← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-study (approximately 10 minutes)

Awards & highlights

Study Summary

This trial is testing whether a virtual reality and olfactory stimuli intervention can help with pain and anxiety around the time of surgery for people who are undergoing cardiothoracic surgery.

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.Check my eligibility

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.See study design

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

Select...

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

Select...

I am scheduled for a major heart or chest surgery.

Select...

I am older than 18 years.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Patients who Complete the Study

Number of Patients who Consent to Study Participation

Single Ease Question (SEQ)

Secondary outcome measures

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

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,932 Previous Clinical Trials

13,198,417 Total Patients Enrolled

Media Library

Virtual Reality and Olfactory Stimuli Multimodal Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04912531 — N/A

Opioid Use Disorder Research Study Groups: Usual Care Arm, Virtual Reality and Olfactory Stimuli Arm

Opioid Use Disorder Clinical Trial 2023: Virtual Reality and Olfactory Stimuli Multimodal Intervention Highlights & Side Effects. Trial Name: NCT04912531 — N/A

Virtual Reality and Olfactory Stimuli Multimodal Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04912531 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ultimate aim of this research initiative?

"The primary objective of this 8-week clinical trial is to track the Amount of Participants who Agree to Participate in the Study. Separately, researchers will monitor Change in Symptom Intensity (Edmonton Symptom Assessment Scale), Patient Satisfaction with Virtual Reality & Olfactory Stimuli Systems and Anxiety Variation (State Trait Anxiety Inventory). High scores on ESAS signify more intense symptoms while higher numbers on STAI imply greater levels of anxiety."

Answered by AI

Are there any openings left in this medical trial?

"Unfortunately, no. Clinicaltrials.gov indicates that this research endeavour was first posted on October 1st 2022 and has not been updated since March 1st of the same year. Although there are presently no openings in this trial, 1014 other medical studies have current vacancies for candidates to join their teams."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virtual Reality and Olfactory Stimuli Multimodal Intervention to Reduce Post-Operative Pain and Anxiety in Patients Undergoing Cardiothoracic Surgery

Chi-Fu Jeffrey Yang 2022. "Virtual Reality and Olfactory Stimuli Multimodal Intervention to Reduce Post-Operative Pain and Anxiety in Patients Undergoing Cardiothoracic Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04912531.