Menopausal SymptomNCT05342610
Effect of Reiki Application on Menopausal Symptoms
A study testing Distant reiki in people with Menopausal Symptom, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
In this randomized controlled study, it was aimed to determine the effect of distant reiki on menopausal symptoms. Two different hypothesis teams have been established for the study. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Symptom
- What is being tested?
- Distant reiki
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 28 Feb 2019
- 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 40 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to participate in research,
- Can read and write in Turkish,
- Open to communication,
- Those who are between the ages of 40-55 and do not experience menstruation for at least one year,
- Experiencing at least one or more of the menopausal symptoms,
- Not applying regular reiki,
- Those who have not surgically entered menopause,
- Women without psychiatric problems
Who cannot join
- Who do not agree to participate in the research,
- Can't read and write Turkish,
- Communication is not possible,
- Those who are younger than 40, older than 55, have experienced menstruation for at least one year,
- Do not experience the symptoms of menopause,
- Using medication for the treatment of menopausal symptoms,
Show all 10Show fewer
- Chronic illness,
- Regular reiki is applied,
- Surgically in menopause,
- Women with psychiatric problems
Trial locations and contacts
1 site in 1 country.
About this study
In this randomized controlled study, it was aimed to determine the effect of distant reiki on menopausal symptoms. Two different hypothesis teams have been established for the study.
These; H0: There is no significant difference between the menopause rating scores of the women in the study group in which distant reiki was applied and the control group without distant reiki.
H1: There is a significant difference between the menopause rating scores of the women in the study group in which distant reiki was applied and the control group without distant reiki.
Read the detailed description
Parallel to the increase in life expectancy by years, the population of women living in the post-menopausal period is also increasing. In order to have a healthy menopause, which is an important part of women's life, it is thought that the distant reiki without health risks by women may be effective in reducing the symptoms of menopause experienced by women. In line with this information, it was aimed to determine the effect of distant reiki on menopausal symptoms. The study was carried out with menopausal women between the ages of 40-55 in Adana province in Turkey. Therefore, in the study, 48 women in the menopausal period between the ages of 40-55 was randomly assigned to reiki and control groups. Distant reiki application for 30 minutes three times a week for four weeks was applied individually to the study group. No intervention was made to the control group for a period of four weeks. The primary expected outcome of the research is the effect of distant reiki on menopausal symptoms of menopausal women. Results was applied three times in total, before the study and control application, 4 weeks and 8 weeks later.
- Conditions
- Menopausal Symptom
- Being tested
- Distant reiki
- Keywords
- Nursing, integrative practice, menopausal symptoms, reiki
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distant reikiOther
Also called Reiki
Reiki; It is the transfer of energy to other people by the hands of the person who receives the theoretical training and attunement (initiation) from the reiki master, close or distant. When the hands are brought closer to the body in suitable positions or when the reiki practitioner visualizes the person in his/her thoughts, the energy flow starts spontaneously and the transferred energy is shaped according to the needs of the reiki recipient. The biggest advantage of Reiki; It is an easy and cost-effective method to ensure that the individual restores the balance between body, mind and spirit, has no side effects, has no negative effects on behavior and attitudes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (distant reiki) group | Experimental | Reiki (complementary and integrative medicine method) was applied individually to the experimental group for 30 minutes three times a week for four weeks. Data collection forms was applied 3 times in total, before the intervention, in the fourth and the eighth week. Receives: Other: Distant reiki |
| Control group | No intervention | No intervention was made to women in the control group. However, data collection forms was applied 3 times in total, before the intervention, in the fourth and the eighth week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause symptoms evaluated using the Menopause Rating Scale
It was developed in German by Schneider et al. In 1992 to measure the severity of menopausal symptoms and was adapted to English in 1996. MRT was adapted to Turkish by Gürkan in our country in 2005. There are "0 = None", "1 = Mild", "2 = Moderate", "3 = Severe" and "4 = Very severe" options for each item in the Likert-type scale consisting of 11 items including menopausal complaints. The total score of the scale is calculated based on the scores given for each item. The lowest score that can be obtained from the scale is 0, the highest score is 44.
