Postoperative Pain Clinical Trial
Official title:
Using a Virtual Reality and Olfactory Stimuli Multimodal Intervention to Reduce Post-Operative Pain and Anxiety in Patients Undergoing Cardiothoracic Surgery
Verified date | May 2023 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | June 30, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Change in Pain Score (Visual Analogue Scale) | It is a scale of 100mm. The patient marks the scale to indicate the intensity of their pain. The minimum value is 0, which indicates no pain and the maximum value is 10, which indicates the worst pain. | Pre- and Post-Intervention (approximately 10 minutes) | |
Secondary | Change in Anxiety Score (State Trait Anxiety Inventory) | The STAI consists of two 20-item self-report inventories. It is a rapid but detailed assessment that distinguishes between basal, transitory emotion (part one inventory - state anxiety) and reactive or anxiety-provoking situations (part two inventory - trait anxiety). Scores range from 20 to 80 with higher scores indicating a greater level of anxiety. | Pre- and Post-Intervention (approximately 10 minutes) | |
Secondary | Opioid Administration | Amount of opioids administered per day, measured in milligram morphine equivalents (MME) | approximately 4 days | |
Secondary | Change in Quality of Life (The Functional Assessment of Cancer Therapy - General )(FACT-G) | It is a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. A higher score indicates a better quality of life. | Pre- and Post-study (approximately 8 weeks) | |
Secondary | Change in Sleep Quality (Pittsburgh Sleep Quality Index) | It is a standardized, widely used self-rated questionnaire that assesses sleep quality and disturbances over a 1-month time interval. Some of the items include scores related to sleep latency, sleep duration, habitual sleep efficiency, sleeping medication, etc. A higher score indicates more acute sleep disturbances. | Pre- and Post-study (approximately 8 weeks) | |
Secondary | Change in Symptom Burden (Edmonton Symptom Assessment Scale) | A questionnaire used to rate the intensity of nine common symptoms experienced by patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. A higher score indicates a worse symptom burden. | Pre- and Post- study (approximately 8 weeks) | |
Secondary | Patient satisfaction with the VR/OS system. | A patient interview with focus questions centered on patient satisfaction with the virtual reality and olfactory stimuli devices. | Post-study (approximately 10 minutes) |
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