NCT05977426

Brief Summary

Objective: This study was conducted to determine the effects of Reiki applied to women in the postmenopausal period on menopausal symptoms and depression levels. Methodology:This randomized controlled study was conducted with postmenopausal women registered in a family health center in eastern Türkiye. The sample of the study consisted of 82 women, 41 in the Reiki group and 41 in the control group. While four sessions of Reiki were applied to the women in the Reiki group, once a week for 4 weeks, no intervention was applied to the control group. Menopause Rating Scale (MRS) and Beck Depression Inventory (BDI) were used to collect data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

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

May 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

July 25, 2023

Last Update Submit

August 2, 2023

Conditions

Keywords

Reikimenopausemenopausal symptomsdepression

Outcome Measures

Primary Outcomes (1)

  • Menopause Rating Scale (MRS)

    The Menopause Rating Scale (MRS) assess the severity of menopausal symptoms. The scale consists of 11 items and 3 subscales. These 3 subscales are called somato-vegetative complaints (such as night sweating and hot flush), psychological complaints (such as anxiety and depression), and urogenital complaints (such as urethral syndrome and vaginal dryness). The scale is in the form of a 5-point Likert type and each item is graded between zero (no complaints) and four (severe symptoms) points. The total score that can be obtained from the scale varies between 0-44 points. An increase in the total score obtained from the scale indicates that the menopausal complaints experienced are intensified.

    Change from menopause symptoms levels at 4 weeks

Secondary Outcomes (1)

  • Beck Depression Inventory (BDI)

    Change from depression levels at 4 weeks

Study Arms (2)

Reiki

EXPERIMENTAL

A sociodemographic questionnaire including questions about age, last menstrual period, education level and income level, Menopause Rating Scale (MRS), Beck Depression Inventory (BDI) were utilized for the collection of research data. And a question investigating the level of being affected by menopause complaints. The question investigating the level of being affected by menopause is: "At which level do menopause complaints affect you?". Women answered this question on a scale of 0 (very little/very slightly) to 10 (extreme/very much). Data were collected from women who applied to the FHC for general healthcare services after receiving service. Women in the experimental group received Reiki once a week for four weeks. No initiative was applied to the pregnant women in the control group. Each session lasted 30-40 minutes. Four weeks after the data collection tools used in the research were filled in as a pre-test, post-test data were obtained with the same measurement tools.

Other: Reiki

Routine checks

NO INTERVENTION

The researchers applied no initiative to the control group, and the women in the control group solely had the routine checks. The women in the control group filled out all pretest forms(A sociodemographic questionnaire including questions about age, last menstrual period, education level and income level, Menopause Rating Scale (MRS), Beck Depression Inventory (BDI)). The post-test forms (MRS, BDI) were re-administered 4 weeks later to women who did not receive any intervention.

Interventions

ReikiOTHER

In the study, women received four Reiki sessions once a week for four weeks from the researchers with Usuı Shiki Ryoho Reiki 1

Reiki

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen between the ages of 45-55 years
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • who were between the ages of 45-55,
  • did not have hearing problems,
  • did not have any psychiatric diseases,
  • were in a natural menopause period,
  • did not take hormone replacement therapy.

You may not qualify if:

  • having a diagnosis of any psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esra Sabanci Baransel

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This study was designed as a randomized controlled trial
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: This study was designed as a randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assit. Prof

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 4, 2023

Study Start

May 1, 2023

Primary Completion

June 1, 2023

Study Completion

July 23, 2023

Last Updated

August 4, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations