NCT06338085

Brief Summary

The aim of this study is to determine the effect of EFT (Emotional Freedom Technique), a nonpharmacological method, on menopausal symptoms and depression in postmenopausal women. By determining the effectiveness of the Emotional Freedom Technique, the applicability of non-pharmacological method treatment in women with depression and menopausal symptoms in postmenopausal period will be proven. As a result of the study, if a positive effect on menopausal symptoms and depression is found in women with EFT, it can be recommended as an evidence-based alternative method in midwifery and nursing care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

March 23, 2024

Last Update Submit

April 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Beck Depression Scale

    It was developed in 1961 by Beck et al. Reliability and validity analysis in Turkey was conducted by Hisli et al. in 1988. The scale consists of 21 questions. Each question is scored between 0-3 points. The total score that can be obtained from the scale is between 0-63. A high score on the scale increases the severity of depression. A score between 10-17 points indicates mild depression, 18-29 points indicates moderate depression, and a score between 30-63 points indicates severe depression. In the Turkish validity analysis of the scale, Cronbach's alpha coefficient was found to be 0.74.

    8 weeks

Secondary Outcomes (1)

  • Menopause Rating Scale (MRS)

    8 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

The researcher will provide the intervention group with Emotional Freedom Technique (EFT) training, which will last for 2 sessions of 45 minutes with 1 day intervals.Participants will then be asked to continue the techniques taught during the training on their own once a day for 8 weeks.

Other: emotional liberation technique

control group

NO INTERVENTION

no intervention will be made to the control group

Interventions

In this intervention, with the technique taught by the researcher, women will self-administer the practice of lightly touching certain points 5 days and 1 time per week for 8 weeks. A whatsup group will be created by the researcher. A reminder message will be sent from this group to do the practice 1 time every day.

intervention group

Eligibility Criteria

AgeUp to 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being in menopausal period (no menstruation in the last 12 months)
  • Literacy,
  • No visual, auditory and mental disabilities

You may not qualify if:

  • Receiving cancer treatment during research,
  • Diagnosed with depression during the research,
  • Taking any psychiatric medication during the study,
  • Receiving hormone replacement therapy before or during the trial
  • Who did not attend the Eft sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

family health center no. 1 in Çayyolu

Ankara, Çankaya, Turkey (Türkiye)

Location

Related Publications (20)

  • Ambikairajah A, Walsh E, Tabatabaei-Jafari H, Cherbuin N. Fat mass changes during menopause: a metaanalysis. Am J Obstet Gynecol. 2019 Nov;221(5):393-409.e50. doi: 10.1016/j.ajog.2019.04.023. Epub 2019 Apr 26.

    PMID: 31034807BACKGROUND
  • Ambikairajah A, Walsh E, Cherbuin N. A review of menopause nomenclature. Reprod Health. 2022 Jan 31;19(1):29. doi: 10.1186/s12978-022-01336-7.

    PMID: 35101087BACKGROUND
  • Bustami M, Matalka KZ, Elyyan Y, Hussein N, Hussein N, Abu Safieh N, Thekrallah F, Mallah E, Abu-Qatouseh L, Arafat T. Age of Natural Menopause Among Jordanian Women and Factors Related to Premature and Early Menopause. Risk Manag Healthc Policy. 2021 Jan 19;14:199-207. doi: 10.2147/RMHP.S289851. eCollection 2021.

    PMID: 33500673BACKGROUND
  • Curta JC, Weissheimer AM. Perceptions and feelings about physical changes in climacteric women. Rev Gaucha Enferm. 2020;41(spe):e20190198. doi: 10.1590/1983-1447.2020.20190198. Epub 2020 May 8. English, Portuguese.

    PMID: 32401861BACKGROUND
  • Trimarco V, Rozza F, Izzo R, De Leo V, Cappelli V, Riccardi C, Di Carlo C. Effects of a new combination of nutraceuticals on postmenopausal symptoms and metabolic profile: a crossover, randomized, double-blind trial. Int J Womens Health. 2016 Oct 11;8:581-587. doi: 10.2147/IJWH.S115948. eCollection 2016.

    PMID: 27785106BACKGROUND
  • Weidner K, Bittner A, Beutel M, Goeckenjan M, Brahler E, Garthus-Niegel S. The role of stress and self-efficacy in somatic and psychological symptoms during the climacteric period - Is there a specific association? Maturitas. 2020 Jun;136:1-6. doi: 10.1016/j.maturitas.2020.03.004. Epub 2020 Mar 13.

    PMID: 32386660BACKGROUND
  • Li X, Ren Z, Ji T, Shi H, Zhao H, He M, Fan X, Guo X, Zha S, Qiao S, Li Y, Pu Y, Liu H, Zhang X. Associations of sleep quality, anxiety symptoms and social support with subjective well-being among Chinese perimenopausal women. J Affect Disord. 2022 Apr 1;302:66-73. doi: 10.1016/j.jad.2022.01.089. Epub 2022 Jan 24.

