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The Effect of Reiki on Anxiety, Stress and Comfort Levels

Primary Purpose

Reiki, Gastro-Intestinal Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Reiki
Sham reiki
Sponsored by
Mardin Artuklu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Reiki focused on measuring Anxiety, Comfort, Endoscopy, Nursing, Reiki, Stress

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients were included in the study who were having an upper GI endoscopy for the first time, who were aged 18 or over, who had not previously had reiki or SR, who did not have a history of an operation in the previous six months, who were not using anxiolytic, hypnotic or sedative drugs, who had no cognitive or effective problems or any hindrance in communication, who were literate and who agreed to take part in the study.

Exclusion Criteria:

  • Patients were not included in the study who had an upper GI endoscopy with more than one elective condition, who were undergoing an emergency upper GI endoscopy, who were using anxiolytic, hypnotic or sedative drugs, who had taken a narcotic analgesic before the procedure, who completed the data collection forms incorrectly or incompletely, who did not wish to voluntarily participate, who had previously had reiki or SR, who had a running nose , a fever, a cough or any complaint of breathing difficulty, who were not literate and who did not agree to take part in the research.

Sites / Locations

  • Hediye Utli

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Reiki

Sham reiki

Control

Arm Description

One of these methods, reiki, has roots which go back thousands of years. Modern reiki was rediscovered and introduced by Mikao Usui in Japan at the end of the 19th century. Reiki means "universal life energy" . The aim in reiki, in which healing energy is purposefully directed, is to provide restoration of unbalanced energy layers which might be the source of physical, emotional or psychological pain.

With the Sham Reiki patients, a nurse without reiki training performed Sham Reiki randomly for approximately, following a protocol which did not include the body's energy centers or chakras.

The control group received no intervention beyond routine care.

Outcomes

Primary Outcome Measures

Visual Analog Scale for Stress
The visual analog scale for stress reliably assesses levels of perceived stress.
State Anxiety Inventory
For state anxiety scores, participants mark the choice on the scale which most suits themselves, choosing from "not at all", "a little", "a lot", or "completely" for each statement.
Short General Comfort Questionnaire
The questionnaire consists of three subdimensions: relief, relaxation and superiority.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2021
Last Updated
April 12, 2021
Sponsor
Mardin Artuklu University
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1. Study Identification

Unique Protocol Identification Number
NCT04843384
Brief Title
The Effect of Reiki on Anxiety, Stress and Comfort Levels
Official Title
The Effect on Anxiety, Stress and Comfort Levels of Reiki Before Gastrointestinal Endoscopy: A Randomized Sham-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mardin Artuklu University

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
Anxiety and stress are problems which are often seen in patients about to undergo upper gastrointestinal endoscopy, and taking them under control is important in calming the person and in reducing complications. The aim of this study was to determine the effect of reiki applied before upper gastrointestinal endoscopy on levels of anxiety, stress and comfort. This was a single-blind, randomized sham-controlled study. Patients who met the inclusion criteria were separated by randomization into three groups: reiki (n=53), sham reiki (n=53) and control (n=53). A total of 159 patients participated in the study. In the reiki group, reiki was applied once for approximately 20-25 minutes before gastrointestinal endoscopy. Collection of data was by a Patient Identification Form, the Visual Analog Scale for Stress, the State Anxiety Inventory, and the Short General Comfort Questionnaire.
Detailed Description
Anxiety and stress are problems which are often seen in patients about to undergo upper GI endoscopy, and taking them under control is important in calming the person and in reducing complications. Studies have been conducted evaluating the effectiveness on these symptoms of various procedures such as aromatherapy, music therapy and reflexology in patients about to undergo upper GI endoscopy (Monfared, Mirzaee Jirdehi, Mansour Ghanaei, Joukar, & Kazemnezhad Leyli, 2020; Shaermoghadam, Shahdadi, Khorsandvakilzadeh, Afshari, & Badakhsh, 2016; Sogabe et al, 2018). Only one study was found which examined the effect of reiki on anxiety before colonoscopy (Hulse, Stuart-Shor, & Russo, 2010), and no studies were found examining the effect of the implementation of reiki on levels of anxiety, stress and comfort in patients about to undergo upper GI endoscopy. This strengthens the particular value of this research. Also, it is thought that the results of this study will contribute to the literature in forming a basis for other studies on the topic. Therefore, the aim of the study was to evaluate the effect of the application of reiki and sham reiki on anxiety, stress and comfort levels in patients about to undergo upper GI endoscopy.This study had a randomized sham-controlled trial design. It was conducted between 2 February 2021 and 1 April 2021 in the Endoscopy Outpatients' Department of a state hospital in the Southeast Region of Turkey. In order to determine the applicability of the data collection form, a pre-application was conducted with 15 patients. The patients who were in the application group were not included in the sample group. The data were collected using the Patient Identification Form, the Visual Analog Scale for Stress (VASS), the State Anxiety Inventory (SAI) and the Short General Comfort Questionnaire (SGCQ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reiki, Gastro-Intestinal Disorder
Keywords
Anxiety, Comfort, Endoscopy, Nursing, Reiki, Stress

