AnxietyPhase 2ERPainNCT00337870

Painful Procedures in the Emergency Department: A Distraction Intervention (3-5 Year Olds)

A Phase 2 study testing PAT in people with Anxiety and Pain, run by IWK Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 3 to 5 yearsHealthy volunteers can take part
Conditions the study is for: Anxiety, Pain
What is being tested?: PAT
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 131 participants
Where: 1 siteCanada
Study dates: Mar 2006to Aug 2009
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 5 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Participants will be eligible for this study if they:
Are between 3-5 years of age
Are presenting in the IWK Emergency Department requiring venipuncture for blood collection or intravenous (IV) initiation.
Are able to read and speak English
Provide written parental authorization

Who cannot join

Participants will be excluded for this study if they:
Are in critical condition as determined by ED staff
Are in significant pain for other reasons other than the venipuncture
Have severe cognitive delay
Require sedation for the venipuncture as determined by the ED staff

Trial locations and contacts

1 site in 1 country.

Canada1 site

IWK Health Centre
Halifax, Nova Scotia, B3K 6R8

Other trials in Canada

About this study

Official title: Painful Procedures in the Emergency Department: Does a Formal Program in Distracting Techniques for Parents and Children Reduce Pain and Anxiety in Children (3-5 Year Olds)?

This study is designed to assess the effectiveness of the video-based intervention over and above current standard practice for pain control in the pediatric emergency department (ED). This is a single-center trial based at the IWK Health Centre. The primary outcome will be based on the Child-Adult Medical Procedures Interaction Scale (CAMPIS) coding of the video-taped pain response of the research participants (3-5 years old).

Read the detailed description

The purpose of this study is to determine if the pain and anxiety that children experience when they have venipuncture procedures performed can be reduced by a video-based distraction and coping strategy intervention. An instructional video has been designed to educate parents and children about what is going to happen during the venipuncture procedure, to teach coping skills that can be used before and during the painful procedure, and to provide distraction during the procedure by using an entertaining video segment.

Approximately 168 children (3-5 years of age) who are seen in the IWK ED requiring venipunctures for blood collection or IV starts will be randomized. Parent and child training in distraction and coping strategies will be provided by means of a self-administered video-delivery via a portable DVD player. Fifty percent of the eligible participants will receive the distraction and coping strategies intervention and 50% will receive the standard medical care provided by the IWK ED. Those receiving standard care will be evaluated for outcome results and then be compared to the intervention group. It is expected that children who receive the intervention will report less pain and anxiety associated with venipunctures than those who receive standard care.

Conditions: Anxiety, Pain
Being tested: PAT
Keywords: Pediatric Anxiety, Pediatric Pain, Emergency room procedures
Medical subject headings: Anxiety Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PATBehavioural
Cognitive-Behavioral/Relaxation Intervention

Study groups in NCT00337870
Study group	Role	What they receive
Treatment	Experimental	50% randomized to receive distraction intervention during painful procedure Receives: Behavioral: PAT
Control	No intervention	50% RANDOMIZED TO RECEIVE NO INTERVENITON

What is being measured

The primary outcome is the main question the study is designed to answer.

CAMPIS coding of visual pain response video-recorded during the procedure
Measured: continuous

Secondary outcomes (3)

Parental reports of: Child pain ratings (Faces Pain Scale Revised)
Measured: post-procedure
Child anxiety ratings
Measured: post procedure
CHEOPS analysis
Measured: post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2006Aug 2009

First posted20 Jun 2006 (estimated)
Study startMar 2006
Primary completionAug 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AnxietyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00337870
Sponsor's protocol ID: 3416
Other IDs: Mayday grant
Acronym: ERPain
Status last verified: Sep 2013
First submitted: 15 Jun 2006
Last updated: 12 Sep 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Painful Procedures in the Emergency Department: Does a Formal Program in Distracting Techniques for Parents and Children Reduce Pain and Anxiety in Children (3-5 Year Olds)?
ClinicalTrials.gov ID: NCT00337870
Acronym / sponsor ID: ERPain / 3416
Conditions: Anxiety, Pain
Keywords: Pediatric Anxiety, Pediatric Pain, Emergency room procedures
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 131 participants (actual)
Lead sponsor: IWK Health CentreUniversity, hospital or other
Collaborators: Mayday Fund
Study start: Mar 2006
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 20 Jun 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment	Experimental	Behavioral: PAT50% randomized to receive distraction intervention during painful procedure
Control	No intervention	–50% RANDOMIZED TO RECEIVE NO INTERVENITON

Who may qualify

Ages: 3 to 5 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Are between 3-5 years of age
Are presenting in the IWK Emergency Department requiring venipuncture for blood collection or intravenous (IV) initiation.
Are able to read and speak English
Provide written parental authorization

Key exclusion criteria (5 listed)

Are in critical condition as determined by ED staff
Are in significant pain for other reasons other than the venipuncture
Have severe cognitive delay
Require sedation for the venipuncture as determined by the ED staff

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PATCognitive-Behavioral/Relaxation Intervention	Behavioural	Treatment

Primary outcome

CAMPIS coding of visual pain response video-recorded during the procedure
Time frame: continuous

3 secondary outcomes

Parental reports of: Child pain ratings (Faces Pain Scale Revised)
Time frame: post-procedure
Child anxiety ratings
Time frame: post procedure
CHEOPS analysis
Time frame: post procedure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2013.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patrick J McGrath, PhD. principal investigator

IWK Health Centre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PAT in people with Anxiety and Pain, run by IWK Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CAMPIS coding of visual pain response video-recorded during the procedure (time frame: continuous). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00337870.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2013.