Pain Effect on Attention Using an Ipad Game App

The Effect of Pain on Short Term Cognitive Performance Using a Computer Assisted/Ipad Game Interface

Cognitive performance will be studied over time using an iPad game interface called the nine choice human game (5CH) in normal volunteer subjects before during and after experimentally induced thermal (cold or warm) pain or control (no intervention).

Study Overview

• Status: Completed
• Conditions: Cognitive Function
• Intervention / Treatment: Other: Heat induced pain; Other: Cold Induced Pain; Other: iPad

Detailed Description

Purpose: to assess the effects of pain on performance in a computer game interface of attention and memory and reliability of the repeated testing.

Rationale: The perioperative period may alter the ability to play an iPad game through changes in attention or memory as result of surgery, anesthesia, pain or medications. This study will describe and quantify and isolate any short term reduction in ability to focus and pay attention to the presence of thermal (cold or warm) pain.

Objectives: Determine if cognitive function is altered from thermal pain (cold or warm) using simple computer/ipad games of attentional performance and cognitive function.

Design and Outcomes: In group 1: no interventions will be used and the subjects will play the ipad game at baseline, 5 minutes later and 10 minutes later. In group 2: The subjects will play the ipad game, then 5 minutes later a thermal probe at 47 degrees C for 90 seconds on the arm or leg will be used while the game is being played. Following 10 minutes of recovery, the subject will play the game again, 5 minutes later the subject will have the foot placed in 10 degree water bath or body temperature water bath while the game is played, and the game will be played 10 minutes later after the foot is warm and dry. Visual analog scale (VAS) pain score from 0-10 will be used to assess discomfort. The subject will be able to stop the game or withdraw at any point. The primary outcome measures will be median cue duration (MCD) in the 9CH game. Secondary outcome measures will be number of correct, incorrect, omissions, time to finish trials, and time to quit for the 9CH. A total of 60 subjects will be studied, 20 subject warm probe/cold water, 20 subjects warm probe/body temperature water, and 20 normal subjects with no intervention.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male and non-pregnant female volunteers between the ages of 18-55.

Exclusion Criteria:

• Any reported learning disabilities, psychomotor impairment including diagnosis of ADD/ADHD, seizures, debilitating neurologic disorders (muscular dystrophy, multiple sclerosis, etc.), genetic diseases, heart disease, stroke, or memory deficits; anything that would impair the ability to hold the iPAD and perform the computer gaming tasks (i.e. blindness, color blindness, upper extremity dysfunction or pain). Also any history of cold induced impaired circulation, cold agglutinins or Raynaud's or insensitivity to cold.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No Intervention Game play; The person will be instructed how to hold the iPad and how to play the game.	Other: iPad
Experimental: Thermal pain and ipad performance; Interventions: Cold induced pain and heat induced pain. The whole group gets thermal heat (n=40) and half (n=20) get cold water foot immersion and half (n=20) get body temperature foot emersion. The person will be instructed how to hold the iPad and how to play the game. The person will then be allowed to play the game until the number of trials is completed or until the person no longer wishes to play.	Other: Heat induced pain; For the heat induced thermal pain, the research nurse will train the subject to estimate pain quantitatively using a 2 cm 2 Peltier controlled thermode (TSA®) applied to the skin of the arm. Typically, the subject is exposed to temperatures between 41° and 49° C using a random staircase method. After the volunteer learns to qualitatively estimate the thermal pain, pain will be established by heating the the leg with a 4 cm2 Peltier controlled thermode (TSA®) for 90 seconds with the probe clamped at a thermal intensity of 47°C.; Other: Cold Induced Pain; Cold pain will be induced by placing a foot in a container of circulating water maintained at 10°C for 90 seconds (n=20). Half (n=20) of the subjects will have the foot placed in body temperature water of 38°C.; Other: iPad

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median cue duration	ipad game performance	2 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number correct	ipad game performance	2 minutes
Premature discontinuation of game	ipad game performance	2 minutes
Number of omitted responses	ipad game performance	2 minutes

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Douglas Ririe, MD, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2016
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: game; Thermal; ipad
• Other Study ID Numbers: IRB00037185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No