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Reiki
Arm Type
Experimental
Arm Description
One of these methods, reiki, has roots which go back thousands of years. Modern reiki was rediscovered and introduced by Mikao Usui in Japan at the end of the 19th century. Reiki means "universal life energy" . The aim in reiki, in which healing energy is purposefully directed, is to provide restoration of unbalanced energy layers which might be the source of physical, emotional or psychological pain.
Arm Title
Sham reiki
Arm Type
Sham Comparator
Arm Description
With the Sham Reiki patients, a nurse without reiki training performed Sham Reiki randomly for approximately, following a protocol which did not include the body's energy centers or chakras.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group received no intervention beyond routine care.
Intervention Type
Other
Intervention Name(s)
Reiki
Intervention Description
Reiki was performed according to the need of each patient and lasted an average of 20-25 minutes. After the procedure, the patients were left to rest for ten minutes. The researcher was focused in a neutral way on the sessions without the intention of healing. After the session, the patients were allowed to rest for ten minutes.
Intervention Type
Other
Intervention Name(s)
Sham reiki
Intervention Description
With the Sham Reiki patients, a nurse without reiki training performed Sham Reiki randomly for approximately 20-25 minutes, following a protocol which did not include the body's energy centers or chakras.
Primary Outcome Measure Information:
Title
Visual Analog Scale for Stress
Description
The visual analog scale for stress reliably assesses levels of perceived stress.
Time Frame
60-90 minutes before the endoscopy
Title
State Anxiety Inventory
Description
For state anxiety scores, participants mark the choice on the scale which most suits themselves, choosing from "not at all", "a little", "a lot", or "completely" for each statement.
Time Frame
60-90 minutes before the endoscopy
Title
Short General Comfort Questionnaire
Description
The questionnaire consists of three subdimensions: relief, relaxation and superiority.
Time Frame
60-90 minutes before the endoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients were included in the study who were having an upper GI endoscopy for the first time, who were aged 18 or over, who had not previously had reiki or SR, who did not have a history of an operation in the previous six months, who were not using anxiolytic, hypnotic or sedative drugs, who had no cognitive or effective problems or any hindrance in communication, who were literate and who agreed to take part in the study. Exclusion Criteria: Patients were not included in the study who had an upper GI endoscopy with more than one elective condition, who were undergoing an emergency upper GI endoscopy, who were using anxiolytic, hypnotic or sedative drugs, who had taken a narcotic analgesic before the procedure, who completed the data collection forms incorrectly or incompletely, who did not wish to voluntarily participate, who had previously had reiki or SR, who had a running nose , a fever, a cough or any complaint of breathing difficulty, who were not literate and who did not agree to take part in the research.
Facility Information:
Facility Name
Hediye Utli
City
Mardin
ZIP/Postal Code
47200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
After the research is published as an article, it will be shared with other researchers.

Learn more about this trial

The Effect of Reiki on Anxiety, Stress and Comfort Levels

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