ReikiNCT04843384
The Effect of Reiki on Anxiety, Stress, and Comfort
A study testing Reiki in people with Reiki and Gastro-Intestinal Disorder, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reiki, Gastro-Intestinal Disorder
- What is being tested?
- Reiki
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2021to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Reiki, Gastro-Intestinal Disorder
- Being tested
- Reiki, Sham reiki
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReikiOther
Reiki
Sham reikiOther
sham Reiki
| Study group | Role | What they receive |
|---|---|---|
| Reiki | Experimental | Experimental Receives: Other: Reiki |
| Sham reiki | Sham comparator | Sham Comparator Receives: Other: Sham reiki |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale for Stress (VASS)
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.
Measured: "Average of 1 year"
State Anxiety Inventory (SAI)
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.
Measured: "Average of 1 year"
Short General Comfort Questionnaire (SGCQ)
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.
Measured: "Average of 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start2 Feb 2021
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ReikiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HEDİYE UTLİ, Mardin Artuklu University
- Investigators
- Birgül VURAL DOĞRU, PhD, Study chair, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843384
- Sponsor's protocol ID
- Hediye
- Status last verified
- Feb 2025
- First submitted
- 5 Apr 2021
- Last updated
- 24 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reiki on Anxiety, Stress, and Comfort Levels Before Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT04843384
- Acronym / sponsor ID
- Hediye
- Conditions
- Reiki, Gastro-Intestinal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reiki | Experimental | Other: ReikiExperimental |
| Sham reiki | Sham comparator | Other: Sham reikiSham Comparator |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReikiReiki | Other | Reiki |
| Sham reikisham Reiki | Other | Sham reiki |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgül VURAL DOĞRU, PhD study chair
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki in people with Reiki and Gastro-Intestinal Disorder, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale for Stress (VASS) (time frame: "Average of 1 year"). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.