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Evaluation of weighted blanket and laughing gas for reducing stress in children aged 6-12 years.

Evaluation of the use of weighted blanket as an adjunct with nitrous oxide-oxygen inhalational sedation on reducing anxiety in children aged 6-12 years during restorative treatment. - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/107059
Enrollment
54
Registered
2026-03-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

None listed

Interventions

Intervention1: Nitrous oxide-oxygen inhalational sedation and weighted blanket: 27 participants in group who will be found anxious using Modified Child Dental Anxiety Scales faces version and come und

Sponsors

Yenepoya Dental College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Children in the age group of 6 to12 years of age requiring class 1 restorative treatment. 2)American Society of Anesthesiologist Physical System 1 (ASA 1) that is a normal healthy patient. 3)Children who will be found anxious using Modified Child Dental Anxiety Scales faces version and come under the score range of 19-31. (MCDASf). Children who are not found anxious using MCDASf will not require treatment under sedation and hence will be excluded from the study. 4)Children requiring Class 1 restorative procedure.

Exclusion criteria

Exclusion criteria: 1)Children who are unable to accept breathing through the nasal mask. 2)Children with epilepsy or seizures and taking medication with sedative effect. 3)Children with prevailing upper respiratory tract infection and chronic obstructive pulmonary disorder. 4)Children with claustrophobia or strong aversion to coverings. 5)Children with Neurological or developmental disorders (e.g., Autism Spectrum Disorder) that might independently influence deep pressure touch stimulation response.

Design outcomes

Primary

MeasureTime frame
The results will provide evidence-based clinical recommendations regarding the use of the weighted blanket as an effective, low-cost, non-pharmacological adjunct to N2O sedation for mildly anxious pediatric patients.Timepoint: 2 years

Secondary

MeasureTime frame
clinical success rate of use of weighted blanket as an adjunct to nitrous oxide-oxygen inhalational sedation in reducing anxiety in children needing dental treatment.Timepoint: 2 years

Countries

India

Contacts

Public ContactDrSundeep Hegde K

yenepoya dental college

sundeephegde@yahoo.co.i98455088803

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026