AzTrials
AzTrials

Cancer PainNCT06328751

Meditation With Virtual Reality for Cancer Pain Relief in the Pain Therapy and Palliative Care Service

A study testing Case group in people with Cancer Pain and Quality of Life, run by Emily Santos Montarroyos at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cancer Pain, Quality of Life, Palliative Medicine
What is being tested?
Case group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
1 siteBrazil
Study dates
7 Nov 2024to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emily S Montarroyos contact

+55 (92) 988024440

emilymontarroyos@hotmail.com

Brazil1 site, 1 recruiting

  • Fundação Centro de Controle de Oncologia do Estado do Amazonas - FCECON

    Manaus, Amazonas, 69040040

    EMILY SANTOS MONTARROYOS, MÉDICA PESQUISADORA, +55 92 36554616, emilymontarroyos@hotmail.com

    Recruiting

Other trials in Brazil

About this study

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

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.

Read the 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.

Being tested
Case group, Active control group, Passive control group
Keywords
Meditation, Cancer Pain, Quality of Life, Virtual Reality
Medical subject headings
Cancer Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Case groupDevice

    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.

  • Active control groupBehavioural

    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.

  • Passive control groupBehavioural

    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.

Study groups in NCT06328751
Study groupRoleWhat they receive
Case GroupExperimentalThe case group will watch a 7-minute immersive virtual reality video of mindfulness meditation with image and sound in the office of the Oncology Control Center Foundation (FCECON), using Samsung® gear VR virtual reality glasses and Samsung® smart watch.
Receives: Device: Case group
Active Control GroupActive comparatorThe active control group will watch a 7-minute mindfulness meditation video presented via cell phone with image and sound in the office of the Oncology Control Center Foundation (FCECON), using a Samsung® smart watch.
Receives: Behavioral: Active control group
Passive Control GroupActive comparatorThe passive control group will perform meditation breathing exercises based on instructions and through an audio played from the health professional for 4 minutes in the office of the Oncology Control Center Foundation (FCECON), using a Samsung® smart watch.
Receives: Behavioral: Passive control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: six months

  2. 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.

    Measured: six months

Secondary outcomes (3)

  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.

    Measured: six months

  2. 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.

    Measured: six months

  3. 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.

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2024
  2. Study start7 Nov 2024
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, experimental, longitudinal, randomized controlled trial (RCT), carried out in three stages.
Masking
Single blind
Who is masked
Participant
Enrolment
129 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06328751
Sponsor's protocol ID
76043823.0.0000.0004
Status last verified
Mar 2025
First submitted
11 Mar 2024
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Swami M, Case AA. Effective Palliative Care: What Is Involved? Oncology (Williston Park). 2018 Apr 15;32(4):180-4.

    PubMed 29684230

  • Sheinfeld Gorin S, Krebs P, Badr H, Janke EA, Jim HS, Spring B, Mohr DC, Berendsen MA, Jacobsen PB. Meta-analysis of psychosocial interventions to reduce pain in patients with cancer. J Clin Oncol. 2012 Feb 10;30(5):539-47. doi: 10.1200/JCO.2011.37.0437. Epub 2012 Jan 17.

    PubMed 22253460

  • Lyman GH, Greenlee H, Bohlke K, Bao T, DeMichele AM, Deng GE, Fouladbakhsh JM, Gil B, Hershman DL, Mansfield S, Mussallem DM, Mustian KM, Price E, Rafte S, Cohen L. Integrative Therapies During and After Breast Cancer Treatment: ASCO Endorsement of the SIO Clinical Practice Guideline. J Clin Oncol. 2018 Sep 1;36(25):2647-2655. doi: 10.1200/JCO.2018.79.2721. Epub 2018 Jun 11.

    PubMed 29889605

  • Mao JJ, Ismaila N, Bao T, Barton D, Ben-Arye E, Garland EL, Greenlee H, Leblanc T, Lee RT, Lopez AM, Loprinzi C, Lyman GH, MacLeod J, Master VA, Ramchandran K, Wagner LI, Walker EM, Bruner DW, Witt CM, Bruera E. Integrative Medicine for Pain Management in Oncology: Society for Integrative Oncology-ASCO Guideline. J Clin Oncol. 2022 Dec 1;40(34):3998-4024. doi: 10.1200/JCO.22.01357. Epub 2022 Sep 19.

