## Protocol Section
### Identification Module
**NCT ID:** NCT01637779

**Brief Title:** A Randomized Controlled Trial About Teaching Parents How to Manage Childhood Immunization Pain

**Official Title:** A Randomized Clinical Trial to Evaluate the Impact of a Fact Sheet About Childhood Immunization Pain Management on Parental Knowledge

#### Organization Study ID Info
**ID:** 11-0231-E
#### Organization
**Class:** OTHER
**Full Name:** University of Toronto
#### Secondary ID Infos
**Domain:** The Hospital for Sick Children
**ID:** 1000032989
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2013-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-10-29

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-10-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-02

**Type:** ACTUAL

#### Start Date
**Date:** 2012-07

**Status Verified Date:** 2013-10

#### Study First Post Date
**Date:** 2012-07-11
**Type:** ESTIMATED
**Study First Submit Date:** 2012-07-08
**Study First Submit QC Date:** 2012-07-08
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** The Hospital for Sick Children

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Toronto

#### Responsible Party

**Investigator Affiliation:** University of Toronto

**Investigator Full Name:** Anna Taddio

**Investigator Title:** Associate Professor, Leslie Dan Faculty of Pharmacy

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** There is no effect of a parent-directed fact sheet about pain management during childhood immunization and pre-test on parent learning about evidence-based pain relieving methods.

**Detailed Description:** Over 90% of young children demonstrate severe distress during vaccination. Pain relieving strategies are uncommonly used, despite a plethora of evidence for physical, pharmacological and psychological techniques. Parents commonly report pain as a harm-related concern for childhood immunizations and are dissatisfied with current practices. Unmitigated pain causes long-term adverse sequelae, including; anticipatory fear and hypersensitivity to pain at future procedures in children, and parental non-compliance with immunization schedules. Health providers and parents report the major barrier to routine use of pain management is parental lack of knowledge about effective strategies. Lack of time is reported as a secondary barrier. An educational tool about immunization pain management targeted to parents that can be practically implemented in the clinical setting within usual time constraints is needed.

### Conditions Module

**Conditions:**

- Mothers of Newborn Infants

**Keywords:**

- randomized controlled trial

- parent education

- pain management

- infant

- immunization

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

#### Enrollment Info

**Count:** 120

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** mothers will review a fact sheet containing information about pain management during immunization then complete a knowledge test afterward

**Intervention Names:**

- Behavioral: Fact sheet

**Label:** fact sheet review

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** mothers will review material unrelated to pain management during immunization then complete a knowledge test

**Intervention Names:**

- Behavioral: Fact sheet

**Label:** control unrelated material

**Type:** PLACEBO_COMPARATOR

#### Arm Group 3

**Description:** mothers do a pre-test, then read a fact sheet about how to manage immunization pain, then repeat the test

**Intervention Names:**

- Behavioral: Fact sheet

**Label:** pre-test, review of fact sheet

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** mothers do a pre-test, then read unrelated material, then repeat the test

**Intervention Names:**

- Behavioral: Fact sheet

**Label:** pre-test, control unrelated information

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- control unrelated material

- fact sheet review

- pre-test, control unrelated information

- pre-test, review of fact sheet

**Description:** fact sheet about pain management during immunization

**Name:** Fact sheet

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** maternal knowledge will be evaluated after reading the fact sheet or control (material unrelated to immunization)

**Measure:** knowledge

**Time Frame:** 10 minutes after intervention (educational material)

#### Secondary Outcomes

**Description:** maternal self-reported use of pain relieving interventions during routine 2-month infant immunizations

**Measure:** utilization of pain relieving interventions

**Time Frame:** 2 months after intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* new mothers with health full-term infants
* 5 minute Apgar 7 or more

Exclusion Criteria:

* non-english speaking mothers
* mothers with psychiatric conditions
* infants admitted to intensive care unit

**Maximum Age:** 60 Years

**Minimum Age:** 15 Years

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Toronto

**Country:** Canada

**Facility:** Mount Sinai Hospital

**State:** Ontario

**Zip:** M5G 1X5

#### Overall Officials

**Official 1:**

**Affiliation:** University of Toronto

**Name:** Anna Taddio, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
