Virtual Reality During Periodontal Frenectomy

Condition(s) studied

Investigational drug(s) / intervention(s)

Virtual Reality-Based Audiovisual Distraction: Participants assigned to the virtual reality group will use a Meta Quest 3 head-mounted device during periodontal frenectomy. A standardized nature video with calming audio will be presented from before local anesthesia until completion of the surgical procedure. The content will be shown from the same starting point with the same brightness and volume settings for all participants. Participants will watch the content passively without interaction.

Standard Periodontal Frenectomy: All participants will undergo clinically indicated periodontal frenectomy under local anesthesia using a standardized surgical protocol. The procedure will be performed by the same surgeon under standardized clinical conditions.

Study summary

The goal of this clinical trial is to learn whether virtual reality can reduce anxiety, pain, and physiological stress responses during periodontal frenectomy in adults who need this surgical procedure.

The main questions it aims to answer are:

Does virtual reality reduce anxiety before and after periodontal frenectomy? Does virtual reality reduce pain during and after the procedure? Does virtual reality have a favorable effect on physiological stress responses such as blood pressure, heart rate, and oxygen saturation? Does virtual reality affect surgical process-related outcomes and early wound healing?

Researchers will compare adults who receive standard periodontal frenectomy with virtual reality-based audiovisual distraction to adults who receive standard periodontal frenectomy without virtual reality.

Participants will:

Complete anxiety and pain questionnaires before the procedure. Undergo periodontal frenectomy under local anesthesia. Be randomly assigned to either the virtual reality group or the control group. Have blood pressure, heart rate, oxygen saturation, and pain levels recorded at defined time points during the procedure.

Record daily pain levels and analgesic use for 7 days after surgery. Return for a 7-day follow-up visit for suture removal and early wound healing assessment.

Eligibility

Primary outcome measure(s)

• Pain Intensity Assessed by Visual Analog Scale During and Immediately After Surgery — After local anesthesia, during the middle phase of surgery, and 10 minutes after completion of surgery
  Pain intensity will be assessed using a 0 to 10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable. Pain will be recorded after local anesthesia, during the middle phase of surgery, and 10 minutes after completion of surgery.
• State Anxiety Score Assessed by the State-Trait Anxiety Inventory-State Form — Baseline before randomization and virtual reality application, and 10 minutes after completion of surgery
  State anxiety will be assessed using the State-Trait Anxiety Inventory-State Form (STAI-S). The STAI-S consists of 20 items scored from 1 to 4, with a total score ranging from 20 to 80. Higher scores indicate higher state anxiety.
• Blood Pressure During Periodontal Frenectomy — Before virtual reality application, after local anesthesia, during the middle phase of surgery, and immediately after surgery
  Systolic and diastolic blood pressure will be measured in millimeters of mercury (mmHg) as physiological indicators of stress response.
• Heart Rate During Periodontal Frenectomy — Baseline before randomization and virtual reality application, after local anesthesia, during the middle phase of surgery, and at completion of surgery
  Heart rate will be measured as beats per minute using pulse oximetry. Heart rate will be used as a physiological indicator of stress response.
• Peripheral Oxygen Saturation During Periodontal Frenectomy — Baseline before randomization and virtual reality application, after local anesthesia, during the middle phase of surgery, and at completion of surgery
  Peripheral oxygen saturation will be measured as percentage using pulse oximetry. Peripheral oxygen saturation will be used as a physiological indicator of stress response.

Trial sites (1)

Other trials for the same condition