Pain Effect on Attention Using an Ipad Game App

NCT03115788 | Completed DMC

• 1 other identifier: IRB00037185
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Cognitive Function

Keywords

Thermal; ipad; game

Outcome Measures

Primary Outcomes (1)

• Median cue duration

  ipad game performance

  2 minutes

Secondary Outcomes (3)

• number correct

  2 minutes

• Premature discontinuation of game

  2 minutes

• Number of omitted responses

  2 minutes

Study Arms (2)

No Intervention Game play

ACTIVE COMPARATOR

The person will be instructed how to hold the iPad and how to play the game.

Other: iPad

Thermal pain and ipad performance

EXPERIMENTAL

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; Other: Cold Induced Pain; Other: iPad

Interventions

Heat induced pain OTHER

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.

Thermal pain and ipad performance

Cold Induced Pain OTHER

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.

Thermal pain and ipad performance

iPad OTHER

No Intervention Game play; Thermal pain and ipad performance

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• Douglas Ririe, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 groups; control and treated

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: April 14, 2017
• Study Start: May 15, 2016
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)