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

NCT05587946 | Unknown

• 1 other identifier: D. Tez
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Endoscopy; virtual reality; pain; anxiety; vital signs

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (4)

• Patient opinions on endoscopy

  Two hours after endoscopy

• Patient opinions on virtual reality glasses and its application

  Two hours after endoscopy

• 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

  Two hours after endoscopy

Study Arms (2)

Intervention/treatment

EXPERIMENTAL

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.

Other: Experimental group

Control group

NO INTERVENTION

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.

Interventions

Experimental group 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.

Also known as: Girişim grubu

Intervention/treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• İBRAHİM NAS: lead
• Ataturk University: collaborator

Study Sites (1)

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

Van, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• GÜLAY İPEK ÇOBAN, Prof.Dr.

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

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

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 20, 2022
• Study Start: January 15, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 3, 2023

Record last verified: 2023-11

Locations

TU (1)