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

NCT ID: NCT05587946

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2023-11-01

Brief Summary

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.

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.

Conditions

Patient Relations, Nurse; Nurse's Role; Supportive Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention/treatment

1. Implementation steps 1-4 of the Control Group will be done.

2. The patient will be informed about the virtual reality application.

3. The patient will be told that they can remove their glasses at any time and stop participating in the study.

4. 2 minutes before the endoscopy process starts, the previously determined video will be started by putting on the Virtual Reality Glasses.

5. Glasses will be worn from the beginning to the end of the procedure.

6. The patient will be observed during the procedure. The data obtained during the observation will be noted.

7. 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.

8. 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.

9. "Semi-Structured Interview Form" will be applied in the interview.

Group Type: EXPERIMENTAL

Experimental group

Intervention Type: OTHER

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.

Control group

1. Hands will be washed.

2. The right patient will be determined, the procedure will be explained to the patient and permission will be obtained.

3. A "Patient Identification Form" will be applied to the individual before the endoscopy procedure.

4. 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.

5. The patient will be observed during the procedure. The data obtained during the observation will be noted.

6. 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Girişim grubu

Eligibility Criteria

Inclusion Criteria

• 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

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

Exclusion Criteria

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

• Those in the control group

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ataturk University

OTHER

Sponsor Role: collaborator

İBRAHİM NAS

OTHER

Sponsor Role: lead

Responsible Party

İBRAHİM NAS

Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

GÜLAY İPEK ÇOBAN, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

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

Van, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

D. Tez

Identifier Type: -

Identifier Source: org_study_id