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Pregnant at RiskNCT06181903

The Effect of Emotional Freedom Technique on Mental Well-Being and Stress Level in Pregnant Women

A study testing Emotional freedom technique group in people with Pregnant at Risk, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnant at Risk
What is being tested?
Emotional freedom technique group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
28 Feb 2024to Aug 2024
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Esra KARATAŞ OKYAY, PhD contact

05432125225

esrakaratas44@hotmail.com

Esra GÜNEY, PhD contact

05432064063

esra.guney@inonu.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Kahramanmaras Sutcu Imam University

    Kahramanmaraş, Onikişubat, 46050

    Esra KARATAŞ OKYAY, PhD, 05432125225, esrakaratas44@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Emotional Freedom Technique Applied to Women With Risky Pregnancy on Mental Well-Being and Stress Level

Emotional freedom technique will be applied to women with risky pregnancy. Emotional freedom technique group and control groups each consisted of 60 pregnant women.

Read the 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.

Being tested
Emotional freedom technique group
Keywords
Pregnant, Well-being, Mental health, Stress, Emotional Freedom Technique
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotional freedom technique groupBehavioural

    Also called No Intervention

    Control group

Study groups in NCT06181903
Study groupRoleWhat they receive
Emotional freedom technique groupExperimentalEmotional freedom technique will be applied to risky pregnant women in the emotional freedom technique group.
Receives: Behavioral: Emotional freedom technique group
Control groupNo interventionPregnant women in the control group will not receive any intervention other than routine hospital care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of the level of Mental Well-Being

    The scale is a 14-item, self-report style scale. The scale consists of positive items including hedonic and eudaimonic dimensions of mental well-being, optimism, feeling useful, relaxation, interest in other people, being energetic and lively, coping with problems, clear thinking, feeling good, feeling close to other people, self-confidence, decision-making, love, interest in new things and being cheerful. The scale covers psychological well-being and subjective well-being and deals with the positive mental health of individuals. The scale is a five-point Likert scale with a minimum score of 14 and a maximum score of 70. Scoring of the scale is as follows: strongly disagree (1), disagree (2), somewhat agree (3), agree (4), strongly agree (5). All items of the scale are positive. High scores on the scale indicate high mental well-being.

    Measured: The Warwick-Edinburgh Mental Well-Being Scale will be administered to two groups of pregnant women on day one (first interview)

  2. Assessment of the level of Mental Well-Being

    The scale is a 14-item, self-report style scale. The scale consists of positive items including hedonic and eudaimonic dimensions of mental well-being, optimism, feeling useful, relaxation, interest in other people, being energetic and lively, coping with problems, clear thinking, feeling good, feeling close to other people, self-confidence, decision-making, love, interest in new things and being cheerful. The scale covers psychological well-being and subjective well-being and deals with the positive mental health of individuals. The scale is a five-point Likert scale with a minimum score of 14 and a maximum score of 70. Scoring of the scale is as follows: strongly disagree (1), disagree (2), somewhat agree (3), agree (4), strongly agree (5). All items of the scale are positive. High scores on the scale indicate high mental well-being.

    Measured: 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).

  3. Assessment of prenatal distress level

    The scale determines pregnant women's social relationships, their physical and emotional symptoms during pregnancy, and their level of anxiety about themselves and their babies. The scale items have options ranging from "Not at all" (0), "A little" (1) and "Very much" (2), and the total score is obtained by summing the scores of the answers given to the scale items. A minimum score of 0 and a maximum score of 34 points are obtained from the scale. An increase in the total score obtained from the scale indicates an increase in the level of prenatal distress perceived by pregnant women.

    Measured: The Prenatal Distress Scale - Revised Version will be administered to two groups of pregnant women on day one (first interview)

  4. Assessment of prenatal distress level

    The scale determines pregnant women's social relationships, their physical and emotional symptoms during pregnancy, and their level of anxiety about themselves and their babies. The scale items have options ranging from "Not at all" (0), "A little" (1) and "Very much" (2), and the total score is obtained by summing the scores of the answers given to the scale items. A minimum score of 0 and a maximum score of 34 points are obtained from the scale. An increase in the total score obtained from the scale indicates an increase in the level of prenatal distress perceived by pregnant women.

    Measured: 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).

  5. Determining the level of anxiety

    Subjective Units of Experience (SUE) will be applied to determine the anxiety level of pregnant women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.

    Measured: The Subjective Units of Experience (SUE) scale will be administered to two groups of pregnant women on day one (first interview)

  6. Determining the level of anxiety

    Subjective Units of Experience (SUE) will be applied to determine the anxiety level of pregnant women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.

    Measured: One hour after the first interview, all pregnant women in all two groups will be administered the SUE (second measure)

  7. Determining the level of anxiety

    Subjective Units of Experience (SUE) will be applied to determine the anxiety level of pregnant women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.

    Measured: Seven days after the first interview, all pregnant women in all two groups will be administered the SUE (third measurement)

  8. Determining the level of anxiety

    Subjective Units of Experience (SUE) will be applied to determine the anxiety level of pregnant women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.

    Measured: One hour after the third measurement, all pregnant women in all two groups will be administered the SUE (fourth measurement)

  9. Determining the level of anxiety

    Subjective Units of Experience (SUE) will be applied to determine the anxiety level of pregnant women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.

    Measured: Seven days after the fourth measurement, all pregnant women in all two groups will be administered the SUE (fifth measurement)

  10. Determining the level of anxiety

    Subjective Units of Experience (SUE) will be applied to determine the anxiety level of pregnant women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.

    Measured: : One hour after the fifth measurement, all pregnant women in all two groups will be administered the SUE (sixth measurement)

  11. Determining the level of anxiety

    Subjective Units of Experience (SUE) will be applied to determine the anxiety level of pregnant women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.

    Measured: Seven days after the sixth measurement, all pregnant women in all two groups will undergo the SUE (seventh measurement).

  12. Determining the level of anxiety

    Subjective Units of Experience (SUE) will be applied to determine the anxiety level of pregnant women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.

    Measured: One hour after the seventh measurement, all pregnant women in all two groups will be administered the SUE (eighth measurement)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2023
  2. Study start28 Feb 2024
  3. Primary completionAug 2024 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

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
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06181903
Sponsor's protocol ID
KSUESRAKARATASOKYAY005
Status last verified
Jul 2024
First submitted
13 Dec 2023
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

Questions about this trial

What is this clinical trial studying?

A study testing Emotional freedom technique group in people with Pregnant at Risk, 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 6 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: status not confirmed, 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Esra KARATAŞ OKYAY, PhD (05432125225, esrakaratas44@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of the level of Mental Well-Being (time frame: The Warwick-Edinburgh Mental Well-Being Scale will be administered to two groups of pregnant women on day one (first interview)). The study lists 12 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 NCT06181903, 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.

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