Virtual Reality Distraction in Patients Undergoing Periodontal Surgery

Evaluation of Virtual Reality Distraction on Dental Anxiety in Patients Undergoing Periodontal Surgery

The goal of this randomized controlled clinical trial is to evaluate the effect of virtual reality technology on anxiety and pain levels in patients undergoing periodontal surgery.

Participants will be randomly assigned into test and control groups. While the patients in the test group will undergo periodontal surgery with virtual reality distraction, the patients in the control group without distraction. After treatment, the groups will be compared regarding anxiety and pain levels.

Study Overview

• Status: Completed
• Conditions: Dental Anxiety; Virtual Reality; Oral Surgery
• Intervention / Treatment: Procedure: Periodontal surgery with virtual reality distraction; Procedure: Periodontal surgery without virtual reality distraction

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kutahya, Turkey, 43100
    • Kütahya Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Individuals over the age of 18
• Systemically healthy patients
• Need for periodontal surgical treatment in the mandibular anterior region
• Scoring 15 or above on the modified dental anxiety scale

Exclusion Criteria:

• Having a history of seizures or a convulsive disorder
• Balance disorders such as nystagmus, vertigo
• Use of psychotropic drugs
• Getting treatment for anxiety
• Presence of dermatological lesions on the face, especially around the eyes
• A lesion in the eye that will prevent the use of virtual reality glasses
• Systemic disease and medication use that contraindicate periodontal surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; The group will include patients who undergo periodontal surgery with virtual reality distraction	Procedure: Periodontal surgery with virtual reality distraction; Periodontal surgery to improve gingival contour and eliminate inflamed periodontal pockets
Experimental: Control group; The group will include patients who undergo periodontal surgery without virtual reality distraction	Procedure: Periodontal surgery without virtual reality distraction; Periodontal surgery to improve gingival contour and eliminate inflamed periodontal pockets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety level	Modified dental anxiety scale where higher scores mean a worse outcome and has a minimum value of 5 and a maximum value of 25	Preoperative, immediately postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	Visual analog scale where higher scores mean a worse outcome and has a minimum value of 0 and a maximum value of 10	Preoperative, immediately postoperative
Systolic blood pressure	Blood pressure will be measured by a sphygmomanometer.	Preoperative, intraoperative, immediately postoperative
Diastolic blood pressure	Blood pressure will be measured by a sphygmomanometer.	Preoperative, intraoperative, immediately postoperative
Heart rate	The frequency of the heartbeat measured by the number of contractions of the heart per minute	Preoperative, intraoperative, immediately postoperative

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Investigators: Principal Investigator: Ezgi Gürbüz, Kütahya Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): April 3, 2023
• Study Completion (Actual): May 2, 2023

Study Registration Dates

• First Submitted: October 15, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 03

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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