DysmenorrheaNCT06075784
The Effect of Reiki on Pain, Stress and Comfort Level in Students Experiencing Dysmenorrhea
A study testing reiki in people with Dysmenorrhea, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of reiki on pain, stress and comfort level in students experiencing dysmenorrhea Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- reiki
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2023to 15 Dec 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Agreeing to participate in the research and volunteering,
- over 18 years of age,
- without a diagnosed psychiatric disease,
- without communication problems,
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine the effect of reiki on pain, stress and comfort level in students experiencing dysmenorrhea
Read the detailed description
Hypotheses 01; there was no difference between the pain score of the reiki group and the pain score of the control group.
H02; there was no difference between the stress score of the reiki group and the stress score of the control group.
H03;there was no difference between the comfort level of the reiki group and the comfort level of the control group.
The study will be carried out in two different groups. The practice will start with meeting the students who experienced dysmenorrhea. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.
Reiki Group The intervention will be applied to the reiki group to be applied in the midwifery department application laboratory. Reiki therapy will be applied by a practitioner with a Reiki application certificate in the application laboratory for 30 minutes while the participants lie down with their eyes closed. 4 sessions of reiki application will be applied to the intervention group for a month. Reiki application will start from the time of menstruation, the first pain scores and comfort conditions will be recorded. Menstruation and general comfort after 4 sessions will be recorded. Any medication and side effects during menstruation with the last reiki application will be recorded by the research team member.
Placebo Reiki will be applied to the participants in the group in the application laboratory of the midwifery department of the faculty of health sciences. The practice will be carried out in the application laboratory for 30 minutes, with the participants sitting with their eyes closed. Reiki life energy will not be transferred to participants in the placebo reiki group. Since the participants' eyes are closed, they will not know that there is a transfer. Placebo Reiki application will be performed in the laboratory 4 times during a month. Placebo application will start from the time of menstruation, and the first pain scores and comfort conditions will be recorded. After 4 sessions, menstruation and general comfort will be recorded. Any medication and side effects during menstruation with the last application will be recorded by the research team member.
- Conditions
- Dysmenorrhea
- Being tested
- reiki
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reikiOther
Also called control group
placebo reiki
| Study group | Role | What they receive |
|---|---|---|
| Reiki | Experimental | The intervention will be applied to the reiki group to be applied in the application laboratory of the midwifery department of the faculty of health sciences. Reiki therapy will be applied by a practitioner with a Reiki application certificate in the application laboratory for 30 minutes while the participants lie down with their eyes closed. 4 sessions of reiki application will be applied to the intervention group for a month. Reiki application will start from the time of menstruation, the first pain scores and comfort conditions will be recorded. Menstruation and general comfort after 4 sessions will be recorded. Any medication and side effects during menstruation with the last reiki application will be recorded by the research team member. Receives: Other: reiki |
| Placebo reiki | Placebo comparator | Placebo Reiki will be applied to the participants in the group in the application laboratory of the midwifery department of the faculty of health sciences. The practice will be carried out in the application laboratory for 30 minutes, with the participants sitting with their eyes closed. Reiki life energy will not be transferred to participants in the placebo reiki group. Since the participants' eyes are closed, they will not know that there is a transfer. Placebo Reiki application will be performed in the laboratory 4 times during a month. Placebo application will start from the time of menstruation, and the first pain scores and comfort conditions will be recorded. After 4 sessions, menstruation and general comfort will be recorded. Any medication and side effects during menstruation with the last application will be recorded by the research team member. Receives: Other: reiki |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain
The Visual Analog Scale is a unidimensional scale commonly used to measure pain intensity. VAS is a measuring tool with a length of 0-10 cm (0-100 mm). This measuring tool can be used horizontally or vertically. High scores from the scale indicate high pain intensity. The cut-off points for pain scores taken from the scale are recommended as 0-4 mm "no pain", 5-44 mm "mild pain", 45-74 mm "moderate pain" and 75-100 mm "severe pain"VAS is a 10-cm-long measurement tool. The left end of the scale reads "no pain at all" and the right end reads "the most intense pian possible". A high score on the scale indicated a high level of pain and a score of 0 pointed to no pain.
