Panda: Evaluation of a Smartphone-based Perioperative Pain Assessment Tool (Panda)
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|ClinicalTrials.gov Identifier: NCT01610882|
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Post-operative Pain||Device: Panda first followed by manual pain assessment Device: Manual first followed by Panda pain assessment||Not Applicable|
The purpose of this study is to ensure that Panda, a smartphone-based pain assessment tool, can be used effectively by children after surgery and that the pain scores it obtains agree with the scores obtained using traditional methods of pain assessment. In particular the aim is to show agreement (a) between pain scores obtained using Panda and pain scores obtained using the Faces Pain Scale-Revised for 4-12 year olds and (b) between pain scores obtained using Panda and pain scores obtained using the Coloured Analogue Scale (CAS) for 5-18 year olds.
We will recruit children between 4 and 18 years old, in general good health, who are scheduled for surgery. We will exclude any child who has a psychiatric diagnosis, developmental delay or brain injury, significant visual impairment or psychomotor dysfunction.
This study is taking place in the Post-anesthetic Care Unit (PACU) at BC Children's Hospital. We will recruit 200 children in total. The study procedures include the following:
Stage 1 - pre-clinical usability study: we will conduct a series of participatory design sessions with nurses in the PACU and with 20 children in the Surgical Day Care Unit (SDCU)
Stage 2 - clinical validation study: children will be asked to rate their pain using both the Panda and a traditional tool (which is used first will be decided randomly); during this stage, children will also be asked their opinion (e.g. which tool they preferred using and about any problems they experienced using either tool).
All scores will be recorded on the Panda device and extracted at the end of each day. No pain medication will be administered on the basis of a pain score obtained using the Panda.
Panda will be compared with the traditional method (FPS-R and CAS) within 3 different age groups (4-8, 8-12 and 12-18), using the following criteria: practicality, based on failure rates in obtaining pain scores from Panda compared with traditional method; preference for Panda compared with traditional method; agreement between the Panda score and the traditional score.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Panda: Evaluation of a Smartphone-based Perioperative Pain Assessment Tool|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Panda evaluation of post-operative pain first, followed by manual method of pain assessment.
Device: Panda first followed by manual pain assessment
Panda is a smart-phone based application designed to assess post-operative pain; manual method involves use of CAS/FPS-R on paper. Panda will be used first, manual method 5 mins later.
Manual evaluation of post-operative pain first followed by Panda pain assessment.
Device: Manual first followed by Panda pain assessment
Panda is a smart-phone based application designed to assess post-operative pain; manual method involves use of CAS/FPS-R on paper. Manual method will be used first, Panda 5 mins later.
- Concordance between the electronic and paper versions of the FPS-R and CAS pain scales [ Time Frame: Up to 2 hours following surgery ]The study aims to measure concordance between the (a) pain scores obtained using Panda and pain scores obtained using the Faces Pain Scale-Revised for 4-12 year olds and (b) pain scores obtained using Panda and pain scores obtained using the Coloured Analogue Scale (CAS) for 5-18 year olds.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610882
|Canada, British Columbia|
|British Columbia Children's Hospital Department of Anesthesia|
|Vancouver, British Columbia, Canada, V6H 3V4|
|Study Director:||Mark Ansermino||UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics|
|Principal Investigator:||Gillian Lauder||UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics|