NCT05342610

Brief Summary

In this randomized controlled study, it was aimed to determine the effect of distant reiki on menopausal symptoms. Two different hypothesis teams have been established for the study. These; H0: There is no significant difference between the menopause rating scores of the women in the study group in which distant reiki was applied and the control group without distant reiki. H1: There is a significant difference between the menopause rating scores of the women in the study group in which distant reiki was applied and the control group without distant reiki.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

November 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

April 19, 2022

Last Update Submit

April 19, 2022

Conditions

Keywords

Nursingintegrative practicemenopausal symptomsreiki

Outcome Measures

Primary Outcomes (1)

  • Menopause symptoms evaluated using the Menopause Rating Scale

    It was developed in German by Schneider et al. In 1992 to measure the severity of menopausal symptoms and was adapted to English in 1996. MRT was adapted to Turkish by Gürkan in our country in 2005. There are "0 = None", "1 = Mild", "2 = Moderate", "3 = Severe" and "4 = Very severe" options for each item in the Likert-type scale consisting of 11 items including menopausal complaints. The total score of the scale is calculated based on the scores given for each item. The lowest score that can be obtained from the scale is 0, the highest score is 44.

    Change from before intervention, 4th and 8th week of intervention

Study Arms (2)

Experimental (distant reiki) group

EXPERIMENTAL

Reiki (complementary and integrative medicine method) was applied individually to the experimental group for 30 minutes three times a week for four weeks. Data collection forms was applied 3 times in total, before the intervention, in the fourth and the eighth week.

Other: Distant reiki

Control group

NO INTERVENTION

No intervention was made to women in the control group. However, data collection forms was applied 3 times in total, before the intervention, in the fourth and the eighth week.

Interventions

Reiki; It is the transfer of energy to other people by the hands of the person who receives the theoretical training and attunement (initiation) from the reiki master, close or distant. When the hands are brought closer to the body in suitable positions or when the reiki practitioner visualizes the person in his/her thoughts, the energy flow starts spontaneously and the transferred energy is shaped according to the needs of the reiki recipient. The biggest advantage of Reiki; It is an easy and cost-effective method to ensure that the individual restores the balance between body, mind and spirit, has no side effects, has no negative effects on behavior and attitudes.

Also known as: Reiki
Experimental (distant reiki) group

Eligibility Criteria

Age40 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen aged 40-55 who are in menopause
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Willing to participate in research,
  • Can read and write in Turkish,
  • Open to communication,
  • Those who are between the ages of 40-55 and do not experience menstruation for at least one year,
  • Experiencing at least one or more of the menopausal symptoms,
  • Not applying regular reiki,
  • Those who have not surgically entered menopause,
  • Women without psychiatric problems

You may not qualify if:

  • Who do not agree to participate in the research,
  • Can't read and write Turkish,
  • Communication is not possible,
  • Those who are younger than 40, older than 55, have experienced menstruation for at least one year,
  • Do not experience the symptoms of menopause,
  • Using medication for the treatment of menopausal symptoms,
  • Chronic illness,
  • Regular reiki is applied,
  • Surgically in menopause,
  • Women with psychiatric problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diğdem LAFCI

Mersin, 33110, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Therapeutic Touch

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective, parallel, two-arm, randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 19, 2022

First Posted

April 22, 2022

Study Start

November 1, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations