Virtual Reality Distraction in Patients Undergoing Periodontal Surgery

• Sponsor: Kutahya Health Sciences University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06092177
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Virtual Reality; Oral Surgery; Dental Anxiety	Procedure: Periodontal surgery with virtual reality distraction; Procedure: Periodontal surgery without virtual reality distraction	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of Virtual Reality Distraction on Dental Anxiety in Patients Undergoing Periodontal Surgery
• Actual Study Start Date: May 2, 2022
• Actual Primary Completion Date: Apr 3, 2023
• Actual Study Completion Date: May 2, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Anxiety level [Preoperative, immediately postoperative]

   Modified dental anxiety scale where higher scores mean a worse outcome and has a minimum value of 5 and a maximum value of 25

Secondary Outcome Measures

1. Pain level [Preoperative, immediately postoperative]

   Visual analog scale where higher scores mean a worse outcome and has a minimum value of 0 and a maximum value of 10

2. Systolic blood pressure [Preoperative, intraoperative, immediately postoperative]

   Blood pressure will be measured by a sphygmomanometer.

3. Diastolic blood pressure [Preoperative, intraoperative, immediately postoperative]

   Blood pressure will be measured by a sphygmomanometer.

4. Heart rate [Preoperative, intraoperative, immediately postoperative]

   The frequency of the heartbeat measured by the number of contractions of the heart per minute

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kutahya Health Sciences University	Kutahya		Turkey	43100

Sponsors and Collaborators

• Kutahya Health Sciences University

Investigators

• Principal Investigator: Ezgi Gurbuz, Kutahya Health Sciences University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ezgi Gürbüz, Assistant Professor, Kutahya Health Sciences University
• ClinicalTrials.gov Identifier: NCT06092177
• Other Study ID Numbers: 03
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 23, 2023
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Oct 23, 2023