Dental Anxiety, Frenectomy, Virtual Reality
Conditions
Brief 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.
Interventions
BEHAVIORALVirtual 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.
PROCEDUREStandard 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.
Sponsors
Muhammed Emin Kalender
Bilecik Seyh Edebali Universitesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and the surgeon/care provider cannot be masked because of the nature of the virtual reality intervention. The 7-day early wound healing assessment will be performed by an outcomes assessor who is blinded to group assignment. The assessor will not be present during surgery, will not access the randomization result, and participants will be instructed not to disclose whether they received virtual reality. Postoperative questionnaires kept in sealed envelopes will be opened only after the blinded wound healing assessment is completed.
Intervention model description
Participants will be randomly assigned to one of two parallel groups: a virtual reality group receiving standard periodontal frenectomy with virtual reality-based audiovisual distraction, or a control group receiving standard periodontal frenectomy without virtual reality. Each participant will remain in the assigned group throughout the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 65 years * Classified as American Society of Anesthesiologists physical status I or II * Presence of a clinical indication for periodontal frenectomy * No previous periodontal surgery experience * No previous virtual reality experience
Exclusion criteria
* Pregnancy or breastfeeding * Visual or hearing impairment that may prevent the use of the virtual reality headset * History of claustrophobia * History of vertigo * Use of analgesic or sedative medication within the last 24 hours * Current substance dependence * Presence of active infection in the surgical area * Current regular use of antidepressants, anxiolytics, antipsychotics, mood stabilizers, sedatives/hypnotics, or other psychotropic medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity Assessed by Visual Analog Scale | Postoperative days 1 to 7 | Postoperative pain intensity will be assessed daily using a 0 to 10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMuhammed Emin Kalender, PhD
Outcome results
None listed