Measured: Change from before intervention, 4th and 8th week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Nov 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal SymptomStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Prospective, parallel, two-arm, randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem Lafci, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342610
- Sponsor's protocol ID
- MersinUnivers
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reiki Application on Menopausal Symptoms
- ClinicalTrials.gov ID
- NCT05342610
- Acronym / sponsor ID
- MersinUnivers
- Conditions
- Menopausal Symptom
- Keywords
- Nursing, integrative practice, menopausal symptoms, reiki
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 22 Apr 2022 (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.
In this randomized controlled study, it was aimed to determine the effect of distant reiki on menopausal symptoms. Two different hypothesis teams have been established for the study.
These; H0: There is no significant difference between the menopause rating scores of the women in the study group in which distant reiki was applied and the control group without distant reiki.
H1: There is a significant difference between the menopause rating scores of the women in the study group in which distant reiki was applied and the control group without distant reiki.
Detailed description
Parallel to the increase in life expectancy by years, the population of women living in the post-menopausal period is also increasing. In order to have a healthy menopause, which is an important part of women's life, it is thought that the distant reiki without health risks by women may be effective in reducing the symptoms of menopause experienced by women. In line with this information, it was aimed to determine the effect of distant reiki on menopausal symptoms. The study was carried out with menopausal women between the ages of 40-55 in Adana province in Turkey. Therefore, in the study, 48 women in the menopausal period between the ages of 40-55 was randomly assigned to reiki and control groups. Distant reiki application for 30 minutes three times a week for four weeks was applied individually to the study group. No intervention was made to the control group for a period of four weeks. The primary expected outcome of the research is the effect of distant reiki on menopausal symptoms of menopausal women. Results was applied three times in total, before the study and control application, 4 weeks and 8 weeks later.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Prospective, parallel, two-arm, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental (distant reiki) group | Experimental | Other: Distant reikiReiki (complementary and integrative medicine method) was applied individually to the experimental group for 30 minutes three times a week for four weeks. Data collection forms was applied 3 times in total, before the intervention, in the fourth and the eighth week. |
| Control group | No intervention | –No intervention was made to women in the control group. However, data collection forms was applied 3 times in total, before the intervention, in the fourth and the eighth week. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Willing to participate in research,
- Can read and write in Turkish,
- Open to communication,
- Those who are between the ages of 40-55 and do not experience menstruation for at least one year,
- Experiencing at least one or more of the menopausal symptoms,
Key exclusion criteria (10 listed)
- Who do not agree to participate in the research,
- Can't read and write Turkish,
- Communication is not possible,
- Those who are younger than 40, older than 55, have experienced menstruation for at least one year,
- Do not experience the symptoms of menopause,
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 |
|---|---|---|
| Distant reikiAlso: ReikiReiki; It is the transfer of energy to other people by the hands of the person who receives the theoretical training and attunement (initiation) from the reiki master, close or distant. When the hands are brought closer to the body in suitable positions or when the reiki practitioner visualizes the person in his/her thoughts, the energy flow starts spontaneously and the transferred energy is shaped according to the needs of the reiki recipient. The biggest advantage of Reiki; It is an easy and cost-effective method to ensure that the individual restores the balance between body, mind and spirit, has no side effects, has no negative effects on behavior and attitudes. | Other | Experimental (distant reiki) group |
Primary outcome
Menopause symptoms evaluated using the Menopause Rating Scale
Time frame: Change from before intervention, 4th and 8th week of intervention
It was developed in German by Schneider et al. In 1992 to measure the severity of menopausal symptoms and was adapted to English in 1996. MRT was adapted to Turkish by Gürkan in our country in 2005. There are "0 = None", "1 = Mild", "2 = Moderate", "3 = Severe" and "4 = Very severe" options for each item in the Likert-type scale consisting of 11 items including menopausal complaints. The total score of the scale is calculated based on the scores given for each item. The lowest score that can be obtained from the scale is 0, the highest score is 44.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distant reiki in people with Menopausal Symptom, run by Mersin 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 22 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopause symptoms evaluated using the Menopause Rating Scale (time frame: Change from before intervention, 4th and 8th week of intervention). 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 22 Apr 2022.