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
Conditions
Interventions
Intervention 1: Control group: 3 to 10 year olds need venipuncture for which no intervention is applied. Intervention 2: Intervention group 1:Melatonin drug under the brand name Nem Life is given to t
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
3 Years to 10 Years
Inclusion criteria
Inclusion criteria: Parental consent No urgent need for venipuncture 3 to 10 years old childs
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Child anxiety. Timepoint: Child's stress before and during intravenous line insertion. Method of measurement: Children's Emotional Manifestation Scale. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMinoo Saeidi
Esfahan University of Medical Sciences
Outcome results
None listed