    PMID: 35085670BACKGROUND
  • Mathew DJ, Kumar S, Jain PK, Shukla SK, Ali N, Singh DR. A Cross-Sectional Study to Assess the Quality of Life of Perimenopausal and Post menopausal Women in Rural Etawah, Uttar Pradesh, India. J Midlife Health. 2020 Jul-Sep;11(3):161-167. doi: 10.4103/jmh.JMH_88_19. Epub 2020 Sep 29.

    PMID: 33384540BACKGROUND
  • Aygün, M. S.,(2019). Evaluation of the frequency and relationship between menopause and depression symptoms in women aged 40-64 years who applied to Ankara University family medicine outpatient clinics.

    BACKGROUND
  • Bach D, Groesbeck G, Stapleton P, Sims R, Blickheuser K, Church D. Clinical EFT (Emotional Freedom Techniques) Improves Multiple Physiological Markers of Health. J Evid Based Integr Med. 2019 Jan-Dec;24:2515690X18823691. doi: 10.1177/2515690X18823691.

    PMID: 30777453BACKGROUND
  • Gordon JL, Halleran M, Beshai S, Eisenlohr-Moul TA, Frederick J, Campbell TS. Endocrine and psychosocial moderators of mindfulness-based stress reduction for the prevention of perimenopausal depressive symptoms: A randomized controlled trial. Psychoneuroendocrinology. 2021 Aug;130:105277. doi: 10.1016/j.psyneuen.2021.105277. Epub 2021 May 19.

    PMID: 34058560BACKGROUND
  • Soares CN. Depression in peri- and postmenopausal women: prevalence, pathophysiology and pharmacological management. Drugs Aging. 2013 Sep;30(9):677-85. doi: 10.1007/s40266-013-0100-1.

    PMID: 23801148BACKGROUND
  • Elsan, T. (2018). Evaluation of the quality of life of menopausal women applying to a PHC area (Master's thesis, Institute of Health Sciences).

    BACKGROUND
  • Deecher D, Andree TH, Sloan D, Schechter LE. From menarche to menopause: exploring the underlying biology of depression in women experiencing hormonal changes. Psychoneuroendocrinology. 2008 Jan;33(1):3-17. doi: 10.1016/j.psyneuen.2007.10.006. Epub 2007 Dec 3.

    PMID: 18063486BACKGROUND
  • Baker, B. S., & Hoffman, C. J. (2015). Emotional Freedom Techniques (EFT) to reduce the side effects associated with tamoxifen and aromatase inhibitor use in women with breast cancer: A service evaluation. European Journal of Integrative Medicine, 7(2), 136-142.

    BACKGROUND
  • Willi J, Suss H, Grub J, Ehlert U. Biopsychosocial predictors of depressive symptoms in the perimenopause-findings from the Swiss Perimenopause Study. Menopause. 2021 Jan 4;28(3):247-254. doi: 10.1097/GME.0000000000001704.

    PMID: 33399325BACKGROUND
  • Vivian-Taylor J, Hickey M. Menopause and depression: is there a link? Maturitas. 2014 Oct;79(2):142-6. doi: 10.1016/j.maturitas.2014.05.014. Epub 2014 Jun 2.

    PMID: 24951102BACKGROUND
  • Augoulea A, Moros M, Lykeridou A, Kaparos G, Lyberi R, Panoulis K. Psychosomatic and vasomotor symptom changes during transition to menopause. Prz Menopauzalny. 2019 Jun;18(2):110-115. doi: 10.5114/pm.2019.86835. Epub 2019 Jun 28.

    PMID: 31485208BACKGROUND
  • Church D, Stapleton P, Sabot D. App-Based Delivery of Clinical Emotional Freedom Techniques: Cross-Sectional Study of App User Self-Ratings. JMIR Mhealth Uhealth. 2020 Oct 14;8(10):e18545. doi: 10.2196/18545.

    PMID: 32862128BACKGROUND
  • Mehdipour A, Abedi P, Ansari S, Dastoorpoor M. The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial. J Complement Integr Med. 2021 May 19;19(3):737-742. doi: 10.1515/jcim-2020-0245. eCollection 2022 Sep 1.

    PMID: 34013673BACKGROUND

Study Officials

  • Meltem UĞURLU

    Gulhane School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: the groups with a conventional therapy control group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Phd Student

Study Record Dates

First Submitted

March 23, 2024

First Posted

March 29, 2024

Study Start

January 1, 2023

Primary Completion

July 30, 2023

Study Completion

November 30, 2024

Last Updated

May 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations