Virtual Reality During Periodontal Frenectomy (VRFren)
7. august 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
70
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Muhammed Emin Kalender, PhD
- Telefonnummer: 902282141746
- E-post: emin.kalender@bilecik.edu.tr
Studiesteder
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Bilecik
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Bilecik, Bilecik, Tyrkia (Türkiye), 11100
- Bilecik Seyh Edebali University Faculty of Dentistry
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Ta kontakt med:
- Muhammed Emin Kalender, DDS, PhD
- Telefonnummer: +902282141746
- E-post: emin.kalender@bilecik.edu.tr
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Pain Intensity Assessed by Visual Analog Scale
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. februar 2027
Studiet fullført (Antatt)
1. august 2027
Datoer for studieregistrering
Først innsendt
4. august 2026
Først innsendt som oppfylte QC-kriteriene
7. august 2026
Først lagt ut (Faktiske)
12. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2026-18
- GAP-2026-750 (Annen identifikator: Bilecik Şeyh Edebali University Scientific Research Projects Coordination Unit)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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