Evaluation of Smartphone Versions of VAS and NRS for Use in Adults

NCT04139590 | Completed

• 1 other identifier: H1601196
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 2

Brief Summary

A large number of patients experience significant pain after surgery, and more patients report pain after discharge from hospital than before. This issue has been observed in patients who receive peripheral nerve blocks, the effects of which often wear off after discharge. There are numerous barriers to the effective control of pain away from the direct supervision of medical professionals, and personalized management strategies are necessary in order to overcome these barriers. The first step of adequate pain management is accurate pain assessment. Therefore, this study aims to validate a smartphone-based pain assessment tool that patients can access at home.

Conditions

Postoperative Pain

Keywords

postoperative pain; Visual Analogue Scale; Numeric Rating Scale; Smartphone

Outcome Measures

Primary Outcomes (4)

• Scale Agreement at Time Zero: Difference between two modes of administration of the visual analogue scale (VAS-100)

  Comparison of two modes of administration of the VAS-100 (paper and smartphone). Investigators will report only the mean difference in pain intensity between the two scales.Both scales will be administered adjacently, the order will be randomly assigned.

  Time zero took place in the postanesthesia care unit (PACU) within 15 minutes of emergence from general anesthesia or procedural sedation, after being deemed appropriate to assess by the bedside nurse

• Scale Agreement at Time Zero: Difference between two modes of administration of the numeric rating scale (NRS-11)

  Comparison of two modes of administration of the NRS-11 (paper and smartphone). Investigators will report only the mean difference in pain intensity between the two scales.Both scales will be administered adjacently, the order will be randomly assigned.

  Time zero took place in the postanesthesia care unit (PACU) within 15 minutes of emergence from general anesthesia or procedural sedation, after being deemed appropriate to assess by the bedside nurse

• Scale Agreement at Time One: Difference between two modes of administration of the visual analogue scale (VAS-100)

  Comparison of two modes of administration of the VAS-100 (paper and smartphone). Investigators will report only the mean difference in pain intensity between the two scales.Both scales will be administered adjacently, the order will be randomly assigned.

  Time One occurred when the patient met the postanesthesia care unit (PACU) discharge criteria as per institutional protocol, modified from PADSS (post anesthesia discharge scoring system), with minimum score 9/10. Up to 72 hours.

• Scale Agreement at Time One: Difference between two modes of administration of the numeric rating scale (NRS-11)

  Comparison of two modes of administration of the NRS-11 (paper and smartphone). Investigators will report only the mean difference in pain intensity between the two scales.Both scales will be administered adjacently, the order will be randomly assigned.

  Time One occurred when the patient met the postanesthesia care unit (PACU) discharge criteria as per institutional protocol, modified from PADSS (post anesthesia discharge scoring system), with minimum score 9/10. Up to 72 hours.

Secondary Outcomes (2)

• Preference of smartphone app or traditional visual analogue scale (VAS-100)

  Before PACU discharge, the subjects were asked whether they preferred the Smartphone app, the original tool, or had no preference.

• Preference of smartphone app or traditional numeric rating scale (NRS-11)

  Before PACU discharge, the subjects were asked whether they preferred the Smartphone app, the original tool, or had no preference.

Study Arms (4)

Visual Analogue Scale - Original

PLACEBO COMPARATOR

Participants indicated the intensity of their pain by marking a "X" along the original paper version of the Visual Analogue Scale.

Device: Visual Analogue Scale - Original

Visual Analogue Scale - Panda

ACTIVE COMPARATOR

Participants indicated the intensity of their pain by marking a "X" on the smartphone screen using the Panda of the Visual Analogue Scale.

Device: Panda

Numeric Rating Scale - Original

PLACEBO COMPARATOR

Participants indicated the intensity of their pain by marking a "X" along the original paper version of the Numeric Rating Scale.

Device: Visual Analogue Scale - Original

Numeric Rating Scale - Panda

ACTIVE COMPARATOR

Participants indicated the intensity of their pain by marking a "X" on the smartphone screen using the Panda of the Numeric Rating Scale.

Device: Panda

Interventions

Panda DEVICE

Numeric Rating Scale - Panda; Visual Analogue Scale - Panda

Visual Analogue Scale - Original DEVICE

Numeric Rating Scale - Original; Visual Analogue Scale - Original

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19 to 75
• ASA status I-III
• Undergoing a procedure with anticipated post-surgical pain

You may not qualify if:

• Undergoing eye surgery
• Significant cognitive impairment or neurological injury
• Psychomotor dysfunction
• Visual impairment
• Admission to the Intensive Care Unit.

Sponsors & Collaborators

• University of British Columbia: lead
• British Columbia Children's Hospital: collaborator
• Providence Health & Services: collaborator

Study Sites (2)

Mount Saint Joseph Hospital

Vancouver, British Columbia, V5T 3N4, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V5Y 0A9, Canada

Location

Related Publications (2)

• Sun T, West N, Ansermino JM, Montgomery CJ, Myers D, Dunsmuir D, Lauder GR, von Baeyer CL. A smartphone version of the Faces Pain Scale-Revised and the Color Analog Scale for postoperative pain assessment in children. Paediatr Anaesth. 2015 Dec;25(12):1264-73. doi: 10.1111/pan.12790.

  PMID: 26507916 BACKGROUND

• Sunderland S, Yarnold CH, Head SJ, Osborn JA, Purssell A, Peel JK, Schwarz SK. Regional Versus General Anesthesia and the Incidence of Unplanned Health Care Resource Utilization for Postoperative Pain After Wrist Fracture Surgery: Results From a Retrospective Quality Improvement Project. Reg Anesth Pain Med. 2016 Jan-Feb;41(1):22-7. doi: 10.1097/AAP.0000000000000325.

  PMID: 26650425 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Cynthia Yarnold, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Participants had to use versions of the scale. They were randomized to using Panda or the original version of the scales first. Scores obtained using the two versions are then compared.

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: October 25, 2019
• Study Start: July 25, 2016
• Primary Completion: August 26, 2016
• Study Completion: August 26, 2016
• Last Updated: October 25, 2019

Record last verified: 2019-10

Locations

CA (2)