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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03115788
Enrollment
12
Registered
2017-04-14
Start date
2016-05-15
Completion date
2025-07-01
Last updated
2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Function

Keywords

Thermal, ipad, game

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.

Interventions

OTHERHeat 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.

OTHERCold 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.

OTHERiPad

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)

Intervention model description

2 groups; control and treated

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Median cue duration2 minutesipad game performance

Secondary

MeasureTime frameDescription
number correct2 minutesipad game performance
Premature discontinuation of game2 minutesipad game performance
Number of omitted responses2 minutesipad game performance

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026