PainNCT00924417
A Distraction Protocol for Peripheral Intravenous (IV) Placement in the Pediatric Emergency Department
A study testing Routine Care and Distraction in people with Pain, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
This is a randomized, controlled trial of a distraction protocol for peripheral intravenous line placement in the pediatric emergency department. Patients and parents will be randomized to one of two interventions: routine care or a teaching session about the cognitive technique known as distraction. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Pain
- What is being tested?
- Routine Care and Distraction
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to May 2010
- Phase
- Interventional
- 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 4 - 9
- Requiring IV placement for medical care in emergency department
- Child cognitively normal
Who cannot join
- No significant chronic medical conditions
- No IV in past 3 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: A Distraction Protocol for Peripheral IV Placement in the Pediatric Emergency Department
This is a randomized, controlled trial of a distraction protocol for peripheral intravenous line placement in the pediatric emergency department. Patients and parents will be randomized to one of two interventions: routine care or a teaching session about the cognitive technique known as distraction. The study seeks to enroll children ages 4-9, who are cognitively normal, who are without significant chronic medical illness, who are receiving intravenous line placement as part of routine care in the pediatric emergency department. Study investigators hypothesize that patients in the intervention group will report less pain than patients in the control group.
Read the detailed description
Routine care patients will have intravenous lines placed in the usual manner.
Intervention patient families will have a teaching session about distraction techniques, and distraction will be used during the intravenous line placement.
- Conditions
- Pain
- Being tested
- Routine Care, Distraction
- Keywords
- Pain associated with peripheral intravenous line placement
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine CareBehavioural
Parent given placebo intervention that entails brief information about what is routine care for intravenous line placement in the emergency department
DistractionBehavioural
Parent given brief information about the cognitive behavioral technique known as distraction. Parent and child then given 3 distraction "toys/tools" to assist with peripheral intravenous line placement.
| Study group | Role | What they receive |
|---|---|---|
| Distraction | Experimental | Parent given brief teaching session on concept of distraction, and parent and child given 3 "distraction" toys/tools to assist with peripheral intravenous line placement. Receives: Behavioral: Distraction |
| Routine care | Other | Patient managed as routine care. Receives: Behavioral: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faces Pain Scale Revised as reported by child
Measured: To be completed 5 minutes after IV placement
Secondary outcomes (1)
Visual Analog Scales to be completed by parent in order to measure: parent distress, patient/child pain, patient/child distress
Measured: 5 minutes after IV completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: Fellow unable to complete enrollment before completing training.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth C. Powell, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Elizabeth Powell, MD, MPH, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924417
- Sponsor's protocol ID
- CMRCIRB#2008-13630
- Status last verified
- Nov 2018
- First submitted
- 18 Jun 2009
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Distraction Protocol for Peripheral IV Placement in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT00924417
- Acronym / sponsor ID
- CMRCIRB#2008-13630
- Conditions
- Pain
- Keywords
- Pain associated with peripheral intravenous line placement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Fellow unable to complete enrollment before completing training.
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Jun 2009 (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.
This is a randomized, controlled trial of a distraction protocol for peripheral intravenous line placement in the pediatric emergency department. Patients and parents will be randomized to one of two interventions: routine care or a teaching session about the cognitive technique known as distraction. The study seeks to enroll children ages 4-9, who are cognitively normal, who are without significant chronic medical illness, who are receiving intravenous line placement as part of routine care in the pediatric emergency department. Study investigators hypothesize that patients in the intervention group will report less pain than patients in the control group.
Detailed description
Routine care patients will have intravenous lines placed in the usual manner.
Intervention patient families will have a teaching session about distraction techniques, and distraction will be used during the intravenous line placement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distraction | Experimental | Behavioral: DistractionParent given brief teaching session on concept of distraction, and parent and child given 3 "distraction" toys/tools to assist with peripheral intravenous line placement. |
| Routine care | Other | Behavioral: Routine CarePatient managed as routine care. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ages 4 - 9
- Requiring IV placement for medical care in emergency department
- Child cognitively normal
Key exclusion criteria (2 listed)
- No significant chronic medical conditions
- No IV in past 3 years
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 |
|---|---|---|
| Routine CareParent given placebo intervention that entails brief information about what is routine care for intravenous line placement in the emergency department | Behavioural | Routine care |
| DistractionParent given brief information about the cognitive behavioral technique known as distraction. Parent and child then given 3 distraction "toys/tools" to assist with peripheral intravenous line placement. | Behavioural | Distraction |
Primary outcome
Faces Pain Scale Revised as reported by child
Time frame: To be completed 5 minutes after IV placement
1 secondary outcome
Visual Analog Scales to be completed by parent in order to measure: parent distress, patient/child pain, patient/child distress
Time frame: 5 minutes after IV completion
Results and safety
The study was stopped early (reason given: Fellow unable to complete enrollment before completing training.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
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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.
Elizabeth Powell, MD, MPH principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Care and Distraction in people with Pain, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 20 Nov 2018. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: Fellow unable to complete enrollment before completing training.). Results are not available in the source record.
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?
Faces Pain Scale Revised as reported by child (time frame: To be completed 5 minutes after IV placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2018.