The Effect of Virtual Reality on Pain, Anxiety and Vital Signs in Endoscopy Patients

Sponsor
İBRAHİM NAS (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05587946
Collaborator
Ataturk University (Other)
80
1
2
14.9
5.4

Study Details

Study Description

Brief Summary

This study will discuss the effect of virtual reality application on pain, anxiety and vital signs in patients undergoing upper gastrointestinal endoscopy. The research will be conducted as a mixed method research that includes quantitative and qualitative methods. In the research, the parallel pattern model, which converges from the mixed method designs, will be used.

Condition or Disease Intervention/Treatment Phase
  • Other: Experimental group
N/A

Detailed Description

Objective: This study will discuss the effect of virtual reality application on pain, anxiety and vital signs in patients undergoing upper gastrointestinal endoscopy. The research will be conducted as a mixed method research that includes quantitative and qualitative methods. In the research, the parallel pattern model, which converges from the mixed method designs, will be used.

Materials and Methods: This study will be carried out with 80 patients (40 experimental group and 40 control group) who applied to the endoscopy unit in a university hospital in Van between 15.01.2022 and 15.12.2022, met the inclusion criteria and agreed to participate in the study. Gpower power analysis was performed to determine the number of samples in the research. "Random Allocation Software" computer program will be used to determine the experimental and control groups. In order to collect data, patient identification form, state anxiety scale and pain visual scale will be applied respectively and vital signs will be measured. In the experimental group, virtual reality glasses will be put on the patient 2 minutes before the endoscopy and a video with nature images will be started. Glasses will be worn throughout the endoscopy procedure. After the endoscopy procedure, the state anxiety scale and pain visual scale will be applied again and vital signs will be measured. In addition, in order to collect the qualitative data of the research, a "semi-structured interview form" will be applied by interviewing the patient after a while. This interview will be recorded with a tape recorder. In the control group, in addition to the standard endoscopy procedure, the state anxiety scale and pain visual scale will be applied before and after the procedure, and vital signs will be measured.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A mixed method study to determine the effect of virtual reality application on pain, anxiety and vital signs in patients undergoing upper gastrointestinal endoscopy.A mixed method study to determine the effect of virtual reality application on pain, anxiety and vital signs in patients undergoing upper gastrointestinal endoscopy.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Investigation of the Effect of Virtual Reality Application on Pain, Anxiety and Vital Signs in Patients Who Have Had Upper Gastrointestinal Endoscopy
Actual Study Start Date :
Jan 15, 2022
Anticipated Primary Completion Date :
Feb 15, 2023
Anticipated Study Completion Date :
Apr 15, 2023

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Anxiety state before endoscopy [Anxiety state reported within the first 10 minutes before the endoscopy procedure]

      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.

    2. Pain intensity before endoscopy [Pain intensity reported within the first 5 minutes prior to the endoscopy procedure]

      Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst Pain

    3. Heart rate before the endoscopy procedure [Just before the endoscopy procedure]

      60 to 100 beats per minute is normal.

    4. Blood pressure before the endoscopy procedure [Just before the endoscopy procedure]

      90/60 mm Hg to 120/80 mm/Hg is normal.

    5. Respiration rate before the endoscopy procedure [Just before the endoscopy procedure]

      12 to 20 breaths per minute is normal.

    6. Body temperature before the endoscopy procedure [Just before the endoscopy procedure]

      Normal Body temperature; 36 to 37-5 degrees is normal.

    7. Oxygen saturation (SpO2) before the endoscopy procedure [Just before the endoscopy procedure]

      Normal oxygen saturation usually ranges from 95% to 100%.

    8. Oxygen saturation (SpO2) after endoscopy procedure [within first 5 minutes after endoscopy procedure]

      Normal oxygen saturation usually ranges from 95% to 100%.

    9. Body temperature after endoscopy procedure [within first 5 minutes after endoscopy procedure]

      Normal Body temperature; 36 to 37-5 degrees is normal.

    10. Respiration rate after endoscopy procedure [Respiratory rate/minute reported in the first 5 minutes after the endoscopy procedure]

      12 to 20 breaths per minute is normal.

    11. Blood pressure after the endoscopy procedure [within first 5 minutes after the endoscopy procedure]

      90/60 mm Hg to 120/80 mm/Hg is normal.

    12. Heart rate after the endoscopy procedure [Heart rate per minute reported in the first 5 minutes after the endoscopy procedure]

      60 to 100 beats per minute is normal.

    13. Post-endoscopy pain [Pain severity reported in the first 5 minutes after the endoscopy procedure]

      Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst Pain

    14. Post-endoscopy anxiety state [Anxiety state reported within the first 10 minutes after the endoscopy procedure]

      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.

    Secondary Outcome Measures

    1. Patient opinions on endoscopy [Two hours after endoscopy]

      General thoughts of the patient about endoscopy

    2. Patient opinions on virtual reality glasses and its application [Two hours after endoscopy]

      General thoughts of the patient about the use of virtual reality glasses during endoscopy

    3. 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 pain

    4. Patient opinions on the effect of virtual reality application on anxiety [Two hours after endoscopy]

      Patient opinions on the effect of virtual reality application on anxiety

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Van Yüzüncü Yıl University, Faculty of Health Sciences, Department of Nursing, Van, Turkey Van Turkey

    Sponsors and Collaborators

    • İBRAHİM NAS
    • Ataturk University

    Investigators

    • Principal Investigator: GÜLAY İPEK ÇOBAN, Prof.Dr., Ataturk University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    İBRAHİM NAS, Lecturer, Ataturk University
    ClinicalTrials.gov Identifier:
    NCT05587946
    Other Study ID Numbers:
    • D. Tez
    First Posted:
    Oct 20, 2022
    Last Update Posted:
    Dec 27, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by İBRAHİM NAS, Lecturer, Ataturk University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 27, 2022