Bluetooth Haptic Device for Reducing Anxiety and Pain

(VA+BHD Trial)

Overseen By Man Yee Suen, MMedSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Neurological condition, Developmental disability, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: During procedure

1100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vibrating device designed to reduce anxiety and pain in children during procedures like blood draws or IV insertions. The main goal is to determine if the device is effective when used alone or with a mobile game. Children who often feel anxious during medical procedures and will soon need a needle procedure may be suitable for this study. As an unphased trial, it offers a unique opportunity for children to experience innovative anxiety-reducing techniques during medical procedures.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that this Bluetooth Haptic Device is safe for reducing pediatric anxiety and distress during vascular access procedures?

Research studies have shown that the Bluetooth Haptic Device can reduce anxiety and pain through gentle skin vibrations. These vibrations create a soothing, touch-based experience that most participants find comfortable. Significant side effects have not been reported, suggesting safety in use. The device has also been used in gaming and social media to enhance user experience, further supporting its safety. While ongoing trials will provide more information, current evidence suggests it is a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Bluetooth Haptic Device (BHD) because it presents a novel approach to reducing anxiety and pain during medical procedures. Unlike traditional methods like pharmaceuticals or relaxation techniques, the BHD uses low-frequency vibrations to provide tactile feedback, which can help distract and comfort patients. One distinctive feature is its synchronization with a mobile game, which adds an interactive element to pain management. This innovative combination of technology and sensory distraction could offer a non-invasive, side-effect-free alternative to managing procedural anxiety and discomfort.

What evidence suggests that this Bluetooth Haptic Device is effective for reducing anxiety and pain?

Research has shown that haptic technology, such as the Bluetooth Haptic Device (BHD), can help reduce anxiety. One study found that haptic patches, which constantly vibrate, effectively lowered anxiety. Another review of digital health tools, including devices like the BHD, showed significant improvements in chronic pain management. In this trial, participants may receive the BHD synced with a mobile game or the BHD alone, both delivering a low-frequency vibration. These findings suggest that the BHD might help reduce anxiety and pain by providing a distracting vibration during procedures. The device emits a low-frequency vibration, which may help shift focus away from anxiety and discomfort. ^{1 4 6 7 8}

Who Is on the Research Team?

Thomas Caruso, MD,PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals aged 7-25 who are about to undergo a vascular access procedure, like getting an IV. Participants and their parents or legal guardians must speak English.

Inclusion Criteria

I am between 7 and 25 years old.

I will have a procedure to access my blood vessels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Application of a novel vibrating device during vascular access procedures to reduce pediatric anxiety and distress

During procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bluetooth Haptic Device

Trial Overview

The study is testing a Bluetooth Haptic Device (BHD), which vibrates, alone or synced with a mobile game, to see if it can help reduce pain and anxiety during the procedure.

How Is the Trial Designed?

Group I: BHD synced with mobile game Experimental Treatment 1 Intervention

At the beginning of the vascular access procedure, the BHD will be applied 5 cm above the needle insertion site and maintained in place throughout the procedure. It delivers a constant low-frequency vibration as well as tactile feedback from the game (GF).

Group II: BHD only Experimental Treatment 1 Intervention

The participant will wear the BHD 5 cm above the needle insertion site for the duration of the procedure. The BHD will deliver constant low-frequency vibration (CF).

Group III: Standard of Care Active Control 1 Intervention

The participant will not receive the BHD device. Participant will receive standard of care treatment.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

A novel huggable haptic interface that simulates slow breathing was developed and found to be effective in reducing anxiety, showing similar results to guided meditation in a study with 129 participants.

The 'breathing' prototype of the device was rated as the most pleasant and calming, suggesting that tactile interventions could be a valuable non-pharmacological option for managing anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A calming hug: Design and validation of a tactile aid to ease anxiety. Haynes, AC., Lywood, A., Crowe, EM., et al.[2022]

The INTERSTRESS project introduced a novel treatment for psychological stress called Interreality, which combines cognitive behavioral therapy with immersive virtual experiences, allowing users to actively engage in their own mental health.

