The Effect of Virtual Reality Application Used During Endoscopy on Pain, Anxiety and Vital Signs: A Mixed Methods Study

In this study, the effect of virtual reality application used during upper gastrointestinal endoscopy on pain, anxiety and vital signs will be investigated. The research will be conducted as a mixed methods research including quantitative and qualitative methods. The exploratory sequence mixed design model, one of the mixed method designs, will be used in the research.

Study Overview

• Status: Enrolling by invitation
• Conditions: Nurse's Role; Supportive Care; Patient Relations, Nurse
• Intervention / Treatment: Other: Experimental group

Detailed Description

Objective: In this study, the effect of virtual reality application used during upper gastrointestinal endoscopy on pain, anxiety and vital signs will be investigated. The research will be conducted as a mixed methods research including quantitative and qualitative methods. The exploratory sequence mixed design model, one of the mixed method designs, will be used in the research.

The research was carried out in the endoscopy unit of a university hospital in Van between November 2022 and March 2023. This research, in which an exploratory sequential mixed design was used, consists of two stages. In the research, the quantitative phase, in which a pretest-posttest design, randomized controlled, experimental method was used, was completed with 75 patients, and the qualitative phase, in which the phenomenological/phenomenological design was used, was completed with 19 patients. Patient introduction form, state anxiety scale, pain visual comparison scale, patient follow-up form and semi-structured interview form were used to collect data. IBM SPSS V23 program (quantitative) and inductive qualitative content analysis (qualitative) were used to analyze the data.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey
    • Van Yüzüncü Yıl University, Faculty of Health Sciences, Department of Nursing, Van, Turkey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Criteria:

Inclusion criteria:

Inclusion criteria for the quantitative study;

• 18 years and older,
• who can read and write Turkish,
• without mental problems,
• Having no vision, hearing or perception problems,
• Diagnostic endoscopy was performed,
• No sedation before and during the procedure
• who volunteered to participate in the study,
• Those who have not taken analgesics in the last 8 hours

Qualitative research inclusion criteria;

• in the experimental group,
• who volunteered to participate in the research

Exclusion Criteria:

Exclusion criteria from quantitative section research;

• sedation applied,
• who want to withdraw from the study,
• Patients using analgesics or anti-anxiety medications before and during the procedure

Exclusion criteria from qualitative departmental research;

