Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-31 @ 10:20 PM
Study NCT ID:
NCT06804967
Status:
RECRUITING
Last Update Posted:
2025-02-24
First Post:
2025-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Virtual Reality Relaxation on the Anxiety Levels
Sponsor:
Indiana University
Organization:
Study Overview
Official Title:
Effects of Virtual Reality Relaxation on the Anxiety Levels of Adolescents and Adults During Orthodontic Bonding: A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to determine the effects of virtual reality relaxation on dental anxiety levels of adolescents and adults during an orthodontic bonding procedure.
The specific aim is to compare changes in the anxiety levels based on 1) psychological outcomes and 2) physiological outcomes between patients who experienced (virtual reality relaxation) VRR intervention during the orthodontic bonding procedure and those in the control group who did not receive the intervention
After provding written consent, subjects will be randomized to either the virtual reality device usage during their bonding procedure or no virtual reality device. They will have vital signs taken/anxiety level measured and answer a questionnaire before and after the device/no device usage (30 minutes).
The specific aim is to compare changes in the anxiety levels based on 1) psychological outcomes and 2) physiological outcomes between patients who experienced (virtual reality relaxation) VRR intervention during the orthodontic bonding procedure and those in the control group who did not receive the intervention
After provding written consent, subjects will be randomized to either the virtual reality device usage during their bonding procedure or no virtual reality device. They will have vital signs taken/anxiety level measured and answer a questionnaire before and after the device/no device usage (30 minutes).
Detailed Description:
On the day of the bonding procedure, informed consent will be obtained from participants and parents/guardians who were not present during the treatment plan presentation appointment. Pre-operative data will be collected, prior to the start of orthodontic treatment. Once the patient is seated, a timer will be set for 5 minutes to allow the patient to recover and get settled in before measurements are taken. After this 5-minute period, the following measurements will be collected: (1) Vitals will be recorded with the patient seated in the upright position, including maximal blood pressure (BP) using Omron 3 series upper arm blood pressure monitor with cuff on the participant's right bicep, and heart rate (HR) and oxygen saturation (SpO2) using Masimo MightySat fingertip pulse oximeter on the right ring finger; (2) The patient's state anxiety will be evaluated through the completion of the five-item state form of Spielberger's State-Trait Anxiety Inventory (STAIS-5); and (3) The patient's current anxiety level will be assessed by completing the Visual Analog Scale for anxiety (VAS-A).
The provider will review with the experimental group participants the purpose of VR and explain in a calm and soothing tone that using VR during dental procedures has been found to relax patients and to reduce their blood pressure and heart rate while also at times increasing oxygen levels. For patients in the experimental group, they will be told they will be immersed in VR for a maximum of 30 minutes. During this time period, one arch, either maxillary or mandibular, will be bonded.
Following the general explanation about the use of VR within a dental procedure, a written list with corresponding visual representation of the available virtual environments (VE) from Nature Treks will be provided (e.g. Orange Sunset, White Winter, Red Savanna). Patients will be requested to choose their preferred VE to experience during the procedure. The investigator will launch the Nature Treks application, hand the headset to the patient to put on, and assist them in adjusting the straps for a comfortable fit. A brief window of approximately 30-60 seconds will be given for them to acclimate to the virtual surroundings and to also confirm the patient's desire to proceed. During this short period, patients will be offered the choice to alter the setting or remain in it for the designated 30-minute duration. The environment selected by patients will be recorded and stored in RedCap. Participants in the control group will not be provided with the VR headset during the procedure and will have full visibility of the clinic area.
Once all relevant questions are answered, the patient will be reclined in the dental chair. The 30-minute timer will start when the orthodontic resident initiates the orthodontic bonding procedure by placing the cheek retractor for isolation.
Post-operative data will be collected 30 minutes after the start of the procedure for both groups. At the 30-minute mark, the procedure will be paused, regardless of whether the entire arch has been bonded, and all correctly positioned brackets will be light-cured to allow for the removal of isolation. The patient will then be positioned upright, and the VR headset will be removed from the experimental group. T1 data will be collected immediately, including the (1) BP, HR, and SpO2, (2) the STAIS-5 completed form, and (3) the VAS-A completed form.
The provider will review with the experimental group participants the purpose of VR and explain in a calm and soothing tone that using VR during dental procedures has been found to relax patients and to reduce their blood pressure and heart rate while also at times increasing oxygen levels. For patients in the experimental group, they will be told they will be immersed in VR for a maximum of 30 minutes. During this time period, one arch, either maxillary or mandibular, will be bonded.
Following the general explanation about the use of VR within a dental procedure, a written list with corresponding visual representation of the available virtual environments (VE) from Nature Treks will be provided (e.g. Orange Sunset, White Winter, Red Savanna). Patients will be requested to choose their preferred VE to experience during the procedure. The investigator will launch the Nature Treks application, hand the headset to the patient to put on, and assist them in adjusting the straps for a comfortable fit. A brief window of approximately 30-60 seconds will be given for them to acclimate to the virtual surroundings and to also confirm the patient's desire to proceed. During this short period, patients will be offered the choice to alter the setting or remain in it for the designated 30-minute duration. The environment selected by patients will be recorded and stored in RedCap. Participants in the control group will not be provided with the VR headset during the procedure and will have full visibility of the clinic area.
Once all relevant questions are answered, the patient will be reclined in the dental chair. The 30-minute timer will start when the orthodontic resident initiates the orthodontic bonding procedure by placing the cheek retractor for isolation.
Post-operative data will be collected 30 minutes after the start of the procedure for both groups. At the 30-minute mark, the procedure will be paused, regardless of whether the entire arch has been bonded, and all correctly positioned brackets will be light-cured to allow for the removal of isolation. The patient will then be positioned upright, and the VR headset will be removed from the experimental group. T1 data will be collected immediately, including the (1) BP, HR, and SpO2, (2) the STAIS-5 completed form, and (3) the VAS-A completed form.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: