The Effect of Reiki on Anxiety, Stress and Comfort Levels

• ClinicalTrials.gov Identifier: NCT04843384
• Recruitment Status: Completed
• First Posted: April 13, 2021
• Last Update Posted: April 13, 2021
• Sponsor: Mardin Artuklu University
• Information provided by (Responsible Party): HEDİYE UTLİ, Mardin Artuklu University

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.

Condition or disease	Intervention/treatment	Phase
Reiki; Gastro-Intestinal Disorder	Other: Reiki; Other: Sham reiki	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 159 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: The Effect on Anxiety, Stress and Comfort Levels of Reiki Before Gastrointestinal Endoscopy: A Randomized Sham-Controlled Trial
• Actual Study Start Date: February 2, 2021
• Actual Primary Completion Date: April 1, 2021
• Actual Study Completion Date: April 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Reiki; 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.	Other: Reiki; 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.
Sham Comparator: Sham reiki; 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.	Other: Sham reiki; 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.
No Intervention: Control; The control group received no intervention beyond routine care.

Outcome Measures

Primary Outcome Measures :

1. Visual Analog Scale for Stress [ Time Frame: 60-90 minutes before the endoscopy ]
   The visual analog scale for stress reliably assesses levels of perceived stress.
2. State Anxiety Inventory [ Time Frame: 60-90 minutes before the endoscopy ]
   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.
3. Short General Comfort Questionnaire [ Time Frame: 60-90 minutes before the endoscopy ]
   The questionnaire consists of three subdimensions: relief, relaxation and superiority.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Turkey

Hediye Utli

Mardin, Turkey, 47200

Sponsors and Collaborators

Mardin Artuklu University

More Information

• Responsible Party: HEDİYE UTLİ, PhD, RN, Assistant Professor, Mardin Artuklu University
• ClinicalTrials.gov Identifier: NCT04843384
• Other Study ID Numbers: Hediye
• First Posted: April 13, 2021
• Last Update Posted: April 13, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

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

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

Keywords provided by HEDİYE UTLİ, Mardin Artuklu University:

Anxiety; Comfort; Endoscopy; Nursing; Reiki; Stress

Additional relevant MeSH terms:

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases