Thermal Pain's Impact on Cognitive Functioning Using iPad Game

Overseen By Douglas Ririe, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Learning disabilities, Neurologic disorders, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment involving Cold Induced Pain, Cold Therapy, Cryotherapy, Cold-Induced Analgesia, Heat induced pain, Thermal Pain, Heat-Induced Pain, Experimental Heat Pain, iPad, iPad, Apple iPad, Nine Choice Human Game (5CH), 5CH, Nine Choice Human Game?

Research shows that using electronic games as a distraction can significantly increase pain tolerance and reduce pain perception, as seen in studies where active gaming was more effective than passive distractions like watching TV. This suggests that using an iPad game could similarly help manage pain by engaging attention and providing distraction. ^{1 2 3 4 5}

Is the use of thermal pain and gaming interventions generally safe for humans?

The studies reviewed suggest that using virtual reality and gaming for pain management is generally safe, with no significant adverse events reported. However, more high-quality research is needed to confirm these findings and better understand any potential risks. ^{6 7 8 9 10}

How does the Nine Choice Human Game (5CH) treatment differ from other treatments for thermal pain's impact on cognitive functioning?

The Nine Choice Human Game (5CH) treatment is unique because it uses an interactive iPad game to engage cognitive functions, potentially distracting from pain and improving cognitive performance, unlike traditional treatments that may not incorporate such interactive and engaging elements. ^{1 5 11 12 13}

Research Team

Douglas Ririe, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for healthy men and non-pregnant women aged 18-55 who can play an iPad game. It's not for those with cold sensitivity issues, learning disabilities, psychomotor impairments like ADD/ADHD, seizures, serious neurological or genetic diseases, heart disease, stroke, memory problems, or physical limitations affecting the hands or eyes.

Inclusion Criteria

I am a healthy adult between 18 and 55 years old and not pregnant.

Exclusion Criteria

History of cold induced impaired circulation

I have heart disease.

I have had a stroke.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants play the iPad game at baseline to assess initial cognitive performance

1 day

1 visit (in-person)

Experimental Phase

Participants undergo thermal pain induction and play the iPad game to assess cognitive performance under pain conditions

1 day

1 visit (in-person)

Recovery and Follow-up

Participants are monitored for cognitive performance after recovery from thermal pain

10 minutes

1 visit (in-person)

Treatment Details

Interventions

• Cold Induced Pain
• Heat induced pain
• iPad
• Nine Choice Human Game (5CH)

Trial Overview Researchers are testing how pain affects attention by having participants play a special iPad game before, during and after being exposed to controlled heat or cold pain stimuli. Some will have no intervention as a control group.

Participant Groups

Group I: Thermal pain and ipad performance Experimental Treatment 3 Interventions

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.

Group II: No Intervention Game play Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

A study involving 55 healthy adults demonstrated that thermal-induced pain significantly impairs cognitive performance during complex tasks, as participants made more errors on the Edinburgh Virtual Errands Task (EVET) when experiencing pain.

Self-reported cognitive intrusion from pain correlated with task performance, suggesting that individuals who feel more distracted by pain are likely to make more mistakes, indicating a need for potential support strategies for those with chronic pain to manage everyday tasks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The disruptive effects of pain on multitasking in a virtual errands task. Moore, DJ., Law, AS.[2019]

The study found that using video games as a distraction significantly reduced the perception of pain in preschool children undergoing intravenous cannulation, compared to a control group.

Children who played video games during the procedure had better bio-physiological responses, with lower heart rates and improved oxygen saturation levels, indicating that video games can effectively help manage stress and pain in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of video game on bio- physiological parameters during intravenous cannulation among preschool children. Rackini, MJ., Shanmugapriya, A., David, A.[2020]

In a study with 60 participants, active distraction using an electronic gaming system significantly increased pain tolerance and reduced pain intensity compared to passive distraction (watching television) and no distraction during a cold pressor task.

A follow-up experiment with 40 participants confirmed that active distraction led to greater enjoyment, less anxiety, and a stronger willingness to repeat the task, reinforcing the effectiveness of electronic games as a method for pain control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic gaming as pain distraction. Jameson, E., Trevena, J., Swain, N.[2022]

In a study involving 50 Hispanic children aged 6-17 with severe burn injuries, the use of virtual reality (VR) during wound care significantly reduced pain intensity compared to standard analgesic medications alone, with worst pain ratings dropping from 7.46 to 5.54 on a scale of 0-10.

The VR group also reported lower levels of 'lowest pain during wound care,' indicating that VR not only helped during the procedure but also contributed to greater overall pain relief in the days following the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Analgesia for Children With Large Severe Burn Wounds During Burn Wound Debridement. Hoffman, HG., Patterson, DR., Rodriguez, RA., et al.[2021]

Experiments with healthy adults showed that pain significantly disrupts attentional performance, particularly in complex tasks like n-back, attentional switching, and divided attention, indicating that pain affects higher-level cognitive functions.

The study suggests that pain acts as a demand for executive control, highlighting the need for new measures to assess how pain impacts attention in various contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The interruptive effect of pain on attention. Moore, DJ., Keogh, E., Eccleston, C.[2022]

Distraction techniques, like playing video games, significantly reduce pain levels compared to experiencing pain alone, demonstrating the effectiveness of behavioral analgesia.