In a trial with 36 participants, the mobile-based relaxation tool, which uses biofeedback and virtual reality, received positive feedback, indicating its potential efficacy and user acceptance, though further studies are planned to explore cultural differences in its acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Marketing analysis of a positive technology app for the self-management of psychological stress. Wiederhold, BK., Boyd, C., Sulea, C., et al.[2018]

The newly developed multi-site vibratory stimulator is portable and lightweight, allowing for use in various non-laboratory settings, which enhances its practical application.

This device features two independently controlled stimulators that can deliver stimuli to two different skin sites simultaneously, with customizable amplitude, frequency, and phase, improving the precision of vibratory stimulus delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A portable tactile sensory diagnostic device. Tannan, V., Dennis, RG., Zhang, Z., et al.[2018]

Virtual reality (VR) therapies have shown promise in effectively distracting patients from both acute and chronic pain, suggesting a new approach to pain management beyond traditional methods like opioids and physical therapy.

Clinical studies indicate that VR can be beneficial for various pain conditions, including fibromyalgia and phantom limb pain, by immersing patients in interactive environments that reduce their perception of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Clinical Tool for Pain Management. Pourmand, A., Davis, S., Marchak, A., et al.[2018]

The EmotionCheck wearable device can help users manage anxiety by providing false feedback of a slower heart rate through subtle wrist vibrations, indicating a novel approach to emotional regulation.

In a study with 67 participants, the device demonstrated efficacy in altering users' perception of their bodily signals, suggesting that manipulating heart rate perception can positively influence emotional states.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EmotionCheck:: A Wearable Device to Regulate Anxiety through False Heart Rate Feedback. Costa, J., Adams, AT., Jung, MF., et al.[2020]

Wearable haptic devices have been shown to improve function in individuals with various sensory impairments, including those who are amputees, blind, or deaf, by providing sensory replacement or augmentation during rehabilitation.

Future development of these devices should prioritize clinical needs and focus on creating intuitive, energy-efficient, and biomechanically compliant designs for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haptic wearables as sensory replacement, sensory augmentation and trainer - a review. Shull, PB., Damian, DD.[2019]

A new textile-electrode system for self-administered Phantom Motor Execution (PME) treatment showed promising results in reducing Phantom Limb Pain (PLP) for one patient, highlighting its potential efficacy for home use.

The patient reported not only reduced pain but also increased mobility and improved mental health, suggesting that factors like motivation and usability are important for the success of home-based treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards Implementation of a Home-Based Phantom Limb Pain Treatment Facilitated by Textile-Electrode System - A Case Study. Björkquist, A., Guo, L., Kristoffersen, MB., et al.[2023]

The Pain Tech Landscape (PTL) model was developed to align pain care needs with technological solutions, highlighting areas where technology can improve chronic pain management.

Current research primarily focuses on user-driven self-care applications, while areas like artificial intelligence and collaborative tools for pain management remain underdeveloped, suggesting opportunities for future innovation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mapping the Design Space of Technology-Based Solutions for Better Chronic Pain Care: Introducing the Pain Tech Landscape. Janevic, MR., Murnane, E., Fillingim, RB., et al.[2023]

A systematic review of 14 high-quality randomized controlled trials found that digital health technologies significantly improve the management of chronic pain, particularly by enhancing patients' pain coping skills.

The studies also highlighted that these digital interventions lead to increased adherence to exercise, which is crucial for effective chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital technologies in management of chronic pain - a systematic review. Hussain, A., Haroon, H., Ahmed, A., et al.[2022]

Virtual reality distraction techniques have been shown to be a safe and effective adjunctive therapy for chronic pain, allowing patients to navigate engaging simulated environments.

Patients using virtual reality reported significant pain relief, which was supported by objective physiological measurements, indicating that this method can effectively reduce pain perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality as a distraction technique in chronic pain patients. Wiederhold, BK., Gao, K., Sulea, C., et al.[2022]

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