• Those in the control group

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention/treatment; Implementation steps 1-4 of the Control Group will be done.; The patient will be informed about the virtual reality application.; The patient will be told that they can remove their glasses at any time and stop participating in the study.; 2 minutes before the endoscopy process starts, the previously determined video will be started by putting on the Virtual Reality Glasses.; Glasses will be worn from the beginning to the end of the procedure.; The patient will be observed during the procedure. The data obtained during the observation will be noted.; After the endoscopy procedure; "State Anxiety Scale", "Visual Comparison Scale" will be re-applied and vital signs will be measured and recorded in the Patient Follow-up Form.; After the endoscopy procedure, patients will be given an interview appointment on the same day to collect the data of the qualitative part of the study.; "Semi-Structured Interview Form" will be applied in the interview.	Other: Experimental group; In recent years, virtual reality has been widely used as a distraction practice in clinical medical care to relieve pain. Virtual reality is a method of viewing computer images to isolate the individual from real life for a while. Virtual reality glasses, consisting of a head-mounted display and glasses connected to a mobile phone, is a computer technology that creates a 3D environment. The virtual reality application, which was originally designed for entertainment purposes, started to be used in the medical field to reduce pain during invasive procedures in parallel with the developments in computer technologies. It is preferred in clinical practice as an easily accessible, non-invasive and inexpensive method.; Other Names: Girişim grubu
No Intervention: Control group; Hands will be washed.; The right patient will be determined, the procedure will be explained to the patient and permission will be obtained.; A "Patient Identification Form" will be applied to the individual before the endoscopy procedure.; Before the endoscopy procedure; "State Anxiety Scale" will be applied in the first 10 minutes, and "Visual Comparison Scale" will be applied in the first 5 minutes. Vital signs will be measured within the first 5 minutes and recorded on the Patient Follow-up Form. Then the individual will be taken to the endoscopy procedure.; The patient will be observed during the procedure. The data obtained during the observation will be noted.; After the endoscopy procedure; "State Anxiety Scale", "Visual Comparison Scale" will be applied again and vital signs will be measured and recorded in the Patient Follow-up Form.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety state before endoscopy	The statements in the state anxiety scale were answered as "not at all", "a little", "a lot" and "totally" according to the feelings of the person. A total score of 20-80 is obtained from the scale. A low score indicates a low level of anxiety, and a high one indicates a high level of anxiety. The score obtained from the scale, on the other hand, indicates mild anxiety between 20-39, moderate anxiety between 40-59 and severe anxiety between 60-80.	Anxiety state reported within the first 10 minutes before the endoscopy procedure
Pain intensity before endoscopy	Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst Pain	Pain intensity reported within the first 5 minutes prior to the endoscopy procedure
Heart rate before the endoscopy procedure	60 to 100 beats per minute is normal.	Just before the endoscopy procedure
Blood pressure before the endoscopy procedure	90/60 mm Hg to 120/80 mm/Hg is normal.	Just before the endoscopy procedure
Respiration rate before the endoscopy procedure	12 to 20 breaths per minute is normal.	Just before the endoscopy procedure
Body temperature before the endoscopy procedure	Normal Body temperature; 36 to 37-5 degrees is normal.	Just before the endoscopy procedure
Oxygen saturation (SpO2) before the endoscopy procedure	Normal oxygen saturation usually ranges from 95% to 100%.	Just before the endoscopy procedure
Oxygen saturation (SpO2) after endoscopy procedure	Normal oxygen saturation usually ranges from 95% to 100%.	within first 5 minutes after endoscopy procedure
Body temperature after endoscopy procedure	Normal Body temperature; 36 to 37-5 degrees is normal.	within first 5 minutes after endoscopy procedure
Respiration rate after endoscopy procedure	12 to 20 breaths per minute is normal.	Respiratory rate/minute reported in the first 5 minutes after the endoscopy procedure
Blood pressure after the endoscopy procedure	90/60 mm Hg to 120/80 mm/Hg is normal.	within first 5 minutes after the endoscopy procedure
Heart rate after the endoscopy procedure	60 to 100 beats per minute is normal.	Heart rate per minute reported in the first 5 minutes after the endoscopy procedure
Post-endoscopy pain	Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst Pain	Pain severity reported in the first 5 minutes after the endoscopy procedure
Post-endoscopy anxiety state	The statements in the state anxiety scale were answered as "not at all", "a little", "a lot" and "totally" according to the feelings of the person. A total score of 20-80 is obtained from the scale. A low score indicates a low level of anxiety, and a high one indicates a high level of anxiety. The score obtained from the scale, on the other hand, indicates mild anxiety between 20-39, moderate anxiety between 40-59 and severe anxiety between 60-80.	Anxiety state reported within the first 10 minutes after the endoscopy procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient opinions on endoscopy	General thoughts of the patient about endoscopy	Two hours after endoscopy
Patient opinions on virtual reality glasses and its application	General thoughts of the patient about the use of virtual reality glasses during endoscopy	Two hours after endoscopy
Patient opinions on the effect of virtual reality application on pain	Patient opinions on the effect of virtual reality application on pain	Two hours after endoscopy
Patient opinions on the effect of virtual reality application on anxiety	Patient opinions on the effect of virtual reality application on anxiety	Two hours after endoscopy

Collaborators and Investigators

• Sponsor: İBRAHİM NAS
• Collaborators: Ataturk University
• Investigators: Principal Investigator: GÜLAY İPEK ÇOBAN, Prof.Dr., Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Actual): November 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: pain; anxiety; Endoscopy; virtual reality; vital signs
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: D. Tez

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No