Primary DysmenorrheaNCT05129852
The Effect Of Reiki And Massage With Sage Oil On Primary Dysmenorrhea
A study testing Sage oil group and Reiki group in people with Primary Dysmenorrhea, run by Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
This study was a randomized controlled trial. It included young girls with primary dysmenorrhea in a district located in the south of Turkey and was conducted between March 01, 2021 and June 30, 2021. The sample size of this research was decided by performing a power analysis in the power statistical program. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Sage oil group and Reiki group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 10 Jul 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being female Not married
Who cannot join
- Psychiatric problem Communication barrier Those who refuse to work
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Reiki And Massage With Sage Oil On Pain In Young Girls With Primary Dysmenorrhea
This study was a randomized controlled trial. It included young girls with primary dysmenorrhea in a district located in the south of Turkey and was conducted between March 01, 2021 and June 30, 2021. The sample size of this research was decided by performing a power analysis in the power statistical program. Considering the parameters of the groups, the effect size was calculated to be 0.5003604. Since α was found to be 0.05 and power (1 - β) was 0.95, a total number of 66 participants were distributed into three equal groups (sage oil massage: 22, Reiki: 22, control: 22). Considering the possibility of case losses, 30 participants were included in each group; finally, a total of 90 people were included in the study. For data collection, a questionnaire regarding sociodemographic characteristics and the visual analog scale (VAS) were used. Reiki and massage with sage oil were applied for 30 minutes, and no application was performed on the control group.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Sage oil group, Reiki group
- Keywords
- midwifery, nurse, alternative therapies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sage oil groupOther
Sometimes called muscatel. Made by steam or water distillation of Salvia sclarea flowering tops and foliage. Yields range from 0.7 to 1.5%. A pale yellow to yellow liquid with a herbaceous odor and a winelike bouquet. Produced in large quantities in France, Russia and Morocco. The oil contains linalyl acetate, linalool and other terpene alcohols (sclareol), as well as their acetates.
Reiki groupBehavioural
Within complementary and integrative health practices, Reiki is an ancient practice of Japanese origin widely used worldwide. Through the touch or approximation of the hands, an enabled therapist applies this technique to eliminate toxins, to balance the organism, and to favor the full functioning of the organism, to reestablish the flow of vital energy. Reiki as bioenergy therapy works with the energy that leads the human body to a calmer state that is linked to health and cure. Reiki therapists conduct the curing energy that enters the top of the head and leaves through the hands.
| Study group | Role | What they receive |
|---|---|---|
| sage oil group | Active comparator | The participants in the sage oil massage group (30 participants in total) had pain in the first 3 days of their menstrual cycle; when the pain started, pain levels were scored by the participants using visual analog scale (VAS). In addition, their blood pressure, body temperature, and pulse rate were measured. The researchers massaged the abdomen with sage oil for 30 minutes, and 30 minutes after the massage, VAS evaluation and blood pressure, body temperature, and pulse rate measurements were performed again. This application was repeated for two menstrual periods. Receives: Other: Sage oil group |
| Reiki group | Active comparator | visual analog scale (VAS) pain scores were also evaluated in the Reiki group (30 participants) when the pain started. The participants experienced pain on the first 3 days of their menstruation. Their blood pressure, body temperature, and pulse rate were also measured. Reiki was applied by a researcher with a Reiki certificate. Thirty minutes after the Reiki application, VAS evaluation and blood pressure, body temperature, and pulse rate measurements were repeated. This application was repeated for two menstrual periods. Receives: Behavioral: Reiki group |
| control group | No intervention | Similarly, in the control group (30 participants),visual analog scale (VAS) pain scores were evaluated when the pain started on the first three days of their menstruation, and their blood pressure, body temperature, and pulse rate were measured. No application was performed; they were only asked to rest. VAS evaluation and blood pressure, body temperature, and pulse rate measurements were performed again after 30 minutes. These measurements were repeated for two menstrual cycles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual Introductory Information Form
Form, information regarding sociodemographic characteristics of the participants was collected.
