Anxiety Disorder of Childhood or AdolescenceNCT02437214
Music to Decrease Pain and Anxiety During Head CTs Performed at the PEds ED
A study testing Use of music for anxiety in children in people with Anxiety Disorder of Childhood or Adolescence, run by Steven Weiss.
Trial summary
A single blinded controlled trial to determine if an intervention of listening to nursery songs with integrated heart beat sounds results in changes in anxiety level in infants and young children less than four years of age in an emergent setting. Read more about this study
- Who is it for?
- Ages 1 month to 36 months, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder of Childhood or Adolescence
- What is being tested?
- Use of music for anxiety in children
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Jul 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 1 month to 36 months
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- We sampled all children up to ages 3 years who present to the PED during the hours that the research assistant was present to collect data.
Who cannot join
- All children requiring trauma room care were excluded because they were not able to move to the study's examination room after triage (their care will be completed in the trauma room). Children with hearing deficit and those who are unable to move to the designated examination room for other reasons including needing oxygen and cardiopulmonary monitoring were excluded as well. The patients were also excluded if we were unable to track their results or chart at final review of patient data.
About this study
Official title: Randomized Single Blinded Clinical Trial on Effects of Nursery Songs in Infants and Young Children's Anxiety Prior and During Head CT
A single blinded controlled trial to determine if an intervention of listening to nursery songs with integrated heart beat sounds results in changes in anxiety level in infants and young children less than four years of age in an emergent setting.
Read the detailed description
This study is a prospective cohort with a randomized single-blinded intervention with convenience sampling design. Our pediatric emergency medicine department (PED) treats nearly 2,500 patients between 1 and 3 years of age annually in 2008-10 and is a regional referral center for specialty care for our state. All data is collected in the PED between May 2008 and July 2010.
One PED examination room is designated as the study room. The music was stored on an ipod played in a portable speaker. The music is from the Compact Disk(CD), "Baby Go to Sleep." This is a commercially available CD.23 The "Baby Go to Sleep" Compact Disk played a combination of the sound of an actual human heartbeat and children's songs. Tempo changes occurred between each song. During the study, the initial three nursery rhymes were played.
The principal investigator's research associates recruit all patients up to 3 years of age presenting to the PED during the hours they were available. Once situated in the room, children both in the control and experimental group received the usual medical care including the evaluation by attending physician to determine if head CT would be performed or not. After subjects were determined to need a head CT by the attending physicians, they were randomly assigned to either the Control(Con) or experimental(Exp) group. Children in the Con group received the usual medical care while children in the Exp group received the usual medical care in combination with the intervention. The intervention was started by the patients nurse without the knowledge of the research associate. In the intervention group, music was played until the CT scan was completed. Research associates rated children's anxiety levels using a visual analogue scale(VAS) and Modified Ramsay Sedation Scale(MRSS) before children were transferred to radiology department for head CT then after children was laid down to go through head CT. Researchers associates were blinded to group by wearing headphones that were tested to ensure that they could not hear whether or not music was playing during the intervention phase.
- Being tested
- Use of music for anxiety in children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of music for anxiety in childrenOther
The "Baby Go to Sleep" CD played a combination of the sound of an actual human heartbeat and children's songs. The concept behind the "Baby Go to Sleep" CD is to blend heart beat sounds, which are known to be calming to infants and children, with children's music. The basic principles of relaxation were incorporated in the arrangements of heartbeat and children's songs, ie: simplicity, repetition, predictability, and simple symmetry (short repeated patterns). The adult human heart in the "Baby Go to Sleep" CD was recorded from the chest and set in consistent tempos for each song ranging from 62 to 78 beats per minute(BPM). The sound of the heartbeat continued between and during songs. Tempo changes occurred between each song.
| Study group | Role | What they receive |
|---|---|---|
| Use of music for anxiety in children | Experimental | Children in the Exp group received the usual medical care in combination with the intervention. The intervention was started by the patients nurse without the knowledge of the research associate. In the intervention group, music was played until the CT scan was completed. Receives: Other: Use of music for anxiety in children |
| Control | No intervention | Children in the Con group received the usual medical care without listening to the music intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale of anxiety
A 100 mm scale completed by the research associate relating the degree of infant anxiety
Measured: up to 10 minutes
Secondary outcomes (1)
Modified Ramsey Sedation Scale
A validated 1-6 likert scale for measuring degree of sedation
Measured: up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startMay 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety Disorder of Childhood or AdolescenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven Weiss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steven Weiss, University of New Mexico
- Investigators
- Steven Weiss, MD, Study director, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437214
- Sponsor's protocol ID
- 07-030
- Status last verified
- Oct 2023
- First submitted
- 16 Apr 2015
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Park G, Weiss SJ, Repar P. Randomized single-blinded clinical trial on effects of nursery songs for infants and young children's anxiety before and during head CT. Am J Emerg Med. 2016 Mar;34(3):663. doi: 10.1016/j.ajem.2015.12.049. Epub 2015 Dec 21. No abstract available.
PubMed 26782796Park G, Weiss SJ, Repar P. Randomized single-blinded clinical trial on effects of nursery songs for infants and young children's anxiety before and during head computed tomography. Am J Emerg Med. 2015 Oct;33(10):1477-82. doi: 10.1016/j.ajem.2015.07.045. Epub 2015 Jul 29.
