Clinical trial NCT05027659: The Effects of Virtual Reality Glasses on Vital Signs and Anxiety in Patients Undergoing Colonoscopy
Official title: The Effects of Virtual Reality Glasses on Vital Signs and Anxiety in Patients Undergoing Colonoscopy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vital Signs
Anxiety
Colonoscopy
Keywords: Anxiety
colonoscopy
pain
virtual reality glasses
vital signs
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial
Primary purpose: OTHER

Brief summary: The present study was conducted with 44 patients who applied to the Endoscopy Unit of a university hospital for sedation-free colonoscopy between January 2, 2020 and September 28, 2020, met the inclusion criteria and agreed to participate in the study. The patients were homogeneously divided into experimental (n=22) and control (n=22) groups based on their gender and history of colonoscopy. The patients in the experimental group watched a 360 degree virtual reailty (VR) video with atmospheric background music over images and sounds of nature through virtual reality glasses while no application was performed for the patients in the control group during the procedure. The "Demographic Information Form", "Trait Anxiety Scale", "Visual Analog Scale-Pain", "Visual Analog Scale-Anxiety", "Vital Signs Monitoring Chart" and "Satisfaction Evaluation on the Virtual Reality Glasses Application" forms were used in the data collection phase. For the study, an ethics committee approval was obtained in addition to written consent by the institutions and patients. Numbers, percentages, the Chi-square test, the Wilcoxon test and the Mann-Whitney U test were used for data analysis.

Detailed description: Aims: This study investigated the effect of VR glasses on vital signs and anxiety in patients undergoing colonoscopy. The research questions are as follows:

* Wearing VR glasses during colonoscopy affects at least one vital sign.
* Wearing VR glasses during colonoscopy affects anxiety. Study design and setting: This study adopted a randomized controlled experimental design. The study population consisted of all patients (N=82) who had a colonoscopy without sedation between January 2, 2020, and September 28, 2020, at the endoscopy unit of a training and research hospital in Kırıkkale, Turkey. Patients were randomized into experimental and control groups before the procedure.

Group 1 (experimental): Virtual reality glasses have a detachable screen frame compatible with smartphones. A VR headset has earphones and sensors that track the user's head movements, giving them the impression that they are moving around in a virtual environment (Arane et al., 2017; Indovina et al., 2018). The investigators used a smartphone and VR glasses to perform the intervention. They connected the phone to the VR headset via a 360o VR video app. Experimental participants wore the VR glasses and watched a 360o VR video of nature scenes with ambiance music during colonoscopy. They put on the VR glasses right before the procedure and took them off right afterward.

Each control group participant (Group 2) underwent the standard procedure.

Sample size calculation: The sample consisted of 44 participants divided into experimental (n=22) and control (n=22). A post-power analysis was conducted on Visual Analog Scale-Pain (VAS-P) scores due to the pandemic. The results showed that the sample was large enough to detect significant differences (effect size = 1.31; type I margin of error (α) = 0.05; test power (1-β) = 0.98).

Randomization: Simple stratified randomization was used for homogeneity.Participants were assigned to the groups based on their gender and colonoscopy history.For each patient randomly assigned to a group (drawing lots), another patient with the same gender and colonoscopy history was included in the other group. For example, the investigators wrote down "experimental" and "control" on pieces of paper for a female participant scheduled for a colonoscopy for the first time and put them in a bag. Then, they asked the nurse in charge to pull one of the pieces of paper out of the bag. In this way, that participant was assigned to the group written on the piece of paper. Afterward, the investigators assigned another patient with the same gender and colonoscopy history to the other group. The nurse pulled a new piece of paper out of the bag for a patient with a different gender and colonoscopy history. The investigatorsassigned that patient to the corresponding group. They followed the same procedure for all groups (Woman-first time colonoscopy; Woman- colonoscopy before; Man-first time colonoscopy; Man- colonoscopy before) to achieve homogenous groups.

Research shows that gender and colonoscopy history affect pain and anxiety during colonoscopy. Therefore, the investigators used the same parameters to randomize participants into the groups, which were similar in terms of gender and colonoscopy history.

Data collection tools: Data were collected using a demographic characteristics questionnaire and the Visual Analog Scale-Anxiety (VAS-A). Vital signs (Blood pressure, pulse rate, and SpO2) were also measured using a monitor. The respiratory rate was measured by the researcher. The pain was assessed using the Visual Analog Scale-Pain (VAS-P). A five-point scale ("very satisfied,""satisfied,""undecided,""dissatisfied," and "very dissatisfied") was used to determine how satisfied participants were with wearing the VR glasses during the procedure.

Research Implementation: Patients were informed about the research purpose and procedure, and consent was obtained from those who agreed to participate. All participants filled out the demographic characteristics questionnaire, VAS-P, and VAS-A, and their vital signs were measured before colonoscopy. The experimental group participants wore the VR glasses and watched a 360 degree VR video of nature scenes with ambiance music during colonoscopy. The control group participants underwent the standard procedure. All participants filled out the VAS-P and VAS-A, and their vital signs were measured after the procedure. How satisfied the experimental group participants were with the VR application was also assessed after the procedure.

Ethical Consideration: The study was approved by an ethics committee (Date: 31.07.2019 \& No:44). Permission was obtained from the hospital (Date: 07.08.2019 \& No: 28955). Patients were informed about the research purpose, procedure, and confidentiality prior to participation and that they could withdraw from the study at any time without any monetary concessions. Written consent was obtained from those who agreed to participate. Permission was obtained from the developer of the 360 degree VR video.

Eligibility criteria: Inclusion Criteria:

* Voluntary
* Scheduled for a colonoscopy without sedation
* Aged 18 to 79 years
* No perception, hearing, and vision impairment that interferes with communication
* Not wearing glasses
* No psychiatric disorder
* No migraine, vertigo, active nausea, vomiting, headache, etc.

Exclusion Criteria:

* no Voluntary
* Scheduled for a colonoscopy with sedation
* not been Aged 18 to 79 years
* participants have been perception, hearing, and vision impairment that interferes with communication
* wearing glasses
* participants have psychiatric disorder
* participants have migraine, vertigo, active nausea, vomiting, headache, etc.

Primary outcomes:
measure: blood pressure
timeFrame: Change in systolic blood pressure during colonoscopy, an average of 20 minutes
measure: pulse rate (heart rate)
timeFrame: Change in pulse rate during colonoscopy, an average of 20 minutes
measure: respiratory rate
timeFrame: Change in respiratory rate during colonoscopy, an average of 20 minutes
measure: peripheral oxygen saturation (SpO2)
timeFrame: Change in peripheral oxygen saturation during colonoscopy, an average of 20 minutes
measure: Pain score
timeFrame: Change in pain score during colonoscopy, an average of 20 minutes
measure: Anxiety score
timeFrame: Change in anxiety score during colonoscopy, an average of 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kirikkale
country: Turkey
facility: Kirikkale University
Study officials:
affiliation: Kırıkkale University
name: Esra DOĞAN YILMAZ RN, PhD, Research Assistant
role: PRINCIPAL_INVESTIGATOR
References: