The Effects of Virtual Reality Glasses on Vital Signs and Anxiety in Patients Undergoing Colonoscopy
Condition: Vital Signs; Anxiety; Colonoscopy
MeSH terms: Anxiety Disorders
Study type: Interventional

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.
    

Intervention name(s): virtual reality glasses
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Anxiety; colonoscopy; pain; virtual reality glasses; vital signs