NCT06075784

Brief Summary

The aim of this study is to determine the effect of reiki on pain, stress and comfort level in students experiencing dysmenorrhea

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 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

First Submitted

Initial submission to the registry

October 4, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

October 4, 2023

Last Update Submit

February 5, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in pain

    The Visual Analog Scale is a unidimensional scale commonly used to measure pain intensity. VAS is a measuring tool with a length of 0-10 cm (0-100 mm). This measuring tool can be used horizontally or vertically. High scores from the scale indicate high pain intensity. The cut-off points for pain scores taken from the scale are recommended as 0-4 mm "no pain", 5-44 mm "mild pain", 45-74 mm "moderate pain" and 75-100 mm "severe pain"VAS is a 10-cm-long measurement tool. The left end of the scale reads "no pain at all" and the right end reads "the most intense pian possible". A high score on the scale indicated a high level of pain and a score of 0 pointed to no pain.

    immediately before reiki application and immediately after the reiki application

  • Change in stress

    The Perceived Stress Scale (PSS-10), developed by Cohen, Kamarck and Mermelstein (1983), consists of 14 items in its original form. A self-report style is the scale. The extent to which an individual perceives some situations in his or her life as stressful It measures. For each item, "Never (0)", "Almost never (1)", "Sometimes" 5-point Likert type scoring ranging from "(2)", "Quite often (3)" and "Very often (4)" It is evaluated based on . In the scale, "perception of inadequacy" and "perception of stress/discomfort" There are two different factors:

    immediately before reiki application and immediately after the reiki application

  • Change in Comfort Level

    The scale, which was developed by Katharine Kolcaba in 1992 to determine the comfort needs of individuals and to evaluate nursing interventions that can provide comfort and the increase in comfort, was adapted to Turkish society by Kuğuoğlu and Karabacak in 2004. The scale, which is a four-point Likert type and consists of 48 items, was created by taking as a guide the taxonomic structure consisting of 3 levels and 4 dimensions consisting of the theoretical components of comfort. Level; While it is evaluated as relief (16 items), relaxation (17 items) and overcoming problems (15 items), the dimension is; It is evaluated in three parts: physical (12 items), psychospiritual (13 items) and socio-cultural (10 items). Negative expressions in the scale are calculated by reverse coding during the evaluation phase. While the lowest total score that can be obtained from the scale is 48, the highest total score is 192.

    immediately before reiki application and immediately after the reiki application

Study Arms (2)

Reiki

EXPERIMENTAL

The intervention will be applied to the reiki group to be applied in the application laboratory of the midwifery department of the faculty of health sciences. Reiki therapy will be applied by a practitioner with a Reiki application certificate in the application laboratory for 30 minutes while the participants lie down with their eyes closed. 4 sessions of reiki application will be applied to the intervention group for a month. Reiki application will start from the time of menstruation, the first pain scores and comfort conditions will be recorded. Menstruation and general comfort after 4 sessions will be recorded. Any medication and side effects during menstruation with the last reiki application will be recorded by the research team member.

Other: reiki

Placebo reiki

PLACEBO COMPARATOR

Placebo Reiki will be applied to the participants in the group in the application laboratory of the midwifery department of the faculty of health sciences. The practice will be carried out in the application laboratory for 30 minutes, with the participants sitting with their eyes closed. Reiki life energy will not be transferred to participants in the placebo reiki group. Since the participants' eyes are closed, they will not know that there is a transfer. Placebo Reiki application will be performed in the laboratory 4 times during a month. Placebo application will start from the time of menstruation, and the first pain scores and comfort conditions will be recorded. After 4 sessions, menstruation and general comfort will be recorded. Any medication and side effects during menstruation with the last application will be recorded by the research team member.

Other: reiki

Interventions

reikiOTHER

placebo reiki

Also known as: control group
Placebo reikiReiki

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsDysmenorrhea
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Agreeing to participate in the research and volunteering,
  • over 18 years of age,
  • without a diagnosed psychiatric disease,
  • without communication problems,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Samsun, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Therapeutic TouchControl Groups

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Serap TOPATAN, assoc. prof. dr

    Ondokuz Mayıs University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 10, 2023

Study Start

October 15, 2023

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

February 7, 2025

Record last verified: 2025-02

Locations