Pain Effect on Attention Using an Ipad Game App

Not Applicable

Recruiting

• Conditions: Cognitive Function
• Interventions: Device: iPad; Other: Heat induced pain; Other: Cold Induced Pain

• Registration Number: NCT03115788
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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).

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 Timeline

• Study Start: 2016-05-15
• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-05
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Intervention Game play	iPad	The person will be instructed how to hold the iPad and how to play the game.
Thermal pain and ipad performance	iPad	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.
Thermal pain and ipad performance	Cold Induced Pain	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.
Thermal pain and ipad performance	Heat induced pain	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.

Primary Outcome Measures

Name	Time	Method
Median cue duration	2 minutes	ipad game performance

Secondary Outcome Measures

Name	Time	Method
number correct	2 minutes	ipad game performance
Premature discontinuation of game	2 minutes	ipad game performance
Number of omitted responses	2 minutes	ipad game performance

Trial Locations

Locations (1)

Wake Forest University School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States