Meditation With Virtual Reality for Cancer Pain Relief in the Pain Therapy and Palliative Care Service
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEmily Santos Montarroyos
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Case group
DeviceMeditation will be taught through a video played on a Samsung® gear VR virtual reality glasses with monitoring of the patient's vital signs by the Samsung® smart watch to promote better quality of life and control cancer pain in patients treated at the Pain Therapy and Palliative Care Service.
Active control group
BehavioralMeditation will be taught through a video played on a Samsung® cell phone with monitoring of the patient's vital signs by the Samsung® smart watch to promote better quality of life and control cancer pain in patients treated at the Pain Therapy and Palliative Care Service.
Passive control group
BehavioralMeditation will be taught through a audio played on a Samsung® cell phone with monitoring of the patient's vital signs by the Samsung® smart watch to promote better quality of life and control cancer pain in patients treated at the Pain Therapy and Palliative Care Service.
Treatment groups
129 Participants
are divided into 3 treatment groupsGroup A: Case GroupExperimental treatment 1 intervention
Group B: Active Control GroupActive comparator 1 intervention
Group C: Passive Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Brief Pain Inventory (Reduced version)
It has a body schema, in which the patient can mark the location of the pain, as well as 8 questions relating to pain intensity, on a scale of 0 to 10, the higher the score on the inventory, the worse the pain intensity.
Time frame
six months2
McGill Quality of Life Questionnaire
Made up of 16 items, divided into domains: physical well-being, psychological well-being, existential well-being, support and physical symptoms. It has a single-item scale that measures overall quality of life, which is not included in the score, but is used to compare scores. It also has an open question for the patient to name the things that have had the greatest effect on their quality of life. The scale has eleven points from 0 to 10, and the higher the final score, the better the quality of life.
Time frame
six monthsSecondary outcomes
1
Hospital Anxiety and Depression Scale (HADS)
A 14-item instrument with two sub-scales, anxiety and depression, with seven items each to assess depression and anxiety. The score for each item can vary from zero to three, with a maximum score of 21 points for each sub-scale (anxiety and depression). Patients with no anxiety/depression are considered to score from 0 to 8, and ≥ 9 have anxiety/depression.
Time frame
six months2
The Edmonton Symptom Assessment Scale (ESAS)
The ESAS is a simple, self-reported questionnaire designed to indicate objective and subjective symptoms. On this scale, the patient or their caregiver/family member assigns a score from 0 to 10 for each symptom, with 0 being the absence and 10 the greatest intensity of the symptom.
Time frame
six months3
The National Comprehensive Cancer Network® (NCCN) Distress Thermometer
The National Comprehensive Cancer Network® (NCCN) Distress Thermometer will be applied as a questionnaire during the 3 moments. It is a translated and validated NCCN tool used to measure the "temperature" of the mental health of people with cancer. The Brazilian version of the NCCN Distress Thermometer and Problem List.
Time frame
six monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emily Santos Montarroyos
Lead sponsor
FUNDAÇÃO CENTRO DE CONTROLE DE ONCOLOGIA DO ESTADO DO AMAZONAS
Sponsor institution
AC Camargo Cancer Center
Collaborator
Source ClinicalTrials.gov