Back to resultsVirtual Reality Distraction in Patients Undergoing Periodontal Surgery
Primary Purpose
Virtual Reality, Oral Surgery, Dental Anxiety
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Periodontal surgery with virtual reality distraction
Periodontal surgery without virtual reality distraction
Sponsored by
About this trial
This is an interventional treatment trial for Virtual Reality
Eligibility Criteria
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
Sites / Locations
- Kutahya Health Sciences University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Test group
Control group
Arm Description
The group will include patients who undergo periodontal surgery with virtual reality distraction
The group will include patients who undergo periodontal surgery without virtual reality distraction
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Systolic blood pressure
Blood pressure will be measured by a sphygmomanometer.
Diastolic blood pressure
Blood pressure will be measured by a sphygmomanometer.
Heart rate
The frequency of the heartbeat measured by the number of contractions of the heart per minute
Full Information
NCT ID
NCT06092177
First Posted
October 15, 2023
Last Updated
October 19, 2023
Sponsor
Kutahya Health Sciences University
1. Study Identification
Unique Protocol Identification Number
NCT06092177
Brief Title
Virtual Reality Distraction in Patients Undergoing Periodontal Surgery
Official Title
Evaluation of Virtual Reality Distraction on Dental Anxiety in Patients Undergoing Periodontal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
April 3, 2023 (Actual)
Study Completion Date
May 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virtual Reality, Oral Surgery, Dental Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test group
Arm Type
Experimental
Arm Description
The group will include patients who undergo periodontal surgery with virtual reality distraction
Arm Title
Control group
Arm Type
Experimental
Arm Description
The group will include patients who undergo periodontal surgery without virtual reality distraction
Intervention Type
Procedure
Intervention Name(s)
Periodontal surgery with virtual reality distraction
Intervention Description
Periodontal surgery to improve gingival contour and eliminate inflamed periodontal pockets
Intervention Type
Procedure
Intervention Name(s)
Periodontal surgery without virtual reality distraction
Intervention Description
Periodontal surgery to improve gingival contour and eliminate inflamed periodontal pockets
Primary Outcome Measure Information:
Title
Anxiety level
Description
Modified dental anxiety scale where higher scores mean a worse outcome and has a minimum value of 5 and a maximum value of 25
Time Frame
Preoperative, immediately postoperative
Secondary Outcome Measure Information:
Title
Pain level
Description
Visual analog scale where higher scores mean a worse outcome and has a minimum value of 0 and a maximum value of 10
Time Frame
Preoperative, immediately postoperative
Title
Systolic blood pressure
Description
Blood pressure will be measured by a sphygmomanometer.
Time Frame
Preoperative, intraoperative, immediately postoperative
Title
Diastolic blood pressure
Description
Blood pressure will be measured by a sphygmomanometer.
Time Frame
Preoperative, intraoperative, immediately postoperative
Title
Heart rate
Description
The frequency of the heartbeat measured by the number of contractions of the heart per minute
Time Frame
Preoperative, intraoperative, immediately postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ezgi Gurbuz
Organizational Affiliation
Kutahya Health Sciences University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kutahya Health Sciences University
City
Kutahya
ZIP/Postal Code
43100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Reality Distraction in Patients Undergoing Periodontal Surgery
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