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Procedural pain and anxiety in childre

Phase 3
Conditions
Procedural pain and anxiety in children.
Medical procedure, unspecified as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Y84.9
Registration Number
IRCT20220128053852N2
Lead Sponsor
Esfahan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
120
Inclusion Criteria

Parental consent
No urgent need for venipuncture
3 to 10 years old childs

Exclusion Criteria

Hearing and vision disorders that prevent the child from interacting
Dissatisfaction of parents to continue the study at any time during the intervention
Chronic or acute use of a sedative drug
The child has been taking painkillers, even acetaminophen, for the last 6 hours
Symptoms of a child's airway disorder
Patients with American Society of Anesthesiologists ’(ASA) classification from grade 3 upwards
Urgent need for venipuncture including decreased level of consciousness, shocks, severe respiratory distress, uncontrolled seizures, arrhythmia
Children at high risk for aspiration such as gastroesophageal reflux disease or gastrointestinal motility disorders

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pain caused by intravenous line insertion. Timepoint: Determining pain score during and after venipuncture. Method of measurement: Face, Legs, Activity, Cry, Consolability scale and Visual analogue scale.
Secondary Outcome Measures
NameTimeMethod
Child anxiety. Timepoint: Child's stress before and during intravenous line insertion. Method of measurement: Children's Emotional Manifestation Scale.
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