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

NCT04912531 | Recruiting DMC FDA Device

• 1 other identifier: 2021P000469
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Postoperative Pain; Opioid Use; Anxiety Postoperative

Outcome Measures

Primary Outcomes (3)

• Number of Patients who Consent to Study Participation

  Of the patients the investigators approach for study participation, the investigators will document the number who consent to study participation.

  On the day of enrollment into the study

• Number of Patients who Complete the Study

  Only patients who are assigned to the intervention arm will be evaluated for this outcome. The investigators will determine the number of patients who complete the study by evaluating the number of patients who enroll in the study, complete all the virtual reality and olfactory stimuli therapy sessions, and complete all study surveys.

  Through study completion, an average of 8 weeks

• Single Ease Question (SEQ)

  The SEQ is a 7 point rating scale used to evaluate how easy or difficult an individual finds it to use a device. A higher score indicates that the user found the device easy to use while a lower score indicates the user found the device difficult to use.

  After the first virtual reality and olfactory stimuli intervention at enrollment

Secondary Outcomes (7)

• Change in Pain Score (Visual Analogue Scale)

  Pre- and Post-Intervention (approximately 10 minutes)

• Change in Anxiety Score (State Trait Anxiety Inventory)

  Pre- and Post-Intervention (approximately 10 minutes)

• Opioid Administration

  approximately 4 days

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

  Pre- and Post-study (approximately 8 weeks)

• Change in Sleep Quality (Pittsburgh Sleep Quality Index)

  Pre- and Post-study (approximately 8 weeks)

Study Arms (2)

Usual Care Arm

NO INTERVENTION

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

Virtual Reality and Olfactory Stimuli Arm

EXPERIMENTAL

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.

Device: Virtual Realty using a Microsoft Hololens, Empatica HR wristband, and EEG; Device: Essence Olfactory Necklace; Device: Bedside Olfaction Device

Interventions

Virtual Realty using a Microsoft Hololens, Empatica HR wristband, and EEG DEVICE

The investigators will use a DeepReality VR with biofeedback using a Microsoft Hololens, Empatica HR wristband and EEG. The Empatica HR wristband will measure HR and the EEG will measure alpha and theta brain waves. To monitor the physiologic data in real-time, data from the EEG and heart rate monitor will be streamed and processed in an Android Application that the investigators previously developed. During data collection, the Android app sends data via OSC to a specific IP and port, which is then collected in the game engine, Unity 3D and processed to adapt the virtual environment. Importantly, each device is inexpensive and can be sanitized and reused by multiple patients.

Virtual Reality and Olfactory Stimuli Arm

Essence Olfactory Necklace DEVICE

The Essence Olfactory Necklace holds a small, lightweight 7 ml capsule that contains an essential oil. Within the capsule is a piezo electric transducer which allows us to control the release of scent via Bluetooth using a smartphone app. Each Essence Necklace will be paired with a google phone that the investigators will use to control the frequency and intensity of scent for each patient. The investigators will limit the frequency to one burst of scent every 20 seconds to avoid habituation. For the scent, the investigators will use diluted lavender essential oil (10% essential oil: 90% water). The investigators chose lavender because in our previous studies, \>97% of users enjoyed the lavender scent. The Essence Necklace is powered with a 3.7V Lithium Battery and has a battery lifetime of approximately 6 hours. The RC can easily recharge the Essence Necklace through a USB micro connector. Additionally, the Essence Necklace can be easily sanitized and reused by multiple patients.

Virtual Reality and Olfactory Stimuli Arm

Bedside Olfaction Device DEVICE

The bedside olfaction device can be clipped on to the side of the patient's bed or beside table. The RC will turn on the night-time olfactory device at 7 pm and will turn off the device at 7 am. When turned on, the device releases scent once every 60 seconds. However, the frequency and intensity of the scent will be adjusted to the patient's preferences. For the scent, the investigators will use diluted lavender essential oil (10% essential oil: 90% water).

Virtual Reality and Olfactory Stimuli Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age \> 18
• No cognitive or psychiatric conditions prohibiting study consent or participation.

You may not qualify if:

• Clinical signs of cardiogenic shock at time of surgery
• Severe irreversible hypertension
• Congenital heart disease
• Chronic renal insufficiency defined by Cr ≥ 2.5 or chronic renal replacement therapy
• Evidence of cirrhosis or hepatic synthetic failure
• Patients with odor allergies or anosmia (lost their sense of smell)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 3, 2021
• Study Start: October 1, 2022
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)