What side effects are associated with this type of intervention?

Common treatments for Opioid Use Disorder include medications such as methadone, buprenorphine, and naltrexone. Methadone and buprenorphine can cause side effects like constipation, sweating, sexual dysfunction, and potential for misuse. Naltrexone may lead to nausea, headache, dizziness, and liver enzyme abnormalities. In contrast, the Virtual Reality and Olfactory Stimuli intervention focuses on sensory distraction and relaxation, which generally have fewer and less severe side effects, such as mild discomfort from the VR headset or sensitivity to scents.

What prior FDA approvals exist?

FDA-approved treatments for Opioid Use Disorder (OUD) include medications such as methadone, buprenorphine, and naltrexone. These medications help manage cravings and withdrawal symptoms, aiding in addiction treatment. The trial involving Virtual Reality and Olfactory Stimuli represents a novel, non-pharmacological approach focusing on sensory distraction and relaxation, differing from the traditional pharmacological treatments.

What other types of research exist?

Promising novel alternatives for Opioid Use Disorder patients include: 1) Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown improvements in sleep-related quality of life and insomnia symptoms, potentially aiding in the management of OUD. 2) Acupuncture and hypnotherapy, which have demonstrated benefits in reducing pain and improving quality of life. 3) Medical cannabis, which may be beneficial for pain management and improving daily functioning. These alternatives offer non-pharmacologic options that can complement traditional treatments for OUD.

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Virtual Reality + Olfactory Intervention for Postoperative Pain and Anxiety

N/A

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No cognitive or psychiatric conditions prohibiting study consent or participation.

Be scheduled to undergo any one of the 5 major types of cardiothoracic surgical operations: coronary artery bypass grafting, aortic valve replacement, aortic valve repair, lung resection, and esophagectomy

Must not have

Clinical signs of cardiogenic shock at time of surgery

Severe irreversible hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-study (approximately 10 minutes)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if using virtual reality and pleasant smells can help reduce pain and anxiety in patients having heart or lung surgery. The treatment aims to offer a safer alternative to traditional medications like opioids. Patients will use VR headsets and scented necklaces to see if it helps them feel better. Virtual reality (VR) has been studied as an effective non-drug method for pain and anxiety management in various medical conditions and procedures.

Who is the study for?

Adults over 18 scheduled for certain cardiothoracic surgeries (like bypass grafting or lung resection) can join, except those with severe heart, kidney, liver issues, odor allergies, anosmia or cognitive/psychiatric conditions affecting consent.

What is being tested?

The study tests if a combo of virtual reality and scented devices can reduce pain and anxiety better than usual care in patients before and after cardiothoracic surgery. Participants are randomly chosen to receive either the VR/olfactory intervention or standard treatment.

What are the potential side effects?

Since this trial uses non-drug methods like VR headsets and scent therapy instead of medications like opioids or benzodiazepines, side effects might include discomfort from wearing the devices but are expected to be minimal compared to drug-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have any mental health conditions that prevent me from understanding or participating in the study.

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I am scheduled for a major heart or chest surgery.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I showed signs of heart failure during surgery.

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I have high blood pressure that cannot be controlled.

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I have allergies to smells or I've lost my sense of smell.

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I have chronic kidney problems or am on dialysis.

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I was born with a heart condition.

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I have liver cirrhosis or my liver is not functioning properly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on the day of enrollment into the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on the day of enrollment into the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and on the day of enrollment into the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Patients who Complete the Study

Number of Patients who Consent to Study Participation

Single Ease Question (SEQ)

Secondary study objectives

Change in Anxiety Score (State Trait Anxiety Inventory)

Change in Pain Score (Visual Analogue Scale)

Change in Quality of Life (The Functional Assessment of Cancer Therapy - General )(FACT-G)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Reality and Olfactory Stimuli ArmExperimental Treatment3 Interventions

Patients will undergo a virtual reality and olfactory stimuli therapy session at their appointment where they receive their pulmonary function test, 90 minutes before surgery, and each day they recover in the hospital. In addition, patients will receive nighttime olfactory stimulation using a bedside olfaction device.

Group II: Usual Care ArmActive Control1 Intervention

No intervention will be given to patients in the usual care arm.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Opioid Use Disorder (OUD) include medications like methadone, buprenorphine, and naltrexone, which work by targeting opioid receptors in the brain to reduce cravings and withdrawal symptoms. Methadone and buprenorphine are opioid agonists that activate these receptors to a lesser degree than opioids, helping to stabilize brain chemistry. Naltrexone is an opioid antagonist that blocks the effects of opioids, preventing the euphoric and sedative effects. Multimodal interventions, such as the use of Virtual Reality and Olfactory Stimuli, aim to provide sensory distraction and relaxation, which can help manage pain and anxiety without relying on opioids. This is crucial for OUD patients as it offers alternative methods to cope with discomfort and stress, potentially reducing the risk of relapse.

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