Multisensory Approaches for Managing Pediatric Dental Anxiety
Evaluation of the Effects of Virtual Reality and Weighted Blanket Use on Dental Anxiety Among School-Aged Children With High Dental Anxiety
The purpose of this prospective, randomized, single-blind clinical study is to evaluate and compare the effectiveness of distraction using virtual reality (VR) glasses and deep-pressure stimulation using weighted blankets on dental anxiety, cooperation, and pain perception in school-aged children. The study focuses on children aged 5-9 years with high dental anxiety (CFSS-DS score ≥39) who require dental procedures involving local anesthesia, such as Class II restorations, pulpotomy, or extractions. Participants will be randomly assigned to four groups: a control group receiving standard behavior guidance, a VR group, a weighted blanket group, and a combined group using both VR and weighted blankets. The study aims to determine the effects of these non-pharmacological, non-invasive, sensory-based interventions on children's clinical experience and physiological parameters.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This clinical trial is designed as a four-arm, randomized controlled study to compare sensory-based behavior guidance techniques in pediatric dentistry.
Study Arms:
Group 1 (Control): Treatment with basic behavior guidance techniques.
Group 2 (VR): Treatment using virtual reality (VR) glasses as a distraction tool.
Group 3 (WB): Treatment using a 3-kg weighted blanket for deep-pressure stimulation.
Group 4 (Combined): Simultaneous use of VR glasses and a weighted blanket.
Methodology:
Children aged 5-9 years who meet the inclusion criteria will be evaluated at multiple time points: pre-treatment, during local anesthesia, and post-treatment.
Outcome Measures:
Dental Anxiety: Assessed using the Facial Image Scale (FIS) and the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS).
Cooperation: Evaluated using the Frankl Behavior Rating Scale and the FLACC (Face, Legs, Activity, Cry, Consolability) scale.
Pain Perception: Measured using the Wong-Baker FACES Pain Rating Scale.
Physiological Parameters: Heart rate and oxygen saturation will be monitored throughout the procedure.
Acceptability: Subjective feedback from children and parents will be collected via post-treatment surveys to assess the feasibility of and satisfaction with the interventions.
Inclusion is restricted to systemically healthy children (ASA I-II) whose body weight (15-30 kg) is compatible with the 3-kg weighted blanket to ensure safety and appropriate therapeutic pressure.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Ayşe Evirken, DDS
- Telefonnummer: +90 543 927 76 86
- E-Mail: ayse.evirken@bezmialem.edu.tr
Studieren Sie die Kontaktsicherung
- Name: Mustafa Sarp Kaya, Associate Professor
- Telefonnummer: +90 532 230 68 01
- E-Mail: mskaya@bezmialem.edu.tr
Studienorte
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Fatih
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Istanbul, Fatih, Türkei (türkiye), 34093
- Rekrutierung
- Bezm-i Alem Vakif University, Faculty of Dentistry, Department of Pediatric Dentistry
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Children aged between 5 and 9 years.
- Children with a total score of 39 or higher on the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS).
- Requirement for dental treatment necessitating local anesthesia, such as Class II restorations, pulpotomy, pulpectomy, or extractions.
- Systemically healthy children classified as ASA I or ASA II.
- Voluntary participation of both the child and the parent, with written informed consent obtained from the parent.
- Body weight between 15 and 30 kg, ensuring that the 3-kg weighted blanket corresponds to 10-20% of the child's body weight.
Exclusion Criteria:
- Children with a CFSS-DS score of 38 or lower.
- Presence of intellectual or developmental disabilities.
- Presence of visual or hearing impairments.
- Presence of neurodevelopmental or neurological disorders, such as epilepsy.
- Acute or chronic respiratory diseases.
- Neuromuscular or orthopedic conditions that may pose a risk during the use of the weighted blanket.
- History of dizziness, nausea, or vertigo associated with virtual reality use.
