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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05924334
Other study ID # 23-4.1T/88
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 4, 2023
Est. completion date August 14, 2023

Study information

Verified date November 2023
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It is planned to perform a triple blind, randomized and placebo -controlled type in order to determine the effect of Kundalini reiki application on the symptoms of premenstrual syndrome.


Description:

Premenstrual syndrome is common as a number of cognitive and emotional symptoms that started about a week before menstruation and has negative effects on the quality of life of women. In this period, symptoms affecting the quality of life are often listed as pain, bloating, edema, appetite changes, weight gain, tenderness, fullness, fatigue, drowsiness, anxiety, depressive symptoms and crying. It is known that women resorted to various methods that are pharmacological or non-pharmacological methods to deal with these symptoms in the premenstrual period. These methods vary from analgesic to hot application or traditional and complementary methods. Reiki is a healing energy that is not exactly included in traditional and complementary practices but has been revealed by research. In short, it is an energy therapy that balances the body and has no negative side effects. There are two types: Usui Reiki and Kundalini Reiki. From this point of view, it is planned to perform a triple blind, randomized and placebo controlled type in order to determine the effect of Kundalini reiki application on the symptoms of premenstrual syndrome. The study is planned to be carried out with Ege University Faculty of Nursing between June 2023 and July 2023. The universe of the study will consist of all students studying at the faculty in 2022-2023. The first stage of the study, which is planned to be carried out in two stages, will be made of descriptive-specific type to determine the students with premenstrual syndrome, no sample selection will not be selected and all the students who meet the criteria of inclusion in the research will be taken. In the second stage, intervention and placebo groups will be identified by randomization among students with premenstrual syndrome. In the Premenstrual periods, Reiki application will be held in the Premenstrual periods and no energy work will be applied to the placebo group. For the second stage, the adequacy of the number of samples will be decided by making power analysis during the study. Research data will be collected by face-to-face interview method using the individual promotion form, premenstrual syndrome scale and SF-36 quality of life scale and SPSS 22.0 package program will be used in statistical data analysis. At the end of the study, although the effectiveness of reiki application against premenstrual symptoms in nursing students is determined, awareness will be created to be used as a applicable method for the development of premenstrual symptom management and quality of life if the result is effective.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date August 14, 2023
Est. primary completion date August 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - PMS scale total score is 110 points and above - Being a volunteer to participate in the reiki application Exclusion Criteria: - Having a pacemaker (Reiki application is not recommended.) - Being pregnant (Reiki application is not recommended.)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
reiki
Processing steps of Reiki application; During the Reiki process, the practitioner will keep the hands just above the recipient. It will be explained to the individual that he may feel the feeling of temperature, tingling, drowsiness, refreshment or healing during therapy. During the application, the person does not need to be in a lying position or remove their clothes. It is enough to remove the jewelry on it. In order to ensure the flow of energy during the application, the arms and legs of the individual should stand open on both sides of the body, and the hands and feet will not be crossed in order not to disrupt the flow of energy. The practitioner will pass the right side of the individual and correct the energy existing around the body with the right hand to the feet and from top to bottom by correcting the energy field of the individual. The application time will be between 20 and 30 minutes on average.
placebo
placebo

Locations

Country Name City State
Turkey Turkey, Ege University Izmir

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intensity of premenstrual symptoms evaluated using the Premenstrual Syndrome Scale The total score of the scale is obtained from the sum of the scores obtained from all sub -dimensions. At least 44 points can be obtained from the scale. Increased score from the scale states that the density of PMS symptoms increased change from baseline (before implementation) and 1st week of practice
Primary quality of life evaluated using the SF-36 Scale Physical function, social functionality, physical role difficulty, emotional role difficulty, energy/vitality, mental health, pain and general health perception. Subscales evaluate health between 0 and 100, and 0 shows the bad health status, while 100 good health status change from baseline (before implementation) and 1st week of practice
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