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

Primary Purpose

Acute Post-operative Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Panda first followed by manual pain assessment
Manual first followed by Panda pain assessment
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Post-operative Pain

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • British Columbia Children's Hospital Department of Anesthesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Panda first

Manual first

Arm Description

Panda evaluation of post-operative pain first, followed by manual method of pain assessment.

Manual evaluation of post-operative pain first followed by Panda pain assessment.

Outcomes

Primary Outcome Measures

Concordance between the electronic and paper versions of the FPS-R and CAS pain scales
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.

Secondary Outcome Measures

Full Information

First Posted
May 29, 2012
Last Updated
October 24, 2017
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01610882
Brief Title
Panda: Evaluation of a Smartphone-based Perioperative Pain Assessment Tool
Acronym
Panda
Official Title
Panda: Evaluation of a Smartphone-based Perioperative Pain Assessment Tool
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Post-operative Pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Panda first
Arm Type
Other
Arm Description
Panda evaluation of post-operative pain first, followed by manual method of pain assessment.
Arm Title
Manual first
Arm Type
Other
Arm Description
Manual evaluation of post-operative pain first followed by Panda pain assessment.
Intervention Type
Device
Intervention Name(s)
Panda first followed by manual pain assessment
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Manual first followed by Panda pain assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Concordance between the electronic and paper versions of the FPS-R and CAS pain scales
Description
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.
Time Frame
Up to 2 hours following surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Ansermino
Organizational Affiliation
UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gillian Lauder
Organizational Affiliation
UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Children's Hospital Department of Anesthesia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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