- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05129852
The Effect Of Reiki And Massage With Sage Oil On Primary Dysmenorrhea
November 11, 2021 updated by: NAZİFE BAKIR, Mehmet Akif Ersoy University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Bucak
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Burdur, Bucak, Turkey
- Nazife Bakir
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Being female Not married
Exclusion Criteria:
Psychiatric problem Communication barrier Those who refuse to work
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: sage oil group
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.
|
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.
|
Active Comparator: Reiki group
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.
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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.
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No Intervention: control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Individual Introductory Information Form
Time Frame: 2 months
|
Form, information regarding sociodemographic characteristics of the participants was collected.
|
2 months
|
VAS pain scores
Time Frame: 2 months
|
Pain levels were scored by the participants using VAS
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2 months
|
Body Mass Index
Time Frame: 2 months
|
Body mass index was calculated by measuring the height and weight of the participants.
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2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
July 10, 2021
Study Registration Dates
First Submitted
October 29, 2021
First Submitted That Met QC Criteria
November 11, 2021
First Posted (Actual)
November 22, 2021
Study Record Updates
Last Update Posted (Actual)
November 22, 2021
Last Update Submitted That Met QC Criteria
November 11, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAKU-BSYO-NB-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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