Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456411
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-30
Brief Title:
Functional Near-Infrared Spectroscopy and Virtual Reality Relaxation Programs for Pain Management in Patients With Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Real-Time Evaluation of Severity of Perceived Pain in Patients With Cancer by Using Functional Near-Infrared Spectroscopy fNIRS and Investigation of Pain Relief Utilizing Virtual Reality Technologies
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial attempts to measure pain severity location of pain and feasibility in patients with cancer using functional near-infrared spectroscopy and virtual reality relaxation programs Functional near-infrared spectroscopy and virtual reality relaxation programs may help relieve pain in patients with cancer who are receiving treatment
Detailed Description:
PRIMARY OBJECTIVES
I Develop an algorithm for objective evaluation of pain severity and distinguish the location of pain without needing patient cooperation
II Find the relationship between fNIRS functional near-infrared spectroscopy features and severity of pain as well as the relationship if any between perceived pain severity and visual perception
SECONDARY OBJECTIVES
I Investigate the effect and the reasoning of the effect of alleviating severity of perceived pain utilizing virtual reality techniques
II Monitor changes of brain activity to find out the reason for pain alleviation caused by virtual reality techniques andor cognitive distraction
OUTLINE Healthy participants are assigned to group A Cancer patients are randomized to group B or group C
GROUP A Participants undergo fNIRS for over 15 minutes
GROUP B Patients undergo fNIRS for over 15 minutes followed by a relaxation period using virtual reality VR for over 15 minutes
GROUP C Patients undergo fNIRS for over 15 minutes
I Develop an algorithm for objective evaluation of pain severity and distinguish the location of pain without needing patient cooperation
II Find the relationship between fNIRS functional near-infrared spectroscopy features and severity of pain as well as the relationship if any between perceived pain severity and visual perception
SECONDARY OBJECTIVES
I Investigate the effect and the reasoning of the effect of alleviating severity of perceived pain utilizing virtual reality techniques
II Monitor changes of brain activity to find out the reason for pain alleviation caused by virtual reality techniques andor cognitive distraction
OUTLINE Healthy participants are assigned to group A Cancer patients are randomized to group B or group C
GROUP A Participants undergo fNIRS for over 15 minutes
GROUP B Patients undergo fNIRS for over 15 minutes followed by a relaxation period using virtual reality VR for over 15 minutes
GROUP C Patients undergo fNIRS for over 15 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-11854 | REGISTRY | None | None |
| I 1720121 | OTHER | Roswell Park Cancer Institute | None |