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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how thermal pain (either hot or cold) affects cognitive performance using a fun iPad game. Participants will play this game before, during, and after exposure to different temperatures to assess its impact on thinking and reaction times. It is ideal for healthy adults without learning disabilities or circulation problems from cold exposure. As an unphased study, this trial provides a unique opportunity to contribute to scientific understanding without the risks associated with new treatments.

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 prior data suggests that this method is safe for studying cognitive performance?

Research has shown that cold therapy is generally safe and well-tolerated, often easing pain and swelling after injuries. Many studies indicate that it reduces pain and helps people resume activities more quickly.

For pain caused by heat, studies reveal that varying heat levels produce different pain sensations. Participants have described their pain during heat treatments, suggesting that people can manage heat pain in a controlled setting. Researchers commonly use both cold and heat treatments to better understand pain.

In summary, both cold and heat treatments are considered safe for use in controlled studies like this one. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how thermal pain influences cognitive functioning through an innovative approach using an iPad game. Unlike traditional methods that might assess cognitive function through pen-and-paper tests or computer programs, this trial uses a dynamic and engaging game format on a widely accessible device. This approach could offer a more interactive and realistic assessment of how pain affects cognitive abilities in everyday scenarios. Moreover, the combination of thermal pain exposure and gameplay could uncover new insights into pain management and its impact on mental processes.

What evidence suggests that this trial's treatments could be effective for cognitive performance?

This trial will compare the effects of cold-induced pain and heat-induced pain on cognitive functioning using an iPad game. Research has shown that both cold and heat pain can affect cognitive performance. Studies have found that cold can impair focus and attention. However, engaging in enjoyable activities like playing games can help manage pain by providing distraction. In the case of heat pain, higher pain levels can hinder task performance, but engaging activities might help maintain cognitive sharpness. Overall, while pain can reduce concentration, playing games or similar activities can help by diverting attention from the pain. ^{2 4 6 7 8}

Who Is on the Research Team?

Douglas Ririe, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3146755/

The Effects of Interactive and Passive Distraction on Cold ... Results Participants showed significantly higher pain tolerance during both interactive and passive distraction relative to baseline. The two distraction ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8470111/

The Effect of Cold Exposure on Cognitive Performance in ... The main findings of the current systematic review are that acute cold exposure induced an impairment of CP (in 15 of the 18 studies) in most of ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03115788/pain-effect-on-attention-using-an-ipad-game-app

Pain Effect on Attention Using an Ipad Game App This study will describe and quantify and isolate any short term reduction in ability to focus and pay attention to the presence of thermal ( ...

4. researchgate.net researchgate.net/publication/365944382_The_Effect_of_Virtual_Reality_on_Cold_Pain_Sensitivity_in_Patients_with_Fibromyalgia_and_Pain-Free_Individuals_A_Randomized_Crossover_Study

The Effect of Virtual Reality on Cold Pain Sensitivity in ... Previous studies that explored the potential of video games have shown the positive effect of distraction on the perception of pain; furthermore, past research ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S030645652400144X

The effects of cold water immersion and partial body ... This study investigated the effects of cold water immersion (CWI) and partial body cryotherapy (PBC) applied within a 15-min post-exercise recovery period.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03115788

Pain Effect on Attention Using an Ipad Game App 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.

7. mdpi.com mdpi.com/2673-9488/4/4/24

An Evidence-Based Approach to Utilizing Cold Therapies ... Ultimately, a plethora of evidence exists to support cold therapy's efficacy in reducing pain and enhancing the return to play/training [9,10,11] ...

8. provider.univerahealthcare.com provider.univerahealthcare.com/documents/d/global/uni-prv-cryotherapy-cold-therapy-devices

Medical Policy - Cryotherapy (Cold Therapy) Devices Cold therapy is considered a standard part of treating pain and inflammation following injuries involving musculoskeletal tissue, trauma, or ...