Weighted Blankets in reducing Fear and Pain of injections in Kids During Dental treatment

Effectiveness of Weighted Blanket-Assisted Deep Pressure Stimulation in Reducing Anxiety and Pain During Local Anesthetic Injection for Pulpectomy in Children Aged 6 12 Years : A Randomized Controlled Trial. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/095261

Enrollment

Registered

2025-09-22

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Non weighted blankets: Procedure: Once seated and reclined in the dental chair, the appropriately sized weighted blanket was placed over the child from shoulders to feet and remained in

Eligibility

Inclusion criteria

Inclusion criteria: Children aged between 6 and 12 years requiring pulpectomy procedure Medically healthy children Demonstrated cooperative or potentially cooperative behaviour using Frankl behaviour rating scale 3 or 4 No previous history of pulpectomy procedures Ability to understand and respond to pain assessment scales

Exclusion criteria

Exclusion criteria: Diagnosed sensory or neurodevelopmental disorders Eg. ASD, ADHD Known allergies to the materials used in weighted blankets Eg. cotton, PET pellets Presence of orthopaedic or musculoskeletal conditions that contraindicate use of weighted blankets

Design outcomes

Primary

Measure	Time frame
The implementation of weighted blankets during pulpectomy procedures is anticipated to significantly attenuate pediatric dental anxiety, foster enhanced patient cooperation, and reduce the incidence of disruptive behaviors. Furthermore, by facilitating autonomic nervous system modulation, this non-pharmacological intervention may contribute to the physiological regulation of stress responses and diminish reliance on sedation or other pharmacological modalities. Timepoint: Objective assessment of anxiety will be evaluated by utilising a digital finger pulse oximeter at three different time intervals from T0 to T2 T0 Before the treatment T1 During the treatment T2 After the treatment Subjective assessment of anxiety will be evaluated by using modified Venham scale at two intervals T0 Before the treatment T1 After the treatment Wong-Baker FACES Pain Scale will be used to evaluate the pain immediately after the administration of local anesthesia.	—

Measure

Time frame

The implementation of weighted blankets during pulpectomy procedures is anticipated to significantly attenuate pediatric dental anxiety, foster enhanced patient cooperation, and reduce the incidence of disruptive behaviors. Furthermore, by facilitating autonomic nervous system modulation, this non-pharmacological intervention may contribute to the physiological regulation of stress responses and diminish reliance on sedation or other pharmacological modalities. Timepoint: Objective assessment of anxiety will be evaluated by utilising a digital finger pulse oximeter at three different time intervals from T0 to T2 T0 Before the treatment T1 During the treatment T2 After the treatment Subjective assessment of anxiety will be evaluated by using modified Venham scale at two intervals T0 Before the treatment T1 After the treatment Wong-Baker FACES Pain Scale will be used to evaluate the pain immediately after the administration of local anesthesia.

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Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr Vinaya Kumar Kulkarni

SMBT Dental College and Hospital Sangamner

vinayakumar53@gmail.com8830483436

Outcome results

None listed

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