The Effect of Information About the Operating Room Environment With Virtual Reality Glasses on the Anxiety Level (VRanxiety)

The Effect of Information About the Operating Room Environment With Virtual Reality Glasses on the Anxiety Level and Vital Findings of the Patients: A Randomized Controlled Study

Virtual Reality (VR) applications, one of the commonly emphasized approaches in the medical field recently, is in place as an intervention method applicable in various fileds of medicine for distraction, experiencing being exposed to events creating stress and palliating anxiety through providing materials which may distract the patient's attention from a stressful condition. The study has been planned in order to evaluate the effect of the notification regarding the theatre environment through virtual reality to the patients, who are to go through abdominal surgical intervention, on the anxiety level and the vital signs during the surgical intervention.

Being a non-pharmacological clinical randomize controlled one, the study shall be conducted in Dr. Burhan Nalbantoğlu State Hospital of TRNC Ministry of Health surgical service and preoperative waiting area.

Sample number has been determined through power analysis using G*Power 3.1.9.2 software. Taking (2017) "The effect of virtual reality in reducing preoperative anxiety in patients prior to arthroscopic knee surgery: A randomised controlled trial" study of Robertson and friends as the reference, the effect size, regarding the anxiety scores of experiment and control groups participants, has been determined as 0,63. Accordingly, sample size has been calculated as 71 people necessary for 95% (1-β=0,95) power at d=0,63 and α=0,05 levels. Taking into account there may be losses during the study, it has been planned to involve 80 people, so as to have 40 people per each group, in the study.

Since the patients, who are to be involved in the study, are not known; in order to assign same quantity of patients to each group prior to the study, randomization shall be done through using block randomization technique in GraphPad software so as to have 40 patients in the intervention group and 40 in the control group. The patients who receive standard clinical care prior to abdominal surgical intervention shall constitute the control group, the patients who receive information about operating room environment through VR goggles in addition to standard clinical care shall constitute the intervention group. The data shall be collected through "Individual characteristics Form", ''Patient Charts'', ''Surgical Anxiety Scale'', ''Galvanic Skin Sensor (GSS) Measurement Table''.

SPSS 26 Statistical analysis program shall be used for evaluating the study data. The acquired data shall be tested at 95% confidence interval, p<0,05 level of significance. Number, percentage distributon and standard deviation for the definitive data analysis, chi square test for experiment and control groups' basic particulars similarity, Shapiro-Wilk for normality analysis of dependent variables, Student t test or Annova for the comparison of pre-test and final test scores of experiment control groups, the comparisons of variables giving normal distribution among the groups as per the normal distributon in the comparison of experiment control groups' pre-test and final test scores, Mann Whitney U test or Kruskal Wallis test for the variables of non-normal distribution shall be used.

Study Overview

• Status: Completed
• Conditions: Preoperative Anxiety
• Intervention / Treatment: Other: VR

Detailed Description

Surgical interventions, which are widely used for health improvement and disease treatment, are one of the most important experiences in an individual's life. Surgical interventions, regardless of simple or life threatening, turn in to a condition leading to individual's loss of control on his body for a limited time and anxiety due to not having sufficient information about the subject although they are positive things which would provide recovery from illness. It is known that more medical complications build up in patients who have higher level of anxiety during the medical process. Although the factors, which trigger the anxiety, vary significantly among the individuals, the effects of common or lasting anxiety cases are usually similar. These factors may lead to effects such as pain, sinus tachycardia, hypertension, cardiac arrhythmia, surgical interventions, increase in anesthesia and analgesia necessities, latency in wound healing and discharge periods. Operating rooms being complex and unusual environments and getting anesthesia lead to anxiety and fear in patients. Since focusing on pharmacological intervetions in the current management of anxiety increases complications, which may build up inthe patient; easy to use, noninvasive non-pharmacological applications are required. Virtual Reality (VR) applications, one of the commonly emphasized approaches in the medical field recently, is in place as an intervention method applicable in various fileds of medicine for distraction, experiencing being exposed to events creating stress and palliating anxiety through providing materials which may distract the patient's attention from a stressful condition. The study has been planned in order to evaluate the effect of the notification regarding the theatre environment through virtual reality to the patients, who are to go through abdominal surgical intervention, on the anxiety level and the vital signs during the surgical intervention.

