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

Nurse's Role Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05587946
• Other study ID #: D. Tez
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Turkey	Van Yüzüncü Yil University, Faculty of Health Sciences, Department of Nursing, Van, Turkey	Van

Sponsors (2)

Lead Sponsor	Collaborator
IBRAHIM NAS	Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Heart rate before the endoscopy procedure	60 to 100 beats per minute is normal.	Just before the endoscopy procedure
Primary	Blood pressure before the endoscopy procedure	90/60 mm Hg to 120/80 mm/Hg is normal.	Just before the endoscopy procedure
Primary	Respiration rate before the endoscopy procedure	12 to 20 breaths per minute is normal.	Just before the endoscopy procedure
Primary	Body temperature before the endoscopy procedure	Normal Body temperature; 36 to 37-5 degrees is normal.	Just before the endoscopy procedure
Primary	Oxygen saturation (SpO2) before the endoscopy procedure	Normal oxygen saturation usually ranges from 95% to 100%.	Just before the endoscopy procedure
Primary	Oxygen saturation (SpO2) after endoscopy procedure	Normal oxygen saturation usually ranges from 95% to 100%.	within first 5 minutes after endoscopy procedure
Primary	Body temperature after endoscopy procedure	Normal Body temperature; 36 to 37-5 degrees is normal.	within first 5 minutes after endoscopy procedure
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Patient opinions on endoscopy	General thoughts of the patient about endoscopy	Two hours after endoscopy
Secondary	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
Secondary	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
Secondary	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