NCT06578715

Brief Summary

The study will be conducted as a randomized controlled experimental study to determine the effects of the Emotional Freedom Technique (EFT) applied to women in menopause on sleep quality and quality of life. It will be conducted with 80 women between the ages of 45-64, registered in a family health center in a city in the east of Turkey, who have been in menopause for at least one year and volunteer to participate in the study. EFT will be applied to the women to be included in the experimental group in the study once a week, a total of four times in a month. The "Participant Information Form", "Utian Quality of Life Scale" and "Pittsburgh Sleep Quality Scale" prepared by the researchers in line with the literature information will be used in the collection of research data.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

October 2, 2024

Status Verified

October 1, 2024

Enrollment Period

Same day

First QC Date

August 28, 2024

Last Update Submit

October 1, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Quality of life levels during menopause

    The difference between the Utian Quality of Life Scale pretest and posttest mean scores of women in both groups. The lowest score that can be obtained from the scale is 23, and the highest score is 115. An increase in the scale score indicates an increase in the quality of life.

    1 month

  • Quality of sleep levels during menopause

    The difference between the Utian Quality of Life Scale pretest and posttest mean scores of women in both groups. The sleep quality of individuals whose total scale score is 5 points or less is considered "good"; the sleep quality of individuals whose score is above 5 points is considered "bad".

    1 month

Study Arms (2)

Control Group

NO INTERVENTION

no intervention will be applied to the control group

Experimental Group

EXPERIMENTAL

EFT will be applied to the women to be included in the experimental group in the study once a week, a total of four times in a month.

Behavioral: Emotional Freedom Technique

Interventions

EFT basically involves serial tapping on acupuncture points, no needles are used, there is no invasive procedure, there are affirmation suggestions, it is an easy, painless, simple but effective method that can be done in minutes. It is realized by applying kinetic energy to certain meridians on the head and chest with the fingertips. The points where the tapping is done are the end points of the meridians in the body. They are located symmetrically on both sides of the body. Since these points are close to the skin surface, they are points that are more easily reached than the deeper buried parts of the meridians. While applying pressure with the fingertips, the individual needs to focus on the problem that bothers him/her. Another thing that needs to be done at the same time is for the person to make positive suggestions to himself/herself vocally.

Experimental Group

Eligibility Criteria

Age45 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteering to participate in the study,
  • Being able to read and write in Turkish,
  • Women between the ages of 45-64 who have not had menstrual bleeding for at least one year (women under the age of 65 who have entered natural menopause),
  • Not being diagnosed with a psychiatric disease,
  • Not using Hormone Replacement Therapy (HRT),
  • Not using antidepressants, antihistamines, benzodiazepines, hypnotics and narcotics, etc.,
  • Not using any complementary and alternative medicine (such as Reiki, phytoestrogens, acupressure).
  • Scoring '5 and above' on the Pittsburgh Sleep Quality Scale

You may not qualify if:

  • Starting to use Hormone Replacement Therapy after starting the study,
  • Starting to use antidepressants, antihistamines, benzodiazepines, hypnotics and narcotics, etc.,
  • Starting to use any complementary and alternative medicine method,
  • Voluntarily leaving the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Aslı SİS ÇELİK

    Ataturk University

    STUDY DIRECTOR

Central Study Contacts

Aslı SİS ÇELİK

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 28, 2024

First Posted

August 29, 2024

Study Start

October 1, 2024

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

October 2, 2024

Record last verified: 2024-10