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Using Visual Milieu Enrichment and Guided Visualization to Augment Patient Well-being and Post-surgical Recovery

Phase 2/Phase 3
18 Years
Not Enrolling
Breast Neoplasms

Thank you

Trial Information

Using Visual Milieu Enrichment and Guided Visualization to Augment Patient Well-being and Post-surgical Recovery

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 d├ęcor. 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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mood disturbance (Profile of Mood States short form)

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Susan L Troyan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Institutional Review Board

Study ID:

2004-P-000115; BIDMC



Start Date:

March 2005

Completion Date:

January 2009

Related Keywords:

  • Breast Neoplasms
  • Mastectomy
  • Randomized Controlled Trial
  • Imagery
  • Breast Neoplasms
  • Neoplasms



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215