PubMed 26314215
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Single Blinded Clinical Trial on Effects of Nursery Songs in Infants and Young Children's Anxiety Prior and During Head CT
- ClinicalTrials.gov ID
- NCT02437214
- Acronym / sponsor ID
- 07-030
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Steven WeissUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 May 2015 (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.
A single blinded controlled trial to determine if an intervention of listening to nursery songs with integrated heart beat sounds results in changes in anxiety level in infants and young children less than four years of age in an emergent setting.
Detailed description
This study is a prospective cohort with a randomized single-blinded intervention with convenience sampling design. Our pediatric emergency medicine department (PED) treats nearly 2,500 patients between 1 and 3 years of age annually in 2008-10 and is a regional referral center for specialty care for our state. All data is collected in the PED between May 2008 and July 2010.
One PED examination room is designated as the study room. The music was stored on an ipod played in a portable speaker. The music is from the Compact Disk(CD), "Baby Go to Sleep." This is a commercially available CD.23 The "Baby Go to Sleep" Compact Disk played a combination of the sound of an actual human heartbeat and children's songs. Tempo changes occurred between each song. During the study, the initial three nursery rhymes were played.
The principal investigator's research associates recruit all patients up to 3 years of age presenting to the PED during the hours they were available. Once situated in the room, children both in the control and experimental group received the usual medical care including the evaluation by attending physician to determine if head CT would be performed or not. After subjects were determined to need a head CT by the attending physicians, they were randomly assigned to either the Control(Con) or experimental(Exp) group. Children in the Con group received the usual medical care while children in the Exp group received the usual medical care in combination with the intervention. The intervention was started by the patients nurse without the knowledge of the research associate. In the intervention group, music was played until the CT scan was completed. Research associates rated children's anxiety levels using a visual analogue scale(VAS) and Modified Ramsay Sedation Scale(MRSS) before children were transferred to radiology department for head CT then after children was laid down to go through head CT. Researchers associates were blinded to group by wearing headphones that were tested to ensure that they could not hear whether or not music was playing during the intervention phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of music for anxiety in children | Experimental | Other: Use of music for anxiety in childrenChildren in the Exp group received the usual medical care in combination with the intervention. The intervention was started by the patients nurse without the knowledge of the research associate. In the intervention group, music was played until the CT scan was completed. |
| Control | No intervention | –Children in the Con group received the usual medical care without listening to the music intervention. |
Who may qualify
- Ages
- 1 month to 36 months
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- We sampled all children up to ages 3 years who present to the PED during the hours that the research assistant was present to collect data.
Key exclusion criteria (1 listed)
- All children requiring trauma room care were excluded because they were not able to move to the study's examination room after triage (their care will be completed in the trauma room). Children with hearing deficit and those who are unable to move to the designated examination room for other reasons including needing oxygen and cardiopulmonary monitoring were excluded as well. The patients were also excluded if we were unable to track their results or chart at final review of patient data.
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 |
|---|---|---|
| Use of music for anxiety in childrenThe "Baby Go to Sleep" CD played a combination of the sound of an actual human heartbeat and children's songs. The concept behind the "Baby Go to Sleep" CD is to blend heart beat sounds, which are known to be calming to infants and children, with children's music. The basic principles of relaxation were incorporated in the arrangements of heartbeat and children's songs, ie: simplicity, repetition, predictability, and simple symmetry (short repeated patterns). The adult human heart in the "Baby Go to Sleep" CD was recorded from the chest and set in consistent tempos for each song ranging from 62 to 78 beats per minute(BPM). The sound of the heartbeat continued between and during songs. Tempo changes occurred between each song. | Other | Use of music for anxiety in children |
Primary outcome
Visual analogue scale of anxiety
Time frame: up to 10 minutes
A 100 mm scale completed by the research associate relating the degree of infant anxiety
1 secondary outcome
Modified Ramsey Sedation Scale
Time frame: up to 10 minutes
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 13 Oct 2023.
- Derived from this study: PubMed 26782796Park G, Weiss SJ, Repar P. Randomized single-blinded clinical trial on effects of nursery songs for infants and young children's anxiety before and during head CT. Am J Emerg Med. 2016 Mar;34(3):663. doi: 10.1016/j.ajem.2015.12.049. Epub 2015 Dec 21. No abstract available.
- Derived from this study: PubMed 26314215Park G, Weiss SJ, Repar P. Randomized single-blinded clinical trial on effects of nursery songs for infants and young children's anxiety before and during head computed tomography. Am J Emerg Med. 2015 Oct;33(10):1477-82. doi: 10.1016/j.ajem.2015.07.045. Epub 2015 Jul 29.
- Individual participant dataSharing planned: No
Related trials for Anxiety Disorder of Childhood or Adolescence
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Obsessive Compulsive Disorder (OCD), Anxiety Disorder of Childhood or Adolescence
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.
Steven Weiss, MD study director
University of New Mexico
Questions about this trial
What is this clinical trial studying?
A study testing Use of music for anxiety in children in people with Anxiety Disorder of Childhood or Adolescence, run by Steven Weiss.
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 1 inclusion and 1 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 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Visual analogue scale of anxiety (time frame: up to 10 minutes). 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 NCT02437214, which also lists 2 linked publications.
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 13 Oct 2023.