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

NCT05899790 | Completed

• 1 other identifier: Eastern MU-SBF-HB-SÇP-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preoperative Anxiety

Keywords

Preoperative anxiety,; virtual reality,; abdominal surgery,; information about the operating room environment

Outcome Measures

Primary Outcomes (1)

• Surgical Anxiety Scale

  maximum: 4 minimum: 0

  two day

Study Arms (2)

Control Group

NO INTERVENTION

Forty patients who received standard care in the pre-abdominal surgery clinic and preoperative waiting area will form the control group.

intervention group

EXPERIMENTAL

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

Interventions

VR OTHER

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.

Also known as: Virtual reality

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Doğu Akdeniz Üniversitesi

Famagusta, 99450, Cyprus

Location

Study Officials

• serpil çağlıyan payas, lecturer

  DOĞU AKDENİZ ÜNİVERSİTESİ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 2 Group 1. İntervention 2. Control

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: June 12, 2023
• Study Start: June 29, 2022
• Primary Completion: November 15, 2022
• Study Completion: December 15, 2022
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)