Quality of LifeNCT05924334
Reiki & Premenstrual Syndrome & Quality of Life
A study testing reiki in people with Quality of Life, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
It is planned to perform a triple blind, randomized and placebo -controlled type in order to determine the effect of Kundalini reiki application on the symptoms of premenstrual syndrome. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- reiki
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Aug 2023to 14 Aug 2023
- 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- PMS scale total score is 110 points and above
- Being a volunteer to participate in the reiki application
Who cannot join
- Having a pacemaker (Reiki application is not recommended.)
- Being pregnant (Reiki application is not recommended.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Kundalini Reiki Intervention on the Symptoms of Premenstrual Syndrome and Quality of Life in Nursing Students: Randomized Controlled Trial
It is planned to perform a triple blind, randomized and placebo -controlled type in order to determine the effect of Kundalini reiki application on the symptoms of premenstrual syndrome.
Read the detailed description
Premenstrual syndrome is common as a number of cognitive and emotional symptoms that started about a week before menstruation and has negative effects on the quality of life of women. In this period, symptoms affecting the quality of life are often listed as pain, bloating, edema, appetite changes, weight gain, tenderness, fullness, fatigue, drowsiness, anxiety, depressive symptoms and crying. It is known that women resorted to various methods that are pharmacological or non-pharmacological methods to deal with these symptoms in the premenstrual period. These methods vary from analgesic to hot application or traditional and complementary methods. Reiki is a healing energy that is not exactly included in traditional and complementary practices but has been revealed by research. In short, it is an energy therapy that balances the body and has no negative side effects. There are two types: Usui Reiki and Kundalini Reiki. From this point of view, it is planned to perform a triple blind, randomized and placebo controlled type in order to determine the effect of Kundalini reiki application on the symptoms of premenstrual syndrome. The study is planned to be carried out with Ege University Faculty of Nursing between June 2023 and July 2023. The universe of the study will consist of all students studying at the faculty in 2022-2023. The first stage of the study, which is planned to be carried out in two stages, will be made of descriptive-specific type to determine the students with premenstrual syndrome, no sample selection will not be selected and all the students who meet the criteria of inclusion in the research will be taken. In the second stage, intervention and placebo groups will be identified by randomization among students with premenstrual syndrome. In the Premenstrual periods, Reiki application will be held in the Premenstrual periods and no energy work will be applied to the placebo group. For the second stage, the adequacy of the number of samples will be decided by making power analysis during the study. Research data will be collected by face-to-face interview method using the individual promotion form, premenstrual syndrome scale and SF-36 quality of life scale and SPSS 22.0 package program will be used in statistical data analysis. At the end of the study, although the effectiveness of reiki application against premenstrual symptoms in nursing students is determined, awareness will be created to be used as a applicable method for the development of premenstrual symptom management and quality of life if the result is effective.
- Conditions
- Quality of Life
- Being tested
- reiki, placebo
- Keywords
- quality of life, reiki, premenstrual syndrome
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reikiOther
Processing steps of Reiki application; During the Reiki process, the practitioner will keep the hands just above the recipient. It will be explained to the individual that he may feel the feeling of temperature, tingling, drowsiness, refreshment or healing during therapy.
During the application, the person does not need to be in a lying position or remove their clothes. It is enough to remove the jewelry on it.
In order to ensure the flow of energy during the application, the arms and legs of the individual should stand open on both sides of the body, and the hands and feet will not be crossed in order not to disrupt the flow of energy.
The practitioner will pass the right side of the individual and correct the energy existing around the body with the right hand to the feet and from top to bottom by correcting the energy field of the individual.
The application time will be between 20 and 30 minutes on average.
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| reiki | Experimental | Processing steps of Reiki application; During the Reiki process, the practitioner will keep the hands just above the recipient. It will be explained to the individual that he may feel the feeling of temperature, tingling, drowsiness, refreshment or healing during therapy.
During the application, the person does not need to be in a lying position or remove their clothes. It is enough to remove the jewelry on it.
In order to ensure the flow of energy during the application, the arms and legs of the individual should stand open on both sides of the body, and the hands and feet will not be crossed in order not to disrupt the flow of energy.
The practitioner will pass the right side of the individual and correct the energy existing around the body with the right hand to the feet and from top to bottom by correcting the energy field of the individual.
The application time will be between 20 and 30 minutes on average. Receives: Other: reiki |
| placebo control | Experimental | The same intervention procedure will be performed with the Reiki Group. Only the placebo group practitioner does not have a Reiki Master certificate. In other words, despite the apparent reiki applied, there will be no energy flow in its real meaning. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of premenstrual symptoms evaluated using the Premenstrual Syndrome Scale
The total score of the scale is obtained from the sum of the scores obtained from all sub -dimensions. At least 44 points can be obtained from the scale. Increased score from the scale states that the density of PMS symptoms increased
Measured: change from baseline (before implementation) and 1st week of practice
quality of life evaluated using the SF-36 Scale
Physical function, social functionality, physical role difficulty, emotional role difficulty, energy/vitality, mental health, pain and general health perception. Subscales evaluate health between 0 and 100, and 0 shows the bad health status, while 100 good health status
Measured: change from baseline (before implementation) and 1st week of practice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start4 Aug 2023
- Primary completion5 Aug 2023
- Study completion14 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Ege 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, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selin PAKER, Ege University
- Investigators
- Figen Kazankaya, Master, Study chair, Ege UniversityGül Ertem, PhD, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924334
- Sponsor's protocol ID
- 23-4.1T/88
- Status last verified
- Nov 2023
- First submitted
- 21 Jun 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kundalini Reiki Intervention on the Symptoms of Premenstrual Syndrome and Quality of Life in Nursing Students: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05924334
- Acronym / sponsor ID
- 23-4.1T/88
- Conditions
- Quality of Life
- Keywords
- quality of life, reiki, premenstrual syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 29 Jun 2023 (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.
