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Study of Fine Art Photographs and Visualization Tapes to Improve Surgical Recovery in Breast Cancer
This study is currently recruiting participants.
Verified by Beth Israel Deaconess Medical Center, September 2007
Sponsored by: Beth Israel Deaconess Medical Center
Information provided by: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00179634
  Purpose

This is a study to assess whether healing suggestions and enhancing visual milieu (large fine art photographs) will improve mental and physical measures of well-being and recovery from surgery. The study will compare breast cancer patients undergoing identical skin sparing mastectomy and reconstruction surgery randomized to three groups:

  1. Usual care control group
  2. Usual care and exposure to fine art photograph
  3. Usual care and fine art photograph and guided visualization tapes.

Condition Intervention Phase
Breast Neoplasms
Behavioral: Visualization relaxation
Device: Visual Milieu Enhancement (Fine art photograph)
Phase II
Phase III

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Mastectomy
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Using Visual Milieu Enrichment and Guided Visualization to Augment Patient Well-Being and Post-Surgical Recovery

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Mood disturbance (Profile of Mood States short form)
  • Post-operative pain
  • Presence of skin necrosis
  • Presence of hematoma
  • Presence of infection
  • Length of hospital stay

Estimated Enrollment: 45
Study Start Date: March 2005
Detailed Description:

In the course of surgical procedures and hospitalization, patients are stressed not only by the discomforts and anxieties associated with their illness and treatment but also by the sterile, intimidating medical environment, with no access to the natural environment. Clinical studies from environmental medicine have suggested that during hospital confinement patients benefit from visually pleasing décor. Enhancing the medical milieu can alleviate patient anxiety and discomfort as well as improve markers of stress such as blood pressure and requirement for analgesics. In addition, research has shown the effectiveness of stress reduction approaches such as Relaxation Response, Guided Imagery, and Hypnosis in mediating clinical psychophysiology overall. Such studies have also shown the lowering of stress levels, inducing faster recovery from surgical anesthesia and perhaps even speeding physical healing overall. Use of these techniques has been shown to give people a greater sense of self-control as well and reduce stress reactions that affect health.

The proposed study represents the next step testing clinical efficacy of a behavioral medicine intervention with breast cancer patients undergoing mastectomy and reconstruction surgery. The current study extends prior research on accelerating healing outcomes through the use of non-pharmacological mental interventions. One prior study demonstrated accelerated bone fracture healing using hypnosis in otherwise healthy young adults. A second study showed enhanced post-surgical wound healing in healthy women undergoing reduction mammoplasty. The current study will generate new data about enhancing outcomes for breast cancer patients undergoing mastectomy and reconstruction. The goal of the trial is to determine whether these ancillary treatments enhance psychological and physical post-surgical recovery as compared to usual care only. The study provides an upside potential to enhance patient well being and to accelerate post-surgical recovery with minimal risk. Should significant positive findings result from this study, it will constitute a pilot test of such modifications of the healthcare delivery environment with an eye toward stimulating greater patient well being and shorter length of stay.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of stage 0, I, or II breast cancer
  • Skin sparing mastectomy with transverse rectus abdominal muscle (TRAM) or deep inferior epigastric perforator (DIEP) flap reconstruction planned
  • Ability to give informed consent
  • Working knowledge of English

Exclusion Criteria:

  • Physical inability to comply to study protocol
  • Diabetes
  • Current smokers
  • Acute psychosis
  • Mental retardation
  • Language barriers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179634

Contacts
Contact: Susan L Troyan, MD 617-667-2066 stroyan@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Susan L Troyan, MD     317-667-2066     stroyan@bidmc.harvard.edu    
Principal Investigator: Susan L Troyan, MD            
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Susan L Troyan, MD Beth Israel Deaconess Medical Center
  More Information

Publications:
Hartig T, Evans GW, Jammer LD, Davis DS, Garling T. Tracking restoration in natural and urban field settings. Journal of Environmental Psychology 23:109-23, 2003
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.
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.
Tusek DL, Church JM, Strong SA, Grass JA, Fazio VW. Guided imagery: a significant advance in the care of patients undergoing elective colorectal surgery. Dis Colon Rectum. 1997 Feb;40(2):172-8.
Blankfield RP. Suggestion, relaxation, and hypnosis as adjuncts in the care of surgery patients: a review of the literature. Am J Clin Hypn. 1991 Jan;33(3):172-86. Review.
Benson H, Friedman R. Harnessing the power of the placebo effect and renaming it "remembered wellness". Annu Rev Med. 1996;47:193-9. Review.
Ewin DM.The effect of hypnosis and mental set on major surgery and burns. Psychiatric Annals 16:115-118, 1986.
Halpin LS, Speir AM, CapoBianco P, Barnett SD. Guided imagery in cardiac surgery. Outcomes Manag. 2002 Jul-Sep;6(3):132-7.
Hoffman JW, Benson H, Arns PA, Stainbrook GL, Landsberg GL, Young JB, Gill A. Reduced sympathetic nervous system responsivity associated with the relaxation response. Science. 1982 Jan 8;215(4529):190-2.
Holden-Lund C. Effects of relaxation with guided imagery on surgical stress and wound healing. Res Nurs Health. 1988 Aug;11(4):235-44.
Lang EV, Benotsch EG, Fick LJ, Lutgendorf S, Berbaum ML, Berbaum KS, Logan H, Spiegel D. Adjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial. Lancet. 2000 Apr 29;355(9214):1486-90.
Glaser R, Kiecolt-Glaser JK, Marucha PT, MacCallum RC, Laskowski BF, Malarkey WB. Stress-related changes in proinflammatory cytokine production in wounds. Arch Gen Psychiatry. 1999 May;56(5):450-6.
Ginandes CS, Rosenthal DI. Using hypnosis to accelerate the healing of bone fractures: a randomized controlled pilot study. Altern Ther Health Med. 1999 Mar;5(2):67-75.
Ginandes C, Brooks P, Sando W, Jones C, Aker J. Can medical hypnosis accelerate post-surgical wound healing? Results of a clinical trial. Am J Clin Hypn. 2003 Apr;45(4):333-51.

Study ID Numbers: 2004-P-000115; BIDMC, West
Study First Received: September 13, 2005
Last Updated: September 19, 2007
ClinicalTrials.gov Identifier: NCT00179634  
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Mastectomy
Randomized Controlled Trial
Imagery

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009