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A clinical study on how ASMR and Virtual Reality can help reduce anxiety related to dental treatment in children aged 7-12 years

Evaluating the effectiveness of Autonomous Sensory Meridian Response and Virtual Reality in alleviating dental anxiety among 7-12 year olds: A randomized clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106852
Enrollment
40
Registered
2026-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: VR + ASMR content in the VR headset: The cartoon of the participant s choice will be displayed in the VR headset for 20 mins. The visual content (VR) includes the selected cartoon and t

Sponsors

Dr Saishanmukha Sudhamayi Erramilli
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 7-12 years old with dental anxiety, confirmed by a score of 19 or higher on the Faces version of Modified Child Dental Anxiety Scale (MCDAS-f). Children with no prior experience with VR. Children who have undergone an invasive procedure under local anaesthesia, children requiring Inferior Alveolar Nerve Block for required dental treatment. Children who are systemically healthy, generally good physical health and categorized as ASA-I based on American Society of Anesthesiologists physical status. Written informed consent obtained parents or guardians and assent from children.

Exclusion criteria

Exclusion criteria: Children visiting a dentist for the first time. Children wearing glasses. Children with score of less than 19 on the Faces version of Modified Child Dental Anxiety Scale (MCDAS-f). Children with no prior exposure to cartoons. Children requiring pharmacological behaviour management. Children with history of any medical conditions, cognitive impairment, balance disorders, motion sickness, nausea or vomiting and claustrophobia.

Design outcomes

Primary

MeasureTime frame
Objective parameters include heart rate, respiratory rate and salivary cortisol levels.Timepoint: Heart rate and Respiratory rate assessment: 1. Baseline - At the waiting area 2. 10 mins - On dental chair with VR headset on or TV on before local anaesthesia injection. 3. 5 mins - During local anaesthesia injection. 4. 10 mins - After local anaesthesia injection. 2ml unstimulated saliva samples collected: 1. Baseline - at the waiting area. 2. 10 mins - after the local anesthesia injection.

Secondary

MeasureTime frame
Subjective parameter includes Facial Image Scale (FIS) scores.Timepoint: 1. Baseline - Before the procedure to assess their anxiety based on their previous experience during a dental procedure. 2. 45 minutes - After the completion of dental procedure to assess the dental anxiety levels experienced during the procedure

Countries

India

Contacts

Public ContactDr Rashmi Nayak

Manipal College of Dental Sciences, Manipal

rashmi.nayak@manipal.edu9845364987

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026