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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04912531
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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).

Study Details

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.

Key Dates

Start date
Oct 1, 2022
Status verified
Feb 2026
Primary completion
May 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Usual Care Arm
    No intervention will be given to patients in the usual care arm.
  • Experimental: Virtual Reality and Olfactory Stimuli Arm
    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.

Primary Outcome Measure

Number of Patients who Consent to Study Participation [ Time Frame: On the day of enrollment into the study ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Chi-Fu J Yang, M.D.
[email protected]
814-574-8695

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