Clinical trial NCT06919497: NOICE vs. Nothing | Thermode
Official title: NOICE vs. Nothing | Thermode: A Prospective, Randomized, Crossover Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Anxiety
Keywords: Thermal Sensory Analyzer (TSA-II)
Peltier-Based Contact Thermode
NOICE device
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective, randomized, crossover study on healthy volunteers evaluating the impact of spatial audio on heat pain threshold (HPT). The primary center for this study will be Lucile Packard Children's Hospital (Stanford University, Palo Alto, CA) and other Stanford affiliated sites.

Detailed description: Virtual reality (VR) is a developing, non-pharmaceutical tool that has been shown to reduce perceived anxiety and pain among patients. Although the use of VR in clinical settings is becoming more prevalent, the technology's application has been limited by variable factors, one being patient reluctance in using the VR headset itself. For patients who are provided the opportunity to utilize VR, there are a subset of patients who find discomfort in utilizing VR, as the visual screen of the VR headset can obstruct the patient's view of their surroundings while undergoing a procedure. While spatial audio applications have been found to be an effective intervention for reducing stress and negative moods and evoking positive emotions for patients, it is unknown to what extent spatial audio can reduce pain perceptions.

This study aims to investigate the effects of spatial audio on heat pain threshold in clinical settings, using the novel NOICE device. Unlike traditional VR, NOICE is an immersive headset that provides only spatial audio elements, which can be modulated using a variety of hand gestures. This device will serve as an alternate form of distraction for participants who prefer to not have their vision obscured when undergoing a procedure.

The objective of this proposal is to evaluate the impact of spatial audio on heat pain threshold (HPT) and heat pain sensitivity (HPS), while also analyzing ergonomics, system usability, and device satisfaction of the NOICE device.

Eligibility criteria: Inclusion Criteria:

* Ages 18 years and older
* English-speaking
* Intact hearing

Exclusion Criteria:

* Use chronotropic heart medications
* Use pain medications
* Current hearing loss

Primary outcomes:
measure: Change in heat pain threshold
timeFrame: Duration of intervention, approximately 15 minutes
Secondary outcomes:
measure: Change in heat pain sensitivity (HPS)
timeFrame: immediately after intervention
measure: Anxiety Level
timeFrame: immediately after intervention
measure: ISO Ergonomic scale
timeFrame: immediately after intervention
measure: System Usability Scale (SUS) Score
timeFrame: immediately after intervention
measure: Device satisfaction
timeFrame: immediately after intervention
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
Study officials:
References: