Pain Clinical Trial
NCT number | NCT01377883 |
Other study ID # | CL_BTX2011 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2010 |
Est. completion date | June 2011 |
Verified date | December 2018 |
Source | Shaare Zedek Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Children with cerebral palsy (CP) undergo multiple painful procedures such as Botulinum toxin (BTX) injections that are administered several times a year. While clown care reduces preoperative anxiety, its effect on painful procedures has not been assessed. We hypothesized that medical clowning reduces pain and anxiety during BTX injections.
Status | Completed |
Enrollment | 25 |
Est. completion date | June 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Children with CP for whom BTX treatment was indicated Exclusion Criteria: - Children with minimal communication skills (n =1) - Autistic spectrum disorders (n =1) - Severe anxiety requiring general anesthesia (n =1) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shaare Zedek Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analogue Scale | Visual Analogue Scale by the child before after BTX injection. Parent rated the pain if the child was younger than 5 years or cognitively impaired | sevral minutes before and after BTX injections |
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