Dental Anxiety in Children, Pain Perception
Conditions
Keywords
pediatric dentistry, dental anxiety, tooth extraction, virtual reality, VR
Brief summary
The goal of this clinical trial is to learn if virtual reality distraction can reduce dental anxiety and pain perception in children aged 6-10 years undergoing simple dental extraction. The main questions it aims to answer are: Does virtual reality distraction lower dental anxiety compared to audio-visual distraction and conventional tell-show-do techniques? Does virtual reality distraction reduce pain perception during dental extraction? Researchers will compare virtual reality distraction, audio-visual distraction (2D cartoons with headset), and conventional tell-show-do with verbal distraction to see which method is most effective in improving child cooperation and reducing anxiety and pain. Participants will: Wear VR glasses to watch immersive 3D cartoons, or Watch 2D cartoons with headset, or Receive the conventional tell-show-do technique with verbal distraction. Outcome measures will include child dental anxiety (CFSS-DS, VCARS), pain perception (Wong-Baker FACES), physiological parameters (pulse rate, SpO₂), and behavioral cooperation (Frankl scale).
Interventions
DEVICEVirtual reality headset
Children wear a virtual reality headset to watch immersive 3D cartoons during dental extraction. This device provides distraction to reduce dental anxiety and pain perception.
BEHAVIORALAudio-visual distraction with 2D cartoons
Children watch 2D cartoons with headset during dental extraction. This behavioral technique provides distraction to reduce dental anxiety and pain perception.
BEHAVIORALTell-show-do with verbal distraction
Children receive the standard tell-show-do technique with verbal distraction during dental extraction. This behavioral method is used to reduce dental anxiety and improve cooperation.
Sponsors
Sultan Qaboos University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a three-arm, parallel group randomized controlled trial in children aged 6-10 years undergoing simple dental extraction. Participants are assigned to virtual reality distraction, audio-visual distraction, or conventional tell-show-do. The study is open-label with outcomes assessed at baseline, injection, extraction, and post-procedure.
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 6 to 10 years * Classified as ASA class 1 or 2 (healthy or with mild systemic disease) * Those who demonstrated Frankl behavior rating 2 and 3 toward dental procedures * Children with NO previous exposure to invasive dental procedure * No prior experience using VR glasses * Requiring extraction of mandibular deciduous molar under local anesthesia
Exclusion criteria
* ASA 3 and above * Those who demonstrated Frankl behavior rating 1 and 4 toward dental procedures * Special needs ( intellectual and developmental) * Children on psychotropic medication * Children wearing glasses * Presence of intra-oral swelling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Dental Anxiety (Self-Report) | Time Points: Baseline (before starting the procedure) and post-operative assessments ( after finishing the extraction) | Change in child dental anxiety will be measured using the Children's Fear Survey Schedule - Dental Subscale (CFSS-DS, Arabic version). The CFSS-DS consists of 15 items, each scored from 1 (not afraid) to 5 (very afraid), yielding a total score range of 15 to 75. Higher scores indicate greater dental anxiety (worse outcome). The unit of measure is the CFSS-DS score. |
| Child Dental Anxiety (Observation-based Assessment) | Time points: This scale will be measured at 4 time points during the procedure: T0(baseline)= 15 min before starting the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 mins after the extraction | Change in child dental anxiety will also be assessed using Venham's Clinical Anxiety Rating Scale (VCARS). This observational scale is scored from 0 (relaxed) to 5 (out of control), with a total score range of 0 to 5. Higher scores indicate greater observed anxiety (worse outcome). |
| 3a: Physiological Monitoring - Pulse Rate | Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction | Pulse rate will be monitored using a pulse oximeter. The unit of measure is beats per minute (bpm). In children, the normal resting pulse rate varies by age: Preschool children (3-5 years): \~80-120 bpm School-aged children (6-12 years): \~70-118 bpm Adolescents (13-18 years): \~60-100 bpm Higher values during the dental procedure indicate greater physiological arousal (worse outcome). |
| 3b: Physiological Monitoring - Oxygen Saturation (SpO₂) | Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction | Oxygen saturation will be monitored using a pulse oximeter. The unit of measure is percentage (%). In healthy children, normal SpO₂ values are typically 95-100% at rest. Lower values indicate poorer physiological status (i.e., worse outcomes). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Perception (Self-Report) | at the end of the procedure | Self-reported pain perception will be measured using the Wong-Baker FACES Pain Rating Scale (Arabic version). This scale ranges from 0 (no pain) to 10 (worst pain), represented by facial expressions. Higher scores indicate greater pain intensity (worse outcome), and lower scores indicate less pain intensity (better outcome) |
| Child Behavior (Observation) | Time Points: Baseline (before the dental extraction procedure) and follow-up assessment at 1 month post-procedure | Child behavior will be assessed using the Frankl Behavior Rating Scale. This scale has four degrees: 1. (Definitely Negative): Refusal of treatment, forceful crying, fearfulness, or extreme negativism. 2. (Negative): Reluctant to accept treatment, uncooperative, some negative attitude but not pronounced. 3. (Positive): Acceptance of treatment, cautious behavior, willingness to comply with the dentist, sometimes with reservation. 4. (Definitely Positive): Good rapport with the dentist, interested in dental procedures, laughing and enjoying the situation. The total score range is 1 to 4. Higher scores indicate more cooperative behavior (better outcome). |
Countries
Oman
Contacts
CONTACTDr.Zamzam AlQulhati Ali AlQulhati, BDS, MFD ( RSCI)
CONTACTAzza AlShidhani Khalid AlShidhani, DclinDent (Ed), MPaeds (RCSEd)
STUDY_DIRECTORDr. Azza Khalid AlSHidhani, DclinDent (Ed), MPaeds (RCSEd)
Pediatric dental clinic , Dental and maxillofacial department (SQUH), University Medical City,
STUDY_DIRECTORDr. Khalifa Mohammed AlAzri, DclinDent (Ed), MPaeds (RCSEd)
Pediatric dental clinic, Dental Center (Alkhoudh), The Medical City of Military and Security Services
PRINCIPAL_INVESTIGATORDr. Zamzam Ali Alqulhati, BDS, MFD(RCSI)
Oman Medical Specialty Boaered
Outcome results
None listed