Measured: 2 months
VAS pain scores
Pain levels were scored by the participants using VAS
Measured: 2 months
Body Mass Index
Body mass index was calculated by measuring the height and weight of the participants.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Mar 2021
- Primary completion30 Jun 2021
- Study completion10 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups with alternative therapy is a randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NAZİFE BAKIR, Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129852
- Sponsor's protocol ID
- MAKU-BSYO-NB-01
- Status last verified
- Nov 2021
- First submitted
- 29 Oct 2021
- Last updated
- 22 Nov 2021
- 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 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Reiki And Massage With Sage Oil On Pain In Young Girls With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT05129852
- Acronym / sponsor ID
- MAKU-BSYO-NB-01
- Conditions
- Primary Dysmenorrhea
- Keywords
- midwifery, nurse, alternative therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 10 Jul 2021 (actual)
- First posted
- 22 Nov 2021 (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.
This study was a randomized controlled trial. It included young girls with primary dysmenorrhea in a district located in the south of Turkey and was conducted between March 01, 2021 and June 30, 2021. The sample size of this research was decided by performing a power analysis in the power statistical program. Considering the parameters of the groups, the effect size was calculated to be 0.5003604. Since α was found to be 0.05 and power (1 - β) was 0.95, a total number of 66 participants were distributed into three equal groups (sage oil massage: 22, Reiki: 22, control: 22). Considering the possibility of case losses, 30 participants were included in each group; finally, a total of 90 people were included in the study. For data collection, a questionnaire regarding sociodemographic characteristics and the visual analog scale (VAS) were used. Reiki and massage with sage oil were applied for 30 minutes, and no application was performed on the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Three groups with alternative therapy is a randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| sage oil group | Active comparator | Other: Sage oil groupThe participants in the sage oil massage group (30 participants in total) had pain in the first 3 days of their menstrual cycle; when the pain started, pain levels were scored by the participants using visual analog scale (VAS). In addition, their blood pressure, body temperature, and pulse rate were measured. The researchers massaged the abdomen with sage oil for 30 minutes, and 30 minutes after the massage, VAS evaluation and blood pressure, body temperature, and pulse rate measurements were performed again. This application was repeated for two menstrual periods. |
| Reiki group | Active comparator | Behavioral: Reiki groupvisual analog scale (VAS) pain scores were also evaluated in the Reiki group (30 participants) when the pain started. The participants experienced pain on the first 3 days of their menstruation. Their blood pressure, body temperature, and pulse rate were also measured. Reiki was applied by a researcher with a Reiki certificate. Thirty minutes after the Reiki application, VAS evaluation and blood pressure, body temperature, and pulse rate measurements were repeated. This application was repeated for two menstrual periods. |
| control group | No intervention | –Similarly, in the control group (30 participants),visual analog scale (VAS) pain scores were evaluated when the pain started on the first three days of their menstruation, and their blood pressure, body temperature, and pulse rate were measured. No application was performed; they were only asked to rest. VAS evaluation and blood pressure, body temperature, and pulse rate measurements were performed again after 30 minutes. These measurements were repeated for two menstrual cycles. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being female Not married
Key exclusion criteria (1 listed)
- Psychiatric problem Communication barrier Those who refuse to work
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 |
|---|---|---|
| Sage oil groupSometimes called muscatel. Made by steam or water distillation of Salvia sclarea flowering tops and foliage. Yields range from 0.7 to 1.5%. A pale yellow to yellow liquid with a herbaceous odor and a winelike bouquet. Produced in large quantities in France, Russia and Morocco. The oil contains linalyl acetate, linalool and other terpene alcohols (sclareol), as well as their acetates. | Other | sage oil group |
| Reiki groupWithin complementary and integrative health practices, Reiki is an ancient practice of Japanese origin widely used worldwide. Through the touch or approximation of the hands, an enabled therapist applies this technique to eliminate toxins, to balance the organism, and to favor the full functioning of the organism, to reestablish the flow of vital energy. Reiki as bioenergy therapy works with the energy that leads the human body to a calmer state that is linked to health and cure. Reiki therapists conduct the curing energy that enters the top of the head and leaves through the hands. | Behavioural | Reiki group |
Primary outcome
Individual Introductory Information Form
Time frame: 2 months
Form, information regarding sociodemographic characteristics of the participants was collected.
VAS pain scores
Time frame: 2 months
Pain levels were scored by the participants using VAS
Body Mass Index
Time frame: 2 months
Body mass index was calculated by measuring the height and weight of the participants.
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 Nov 2021.
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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 Sage oil group and Reiki group in people with Primary Dysmenorrhea, run by Mehmet Akif Ersoy 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 1 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 22 Nov 2021. 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?
Individual Introductory Information Form (time frame: 2 months). 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 22 Nov 2021.