Being a non-pharmacological clinical randomize controlled one, the study shall be conducted in Dr. Burhan Nalbantoğlu State Hospital of TRNC Ministry of Health surgical service and preoperative waiting area. The criteria for being involved in the study have been defined as patients who are of 18 years old and over, are to go through abdominal surgical intervention, are conscious, have orientation of place-person and time, do not have any visual, audial or mental problem, have the ability of understanding the instructions of the study and reacting, can communicate in Turkish and give written approval for participating in the study. The criteria of being excluded form the study have been defined as the patients who regularly receive phytotherapy or pharmacotherapy for anxiety, are diagnosed with hypertension, cardiac arrhythmia, have facial injuries preventing comfortable utilization of VR hardware and are unpremedicated. The criteria of elimination from the study shall be composed of the patients who want to quit at own request, can not comply with the study process and conditions.

Sample number has been determined through power analysis using G*Power 3.1.9.2 software. Taking (2017) "The effect of virtual reality in reducing preoperative anxiety in patients prior to arthroscopic knee surgery: A randomised controlled trial" study of Robertson and friends as the reference, the effect size, regarding the anxiety scores of experiment and control groups participants, has been determined as 0,63. Accordingly, sample size has been calculated as 71 people necessary for 95% (1-β=0,95) power at d=0,63 and α=0,05 levels. Taking into account there may be losses during the study, it has been planned to involve 80 people, so as to have 40 people per each group, in the study.

Since the patients, who are to be involved in the study, are not known; in order to assign same quantity of patients to each group prior to the study, randomization shall be done through using block randomization technique in GraphPad software so as to have 40 patients in the intervention group and 40 in the control group. The patients who receive standard clinical care prior to abdominal surgical intervention shall constitute the control group, the patients who receive information about operating room environment through VR goggles in addition to standard clinical care shall constitute the intervention group. The data shall be collected through "Individual characteristics Form", ''Patient Charts'', ''Surgical Anxiety Scale'', ''Galvanic Skin Sensor (GSS) Measurement Table''.

SPSS 26 Statistical analysis program shall be used for evaluating the study data. The acquired data shall be tested at 95% confidence interval, p<0,05 level of significance. Number, percentage distributon and standard deviation for the definitive data analysis, chi square test for experiment and control groups' basic particulars similarity, Shapiro-Wilk for normality analysis of dependent variables, Student t test or Annova for the comparison of pre-test and final test scores of experiment control groups, the comparisons of variables giving normal distribution among the groups as per the normal distributon in the comparison of experiment control groups' pre-test and final test scores, Mann Whitney U test or Kruskal Wallis test for the variables of non-normal distribution shall be used.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cyprus
  • Famagusta, Cyprus, 99450
    • doğu akdeniz üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• who are of 18 years old and over,
• are to go through abdominal surgical intervention,
• are conscious, have orientation of place-person and time,
• do not have any visual,
• audial or mental problem,
• have the ability of understanding the instructions of the study and reacting,
• can communicate in Turkish
• and give written approval for participating in the study

Exclusion Criteria:

• the patients who regularly receive phytotherapy or pharmacotherapy for anxiety,
• are diagnosed with hypertension,
• cardiac arrhythmia,
• have facial injuries preventing comfortable utilization of VR hardware
• and are unpremedicated.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Forty patients who received standard care in the pre-abdominal surgery clinic and preoperative waiting area will form the control group.
Experimental: intervention group; In addition to standard care, 40 patients who were informed about the SG application and the operating room environment will form the intervention group.	Other: VR; The first interview with the patients in the intervention group will be held in the afternoon, the day before the surgery. After completing the forms and scale the video containing information about the operating room environment will be applied to the patients through SG glasses and headphones. Before the surgical intervention, patients admitted to the pre-operative waiting area from the clinic, the video containing information about the operating room environment will be watched by the patients through SG glasses and headphones.; Other Names: Virtual reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Anxiety Scale	maximum: 4 minimum: 0	two day

Collaborators and Investigators

• Sponsor: Eastern Mediterranean University
• Investigators: Principal Investigator: serpil çağlıyan payas, lecturer, doğu akdeniz üniversitesi

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: virtual reality,; Preoperative anxiety,; abdominal surgery,; information about the operating room environment
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Eastern MU-SBF-HB-SÇP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Clinical Study Report
2. Clinical Study Report
3. Clinical Study Report

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No