Individuals who tend to catastrophize report higher pain levels regardless of distraction, but the impact of distraction on pain perception changes over time, suggesting that both factors interact in complex ways during pain experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catastrophizing delays the analgesic effect of distraction. Campbell, CM., Witmer, K., Simango, M., et al.[2021]

A systematic review of 13 studies involving 680 patients found that gaming significantly reduced pain-related fear and anxiety compared to other treatments and no treatment, indicating its potential as a therapeutic tool for chronic musculoskeletal pain.

However, the evidence quality was low, and gaming did not show superiority in reducing pain catastrophizing or depression, highlighting the need for more rigorous studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Gaming on Pain-Related Fear, Pain Catastrophizing, Anxiety, and Depression in Patients with Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis. Gava, V., Fialho, HRF., Calixtre, LB., et al.[2022]

A study involving 77 healthy volunteers demonstrated that a High-Tech VR helmet significantly reduced procedural pain more effectively than a Low-Tech VR helmet, with participants reporting up to 34% less worst pain and 46% less pain unpleasantness.

The High-Tech VR helmet also led to a higher percentage of participants experiencing clinically significant pain reduction (65% vs. 29% in the Low-Tech group), emphasizing the importance of VR technology quality in pain management during medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. Hoffman, HG., Seibel, EJ., Richards, TL., et al.[2022]

Interacting with virtual objects using embodied avatar hands significantly reduced pain perception in healthy participants, showing that this immersive VR experience can effectively alleviate acute pain.

While the interactive avatar VR reduced pain ratings, it also led to more errors in an attention-demanding task, suggesting that the cognitive engagement in VR may influence pain perception through an attention mechanism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interacting with virtual objects via embodied avatar hands reduces pain intensity and diverts attention. Hoffman, HG.[2021]

Virtual reality (VR) has been found to be an effective method for reducing both acute and chronic pain, with significant improvements in pain intensity (72.1%) and quality (75.0%) observed across 70 studies involving 4105 participants.

The primary mechanism of pain relief through VR is distraction, especially for acute pain, while embodiment is more commonly associated with chronic pain, indicating that different types of pain may benefit from tailored VR approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The State of Science in the Use of Virtual Reality in the Treatment of Acute and Chronic Pain: A Systematic Scoping Review. Baker, NA., Polhemus, AH., Haan Ospina, E., et al.[2023]

Participants experienced less pain while engaged in a working memory task compared to a control condition, suggesting that cognitive engagement can reduce the perception of pain.

However, higher levels of heat pain negatively impacted task performance, indicating that pain can interfere with cognitive functions, particularly executive working memory, through shared cognitive resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance-dependent inhibition of pain by an executive working memory task. Buhle, J., Wager, TD.[2021]

The study involving 21 participants used functional near-infrared spectroscopy (fNIRS) to examine how pain and cognitive task difficulty affect attention networks, revealing that pain increases connectivity in the ventral attention network (VAN) while also enhancing top-down processing in the dorsal attention network (DAN) during challenging tasks.

High cognitive demand not only heightened top-down attentional pathways but also indicated that the left intraparietal sulcus and right inferior frontal gyrus play crucial roles in managing attention under pain, suggesting a complex interaction between cognitive load and pain perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional connectivity across dorsal and ventral attention networks in response to task difficulty and experimental pain. Fairclough, SH., Stamp, K., Dobbins, C.[2022]

In a study with 60 healthy volunteers, noxious heat stimulation (HS) resulted in the highest pain perception ratings compared to groups exposed to auditory stimulation (AS) alone or combined with cognitive tasks (CT), indicating that heat pain is more intense than competing sensory inputs.

The presence of a cognitive task did not significantly reduce pain perception when combined with heat and auditory stimulation, suggesting that competing sensory processing can influence pain perception without necessarily enhancing cognitive distraction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of noxious heat, auditory stimulation, a cognitive task, and time on task on pain perception and performance accuracy in healthy volunteers: a new experimental model. Pud, D., Sapir, S.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

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Effectiveness of video game on bio- physiological parameters during intravenous cannulation among preschool children. [2020]

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Electronic gaming as pain distraction. [2022]

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Virtual Reality Analgesia for Children With Large Severe Burn Wounds During Burn Wound Debridement. [2021]

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Catastrophizing delays the analgesic effect of distraction. [2021]

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Effects of Gaming on Pain-Related Fear, Pain Catastrophizing, Anxiety, and Depression in Patients with Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis. [2022]

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Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. [2022]

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Interacting with virtual objects via embodied avatar hands reduces pain intensity and diverts attention. [2021]

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The State of Science in the Use of Virtual Reality in the Treatment of Acute and Chronic Pain: A Systematic Scoping Review. [2023]

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Performance-dependent inhibition of pain by an executive working memory task. [2021]

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Functional connectivity across dorsal and ventral attention networks in response to task difficulty and experimental pain. [2022]

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The effects of noxious heat, auditory stimulation, a cognitive task, and time on task on pain perception and performance accuracy in healthy volunteers: a new experimental model. [2021]