It is planned to perform a triple blind, randomized and placebo -controlled type in order to determine the effect of Kundalini reiki application on the symptoms of premenstrual syndrome.
Detailed description
Premenstrual syndrome is common as a number of cognitive and emotional symptoms that started about a week before menstruation and has negative effects on the quality of life of women. In this period, symptoms affecting the quality of life are often listed as pain, bloating, edema, appetite changes, weight gain, tenderness, fullness, fatigue, drowsiness, anxiety, depressive symptoms and crying. It is known that women resorted to various methods that are pharmacological or non-pharmacological methods to deal with these symptoms in the premenstrual period. These methods vary from analgesic to hot application or traditional and complementary methods. Reiki is a healing energy that is not exactly included in traditional and complementary practices but has been revealed by research. In short, it is an energy therapy that balances the body and has no negative side effects. There are two types: Usui Reiki and Kundalini Reiki. From this point of view, it is planned to perform a triple blind, randomized and placebo controlled type in order to determine the effect of Kundalini reiki application on the symptoms of premenstrual syndrome. The study is planned to be carried out with Ege University Faculty of Nursing between June 2023 and July 2023. The universe of the study will consist of all students studying at the faculty in 2022-2023. The first stage of the study, which is planned to be carried out in two stages, will be made of descriptive-specific type to determine the students with premenstrual syndrome, no sample selection will not be selected and all the students who meet the criteria of inclusion in the research will be taken. In the second stage, intervention and placebo groups will be identified by randomization among students with premenstrual syndrome. In the Premenstrual periods, Reiki application will be held in the Premenstrual periods and no energy work will be applied to the placebo group. For the second stage, the adequacy of the number of samples will be decided by making power analysis during the study. Research data will be collected by face-to-face interview method using the individual promotion form, premenstrual syndrome scale and SF-36 quality of life scale and SPSS 22.0 package program will be used in statistical data analysis. At the end of the study, although the effectiveness of reiki application against premenstrual symptoms in nursing students is determined, awareness will be created to be used as a applicable method for the development of premenstrual symptom management and quality of life if the result is effective.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| reiki | Experimental | Other: reikiProcessing steps of Reiki application; During the Reiki process, the practitioner will keep the hands just above the recipient. It will be explained to the individual that he may feel the feeling of temperature, tingling, drowsiness, refreshment or healing during therapy. During the application, the person does not need to be in a lying position or remove their clothes. It is enough to remove the jewelry on it. In order to ensure the flow of energy during the application, the arms and legs of the individual should stand open on both sides of the body, and the hands and feet will not be crossed in order not to disrupt the flow of energy. The practitioner will pass the right side of the individual and correct the energy existing around the body with the right hand to the feet and from top to bottom by correcting the energy field of the individual. The application time will be between 20 and 30 minutes on average. |
| placebo control | Experimental | Other: placeboThe same intervention procedure will be performed with the Reiki Group. Only the placebo group practitioner does not have a Reiki Master certificate. In other words, despite the apparent reiki applied, there will be no energy flow in its real meaning. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- PMS scale total score is 110 points and above
- Being a volunteer to participate in the reiki application
Key exclusion criteria (2 listed)
- Having a pacemaker (Reiki application is not recommended.)
- Being pregnant (Reiki application is not recommended.)
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 |
|---|---|---|
| reikiProcessing steps of Reiki application; During the Reiki process, the practitioner will keep the hands just above the recipient. It will be explained to the individual that he may feel the feeling of temperature, tingling, drowsiness, refreshment or healing during therapy. During the application, the person does not need to be in a lying position or remove their clothes. It is enough to remove the jewelry on it. In order to ensure the flow of energy during the application, the arms and legs of the individual should stand open on both sides of the body, and the hands and feet will not be crossed in order not to disrupt the flow of energy. The practitioner will pass the right side of the individual and correct the energy existing around the body with the right hand to the feet and from top to bottom by correcting the energy field of the individual. The application time will be between 20 and 30 minutes on average. | Other | reiki |
| placeboplacebo | Other | placebo control |
Primary outcome
Intensity of premenstrual symptoms evaluated using the Premenstrual Syndrome Scale
Time frame: change from baseline (before implementation) and 1st week of practice
The total score of the scale is obtained from the sum of the scores obtained from all sub -dimensions. At least 44 points can be obtained from the scale. Increased score from the scale states that the density of PMS symptoms increased
quality of life evaluated using the SF-36 Scale
Time frame: change from baseline (before implementation) and 1st week of practice
Physical function, social functionality, physical role difficulty, emotional role difficulty, energy/vitality, mental health, pain and general health perception. Subscales evaluate health between 0 and 100, and 0 shows the bad health status, while 100 good health status
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 15 Nov 2023.
- 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.
Figen Kazankaya, Master study chair
Ege University
Gül Ertem, PhD study director
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reiki in people with Quality of Life, run by Ege 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 2 inclusion and 2 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 15 Nov 2023. 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?
Intensity of premenstrual symptoms evaluated using the Premenstrual Syndrome Scale (time frame: change from baseline (before implementation) and 1st week of practice). 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 15 Nov 2023.