NCT04843384

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

April 5, 2021

Last Update Submit

February 19, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    "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.

    "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.

    "Average of 1 year"

Study Arms (3)

Reiki

EXPERIMENTAL

Experimental

Other: Reiki

Sham reiki

SHAM COMPARATOR

Sham Comparator

Other: Sham reiki

Control

NO INTERVENTION

Control

Interventions

ReikiOTHER

Reiki

Reiki

sham Reiki

Sham reiki

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hediye Utli

Mardin, 47200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Therapeutic Touch

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Officials

  • Birgül VURAL DOĞRU, PhD

    Mersin University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, RN, Assistant Professor

Study Record Dates

First Submitted

April 5, 2021

First Posted

April 13, 2021

Study Start

February 2, 2021

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations