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Can a Weighted Blanket Calm Childrenâ??s Dental Anxiety?

Effectiveness of Weighted Blanketâ??Induced Deep Pressure Stimulation on Dental Anxiety During Local Anaesthesia in Children: A Prospective Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105214
Enrollment
20
Registered
2026-03-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

None listed

Interventions

Intervention1: Weighted blanket: Weighted blanket (10â??15 % of childâ??s body weight) made of hypoallergenic cotton with evenly distributed pellets placed from shoulders to feet during local anaesthe

Sponsors

Khushi Sethia
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 6 â?? 10 years ASA Iâ??II health status Requiring local anaesthesia for dental treatment No previous intra-oral injection experience No known allergy to lidocaine No history of failed or painful dental procedures Cooperative behaviour (Frankl 3 or 4)

Exclusion criteria

Exclusion criteria: History of painful or invasive medical/dental procedures Previous negative dental behaviour record Epilepsy or other neurological disorder Requirement for sedation or general anesthesia Medications influencing cortisol or autonomic function (e.g., corticosteroids)

Design outcomes

Primary

MeasureTime frame
Facial Image Scale (FIS) score measured before starting procedure, mid procedure, immediately after procedure. Scale range is 1 to 5 Less than 1 is least anxiety 3 is moderate/ neutral anxiety Greater than 3 is high anxiety or dental phobia.Timepoint: same dental appointment single visit assessment before starting the procedure mid procedure Immediately after the procedure.

Secondary

MeasureTime frame
Heart rate beats per minute recorded using a pulse oximeter dental anxiety using Facial Image Scale (FIS)Timepoint: After blanket placement Baseline before starting the procedure mid procedure Immediately after procedure

Countries

India

Contacts

Public ContactKhushi Sethia

Saveetha dental college and hospital

152511001.sdc@saveetha.com9619493883

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026