Impact of Relaxing Visual Immersion on Anxiety During Anti-cancer Treatment.

NCT04528238 | Withdrawn

• 1 other identifier: IMAVANX
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Since the 60's and 70's, the soar of audiovisual technologies allowed the development of virtual reality (VR). These technologies were then adapted to help reducing anxiety and pain during medical procedures. For visual or audio stimulation, the use of glasses or helmet is frequent. However, little is know about the efficacy of technologies which are not isolating the patient from his real environment during medical care. With this study, the investigators will assess the impact of this kind of sensitive stimulation without isolating the patient, on reducing the anxiety during intravenous treatment in patients with cancer. The machine the investigators are using is projecting relaxing nature movies on the ceiling of the room, with nature sounds or relaxing music.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Assess the impact of RVI on anxiety during the first intravenous cancer treatment session in cancer patients treated or not by anxiolytics

  Assessment of anxiety using the State-Trait Anxiety Inventory (STAI). The difference in the STAI-State anxiety score (STAI form Y-A) between e and after intervention will be studied in each group. A difference of at least 5 points of the change average before and after intervention between the experimental group and the control group will be considered as the minimum clinically significant difference.

  Baseline : first visit for intravenous anti-cancer treatment.

Secondary Outcomes (12)

• Assessment of pain felt.

  Up to 2 years, during 3 anti-cancer treatment sessions.

• Assessment of asthenia.

  Up to 2 years, during 3 anti-cancer treatment sessions.

• Assessment of nausea.

  Up to 2 years, during 3 anti-cancer treatment sessions.

• Assessment of psychological distress.

  Up to 2 years, during 3 anti-cancer treatment sessions.

• Assessment of the perception of elapsed time.

  Up to 2 years, during 3 anti-cancer treatment sessions.

Study Arms (2)

Relaxing Visual Immersion

EXPERIMENTAL

The patients will benefit a Relaxing Visual Immersion during the intravenous treatment for their cancer.

Other: Relaxing Visual Immersion

No sensitive stimulation

NO INTERVENTION

The patients will not receive Relaxing Visual Immersion during the intravenous treatment for their cancer.

Interventions

Relaxing Visual Immersion OTHER

During the intravenous treatment for cancer, a nature movie will be projected on the ceiling of the room, along with natural sounds or a relaxing music. The patient will choose the movie or movies he wants to watch and can decide to stop the Relaxing Visual Immersion (RVI) at any time. The RVI is a system that does not isolate the patient from his familiar or medical entourage and which integrates virtual scenarios in the environment of care.

Relaxing Visual Immersion

Eligibility Criteria

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

You may qualify if:

• Male or female aged 18 and over.
• Patient with cancer (any location) who need to receive an intravenous (IV) cancer treatment (adjuvant, neoadjuvant or palliative) when taking initial disease burden or upon relapse (the IV treatments concomitant with radiotherapy are also possible).
• Patients scheduled for at least 3 consecutive sessions of IV anti-cancer treatment.
• Patient under health insurance plan.
• Information and signature of informed consent by the patient to participate in the study.

You may not qualify if:

• Pregnant women.
• Vulnerable patient (psychiatric illness, detainee, under legal protection, emancipated child).

Sponsors & Collaborators

• Elsan: lead

Related Publications (16)

• Berto R. The role of nature in coping with psycho-physiological stress: a literature review on restorativeness. Behav Sci (Basel). 2014 Oct 21;4(4):394-409. doi: 10.3390/bs4040394.

  PMID: 25431444 BACKGROUND

• Schweitzer M, Gilpin L, Frampton S. Healing spaces: elements of environmental design that make an impact on health. J Altern Complement Med. 2004;10 Suppl 1:S71-83. doi: 10.1089/1075553042245953.

  PMID: 15630824 BACKGROUND

• Lembo T, Fitzgerald L, Matin K, Woo K, Mayer EA, Naliboff BD. Audio and visual stimulation reduces patient discomfort during screening flexible sigmoidoscopy. Am J Gastroenterol. 1998 Jul;93(7):1113-6. doi: 10.1111/j.1572-0241.1998.00339.x.

  PMID: 9672340 BACKGROUND

• Drahota A, Ward D, Mackenzie H, Stores R, Higgins B, Gal D, Dean TP. Sensory environment on health-related outcomes of hospital patients. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD005315. doi: 10.1002/14651858.CD005315.pub2.

  PMID: 22419308 BACKGROUND

• Diette GB, Lechtzin N, Haponik E, Devrotes A, Rubin HR. Distraction therapy with nature sights and sounds reduces pain during flexible bronchoscopy: a complementary approach to routine analgesia. Chest. 2003 Mar;123(3):941-8. doi: 10.1378/chest.123.3.941.

  PMID: 12628899 BACKGROUND

• Lee DW, Chan AC, Wong SK, Fung TM, Li AC, Chan SK, Mui LM, Ng EK, Chung SC. Can visual distraction decrease the dose of patient-controlled sedation required during colonoscopy? A prospective randomized controlled trial. Endoscopy. 2004 Mar;36(3):197-201. doi: 10.1055/s-2004-814247.

  PMID: 14986215 BACKGROUND

• Chirico A, Lucidi F, De Laurentiis M, Milanese C, Napoli A, Giordano A. Virtual Reality in Health System: Beyond Entertainment. A Mini-Review on the Efficacy of VR During Cancer Treatment. J Cell Physiol. 2016 Feb;231(2):275-87. doi: 10.1002/jcp.25117.

  PMID: 26238976 BACKGROUND

• Sander Wint S, Eshelman D, Steele J, Guzzetta CE. Effects of distraction using virtual reality glasses during lumbar punctures in adolescents with cancer. Oncol Nurs Forum. 2002 Jan-Feb;29(1):E8-E15. doi: 10.1188/02.ONF.E8-E15.

  PMID: 11845217 BACKGROUND

• Gershon J, Zimand E, Pickering M, Rothbaum BO, Hodges L. A pilot and feasibility study of virtual reality as a distraction for children with cancer. J Am Acad Child Adolesc Psychiatry. 2004 Oct;43(10):1243-9. doi: 10.1097/01.chi.0000135621.23145.05.

  PMID: 15381891 BACKGROUND

• Banos RM, Espinoza M, Garcia-Palacios A, Cervera JM, Esquerdo G, Barrajon E, Botella C. A positive psychological intervention using virtual reality for patients with advanced cancer in a hospital setting: a pilot study to assess feasibility. Support Care Cancer. 2013 Jan;21(1):263-70. doi: 10.1007/s00520-012-1520-x. Epub 2012 Jun 13.

  PMID: 22688373 BACKGROUND

• Espinoza M, Banos RM, Garcia-Palacios A, Cervera JM, Esquerdo G, Barrajon E, Botella C. Promotion of emotional wellbeing in oncology inpatients using VR. Stud Health Technol Inform. 2012;181:53-7.

  PMID: 22954828 BACKGROUND

• Schneider SM, Ellis M, Coombs WT, Shonkwiler EL, Folsom LC. Virtual reality intervention for older women with breast cancer. Cyberpsychol Behav. 2003 Jun;6(3):301-7. doi: 10.1089/109493103322011605.

  PMID: 12855087 BACKGROUND

• Schneider SM, Hood LE. Virtual reality: a distraction intervention for chemotherapy. Oncol Nurs Forum. 2007 Jan;34(1):39-46. doi: 10.1188/07.ONF.39-46.

  PMID: 17562631 BACKGROUND

• Schneider SM, Kisby CK, Flint EP. Effect of virtual reality on time perception in patients receiving chemotherapy. Support Care Cancer. 2011 Apr;19(4):555-64. doi: 10.1007/s00520-010-0852-7. Epub 2010 Mar 26.

  PMID: 20336327 BACKGROUND

• Gershon J, Zimand E, Lemos R, Rothbaum BO, Hodges L. Use of virtual reality as a distractor for painful procedures in a patient with pediatric cancer: a case study. Cyberpsychol Behav. 2003 Dec;6(6):657-61. doi: 10.1089/109493103322725450.

  PMID: 14756933 BACKGROUND

• Klosky JL, Tyc VL, Srivastava DK, Tong X, Kronenberg M, Booker ZJ, de Armendi AJ, Merchant TE. Brief report: Evaluation of an interactive intervention designed to reduce pediatric distress during radiation therapy procedures. J Pediatr Psychol. 2004 Dec;29(8):621-6. doi: 10.1093/jpepsy/jsh064.

  PMID: 15491984 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 27, 2020
• Study Start: September 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share