    PubMed 36122322

  • Aisenberg-Shafran D, Shturm L. The effects of mindfulness meditation versus CBT for anxiety on emotional distress and attitudes toward seeking mental health treatment: a semi-randomized trial. Sci Rep. 2022 Nov 16;12(1):19711. doi: 10.1038/s41598-022-24256-9.

    PubMed 36385638

  • Deng G. Integrative Medicine Therapies for Pain Management in Cancer Patients. Cancer J. 2019 Sep/Oct;25(5):343-348. doi: 10.1097/PPO.0000000000000399.

    PubMed 31567462

  • Kabat-Zinn J, Massion AO, Kristeller J, Peterson LG, Fletcher KE, Pbert L, Lenderking WR, Santorelli SF. Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders. Am J Psychiatry. 1992 Jul;149(7):936-43. doi: 10.1176/ajp.149.7.936.

    PubMed 1609875

  • Mo J, Vickerstaff V, Minton O, Tavabie S, Taubert M, Stone P, White N. How effective is virtual reality technology in palliative care? A systematic review and meta-analysis. Palliat Med. 2022 Jul;36(7):1047-1058. doi: 10.1177/02692163221099584. Epub 2022 May 30.

    PubMed 35635018

  • Mao JJ, Pillai GG, Andrade CJ, Ligibel JA, Basu P, Cohen L, Khan IA, Mustian KM, Puthiyedath R, Dhiman KS, Lao L, Ghelman R, Caceres Guido P, Lopez G, Gallego-Perez DF, Salicrup LA. Integrative oncology: Addressing the global challenges of cancer prevention and treatment. CA Cancer J Clin. 2022 Mar;72(2):144-164. doi: 10.3322/caac.21706. Epub 2021 Nov 9.

    PubMed 34751943

  • Latte-Naor S, Mao JJ. Putting Integrative Oncology Into Practice: Concepts and Approaches. J Oncol Pract. 2019 Jan;15(1):7-14. doi: 10.1200/JOP.18.00554.

    PubMed 30629900

  • Bao T, Greenlee H, Lopez AM, Kadro ZO, Lopez G, Carlson LE. How to Make Evidence-Based Integrative Medicine a Part of Everyday Oncology Practice. Am Soc Clin Oncol Educ Book. 2023 May;43:e389830. doi: 10.1200/EDBK_389830.

    PubMed 37200595

  • Austin PD, Siddall PJ, Lovell MR. Feasibility and acceptability of virtual reality for cancer pain in people receiving palliative care: a randomised cross-over study. Support Care Cancer. 2022 May;30(5):3995-4005. doi: 10.1007/s00520-022-06824-x. Epub 2022 Jan 21.

    PubMed 35064330

  • Guenther M, Gorlich D, Bernhardt F, Pogatzki-Zahn E, Dasch B, Krueger J, Lenz P. Virtual reality reduces pain in palliative care-A feasibility trial. BMC Palliat Care. 2022 Oct 5;21(1):169. doi: 10.1186/s12904-022-01058-4.

    PubMed 36195865

  • Gupta A, Scott K, Dukewich M. Innovative Technology Using Virtual Reality in the Treatment of Pain: Does It Reduce Pain via Distraction, or Is There More to It? Pain Med. 2018 Jan 1;19(1):151-159. doi: 10.1093/pm/pnx109.

    PubMed 29025113

  • Ferreira KA, Teixeira MJ, Mendonza TR, Cleeland CS. Validation of brief pain inventory to Brazilian patients with pain. Support Care Cancer. 2011 Apr;19(4):505-11. doi: 10.1007/s00520-010-0844-7. Epub 2010 Mar 10.

    PubMed 20221641

Questions about this trial

What is this clinical trial studying?

A study testing Case group in people with Cancer Pain and Quality of Life, run by Emily Santos Montarroyos at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emily S Montarroyos (+55 (92) 988024440, emilymontarroyos@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brief Pain Inventory (Reduced version) (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06328751, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in