Clinical trial NCT05587946: The Effect of Virtual Reality Application Used During Endoscopy on Pain, Anxiety and Vital Signs: A Mixed Methods Study
Official title: The Effect of Virtual Reality Application Used During Endoscopy on Pain, Anxiety and Vital Signs: A Mixed Methods Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Patient Relations, Nurse
Nurse's Role
Supportive Care
Keywords: Endoscopy
virtual reality
pain
anxiety
vital signs
Lead sponsor: Ataturk University
Sponsor class: OTHER
Collaborators: name: Ataturk University
First posted: 2022-10-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Effect of Virtual Reality Application Used During Endoscopy on Pain, Anxiety and Vital Signs: A Mixed Methods Study
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety state before endoscopy
timeFrame: Anxiety state reported within the first 10 minutes before the endoscopy procedure
measure: Pain intensity before endoscopy
timeFrame: Pain intensity reported within the first 5 minutes prior to the endoscopy procedure
measure: Heart rate before the endoscopy procedure
timeFrame: Just before the endoscopy procedure
measure: Blood pressure before the endoscopy procedure
timeFrame: Just before the endoscopy procedure
measure: Respiration rate before the endoscopy procedure
timeFrame: Just before the endoscopy procedure
measure: Body temperature before the endoscopy procedure
timeFrame: Just before the endoscopy procedure
measure: Oxygen saturation (SpO2) before the endoscopy procedure
timeFrame: Just before the endoscopy procedure
measure: Oxygen saturation (SpO2) after endoscopy procedure
timeFrame: within first 5 minutes after endoscopy procedure
measure: Body temperature after endoscopy procedure
timeFrame: within first 5 minutes after endoscopy procedure
measure: Respiration rate after endoscopy procedure
timeFrame: Respiratory rate/minute reported in the first 5 minutes after the endoscopy procedure
measure: Blood pressure after the endoscopy procedure
timeFrame: within first 5 minutes after the endoscopy procedure
measure: Heart rate after the endoscopy procedure
timeFrame: Heart rate per minute reported in the first 5 minutes after the endoscopy procedure
measure: Post-endoscopy pain
timeFrame: Pain severity reported in the first 5 minutes after the endoscopy procedure
measure: Post-endoscopy anxiety state
timeFrame: Anxiety state reported within the first 10 minutes after the endoscopy procedure
Secondary outcomes:
measure: Patient opinions on endoscopy
timeFrame: Two hours after endoscopy
measure: Patient opinions on virtual reality glasses and its application
timeFrame: Two hours after endoscopy
measure: Patient opinions on the effect of virtual reality application on pain
timeFrame: Two hours after endoscopy
measure: Patient opinions on the effect of virtual reality application on anxiety
timeFrame: Two hours after endoscopy
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yüzüncü Yıl University, Faculty of Health Sciences, Department of Nursing, Van, Turkey
Study officials:
affiliation: Ataturk University
name: GÜLAY İPEK ÇOBAN, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References: