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

NCT06328751 | Recruiting DMC FDA Device

• 1 other identifier: 76043823.0.0000.0004
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Pain; Quality of Life; Palliative Medicine

Keywords

Meditation; Cancer Pain; Quality of Life; Virtual Reality

Outcome Measures

Primary Outcomes (2)

• 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.

  six months

• 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.

  six months

Secondary Outcomes (3)

• Hospital Anxiety and Depression Scale (HADS)

  six months

• The Edmonton Symptom Assessment Scale (ESAS)

  six months

• The National Comprehensive Cancer Network® (NCCN) Distress Thermometer

  six months

Study Arms (3)

Case Group

EXPERIMENTAL

The 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.

Device: Case group

Active Control Group

ACTIVE COMPARATOR

The 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.

Behavioral: Active control group

Passive Control Group

ACTIVE COMPARATOR

The 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.

Behavioral: Passive control group

Interventions

Case group DEVICE

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.

Case Group

Active control group BEHAVIORAL

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.

Active Control Group

Passive control group BEHAVIORAL

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.

Passive Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emily Santos Montarroyos: lead
• AC Camargo Cancer Center: collaborator

Study Sites (1)

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

Manaus, Amazonas, 69040040, Brazil

RECRUITING

Related Publications (17)

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

  PMID: 29684230 BACKGROUND

• 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.

  PMID: 22253460 BACKGROUND

• 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.

  PMID: 29889605 BACKGROUND

• 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.

  PMID: 36122322 BACKGROUND

• 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.

  PMID: 36385638 BACKGROUND

• 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.

  PMID: 31567462 BACKGROUND

• 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.

  PMID: 1609875 BACKGROUND

• 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.

  PMID: 35635018 BACKGROUND

• 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.

  PMID: 34751943 BACKGROUND

• 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.

  PMID: 30629900 BACKGROUND

• 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.

  PMID: 37200595 BACKGROUND

• 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.

  PMID: 35064330 BACKGROUND

• 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.

  PMID: 36195865 BACKGROUND

• 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.

  PMID: 29025113 BACKGROUND

• 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.

  PMID: 20221641 BACKGROUND

• Seiler A, Schettle M, Amann M, Gaertner S, Wicki S, Christ SM, Theile G, Feuz M, Hertler C, Blum D. Virtual Reality Therapy in Palliative Care: A Case Series. J Palliat Care. 2026 Jan;41(1):19-27. doi: 10.1177/08258597221086767. Epub 2022 Mar 16.

  PMID: 35293818 BACKGROUND

• Montarroyos ES, Lima S, Barreto R, Moyses R, Cardenas LZ. Integrating Immersive Virtual Reality Meditation into Palliative Oncology: A Randomized Trial Protocol for Evaluating Pain Relief and Quality of Life. Healthcare (Basel). 2026 Jan 21;14(2):266. doi: 10.3390/healthcare14020266.

  PMID: 41595402 DERIVED

Related Links

• Ministry of Health. National Cancer Institute. Estimates of Cancer Incidence in Brazil. Estimates 2023. Rio de Janeiro: INCA, 2022.
• National Comprehensive Cancer Network. A tool translated from the NCCN measures the "temperature" of the mental health of people with cancer.

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emily S Montarroyos

  Fundação Centro de Controle de Oncologia do Estado do Amazonas (FCECON)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily S Montarroyos

CONTACT

+55 (92) 988024440; emilymontarroyos@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physician

Model Details: This is a prospective, experimental, longitudinal, randomized controlled trial (RCT), carried out in three stages.

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 25, 2024
• Study Start: November 7, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)