Virtual Reality Clinical Trial
Official title:
Evaluation of Virtual Reality Distraction on Dental Anxiety in Patients Undergoing Periodontal Surgery
NCT number | NCT06092177 |
Other study ID # | 03 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2, 2022 |
Est. completion date | May 2, 2023 |
Verified date | April 2022 |
Source | Kutahya Health Sciences University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Kutahya Health Sciences University | Kutahya |
Lead Sponsor | Collaborator |
---|---|
Kutahya Health Sciences University |
Turkey,
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 |
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