Please select the eligibility criteria that correspond to the clinical trial below.
Title: Childhood Immunization: Reducing Immunization Distress (RID) Using Multi-Modal Distraction
Brief Summary: The purpose of this study is to compare the effectiveness of a more feasible method for reducing the pain and distress of childhood immunization with the standard method in use at the Pediatric Medical Group. A secondary aim is to evaluate the impact of parental involvement on the parent and child satisfaction with the immunization experience.

Study Hypotheses: In the standard, pre-kindergarten, two- or three vaccine sequence, there will be no statistically significant group differences between PPT and ST with respect to:

1. Child self-reported pain using the Faces Pain Scale-Revised (FPS-R) scale13 (primary outcome);
2. Parent report of child pain using the FPS-R;
3. Observer-rated child distress and pain using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale14;
4. Parent and child satisfaction with pain management during immunization measured by a 5-point Likert type scales;
5. Time required for completion of immunization from initiation of ST or PPT to 2 minutes after completion of the last injection.


Options:
A: Inclusion Criteria:

* Children, ages 4-6 years, scheduled to receive the standard pre-kindergarten immunizations. This consists of two injections: the Dtap (diphtheria, tetanus, acellular pertussis) and IPV (injectable polio vaccine) or three injections: DTAP, IPV and MMR (measles, mumps, rubella);
* With or without prior exposure to ST at PMG;
* English speaking subject and parents

Exclusion Criteria:

* Acute concurrent illness;
* Invasive procedures such as cannulation, venipuncture or urinary VCG in the preceding 6 months;
* Hospitalization or ED visit, within the prior 6 months;
* Chronic medical conditions requiring repeated painful interventions;
* Inability to respond age appropriately with verbal and written answers to questions, to pain scale measures, or to questionnaires;
* Refusal to be videotaped.
B: Inclusion Criteria:

* Patients requiring venipuncture in a pediatric emergency department
* Informed consent
* Patient assent

Exclusion criteria:

* Patients with sickle cell or other sensitivity to cold
* Nerve damage in the area
* Abrasion or break in skin where device would be placed
* Critically ill
C: Inclusion Criteria:

* Children reporting to study center with dental problems
* Dental procedure requiring local anesthesia
* Informed consent from the parents

Exclusion Criteria:

* Mentally challenged children
* Medical problems negating use of local anesthesia and/or surgical intervention
D: Inclusion Criteria:

* Children attending the pediatric ED between the ages of 3 and 6 years - Undergoing an IV placement
* Conscious
* Have sufficient knowledge of the English language to understand and follow instructions and complete the age-appropriate pain assessment

Exclusion Criteria:

* Children with hearing impairments, developmental disabilities, or sensory impairment to pain (e.g., spina bifida)
* Children will be excluded at the discretion of the attending staff (e.g., child in critical condition; requires urgent IV placement; or has altered level of consciousness).

Answer: A