- Refusal of the specific interventions, namely VR glasses or the weighted blanket, by the child or the parent.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: Control Group
Participants in this group will receive dental treatment using only basic behavior guidance techniques, such as tell-show-do and positive reinforcement, without any additional sensory interventions. |
Traditional non-pharmacological behavior management techniques, including the "Tell-Show-Do" method, positive reinforcement, and distraction through verbal communication, will be used as a standard protocol. |
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Experimental: Virtual Reality Group
Participants will wear virtual reality (VR) glasses during the dental procedure. The VR system will be used as a visual and auditory distraction tool to reduce dental anxiety and pain perception. |
The participant will wear a Virtual Reality headset during the dental procedure. Audio-visual content specifically selected for pediatric distraction will be played to divert the child's attention away from dental stimuli and reduce anxiety. |
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Experimental: Weighted Blanket Group
Participants will be covered with a 3-kg weighted blanket during the dental procedure to provide deep-pressure stimulation. This non-pharmacological intervention aims to promote relaxation and reduce physiological stress responses. |
A 3 kg weighted blanket will be placed over the participant's body during the dental treatment. This intervention aims to provide deep pressure stimulation to promote relaxation and decrease behavioral stress responses. |
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Experimental: Combined Intervention Group
Participants in this group will receive a combination of the two interventions during the entire dental procedure: virtual reality (VR) glasses for distraction and a weighted blanket for deep-pressure stimulation. |
The participant will wear a Virtual Reality headset during the dental procedure. Audio-visual content specifically selected for pediatric distraction will be played to divert the child's attention away from dental stimuli and reduce anxiety. A 3 kg weighted blanket will be placed over the participant's body during the dental treatment. This intervention aims to provide deep pressure stimulation to promote relaxation and decrease behavioral stress responses. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) Score
Zeitfenster: During the dental examination session, before dental treatment.
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Dental fear and anxiety will be assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). The total score ranges from 15 to 75, with higher scores indicating greater dental fear and anxiety. |
During the dental examination session, before dental treatment.
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Facial Image Scale (FIS) Score
Zeitfenster: Immediately before dental treatment, immediately after local anesthetic injection, and immediately after completion of dental treatment.
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Dental anxiety will be assessed using the Facial Image Scale (FIS), a 5-point facial image scale ranging from 1 to 5, with higher scores indicating greater dental anxiety. FIS scores will be recorded at three time points: immediately before dental treatment, immediately after local anesthetic injection, and immediately after completion of dental treatment. |
Immediately before dental treatment, immediately after local anesthetic injection, and immediately after completion of dental treatment.
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Frankl Behavior Rating Scale Score
Zeitfenster: Immediately before dental treatment ande immediately after dental treatment.
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Child behavior and cooperation during dental treatment will be assessed using the Frankl Behavior Rating Scale, which categorizes behavior into four levels ranging from definitely negative to definitely positive. |
Immediately before dental treatment ande immediately after dental treatment.
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FLACC Behavioral Pain Assessment Score
Zeitfenster: Immediately before dental treatment, immediately after local anesthetic injection, and immediately after completion of dental treatment.
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Pain-related behavioral responses will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale. The total score ranges from 0 to 10, with higher scores indicating greater pain-related behavioral response. Assessment will be performed by an independent evaluator blinded to group allocation using standardized video recordings. |
Immediately before dental treatment, immediately after local anesthetic injection, and immediately after completion of dental treatment.
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Wong-Baker FACES Pain Rating Scale Score
Zeitfenster: Immediately before and immediately after local anesthetic injection.
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Self-reported pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale, ranging from 0 to 10, with higher scores indicating greater pain intensity. |
Immediately before and immediately after local anesthetic injection.
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Heart Rate
Zeitfenster: Immediately before dental treatment, immediately before and immediately after local anesthetic injection and immediately after completion of dental treatment.
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Heart rate will be measured in beats per minute (bpm) using a pulse oximeter. |
Immediately before dental treatment, immediately before and immediately after local anesthetic injection and immediately after completion of dental treatment.
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Peripheral Oxygen Saturation (SpO₂)
Zeitfenster: Immediately before dental treatment, immediately before and immediately after local anesthetic injection and immediately after completion of dental treatment.
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Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter and recorded as percentage (%). |
Immediately before dental treatment, immediately before and immediately after local anesthetic injection and immediately after completion of dental treatment.
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Mustafa Sarp Kaya, Associate Professor, Bezm-i Alem Vakif University, Faculty of Dentistry, Department of Pediatric Dentistry
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2026/915
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Individual participant data will not be shared to protect participant confidentiality and privacy in accordance with the ethical committee approval and local data protection regulations.
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