Clinical trial NCT06578715: Emotional Freedom Technique (EFT) Applied to Postmenopausal Women on Sleep and Quality of Life
Official title: The Effect of Emotional Freedom Technique (EFT) Applied to Postmenopausal Women on Sleep and Quality of Life: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Menopause Related Conditions
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 80
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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 volunteered to participate in the study.

The "simple randomization method" will be selected as the randomization method in the study in order to provide an equal number of samples in two groups. A random number table will be created in a computer environment using the httpp://www.randomizer.org/website for the 80 participants to be sampled, with numbers from 1 to 80 in two groups. It will be decided by tossing a coin to determine which group the groups should be in. The names on the list will be evaluated according to the group corresponding to that order in the table, and accordingly, 40 women will be assigned to the experimental group and 40 women will be assigned to the control group.

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.

When the research is completed, the data of the experimental and control groups (coded as X and Y) will be transferred to the computer environment by a statistician independent of the research and the data will be analyzed and the findings will be reported. Our research is planned to be conducted as a single-blind study in which the statistician will be blinded.

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.

Pre-Test Data will be collected between September-October 2024, the interim measurement after the EFT intervention will be made between October-November 2024, and the final measurement will be made between November-December 2024.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Quality of life levels during menopause
timeFrame: 1 month
measure: Quality of sleep levels during menopause
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ataturk University
name: Aslı SİS ÇELİK
role: STUDY_DIRECTOR
References: