Virtual Reality Distraction in Patients Undergoing Periodontal Surgery

Virtual Reality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06092177
• Other study ID #: 03
• Status: Completed
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: May 2, 2023

Study information

• Verified date: April 2022
• Source: Kutahya Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2, 2023
• Est. primary completion date: April 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety
• Oral Surgery
• Virtual Reality

Intervention

Procedure:
• Periodontal surgery with virtual reality distraction
Periodontal surgery to improve gingival contour and eliminate inflamed periodontal pockets
• Periodontal surgery without virtual reality distraction
Periodontal surgery to improve gingival contour and eliminate inflamed periodontal pockets

Locations

Country	Name	City	State
Turkey	Kutahya Health Sciences University	Kutahya

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Systolic blood pressure	Blood pressure will be measured by a sphygmomanometer.	Preoperative, intraoperative, immediately postoperative
Secondary	Diastolic blood pressure	Blood pressure will be measured by a sphygmomanometer.	Preoperative, intraoperative, immediately postoperative
Secondary	Heart rate	The frequency of the heartbeat measured by the number of contractions of the heart per minute	Preoperative, intraoperative, immediately postoperative