Measured: immediately before reiki application and immediately after the reiki application
Change in stress
The Perceived Stress Scale (PSS-10), developed by Cohen, Kamarck and Mermelstein (1983), consists of 14 items in its original form. A self-report style is the scale. The extent to which an individual perceives some situations in his or her life as stressful It measures. For each item, "Never (0)", "Almost never (1)", "Sometimes" 5-point Likert type scoring ranging from "(2)", "Quite often (3)" and "Very often (4)" It is evaluated based on . In the scale, "perception of inadequacy" and "perception of stress/discomfort"
There are two different factors:
Measured: immediately before reiki application and immediately after the reiki application
Change in Comfort Level
The scale, which was developed by Katharine Kolcaba in 1992 to determine the comfort needs of individuals and to evaluate nursing interventions that can provide comfort and the increase in comfort, was adapted to Turkish society by Kuğuoğlu and Karabacak in 2004. The scale, which is a four-point Likert type and consists of 48 items, was created by taking as a guide the taxonomic structure consisting of 3 levels and 4 dimensions consisting of the theoretical components of comfort. Level; While it is evaluated as relief (16 items), relaxation (17 items) and overcoming problems (15 items), the dimension is; It is evaluated in three parts: physical (12 items), psychospiritual (13 items) and socio-cultural (10 items). Negative expressions in the scale are calculated by reverse coding during the evaluation phase. While the lowest total score that can be obtained from the scale is 48, the highest total score is 192.
Measured: immediately before reiki application and immediately after the reiki application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start15 Oct 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye BAL, Ondokuz Mayıs University
- Investigators
- Serap TOPATAN, assoc. prof. dr, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075784
- Sponsor's protocol ID
- 2022/9
- Status last verified
- Feb 2025
- First submitted
- 4 Oct 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reiki on Pain, Stress and Comfort Level in Students Experiencing Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06075784
- Acronym / sponsor ID
- 2022/9
- Conditions
- Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 10 Oct 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.
The aim of this study is to determine the effect of reiki on pain, stress and comfort level in students experiencing dysmenorrhea
Detailed description
Hypotheses 01; there was no difference between the pain score of the reiki group and the pain score of the control group.
H02; there was no difference between the stress score of the reiki group and the stress score of the control group.
H03;there was no difference between the comfort level of the reiki group and the comfort level of the control group.
The study will be carried out in two different groups. The practice will start with meeting the students who experienced dysmenorrhea. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.
Reiki Group The intervention will be applied to the reiki group to be applied in the midwifery department application laboratory. Reiki therapy will be applied by a practitioner with a Reiki application certificate in the application laboratory for 30 minutes while the participants lie down with their eyes closed. 4 sessions of reiki application will be applied to the intervention group for a month. Reiki application will start from the time of menstruation, the first pain scores and comfort conditions will be recorded. Menstruation and general comfort after 4 sessions will be recorded. Any medication and side effects during menstruation with the last reiki application will be recorded by the research team member.
