NCT05924334

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 4, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2023

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

1 day

First QC Date

June 21, 2023

Last Update Submit

November 14, 2023

Conditions

Keywords

quality of lifereikipremenstrual syndrome

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

reiki

EXPERIMENTAL

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.

Other: reiki

placebo control

EXPERIMENTAL

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.

Other: placebo

Interventions

reikiOTHER

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.

reiki
placeboOTHER

placebo

placebo control

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • PMS scale total score is 110 points and above
  • Being a volunteer to participate in the reiki application

You may not qualify if:

  • Having a pacemaker (Reiki application is not recommended.)
  • Being pregnant (Reiki application is not recommended.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkey, Ege University

Izmir, 35330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Officials

  • Figen Kazankaya, Master

    Ege University

    STUDY CHAIR
  • Gül Ertem, PhD

    Ege University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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 triple blinding will be performed and reliable results will be obtained.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective, randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

June 21, 2023

First Posted

June 29, 2023

Study Start

August 4, 2023

Primary Completion

August 5, 2023

Study Completion

August 14, 2023

Last Updated

November 15, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations