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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05129852
Other study ID # MAKU-BSYO-NB-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date July 10, 2021

Study information

Verified date November 2021
Source Mehmet Akif Ersoy University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date July 10, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Being female Not married Exclusion Criteria: Psychiatric problem Communication barrier Those who refuse to work

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sage oil group
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.
Behavioral:
Reiki group
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.

Locations

Country Name City State
Turkey Nazife Bakir Burdur Bucak

Sponsors (1)

Lead Sponsor Collaborator
Mehmet Akif Ersoy University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Individual Introductory Information Form Form, information regarding sociodemographic characteristics of the participants was collected. 2 months
Primary VAS pain scores Pain levels were scored by the participants using VAS 2 months
Primary Body Mass Index Body mass index was calculated by measuring the height and weight of the participants. 2 months
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