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NCT04912531 · ClinicalTrials.gov registry record · NA
Virtual Reality and Olfactory Stimuli Multimodal Intervention to Reduce Post-Operative Pain and Anxiety in Patients Undergoing Cardiothoracic Surgery
A NA study of Opioid Use and Postoperative Pain, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT04912531 is a NA study of Opioid Use and Postoperative Pain that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 80 participants, below the 148,259-participant average among 105 other Opioid Use trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04912531, a NA study of Opioid Use and Postoperative Pain, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients who undergo cardiothoracic surgery often experience pain and anxiety around the time of surgery. Currently, treatments for pain and anxiety around the time of surgery include opioids and benzodiazepines, which can have severe side effects and can be ineffective. Interventions combining virtual reality with olfactory stimuli are a promising alternative to opioids and benzodiazepines in the treatment of pain and anxiety around the time of surgery. The aim of this study is to evaluate the feasibility of a virtual reality and olfactory stimuli multimodal intervention in patients undergoing cardiothoracic surgery. In addition, the investigators will evaluate the preliminary effects of the VR/OS intervention on patient pain and anxiety before and after cardiothoracic surgery. Patients who meet study inclusion criteria and are undergoing cardiothoracic surgery may participate in this study. Patients have an equal being assigned to undergo the virtual reality and olfactory stimuli intervention or continue getting usual medical care with their doctor. If the patient is assigned to receive the virtual reality and olfactory stimuli intervention, the first therapy session will take place approximately two to four weeks before surgery. This will involve wearing a virtual reality headset and scented necklace for approximately 10 minutes. The second session will occur 90 minutes before the surgery. Additionally, for each day the patient recovers in the hospital after surgery, the patient will receive one session in the afternoon. During the patient's in-hospital recovery at night, they will receive lavender scented therapy.
Conditions Studied
Interventions
- DEVICE Virtual Realty using a Microsoft Hololens, Empatica HR wristband, and EEG
- DEVICE Essence Olfactory Necklace
- DEVICE Bedside Olfaction Device
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-10-01 |
| Est. Completion | 2028-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04912531
The ClinicalTrials.gov registry entry for NCT04912531 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 148,259-participant average among 105 other Opioid Use trials with a reported enrollment target (100% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Opioid Use appearing as the primary indexed condition, and to 3 interventions - of which Virtual Realty using a Microsoft Hololens, Empatica HR wristband, and EEG is the first listed.
NCT04912531 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04912531 about?
NCT04912531 is a clinical study titled "Virtual Reality and Olfactory Stimuli Multimodal Intervention to Reduce Post-Operative Pain and Anxiety in Patients Undergoing Cardiothoracic Surgery". Patients who undergo cardiothoracic surgery often experience pain and anxiety around the time of surgery. Currently, treatments for pain and anxiety around the time of surgery include opioids and benzodiazepines, which can have severe side effects and can be ineffective. Interventions combining virt...
What is the current status of trial NCT04912531?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2022-10-01. Estimated completion is 2028-06-30.
What conditions does trial NCT04912531 study?
This clinical trial studies the following conditions: Opioid Use, Postoperative Pain, Anxiety Postoperative.
What interventions are being tested in trial NCT04912531?
The interventions under investigation include: Virtual Realty using a Microsoft Hololens, Empatica HR wristband, and EEG (DEVICE), Essence Olfactory Necklace (DEVICE), Bedside Olfaction Device (DEVICE).
Who is sponsoring clinical trial NCT04912531?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04912531 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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