Study of the Impact of a Pain Diary in Pediatric Patients
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 17, 2009 | ||||
| Last Updated Date | May 2, 2013 | ||||
| Start Date ICMJE | June 2009 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE |
|
||||
| Change History | Complete list of historical versions of study NCT00935207 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of the Impact of a Pain Diary in Pediatric Patients | ||||
| Official Title ICMJE | The Impact of a Pain Diary on the Communication of Pain in Pediatric Patients | ||||
| Brief Summary | The purpose of this study is to show the impact of a pain diary on the communication of pain by pediatric patients. Participants will be given a pain diary after consent and asked to complete the record each time they have pain. A survey about the efficacy of the pain diary will be taken prior to discharge by the nurse, physician, patient and parents. The hypothesis is that the pain diary will improve the communication. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Inpatients at the Blair E. Batson Hospital for Children 3-19 years of age, receiving regular controlled substance analgesic defined as: codeine with acetaminophen, fentanyl, hydromorphone, meperidine, morphine, oxycodone with acetaminophen, propoxyphene with acetaminophen, and hydrocodone with acetaminophen. |
||||
| Condition ICMJE | Pain | ||||
| Intervention ICMJE | Other: Pediatric Pain Diary
Pain diary designed for pediatric patients |
||||
| Study Group/Cohort (s) | Pediatric Pain Diary
Patients will be give a pain diary to complete.
Intervention: Other: Pediatric Pain Diary |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 8 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 3 Years to 19 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00935207 | ||||
| Other Study ID Numbers ICMJE | 2009-0054 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Andrew Ostrenga, University of Mississippi Medical Center | ||||
| Study Sponsor ICMJE | University of Mississippi Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Mississippi Medical Center | ||||
| Verification Date | May 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||