search
Back to results

Reiki & Premenstrual Syndrome & Quality of Life

Primary Purpose

Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
reiki
placebo
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Quality of Life focused on measuring quality of life, reiki, premenstrual syndrome

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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.)

Sites / Locations

  • Turkey, Ege University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

reiki

placebo control

Arm Description

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.

The same intervention procedure will be performed with the Reiki Group. Only the placebo group practitioner does not have a Reiki Master certificate. In other words, despite the apparent reiki applied, there will be no energy flow in its real meaning.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
June 21, 2023
Last Updated
August 14, 2023
Sponsor
Ege University
search

1. Study Identification

Unique Protocol Identification Number
NCT05924334
Brief Title
Reiki & Premenstrual Syndrome & Quality of Life
Official Title
Effect of Kundalini Reiki Intervention on the Symptoms of Premenstrual Syndrome and Quality of Life in Nursing Students: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 4, 2023 (Actual)
Primary Completion Date
August 5, 2023 (Actual)
Study Completion Date
August 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life
Keywords
quality of life, reiki, premenstrual syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized controlled trial
Masking
ParticipantInvestigator
Masking Description
In the research, practitioners and evaluator are different from each other. While the International Researcher with the International IAOTH -approved "Kundalini Reiki Master" certificate, he will be the Primary practitioner, one of the two other researchers will be a placebo practitioner and the other evaluator. In this way, the bias of the practitioners and the evaluation will disappear and double blinding will be performed and reliable results will be obtained.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
reiki
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo control
Arm Type
Experimental
Arm Description
The same intervention procedure will be performed with the Reiki Group. Only the placebo group practitioner does not have a Reiki Master certificate. In other words, despite the apparent reiki applied, there will be no energy flow in its real meaning.
Intervention Type
Other
Intervention Name(s)
reiki
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Intensity of premenstrual symptoms evaluated using the Premenstrual Syndrome Scale
Description
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
Time Frame
change from baseline (before implementation) and 1st week of practice
Title
quality of life evaluated using the SF-36 Scale
Description
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
Time Frame
change from baseline (before implementation) and 1st week of practice

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Figen Kazankaya, Master
Organizational Affiliation
Ege University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gül Ertem, PhD
Organizational Affiliation
Ege University
Official's Role
Study Director
Facility Information:
Facility Name
Turkey, Ege University
City
İzmir
ZIP/Postal Code
35330
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Reiki & Premenstrual Syndrome & Quality of Life

We'll reach out to this number within 24 hrs