Back to resultsThe Effect Of Reiki And Massage With Sage Oil On Primary Dysmenorrhea
Primary Purpose
Primary Dysmenorrhea
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sage oil group
Reiki group
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring midwifery, nurse, alternative therapies
Eligibility Criteria
Inclusion Criteria:
Being female Not married
Exclusion Criteria:
Psychiatric problem Communication barrier Those who refuse to work
Sites / Locations
- Nazife Bakir
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
sage oil group
Reiki group
control group
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Individual Introductory Information Form
Form, information regarding sociodemographic characteristics of the participants was collected.
VAS pain scores
Pain levels were scored by the participants using VAS
Body Mass Index
Body mass index was calculated by measuring the height and weight of the participants.
Secondary Outcome Measures
Full Information
NCT ID
NCT05129852
First Posted
October 29, 2021
Last Updated
November 11, 2021
Sponsor
Mehmet Akif Ersoy University
1. Study Identification
Unique Protocol Identification Number
NCT05129852
Brief Title
The Effect Of Reiki And Massage With Sage Oil On Primary Dysmenorrhea
Official Title
The Effect Of Reiki And Massage With Sage Oil On Pain In Young Girls With Primary Dysmenorrhea
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mehmet Akif Ersoy University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
midwifery, nurse, alternative therapies
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three groups with alternative therapy is a randomized controlled trial
Masking
Participant
Masking Description
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.
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.
Similarly, in the control group (30 participants), 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.
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sage oil group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Reiki group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sage oil group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reiki group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Individual Introductory Information Form
Description
Form, information regarding sociodemographic characteristics of the participants was collected.
Time Frame
2 months
Title
VAS pain scores
Description
Pain levels were scored by the participants using VAS
Time Frame
2 months
Title
Body Mass Index
Description
Body mass index was calculated by measuring the height and weight of the participants.
Time Frame
2 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Being female Not married
Exclusion Criteria:
Psychiatric problem Communication barrier Those who refuse to work
Facility Information:
Facility Name
Nazife Bakir
City
Burdur
State/Province
Bucak
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
The Effect Of Reiki And Massage With Sage Oil On Primary Dysmenorrhea
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