ImmunizationNCT01463176
Music Therapy as Procedural Support for Young Children Undergoing Immunizations
A study testing Music Therapy in people with Immunization, run by Florida State University at 3 sites in United States.
Trial summary
Many young children undergo medical procedures that are painful and distressing. Negative experiences during medical procedures can have serious long-term effects, including fear and avoidance of medical procedures during adulthood. Read more about this study
- Who is it for?
- Ages 48 to 72 monthsHealthy volunteers can take part
- Conditions the study is for
- Immunization
- What is being tested?
- Music Therapy
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2011to Aug 2012
- 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 48 to 72 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants will be pediatric patients (N = 60) from 48 to 72 months of age who are undergoing immunizations, as well as their parents/legal guardians (N = 60) and the healthcare staff who are conducting/assisting with their procedure (N = 60).
Who cannot join
- Any children whose parents are non-English speakers or staff who are non-English speakers will be excluded.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memorial Pediatrics
Bainbridge, Georgia, 39819
Tallahassee Primary Care Associates
Tallahassee, Florida, 32303
Tallahassee Memorial HealthCare Family Medicine Clinic
Tallahassee, Florida, 32308
About this study
Official title: Music Therapy as Procedural Support for Young Children Undergoing Immunizations: A Randomized Controlled Study
Many young children undergo medical procedures that are painful and distressing. Negative experiences during medical procedures can have serious long-term effects, including fear and avoidance of medical procedures during adulthood. Distraction interventions can help prevent children from forming negative memories of medical procedures. Live music therapy has been shown to alleviate pediatric distress during both invasive and non-invasive procedures. The objective of this study is to examine the effects of music therapy on the child's distress behaviors and time to calm, as well as the length of the procedure and use of restraint, and parents' and healthcare staffs' behaviors during the procedure, for young children undergoing immunizations and influenza vaccinations. It is hypothesized that children receiving music therapy will show fewer distress behaviors, calm more quickly, and have shorter procedures with fewer instances of restraint compared to children who receive standard care. In addition, it is predicted that adults (parents and staff) will show fewer distress-promoting behaviors during, before, and after the procedures.
- Conditions
- Immunization
- Being tested
- Music Therapy
- Keywords
- Music Therapy, Child Psychology, Vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
Live music therapy is interactive and incorporates behavioral cues for coping techniques during the procedure, using patient-preferred music.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Children in the Standard Care Control group will receive standard care and will be videotaped by the music therapist but will not receive music therapy during their immunization |
| Music Therapy | Experimental | Children in this group will receive live music therapy during their immunization. Receives: Behavioral: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's behavioral distress, as measured by the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)
Distress will be assessed at fifteen second intervals throughout the procedure by trained observers upon review of videos of procedures (within approximately one month of procedure)
Measured: From the time the nurse enters the treatment room until the child leaves the treatment room after the procedure (approximately 5-10 minutes)
Secondary outcomes (4)
Child and adult behaviors, as measured by the Child-Adult Medical Procedure Interaction Scale- Short Form (CAMPIS-SF)
Child and adult behaviors will be assessed at fifteen second intervals throughout the procedure by trained observers upon review of videos of procedures (within approximately one month of procedure).
Measured: From the time the nurse enters the treatment room until the child leaves the treatment room after the procedure (approximately 5-10 minutes)
Child's pain and distress, reported by the child's parent using the Universal Pain Assessment Tool
Measured: After the procedure, when the child and parent have left the treatment room (within approximately 5 minutes of the procedure).
Parent perceptions of and satisfaction with the procedure, measured using a researcher-designed satisfaction survey
Measured: After the procedure, when the child and parent have left the treatment room (within approximately 5 minutes of the procedure).
Length of time it takes the child to calm after the procedure, in minutes and seconds
Assessed by trained observers upon review of a video tape of the procedure (within approximately a month of the procedure)
Measured: Observers will begin recording the length of time to calm starting with the needle insertion and ending when the child receives a CHEOPS score of 6 or less (within approximately 5 minutes after needle insertion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunizationStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivia S Yinger, MME, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463176
- Sponsor's protocol ID
- 2011.6797
- Status last verified
- Aug 2015
- First submitted
- 20 Oct 2011
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy as Procedural Support for Young Children Undergoing Immunizations: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01463176
- Acronym / sponsor ID
- 2011.6797
- Conditions
- Immunization
- Keywords
- Music Therapy, Child Psychology, Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 Nov 2011 (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 young children undergo medical procedures that are painful and distressing. Negative experiences during medical procedures can have serious long-term effects, including fear and avoidance of medical procedures during adulthood. Distraction interventions can help prevent children from forming negative memories of medical procedures. Live music therapy has been shown to alleviate pediatric distress during both invasive and non-invasive procedures. The objective of this study is to examine the effects of music therapy on the child's distress behaviors and time to calm, as well as the length of the procedure and use of restraint, and parents' and healthcare staffs' behaviors during the procedure, for young children undergoing immunizations and influenza vaccinations. It is hypothesized that children receiving music therapy will show fewer distress behaviors, calm more quickly, and have shorter procedures with fewer instances of restraint compared to children who receive standard care. In addition, it is predicted that adults (parents and staff) will show fewer distress-promoting behaviors during, before, and after the procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Children in the Standard Care Control group will receive standard care and will be videotaped by the music therapist but will not receive music therapy during their immunization |
| Music Therapy | Experimental | Behavioral: Music TherapyChildren in this group will receive live music therapy during their immunization. |
Who may qualify
- Ages
- 48 to 72 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants will be pediatric patients (N = 60) from 48 to 72 months of age who are undergoing immunizations, as well as their parents/legal guardians (N = 60) and the healthcare staff who are conducting/assisting with their procedure (N = 60).
Key exclusion criteria (1 listed)
- Any children whose parents are non-English speakers or staff who are non-English speakers will be excluded.
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 TherapyLive music therapy is interactive and incorporates behavioral cues for coping techniques during the procedure, using patient-preferred music. | Behavioural | Music Therapy |
Primary outcome
Child's behavioral distress, as measured by the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)
Time frame: From the time the nurse enters the treatment room until the child leaves the treatment room after the procedure (approximately 5-10 minutes)
Distress will be assessed at fifteen second intervals throughout the procedure by trained observers upon review of videos of procedures (within approximately one month of procedure)
4 secondary outcomes
Child and adult behaviors, as measured by the Child-Adult Medical Procedure Interaction Scale- Short Form (CAMPIS-SF)
Time frame: From the time the nurse enters the treatment room until the child leaves the treatment room after the procedure (approximately 5-10 minutes)
Child's pain and distress, reported by the child's parent using the Universal Pain Assessment Tool
Time frame: After the procedure, when the child and parent have left the treatment room (within approximately 5 minutes of the procedure).
Parent perceptions of and satisfaction with the procedure, measured using a researcher-designed satisfaction survey
Time frame: After the procedure, when the child and parent have left the treatment room (within approximately 5 minutes of the procedure).
Length of time it takes the child to calm after the procedure, in minutes and seconds
Time frame: Observers will begin recording the length of time to calm starting with the needle insertion and ending when the child receives a CHEOPS score of 6 or less (within approximately 5 minutes after needle insertion).
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 11 Aug 2015.
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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.
Olivia S Yinger, MME principal investigator
Florida State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Immunization, run by Florida State University at 3 sites 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 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 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
Child's behavioral distress, as measured by the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) (time frame: From the time the nurse enters the treatment room until the child leaves the treatment room after the procedure (approximately 5-10 minutes)). 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 11 Aug 2015.