Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06591195
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Distraction As Multimodal Pain Management
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Distraction As Multimodal Pain Management for Children in Resource-constrained Settings DISTRACT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISTRACT
Brief Summary:
A randomized controlled trial will be performed at the Ngwelezana Hospital Empangeni South Africa Paediatric patients between the age of 5-12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic without sedation will be randomized into two groups the control group will receive standard practice of care which concerns a dressing change without any distraction methods and the intervention group will receive distraction by use of a kaleidoscope as additional method for potential pain alleviation Patients in both groups will receive paracetamol or non-steroidal anti-inflammatory drugs when required according to hospital protocol The primary outcome will be the change in pain score from pre-procedural to pain score during the dressing change and will be analysed with a linear regression analysis Additionally sub analyses will be performed to evaluate potentially modifying factors on the treatment effect This will also be evaluated with a linear regression analysis This will be correlated with care giver and health care worker observational pain scores
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None