Clinical trial NCT06328751: Meditation With Virtual Reality for Cancer Pain Relief in the Pain Therapy and Palliative Care Service
Official title: Study With Cancer Patients at the CECON Foundation's Pain Therapy and Palliative Care Service: Meditation With Immersive Virtual Reality for Pain Relief
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Pain
Quality of Life
Palliative Medicine
Keywords: Meditation
Cancer Pain
Quality of Life
Virtual Reality
Lead sponsor: FUNDAÇÃO CENTRO DE CONTROLE DE ONCOLOGIA DO ESTADO DO AMAZONAS
Sponsor class: NETWORK
Collaborators: name: AC Camargo Cancer Center
First posted: 2024-03-25
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, experimental, longitudinal, randomized controlled trial (RCT), carried out in three stages.
Primary purpose: TREATMENT

Brief summary: Cancer is a disabling, challenging and growing global disease. Although early diagnosis and adequate treatment of oncological disease have been developing rapidly, a large part of the population remains without access to specialized services and routinely evolve to symptoms and sequelae with uncontrolled pain, worse quality of life and suffering. Complementary therapies to control pain and improve the well-being of cancer patients are fundamental tools of integrative oncology medicine. This study proposes to use immersive virtual reality to encourage cancer patients to carry out the regular practice of meditation, as an effective tool in pain management and in the search for a better quality of life, based on a structured intervention that encourages autonomy as important part of your treatment. Two studies will be carried out at the Pain Therapy and Palliative Care Service of the Amazonas State Oncology Control Center Foundation (FCECON). Study 1 will be a cross-sectional study to describe the variables associated with the diagnosis and treatment of patients' pain and Study 2 will be a Randomized Controlled Trial that will analyze the impact of an intervention performed with meditation through immersive virtual reality for pain relief. pain in these patients. It is expected that the regular practice of meditation through immersive virtual reality will promote pain relief and improve the quality of life of cancer pain patients.

Detailed description: This is a prospective, experimental, longitudinal study of the randomized controlled trial (RCT) type, carried out in three stages. Randomization will be carried out entirely using a specific application called Randomizer ® for Clinical Trial Lite. The defined sample was 39 participants per group. This would mean a total of 117 participants, divided into 3 groups of 39 participants each. Furthermore, considering the possibility of loss to follow-up, 12% was added to the final figure of 39 participants, due to the possibility of loss to follow-up, giving a final sample of 129 participants, divided into 3 groups: Experimental group; Passive control group and Active control group, with 43 participants in each group. At moment 1 (M1) all the patients will answer the sociodemographic and clinical questionnaire, and the other Quality of Life, Psychological Morbidity, pain scale and symptom scale instruments, after which they will perform the meditation used in the group to which they were randomly assigned, in the experimental case group (Group A) a 7-minute immersive virtual reality video of mindfulness meditation with image and sound in a comfortable chair in the office of the Oncology Control Center Foundation (FCECON), using Samsung® gear virtual reality (VR) glasses and Samsung® smartwatch; in the active control group (Group B) a 7-minute video of mindfulness meditation on a cell phone with image and sound in a comfortable chair in the office of the Oncology Control Center Foundation (FCECON), using Samsung® smart watch; and in the passive control group (Group C) breathing exercises based on instructions from the health professional for 4 minutes in a comfortable chair in the office of the Oncology Control Center Foundation (FCECON), using Samsung® smart watch. After watching the video, all patients will answer the 4 Quality of Life, Psychological Morbidity, pain scale and symptom scale instruments and will receive instructions on how to perform the meditation, using a free app that offers mindfulness meditation videos for offline use with images and sound for 3 minutes three times for 4 weeks in a home environment. They will receive Short Message Service (SMS) alerts on their cell phones to remind them to do the video-guided home meditation on Mondays, Wednesdays and Fridays between 9am and 10am. A printed form will be given to each patient with the dates of the meditation to mark their satisfaction with the meditation by classifying it as totally dissatisfied - I hated it, dissatisfied - I didn't like it, indifferent, satisfied - I liked it or totally satisfied - I loved it. All the previous steps will be repeated in Moment 2 (M2), 4 weeks after Moment 1 (about 1 month), and in Moment 3 (M3): 8 weeks after Moment 1 (about 2 months). All patients, regardless of group, will be taught by different means to practice guided meditation regularly and will use the Samsung Smart watch Galaxy Watch6 LTE 44mm Super Active Matrix Organic Light Emitting Diode (AMOLED) Screen 1.47, Graphite, exclusively during the interview and meditation, handled by the researcher, at the Pain Therapy and Palliative Care Service of the Oncology Control Center Foundation (FCECON), at the three moments of the research. This watch has the following devices and capabilities: "BioActive Sensor - Optical Heartbeat, Electrocardiogram and Bioelectrical Impedance Analysis, in addition to the customizable heart rate zone, the Oximeter, Fall Detection and Emergency Call, and sleep quality monitoring". And it will be used to track quantitative variables: heart rate and blood oxygen saturation. It will also allow the patient to be monitored using the Brazilian version of the Distress Thermometer and Problem List from the National Comprehensive Cancer Network (NCCN), which is a free resource that identifies and addresses unpleasant experiences that can make it more difficult to deal with cancer, its symptoms or treatment. Finally, it will also be possible to use the smart watch to answer the visual pain scale for audio feedback. All participants will use their own Android cell phone with the functions installed for the use of the smartwatch and it will capture body movement data by acceleration signals, location with anonymized global positioning system (GPS) data, encrypted speech. The mobile questionnaire app, the visual pain scale and the Brazilian version of the Distress Thermometer and Problem List from the National Comprehensive Cancer Network (NCCN) - will be installed.

Eligibility criteria: Inclusion Criteria:

* Be followed up at the Pain Therapy and Palliative Care Service (STDCP) to control symptoms resulting from any type of cancer at any stage;
* Have a diagnosis of chronic pain, recorded in the medical records.
* Be between 18 and 75 years old on the date of the first collection;
* Be able to understand Portuguese (read and write);
* Have normal vision and hearing;
* Have a cell phone with an Android system;
* Be able to make head movements and have sufficient motor control to make body movements;
* Agree to take part in the study and sign the Informed Consent Form (ICF).

Exclusion Criteria:

* Indigenous patients (due to cultural and linguistic peculiarities and special legislation);
* Patients with records of serious psychiatric illnesses (DSM-5 - Diagnostic and Statistical Manual of Mental Disorders - schizophrenia, schizotypal disorders, delusional disorders, borderline and dementias);
* Impairment of the ability to understand or communicate based on the researcher's assessment;
* Report of discomfort with the use of Immersive Virtual Reality;
* Progression of the disease with limitation in maintaining the proposed regular outpatient visits;
* Patients with brain tumors, brain metastases or a previous history of seizures.

Primary outcomes:
measure: Brief Pain Inventory (Reduced version)
timeFrame: six months
measure: McGill Quality of Life Questionnaire
timeFrame: six months
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: six months
measure: The Edmonton Symptom Assessment Scale (ESAS)
timeFrame: six months
measure: The National Comprehensive Cancer Network® (NCCN) Distress Thermometer
timeFrame: six months
Other outcomes:
Locations:
city: Manaus
country: Brazil
facility: Fundação Centro de Controle de Oncologia do Estado do Amazonas - FCECON
state: AM
Study officials:
affiliation: Fundação Centro de Controle de Oncologia do Estado do Amazonas (FCECON)
name: Emily S Montarroyos
role: PRINCIPAL_INVESTIGATOR
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