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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Experimental group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The Effect of Virtual Reality Application Used During Endoscopy on Pain, Anxiety and Vital Signs: A Mixed Methods Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention/treatment<br>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<br>* 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.<br>* Other names: Girişim grubu;|
| No Intervention: Control group<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopy, virtual reality, pain, anxiety, vital signs