Placebo Reiki will be applied to the participants in the group in the application laboratory of the midwifery department of the faculty of health sciences. The practice will be carried out in the application laboratory for 30 minutes, with the participants sitting with their eyes closed. Reiki life energy will not be transferred to participants in the placebo reiki group. Since the participants' eyes are closed, they will not know that there is a transfer. Placebo Reiki application will be performed in the laboratory 4 times during a month. Placebo application will start from the time of menstruation, and the first pain scores and comfort conditions will be recorded. After 4 sessions, menstruation and general comfort will be recorded. Any medication and side effects during menstruation with the last application will be recorded by the research team member.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reiki | Experimental | Other: reikiThe intervention will be applied to the reiki group to be applied in the application laboratory of the midwifery department of the faculty of health sciences. Reiki therapy will be applied by a practitioner with a Reiki application certificate in the application laboratory for 30 minutes while the participants lie down with their eyes closed. 4 sessions of reiki application will be applied to the intervention group for a month. Reiki application will start from the time of menstruation, the first pain scores and comfort conditions will be recorded. Menstruation and general comfort after 4 sessions will be recorded. Any medication and side effects during menstruation with the last reiki application will be recorded by the research team member. |
| Placebo reiki | Placebo comparator | Other: reikiPlacebo Reiki will be applied to the participants in the group in the application laboratory of the midwifery department of the faculty of health sciences. The practice will be carried out in the application laboratory for 30 minutes, with the participants sitting with their eyes closed. Reiki life energy will not be transferred to participants in the placebo reiki group. Since the participants' eyes are closed, they will not know that there is a transfer. Placebo Reiki application will be performed in the laboratory 4 times during a month. Placebo application will start from the time of menstruation, and the first pain scores and comfort conditions will be recorded. After 4 sessions, menstruation and general comfort will be recorded. Any medication and side effects during menstruation with the last application will be recorded by the research team member. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Agreeing to participate in the research and volunteering,
- over 18 years of age,
- without a diagnosed psychiatric disease,
- without communication problems,
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| reikiAlso: control groupplacebo reiki | Other | Placebo reiki, Reiki |
Primary outcome
Change in pain
Time frame: immediately before reiki application and immediately after the reiki application
The Visual Analog Scale is a unidimensional scale commonly used to measure pain intensity. VAS is a measuring tool with a length of 0-10 cm (0-100 mm). This measuring tool can be used horizontally or vertically. High scores from the scale indicate high pain intensity. The cut-off points for pain scores taken from the scale are recommended as 0-4 mm "no pain", 5-44 mm "mild pain", 45-74 mm "moderate pain" and 75-100 mm "severe pain"VAS is a 10-cm-long measurement tool. The left end of the scale reads "no pain at all" and the right end reads "the most intense pian possible". A high score on the scale indicated a high level of pain and a score of 0 pointed to no pain.
Change in stress
Time frame: immediately before reiki application and immediately after the reiki application
The Perceived Stress Scale (PSS-10), developed by Cohen, Kamarck and Mermelstein (1983), consists of 14 items in its original form. A self-report style is the scale. The extent to which an individual perceives some situations in his or her life as stressful It measures. For each item, "Never (0)", "Almost never (1)", "Sometimes" 5-point Likert type scoring ranging from "(2)", "Quite often (3)" and "Very often (4)" It is evaluated based on . In the scale, "perception of inadequacy" and "perception of stress/discomfort" There are two different factors:
Change in Comfort Level
Time frame: immediately before reiki application and immediately after the reiki application
The scale, which was developed by Katharine Kolcaba in 1992 to determine the comfort needs of individuals and to evaluate nursing interventions that can provide comfort and the increase in comfort, was adapted to Turkish society by Kuğuoğlu and Karabacak in 2004. The scale, which is a four-point Likert type and consists of 48 items, was created by taking as a guide the taxonomic structure consisting of 3 levels and 4 dimensions consisting of the theoretical components of comfort. Level; While it is evaluated as relief (16 items), relaxation (17 items) and overcoming problems (15 items), the dimension is; It is evaluated in three parts: physical (12 items), psychospiritual (13 items) and socio-cultural (10 items). Negative expressions in the scale are calculated by reverse coding during the evaluation phase. While the lowest total score that can be obtained from the scale is 48, the highest total score is 192.
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 7 Feb 2025.
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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.
Serap TOPATAN, assoc. prof. dr study director
Ondokuz Mayıs 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 Dysmenorrhea, run by Ondokuz Mayıs 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 4 inclusion and 1 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 7 Feb 2025. 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. Some participants in this study may receive a placebo. 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?
Change in pain (time frame: immediately before reiki application and immediately after the reiki application). The study lists 3 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 7 Feb 2025.