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The Effect of Reiki on Pain, Stress and Comfort Level in Students Experiencing Dysmenorrhea

Primary Purpose

Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
reiki
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dysmenorrhea

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Agreeing to participate in the research and volunteering, over 18 years of age, without a diagnosed psychiatric disease, without communication problems, Exclusion Criteria: -

Sites / Locations

  • Ondokuz Mayis University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Reiki

Placebo reiki

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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:
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.

Secondary Outcome Measures

Full Information

First Posted
October 4, 2023
Last Updated
October 10, 2023
Sponsor
Ondokuz Mayıs University
Collaborators
Serap TOPATAN,Associate Professor
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1. Study Identification

Unique Protocol Identification Number
NCT06075784
Brief Title
The Effect of Reiki on Pain, Stress and Comfort Level in Students Experiencing Dysmenorrhea
Official Title
The Effect of Reiki on Pain, Stress and Comfort Level in Students Experiencing Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University
Collaborators
Serap TOPATAN,Associate Professor

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to determine the effect of reiki on pain, stress and comfort level in students experiencing dysmenorrhea
Detailed Description
Hypotheses 01; there was no difference between the pain score of the reiki group and the pain score of the control group. H02; there was no difference between the stress score of the reiki group and the stress score of the control group. H03;there was no difference between the comfort level of the reiki group and the comfort level of the control group. The study will be carried out in two different groups. The practice will start with meeting the students who experienced dysmenorrhea. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups. Reiki Group The intervention will be applied to the reiki group to be applied in the midwifery department application laboratory. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reiki
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo reiki
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
reiki
Other Intervention Name(s)
control group
Intervention Description
placebo reiki
Primary Outcome Measure Information:
Title
Change in pain
Description
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.
Time Frame
immediately before reiki application and immediately after the reiki application
Title
Change in stress
Description
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:
Time Frame
immediately before reiki application and immediately after the reiki application
Title
Change in Comfort Level
Description
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.
Time Frame
immediately before reiki application and immediately after the reiki application

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Dysmenorrhea
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Agreeing to participate in the research and volunteering, over 18 years of age, without a diagnosed psychiatric disease, without communication problems, Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serap TOPATAN, assoc. prof. dr
Organizational Affiliation
Ondokuz Mayıs University
Official's Role
Study Director
Facility Information:
Facility Name
Ondokuz Mayis University
City
Samsun
ZIP/Postal Code
55200
Country
Turkey

12. IPD Sharing Statement

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The Effect of Reiki on Pain, Stress and Comfort Level in Students Experiencing Dysmenorrhea

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