Virtual Reality During Periodontal Frenectomy (VRFren)
7 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
70
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Muhammed Emin Kalender, PhD
- Numéro de téléphone: 902282141746
- E-mail: emin.kalender@bilecik.edu.tr
Lieux d'étude
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Bilecik
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Bilecik, Bilecik, Turquie (Türkiye), 11100
- Bilecik Seyh Edebali University Faculty of Dentistry
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Contact:
- Muhammed Emin Kalender, DDS, PhD
- Numéro de téléphone: +902282141746
- E-mail: emin.kalender@bilecik.edu.tr
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain Intensity Assessed by Visual Analog Scale During and Immediately After Surgery
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Postoperative Pain Intensity Assessed by Visual Analog Scale
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 février 2027
Achèvement de l'étude (Estimé)
1 août 2027
Dates d'inscription aux études
Première soumission
4 août 2026
Première soumission répondant aux critères de contrôle qualité
7 août 2026
Première publication (Réel)
12 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2026-18
- GAP-2026-750 (Autre identifiant: Bilecik Şeyh Edebali University Scientific Research Projects Coordination Unit)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .