The Effect of Reiki on Anxiety, Stress and Comfort Levels

Gastro-Intestinal Disorder Clinical Trial

Official title:

The Effect on Anxiety, Stress and Comfort Levels of Reiki Before Gastrointestinal Endoscopy: A Randomized Sham-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04843384
• Other study ID #: Hediye
• Status: Completed
• Phase: N/A
• Start date: February 2, 2021
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2021
• Source: Mardin Artuklu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastro-Intestinal Disorder
• Gastrointestinal Diseases
• Intestinal Diseases
• Reiki

Intervention

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 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.

Locations

Country	Name	City	State
Turkey	Hediye Utli	Mardin

Sponsors (1)

Lead Sponsor	Collaborator
Mardin Artuklu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale for Stress	The visual analog scale for stress reliably assesses levels of perceived stress.	60-90 minutes before the endoscopy
Primary	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.	60-90 minutes before the endoscopy
Primary	Short General Comfort Questionnaire	The questionnaire consists of three subdimensions: relief, relaxation and superiority.	60-90 minutes before the endoscopy