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

NCT05027659 | Completed

• 1 other identifier: EYILMAZ-experimental study
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Vital Signs; Anxiety; Colonoscopy

Keywords

Anxiety; colonoscopy; pain; virtual reality glasses; vital signs

Outcome Measures

Primary Outcomes (6)

• blood pressure

  mmHg. higher scores mean a worse

  Change in systolic blood pressure during colonoscopy, an average of 20 minutes

• pulse rate (heart rate)

  beats per minute. higher scores mean a worse

  Change in pulse rate during colonoscopy, an average of 20 minutes

• respiratory rate

  respiratory rate per minute. higher scores mean a worse

  Change in respiratory rate during colonoscopy, an average of 20 minutes

• 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

• 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

• 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

Study Arms (2)

intervention

EXPERIMENTAL

This study was carried out with two groups. Virtual reality glasses were used for the intervention group.

Other: virtual reality glasses

control

NO INTERVENTION

No application was made to the control group, standard procedure was followed.

Interventions

virtual reality glasses OTHER

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.

intervention

Eligibility Criteria

• Age: 18 Years - 79 Years
• Gender Eligibility Details: Research shows that gender affect pain and anxiety during colonoscopy. Therefore, we randomized participants into the groups, which were similar in terms of gender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Esra DOĞAN YILMAZ, RN, MSc: lead

Study Sites (1)

Kirikkale University

Kırıkkale, 71450, Turkey (Türkiye)

Location

Related Publications (1)

• Dogan Yilmaz E, Unlusoy Dincer N. The Effects of Virtual Reality Glasses on Vital Signs and Anxiety in Patients Undergoing Colonoscopy: A Randomized Controlled Trial. Gastroenterol Nurs. 2023 Jul-Aug 01;46(4):318-328. doi: 10.1097/SGA.0000000000000733. Epub 2023 Jun 5.

  PMID: 37278621 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esra DOĞAN YILMAZ RN, PhD, Research Assistant

  Kırıkkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data of the study were entered by a person other than the researcher. Statistical analysis was performed by a person other than the researcher. In the study, virtual reality glasses were worn on the participants of experimental group. For this reason, blinding could not be done for the participants. The researcher herself collected all data because the hospital restricted traffic in and out of the unit due to the pandemic. Therefore, the evaluator was not blinded to the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Model Details: A randomized controlled trial

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 30, 2021
• Study Start: January 2, 2020
• Primary Completion: September 28, 2020
• Study Completion: December 20, 2020
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)