Menopause Related ConditionsNCT06578715
Emotional Freedom Technique (EFT) Applied to Postmenopausal Women on Sleep and Quality of Life
A study testing Emotional Freedom Technique in people with Menopause Related Conditions, run by Ataturk University.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause Related Conditions
- What is being tested?
- Emotional Freedom Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Nov 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 45 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Emotional Freedom Technique (EFT) Applied to Postmenopausal Women on Sleep and Quality of Life: A Randomized Controlled Trial
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.
Read more
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.
Read the 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.
- Conditions
- Menopause Related Conditions
- Being tested
- Emotional Freedom Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Freedom TechniqueBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Emotional Freedom Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause Related ConditionsStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı SİS ÇELİK, Ataturk University
- Investigators
- Aslı SİS ÇELİK, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578715
- Sponsor's protocol ID
- aslı12
- Status last verified
- Oct 2024
- First submitted
- 28 Aug 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Emotional Freedom Technique (EFT) Applied to Postmenopausal Women on Sleep and Quality of Life: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06578715
- Acronym / sponsor ID
- aslı12
- Conditions
- Menopause Related Conditions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 29 Aug 2024 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –no intervention will be applied to the control group |
| Experimental Group | Experimental | Behavioral: Emotional Freedom TechniqueEFT 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. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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),
Key exclusion criteria (4 listed)
- 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.
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 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. | Behavioural | Experimental Group |
Primary outcome
Quality of life levels during menopause
Time frame: 1 month
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.
Quality of sleep levels during menopause
Time frame: 1 month
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".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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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.
Aslı SİS ÇELİK study director
Ataturk University
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Freedom Technique in people with Menopause Related Conditions, run by Ataturk University.
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 8 inclusion and 4 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 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Aslı SİS ÇELİK (05434668242, aslisis@atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life levels during menopause (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2024.