaluation of the level of well-being
Time frame: 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.
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.
Evaluation of the level of cortisol
Time frame: 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.
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.
Evaluation of the level of cortisol
Time frame: Seven day after the first interview, saliva samples were taken from all pregnant women in all three groups as a post-test.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Results publication: PubMed 31003663Irmak 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.
- Description citation linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. we don't share individual participant data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Karataş Okyay, Phd principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Freedom Technique and Music in people with Pregnancy Loss and Anxiety, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the level of anxiety (time frame: In the first interview, SUE was applied to all pregnant women in all three groups as a pre-test at any time of pregnancy.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05344144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.