NCT05922787

Brief Summary

Background and Purpose: This study aimed to determine the effect of Reiki on sexual function and sexual self-confidence in women with sexual distress. Materials and Methods: This randomized controlled study was conducted with women between the ages of 15-49 years who were registered at a family health center in the eastern region of Turkey and had sexual distress. The sample of the study consisted of 106 women, 53 in the experimental group and 53 in the control group. Women in the experimental group received Reiki once a week for four weeks, while no intervention was applied to those in the control group. Data were collected using the Female Sexual Distress Scale-Revised (FSDS-R), the Arizona Sexual Experiences Scale (ASEX), and the Sexual Self-confidence Scale (SSS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

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

September 20, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

June 16, 2023

Last Update Submit

July 13, 2023

Conditions

Keywords

reikisexual distresssexual self-confidencesexual experience

Outcome Measures

Primary Outcomes (1)

  • Female Sexual Distress Scale-Revised (FSDS-R)

    The FSDS-R was assesses various aspects of sexual distress in women, including subjective stress and psychological impact associated with sexual dysfunction and is used to identify women with and without sexual dysfunction. The scale consists of 13 items on a five-point Likert scale ranging from never (0) to always. Total scale score ranges between 0 and 52. A higher score indicates higher levels of sexual distress. A cutoff score of ≥11.5 has been recommended to detect the presence of sexually-related personal distress in Turkish women.

    Change from Sexual Distress at 4 weeks

Secondary Outcomes (2)

  • Arizona Sexual Experiences Scale (ASEX)

    Change from Sexual Experiences at 4 weeks

  • Sexual Self-confidences Scale (SSS)

    Change from Sexual Self-confidences at 4 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Personal Information Form, Female Sexual Distress Scale-Revised (FSD-R),Arizona Sexual Experiences Scale (ASEX),Sexual Self-Confidences Scale (SSS) were utilized for the collection of research data. First of all, FSD-R was applied to the women, and the women who obtained a score above11.5 points or more from the FSD-R were invited to the study.Then, the Personal Information Form, ASEX, and SSS were first applied to the women invited to the study. 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. The FSD-R, ASEX and SSS were applied to all participant women after four weeks following the first application. The application of the measurement tools took 10-15 minutes.

Other: Reiki

Control

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(Personal Information Form, FSD-R, ASEX, SSS. The post-test forms (FSD-R, ASEX, SSS) 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

Experimental

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen between the ages of 15-49 years
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being a woman,
  • Scoring 11.5 or above on the Female Sexual Distress Scale-Revised (FSDS-R)
  • Being sexually active during the study.

You may not qualify if:

  • being pregnant or postpartum
  • having a diagnosis of any psychiatric illness or sexual dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fırat University

Elâzığ, Province, 23119, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sexuality

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

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

June 16, 2023

First Posted

June 28, 2023

Study Start

September 20, 2022

Primary Completion

April 20, 2023

Study Completion

June 1, 2023

Last Updated

July 17, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations