Panda: Evaluation of a Smartphone-based Perioperative Pain Assessment Tool

This study is currently recruiting participants.
Verified January 2013 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01610882
First received: May 29, 2012
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

This study will evaluate Panda, a smartphone-based pain assessment tool. During a child's recovery from surgery, a Post-Anesthetic Care Unit nurse will assess their pain, which helps determine what medication they need. Traditionally, this involves asking the child to rate their pain on a scale from 1 to 10, by moving a slider along a coloured scale or pointing to one of a series of faces on a piece of card. The Panda uses the same methods, but presents them on a smartphone screen. Our evaluation will ensure that the Panda gives the same pain scores as the traditional methods.


Condition Intervention
Acute Post-operative Pain
Device: Panda first followed by manual pain assessment
Device: Manual first followed by Panda pain assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Panda: Evaluation of a Smartphone-based Perioperative Pain Assessment Tool

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Concordance between the electronic and paper versions of the FPS-R and CAS pain scales [ Time Frame: Up to 2 hours following surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: May 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Panda first
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 first
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing a surgical procedure for which there is an anticipated post-surgical pain model
  • Age 4 - 18 years
  • ASA I-III, not requiring admission to PICU
  • Written parental/guardian informed consent and subject informed assent when required (subject age ≥ 7 years)

Exclusion Criteria:

  • Children who have not undergone a surgical procedure (e.g. MRI, X-ray or endoscopy patients)
  • Inability or refusal to provide informed consent/assent
  • Developmental delay, neurological injury or psychomotor dysfunction
  • Children who have a significant visual impairment or have undergone eye surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01610882

Locations
Canada, British Columbia
British Columbia Children's Hospital Department of Anesthesia Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Joanne Lim     6048752000 ext 6669     jlim2@cw.bc.ca    
Principal Investigator: Gillian Lauder            
Sponsors and Collaborators
University of British Columbia
Investigators
Study Director: Mark Ansermino UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics
Principal Investigator: Gillian Lauder UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01610882     History of Changes
Other Study ID Numbers: H12-01273
Study First Received: May 29, 2012
Last Updated: January 17, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013