- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04843384
The Effect of Reiki on Anxiety, Stress, and Comfort
February 19, 2025 updated by: HEDİYE UTLİ, Mardin Artuklu University
The Effect of Reiki on Anxiety, Stress, and Comfort Levels Before Gastrointestinal Endoscopy
Upper gastrointestinal (GI) endoscopy is a procedure that is used in the examination, diagnosis, and treatment of the esophagus, stomach, and duodenum.
With developments in present-day technology, it is safe and widely used.
This study's aim is to determine the effect of Reiki when applied before upper gastrointestinal endoscopy on levels of anxiety, stress, and comfort.
This single-blind, randomized, sham-controlled study was held between February and July 2021.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Anxiety and stress are problems that are often seen in patients undergoing upper GI endoscopy, and managing them is an important step in calming the patient and thereby reducing complications.The results of this study will contribute to the literature in forming a basis for other studies on the topic.
The aim of this study is to evaluate the effects of the application of Reiki and sham Reiki on anxiety, stress, and comfort levels in patients undergoing upper GI endoscopy.
Study Type
Interventional
Enrollment (Actual)
159
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mardin, Turkey, 47200
- Hediye Utli
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion criteria
- patients who were having an upper GI endoscopy for the first time,
- patients who were age 18 or over,
- patients who had not previously had Reiki or sham Reiki (SR),
- patients who did not have a history of an operation in the previous six months,
- patients who were not using anxiolytic, hypnotic, or sedative drugs,
- patients who had no cognitive or effective problems or any hindrance in communication,
- patients who was literate, and who agreed to take part in the study.
Exclusion criteria
- patients who had an upper GI endoscopy with more than one elective condition,
- patients who was undergoing an emergency upper GI endoscopy,
- patients who were using anxiolytic, hypnotic, or sedative drugs,
- patients who had taken an opioid analgesic before the procedure,
- patients who completed the data collection forms incorrectly or incompletely,
- patients who had previously had Reiki or SR,
- patients who had a runny nose, fever, cough or any complaint of breathing difficulty,
- patients who were not literate and who did not wish to voluntarily participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Reiki
Experimental
|
Reiki
|
|
Sham Comparator: Sham reiki
Sham Comparator
|
sham Reiki
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale for Stress (VASS)
Time Frame: "Average of 1 year"
|
The VASS reliably assesses levels of perceived stress.The VASS used in this study is a horizontal line with two points labeled "No stress" and "High stress" at a distance of 0 and 10 cm from each other.
|
"Average of 1 year"
|
|
State Anxiety Inventory (SAI)
Time Frame: "Average of 1 year"
|
The SAI was developed by Spielberger et al., and the validity and reliability of the Turkish version were tested by Oner and Le Compte in 1974 to 1977.The highest possible score is 80, and the lowest is 20.
|
"Average of 1 year"
|
|
Short General Comfort Questionnaire (SGCQ)
Time Frame: "Average of 1 year"
|
The SGCQ was devised by Kolcaba et al. in 2006 and adapted to Turkish society by Citlik et al. in 2018.
It consists of 28 items, and the items on the scale score between 28 and 168 in total.
|
"Average of 1 year"
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Birgül VURAL DOĞRU, PhD, Mersin University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2021
Primary Completion (Actual)
April 1, 2021
Study Completion (Actual)
April 1, 2021
Study Registration Dates
First Submitted
April 5, 2021
First Submitted That Met QC Criteria
April 12, 2021
First Posted (Actual)
April 13, 2021
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 19, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hediye
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
After the research is published as an article, it will be shared with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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