Virtual Reality During Periodontal Frenectomy (VRFren)
7 augusti 2026 uppdaterad av: Muhammed Emin Kalender
Evaluation of the Effects of Virtual Reality Application on Anxiety, Pain, and Physiological Stress Responses During Periodontal Frenectomy
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
70
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Muhammed Emin Kalender, PhD
- Telefonnummer: 902282141746
- E-post: emin.kalender@bilecik.edu.tr
Studieorter
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Bilecik
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Bilecik, Bilecik, Turkiet (Türkiye), 11100
- Bilecik Seyh Edebali University Faculty of Dentistry
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Kontakt:
- Muhammed Emin Kalender, DDS, PhD
- Telefonnummer: +902282141746
- E-post: emin.kalender@bilecik.edu.tr
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Virtual Reality Group
Participants in this group will receive standard periodontal frenectomy under local anesthesia with virtual reality-based audiovisual distraction during the procedure.
After baseline assessments and randomization, a Meta Quest 3 head-mounted virtual reality device will be placed before local anesthesia.
Participants will passively watch a standardized nature video with calming audio until the surgical procedure is completed.
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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.
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.
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Aktiv komparator: Control Group
Participants in this group will receive standard periodontal frenectomy under local anesthesia without virtual reality or any other audiovisual distraction method.
The surgical protocol, surgeon, local anesthesia protocol, and clinical environment will be the same as in the virtual reality group.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Pain Intensity Assessed by Visual Analog Scale During and Immediately After Surgery
Tidsram: After local anesthesia, during the middle phase of surgery, and 10 minutes after completion of surgery
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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.
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After local anesthesia, during the middle phase of surgery, and 10 minutes after completion of surgery
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State Anxiety Score Assessed by the State-Trait Anxiety Inventory-State Form
Tidsram: Baseline before randomization and virtual reality application, and 10 minutes after completion of surgery
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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.
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Baseline before randomization and virtual reality application, and 10 minutes after completion of surgery
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Blood Pressure During Periodontal Frenectomy
Tidsram: Before virtual reality application, after local anesthesia, during the middle phase of surgery, and immediately after surgery
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Systolic and diastolic blood pressure will be measured in millimeters of mercury (mmHg) as physiological indicators of stress response.
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Before virtual reality application, after local anesthesia, during the middle phase of surgery, and immediately after surgery
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Heart Rate During Periodontal Frenectomy
Tidsram: Baseline before randomization and virtual reality application, after local anesthesia, during the middle phase of surgery, and at completion of surgery
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Heart rate will be measured as beats per minute using pulse oximetry.
Heart rate will be used as a physiological indicator of stress response.
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Baseline before randomization and virtual reality application, after local anesthesia, during the middle phase of surgery, and at completion of surgery
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Peripheral Oxygen Saturation During Periodontal Frenectomy
Tidsram: Baseline before randomization and virtual reality application, after local anesthesia, during the middle phase of surgery, and at completion of surgery
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Peripheral oxygen saturation will be measured as percentage using pulse oximetry.
Peripheral oxygen saturation will be used as a physiological indicator of stress response.
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Baseline before randomization and virtual reality application, after local anesthesia, during the middle phase of surgery, and at completion of surgery
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postoperative Pain Intensity Assessed by Visual Analog Scale
Tidsram: Postoperative days 1 to 7
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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.
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Postoperative days 1 to 7
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 februari 2027
Avslutad studie (Beräknad)
1 augusti 2027
Studieregistreringsdatum
Först inskickad
4 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
7 augusti 2026
Första postat (Faktisk)
12 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2026-18
- GAP-2026-750 (Annan identifierare: Bilecik Şeyh Edebali University Scientific Research Projects Coordination Unit)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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