The Effects of Virtual Reality Glasses on Vital Signs and Anxiety in Patients Undergoing Colonoscopy

Anxiety Clinical Trial

Official title:

The Effects of Virtual Reality Glasses on Vital Signs and Anxiety in Patients Undergoing Colonoscopy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05027659
• Other study ID #: EYILMAZ-experimental study
• Status: Completed
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: August 2021
• Source: Kirikkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 20, 2020
• Est. primary completion date: September 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Colonoscopy
• Vital Signs

Intervention

Other:
• virtual reality glasses
Virtual reality (VR) 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. The investigators used a smartphone and VR glasses to perform the intervention. They connected the phone to the VR headset via a 360 degree VR video app. Experimental participants wore the VR glasses and watched a 360 degree 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.

Locations

Country	Name	City	State
Turkey	Kirikkale University	Kirikkale

Sponsors (1)

Lead Sponsor	Collaborator
Esra DOGAN YILMAZ, RN, MSc

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure	mmHg. higher scores mean a worse	Change in systolic blood pressure during colonoscopy, an average of 20 minutes
Primary	pulse rate (heart rate)	beats per minute. higher scores mean a worse	Change in pulse rate during colonoscopy, an average of 20 minutes
Primary	respiratory rate	respiratory rate per minute. higher scores mean a worse	Change in respiratory rate during colonoscopy, an average of 20 minutes
Primary	peripheral oxygen saturation (SpO2)	Approaching 100% is considered positive. higher scores mean a better	Change in peripheral oxygen saturation during colonoscopy, an average of 20 minutes
Primary	Pain score	Visual Analog Scale-Pain (VAS-P), which is a 10cm long line with anchor statements "0=no pain" at the left-most end and "10=unbearable pain" at the right-most end. minimum=0, maximum=10; higher scores mean a worse and lower scores mean a better	Change in pain score during colonoscopy, an average of 20 minutes
Primary	Anxiety score	Visual Analog Scale-Anxiety (VAS-A), which is a 10 cm long horizontal line with anchor statements "0=no anxiety at all" at the left-most end and "10=worst anxiety imaginable" at the right-most end. minimum=0, maximum=10; higher scores mean a worse and lower scores mean a better	Change in anxiety score during colonoscopy, an average of 20 minutes