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Virtual Reality During Periodontal Frenectomy (VRFren)

7. august 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • Bilecik
      • Bilecik, Bilecik, Tyrkiet (Türkiye), 11100
        • Bilecik Seyh Edebali University Faculty of Dentistry
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

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Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Procedure: 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.
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.
Procedure: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Intensity Assessed by Visual Analog Scale During and Immediately After Surgery
Tidsramme: 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.
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
Tidsramme: 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.
Baseline before randomization and virtual reality application, and 10 minutes after completion of surgery
Blood Pressure During Periodontal Frenectomy
Tidsramme: 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.
Before virtual reality application, after local anesthesia, during the middle phase of surgery, and immediately after surgery
Heart Rate During Periodontal Frenectomy
Tidsramme: 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.
Baseline before randomization and virtual reality application, after local anesthesia, during the middle phase of surgery, and at completion of surgery
Peripheral Oxygen Saturation During Periodontal Frenectomy
Tidsramme: 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.
Baseline before randomization and virtual reality application, after local anesthesia, during the middle phase of surgery, and at completion of surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Pain Intensity Assessed by Visual Analog Scale
Tidsramme: 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.
Postoperative days 1 to 7

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Muhammed Emin Kalender

Samarbejdspartnere

Bilecik Seyh Edebali Universitesi

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. februar 2027

Studieafslutning (Anslået)

1. august 2027

Datoer for studieregistrering

Først indsendt

4. august 2026

Først indsendt, der opfyldte QC-kriterier

7. august 2026

Først opslået (Faktiske)

12. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2026-18
  • GAP-2026-750 (Anden identifikator: Bilecik Şeyh Edebali University Scientific Research Projects Coordination Unit)

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