PainNCT00761033
Music to Reduce Pain and Anxiety in the Pediatric Emergency Department
A study testing music in people with Pain and Distress, run by University of Alberta at 1 site in Canada.
Trial summary
Many medical procedures aimed at helping children can cause them pain and distress. If children experience certain levels of pain or distress, it can have long lasting negative effects. The emergency department can be a particularly stressful place for children and their parents. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- What is being tested?
- music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2008to not given
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music to Reduce Pain and Anxiety in the Pediatric Emergency Department: a Randomized Controlled Trial of Children 3-6 Years Undergoing Intravenous Placement
Many medical procedures aimed at helping children can cause them pain and distress. If children experience certain levels of pain or distress, it can have long lasting negative effects. The emergency department can be a particularly stressful place for children and their parents. There are also many procedures that children may have in the emergency department that can cause pain and distress. These include procedures such as needle pokes, stitches, or setting a broken bone. Two common methods of managing a child's pain in the emergency department are drugs and distraction. Drugs are not always practical and may come with unwanted side effects. Distraction is often used formally or informally and by parents or the health professionals. One form of distraction involves listening to music. This can lower the child's pain and distress by moving their attention from the painful stimulus, for example a needle poke, to a more pleasant sensation such as familiar children's songs. This study will test whether music is useful to help lower pain and distress for young children (ages 3 to 6 years) who are visiting an emergency department and need an intravenous line. Music is safe and pleasant for children. The results from this study could be important for many children receiving medical care.
- Being tested
- music
- Keywords
- children undergoing intravenous placement in the pediatric emergency department
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicBehavioural
| Study group | Role | What they receive |
|---|---|---|
| music | Experimental | children will listen to music during procedure Receives: Behavioral: music |
| Standard care | Other | Standard care Receives: Behavioral: music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation Scale of Behavioral Distress-Revised (OSBD-R)
Secondary outcomes (1)
Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Stollery Children's Hospital Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761033
- Sponsor's protocol ID
- B-010908
- Status last verified
- Dec 2016
- First submitted
- 25 Sep 2008
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hartling L, Newton AS, Liang Y, Jou H, Hewson K, Klassen TP, Curtis S. Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial. JAMA Pediatr. 2013 Sep;167(9):826-35. doi: 10.1001/jamapediatrics.2013.200.
PubMed 23857075
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music to Reduce Pain and Anxiety in the Pediatric Emergency Department: a Randomized Controlled Trial of Children 3-6 Years Undergoing Intravenous Placement
- ClinicalTrials.gov ID
- NCT00761033
- Acronym / sponsor ID
- B-010908
- Keywords
- children undergoing intravenous placement in the pediatric emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Stollery Children's Hospital Foundation
- Study start
- Oct 2008
- First posted
- 26 Sep 2008 (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.
Many medical procedures aimed at helping children can cause them pain and distress. If children experience certain levels of pain or distress, it can have long lasting negative effects. The emergency department can be a particularly stressful place for children and their parents. There are also many procedures that children may have in the emergency department that can cause pain and distress. These include procedures such as needle pokes, stitches, or setting a broken bone. Two common methods of managing a child's pain in the emergency department are drugs and distraction. Drugs are not always practical and may come with unwanted side effects. Distraction is often used formally or informally and by parents or the health professionals. One form of distraction involves listening to music. This can lower the child's pain and distress by moving their attention from the painful stimulus, for example a needle poke, to a more pleasant sensation such as familiar children's songs. This study will test whether music is useful to help lower pain and distress for young children (ages 3 to 6 years) who are visiting an emergency department and need an intravenous line. Music is safe and pleasant for children. The results from this study could be important for many children receiving medical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music | Experimental | Behavioral: musicchildren will listen to music during procedure |
| Standard care | Other | Behavioral: musicStandard care |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
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 |
|---|---|---|
| music | Behavioural | Standard care, music |
Primary outcome
Observation Scale of Behavioral Distress-Revised (OSBD-R)
1 secondary outcome
Pain
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 8 Dec 2016.
- Results publication: PubMed 23857075Hartling L, Newton AS, Liang Y, Jou H, Hewson K, Klassen TP, Curtis S. Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial. JAMA Pediatr. 2013 Sep;167(9):826-35. doi: 10.1001/jamapediatrics.2013.200.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music in people with Pain and Distress, run by University of Alberta 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 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: finished, as of the sponsor's last update on 8 Dec 2016. 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.
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?
Observation Scale of Behavioral Distress-Revised (OSBD-R). 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 NCT00761033, which also lists 1 linked publication.
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 8 Dec 2016.