Study of Fine Art Photographs and Visualization Tapes to Improve Surgical Recovery in Breast Cancer

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT00179634
Collaborator
(none)
24
1
3
36.9
0.7

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: Visualization relaxation
  • Behavioral: Visual Milieu Enhancement (Fine art photograph)
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Using Visual Milieu Enrichment and Guided Visualization to Augment Patient Well-being and Post-surgical Recovery
Study Start Date :
Mar 1, 2005
Actual Primary Completion Date :
Mar 27, 2008
Actual Study Completion Date :
Mar 27, 2008

Arms and Interventions

Arm Intervention/Treatment
No Intervention: 1

Usual Care

Experimental: 2

Usual care and exposure to a visually enriched milieu (landscape photograph)

Behavioral: Visual Milieu Enhancement (Fine art photograph)

Experimental: 3

Usual care, exposure to a visually enriched milieu and audio taped guided visualization with healing suggestions.

Behavioral: Visualization relaxation

Behavioral: Visual Milieu Enhancement (Fine art photograph)

Outcome Measures

Primary Outcome Measures

  1. Mood disturbance (Profile of Mood States short form) [4 weeks]

  2. Post-operative pain [4 weeks]

  3. Presence of skin necrosis [4 weeks]

  4. Presence of hematoma [4 weeks]

  5. Presence of infection [4 weeks]

  6. Length of hospital stay [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

Sponsors and Collaborators

  • Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Susan L Troyan, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
James Rodrigue, Professor of Psychology in the Department of Psychiatry, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00179634
Other Study ID Numbers:
  • 2004P000115
  • West
First Posted:
Sep 16, 2005
Last Update Posted:
Mar 24, 2017
Last Verified:
Mar 1, 2017
Keywords provided by James Rodrigue, Professor of Psychology in the Department of Psychiatry, Beth Israel Deaconess Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2017