Trial Title:
Meditation With Virtual Reality for Cancer Pain Relief in the Pain Therapy and Palliative Care Service
NCT ID:
NCT06328751
Condition:
Cancer Pain
Quality of Life
Palliative Medicine
Conditions: Official terms:
Cancer Pain
Conditions: Keywords:
Meditation
Cancer Pain
Quality of Life
Virtual Reality
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a prospective, experimental, longitudinal, randomized controlled trial (RCT),
carried out in three stages.
Primary purpose:
Treatment
Masking:
Single (Participant)
Masking description:
Randomization will be carried out using a specific application called Randomizer ® for
Clinical Trial Lite, which is a secure and validated application that works with
encrypted network traffic using Transport Layer Security (TLS), a strong encryption.
There will be 3 groups which will be divided into the Case Group, the Active Control
Group and the Passive Control Group. Each patient will be seen individually wearing a
Samsung® smartwatch and will not know about the other patients' meditation. The case
group will watch a 7-minute immersive virtual reality video of mindfulness meditation
with image and sound in the Oncology Control Center Foundation (FCECON) office, using
Samsung® gear VR virtual reality glasses. The active control group will watch a 7-minute
mindfulness meditation video presented via cell phone with image and sound at the office.
The passive control group will perform breathing exercises based on the healthcare
professional's instructions for 4 minutes in the office.
Intervention:
Intervention type:
Device
Intervention name:
Case group
Description:
Meditation 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.
Arm group label:
Case Group
Intervention type:
Behavioral
Intervention name:
Active control group
Description:
Meditation 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.
Arm group label:
Active Control Group
Intervention type:
Behavioral
Intervention name:
Passive control group
Description:
Meditation 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.
Arm group label:
Passive Control Group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
March 31, 2024
Completion date:
August 30, 2025
Lead sponsor:
Agency:
Emily Santos Montarroyos
Agency class:
Other
Collaborator:
Agency:
AC Camargo Cancer Center
Agency class:
Other
Source:
FUNDAÇÃO CENTRO DE CONTROLE DE ONCOLOGIA DO ESTADO DO AMAZONAS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06328751
http://www.inca.gov.br
https://www.inca.gov.br/sites/ufu.sti.inca.local/files/media/document/dieta_nutricao_atividade_fisica_e_cancer_resumo_do_terceiro_relatorio_de_especialistas_com_uma_perspectiva_brasileira.pdf
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