Clinical trial NCT04912531: Virtual Reality and Olfactory Stimuli Multimodal Intervention to Reduce Post-Operative Pain and Anxiety in Patients Undergoing Cardiothoracic Surgery
Official title: Using a Virtual Reality and Olfactory Stimuli Multimodal Intervention to Reduce Post-Operative Pain and Anxiety in Patients Undergoing Cardiothoracic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Anxiety Postoperative
Opioid Use
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Every year, over 500,000 individuals in the United States undergo cardiothoracic surgery for heart and lung disease. Cardiothoracic surgery can be an extremely traumatic experience for the patient. Their chest wall muscles and tissues can be cut, crushing the intercostal nerves and irritating the pleura. During the perioperative period, over 16% of patients suffer from clinically significant anxiety, and up to 57% of patients experience stabbing and throbbing chest and shoulder pain that can persist for months to years.

Currently, perioperative pain is most often treated with opioids, and treatments for perioperative anxiety are limited and can have severe side-effects. Interventions using virtual reality may be a promising alternative to opioids and benzodiazepines in the treatment of perioperative pain and anxiety. Virtual Reality consists of immersing patients into a computer-generated environment and exposing users to visual and audio sensory inputs. Through visual and audio cues that modulate pain-related brain activity in the thalamus, VR can increase pain tolerance. Encouragingly, studies have demonstrated the ability of VR to decrease pain intensity and increase pain tolerance in patients suffering from chronic pain. In addition, olfactory stimuli play a crucial, yet distinct, role in pain perception and relaxation. The olfactory bulb projects directly and without thalamic relay to brain regions that are involved in the processing of emotion and pain. Studies have shown that there is significant overlap between brain regions activated by painful stimuli and olfactory stimuli. When an individual smells a pleasant scent, olfactory stimuli activate the amygdala and alter its connectivity and functional coupling with brain regions linked to pain perception.

There is potential for an intervention combining VR and OS to lead to a greater reduction in pain and anxiety. Pain and anxiety are characterized by multiple neural pathways. Pain results from the activation of a widely distributed brain network, including the thalamus, insular cortex and secondary somatosensory cortex. Anxiety results from a combination of neuroendocrine, neurotransmitter, and neuroanatomical disruptions in the limbic system. Of note, studies have shown that although pain and anxiety have distinct neural pathways, anxiety modulates the perception of pain, and preoperative anxiety is associated with increased postoperative pain. However, current treatments for perioperative pain and anxiety are often ineffective because they only address one of the many pathways that contribute to pain and anxiety. As such, multimodal interventions are necessary to achieve optimal pain and anxiety control. Although OS and VR both reduce pain and anxiety, they have been shown to activate different regions of the brain. VR reduces pain and anxiety by directly modulating pain-related brain activity in the prefrontal cortex and primary and secondary somatosensory cortex, decreasing pain intensity and increasing user's ability to tolerate pain. OS activates the limbic system, including the amygdala and hippocampus, reducing pain and anxiety by altering its connectivity and functional coupling with brain regions linked to pain perception.

The aim of this study is to evaluate the feasibility of a VR and OS 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. This is a prospective, randomized study. A total of 80 patients are anticipated to participate in this study. All patients are expected to be enrolled at Massachusetts General Hospital (MGH). Eligible patients will be randomized 1:1 to the VR/OS intervention or usual care approximately 2-4 weeks prior to their scheduled cardiothoracic operation.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Number of Patients who Consent to Study Participation
timeFrame: On the day of enrollment into the study
measure: Number of Patients who Complete the Study
timeFrame: Through study completion, an average of 8 weeks
measure: Single Ease Question (SEQ)
timeFrame: After the first virtual reality and olfactory stimuli intervention at enrollment
Secondary outcomes:
measure: Change in Pain Score (Visual Analogue Scale)
timeFrame: Pre- and Post-Intervention (approximately 10 minutes)
measure: Change in Anxiety Score (State Trait Anxiety Inventory)
timeFrame: Pre- and Post-Intervention (approximately 10 minutes)
measure: Opioid Administration
timeFrame: approximately 4 days
measure: Change in Quality of Life (The Functional Assessment of Cancer Therapy - General )(FACT-G)
timeFrame: Pre- and Post-study (approximately 8 weeks)
measure: Change in Sleep Quality (Pittsburgh Sleep Quality Index)
timeFrame: Pre- and Post-study (approximately 8 weeks)
measure: Change in Symptom Burden (Edmonton Symptom Assessment Scale)
timeFrame: Pre- and Post- study (approximately 8 weeks)
measure: Patient satisfaction with the VR/OS system.
timeFrame: Post-study (approximately 10 minutes)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: