NCT00179634

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2008

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

3.1 years

First QC Date

September 13, 2005

Last Update Submit

March 22, 2017

Conditions

Breast Neoplasms

Keywords

MastectomyRandomized Controlled TrialImagery

Outcome Measures

Primary Outcomes (6)

  • Mood disturbance (Profile of Mood States short form)

    4 weeks

  • Post-operative pain

    4 weeks

  • Presence of skin necrosis

    4 weeks

  • Presence of hematoma

    4 weeks

  • Presence of infection

    4 weeks

  • Length of hospital stay

    4 weeks

Study Arms (3)

1

NO INTERVENTION

Usual Care

2

EXPERIMENTAL

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

Behavioral: Visual Milieu Enhancement (Fine art photograph)

3

EXPERIMENTAL

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

Behavioral: Visualization relaxationBehavioral: Visual Milieu Enhancement (Fine art photograph)

Interventions

Visualization relaxationBEHAVIORAL
3
Visual Milieu Enhancement (Fine art photograph)BEHAVIORAL
23

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Physical inability to comply to study protocol
  • Diabetes
  • Current smokers
  • Acute psychosis
  • Mental retardation
  • Language barriers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (14)

  • 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

    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: 12628899BACKGROUND

  • 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: 9672340BACKGROUND

  • 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. doi: 10.1007/BF02054983.

    PMID: 9075752BACKGROUND

  • 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. doi: 10.1080/00029157.1991.10402927.

    PMID: 2012007BACKGROUND

  • Benson H, Friedman R. Harnessing the power of the placebo effect and renaming it "remembered wellness". Annu Rev Med. 1996;47:193-9. doi: 10.1146/annurev.med.47.1.193.

    PMID: 8712773BACKGROUND

  • Ewin DM.The effect of hypnosis and mental set on major surgery and burns. Psychiatric Annals 16:115-118, 1986.

    BACKGROUND

  • Halpin LS, Speir AM, CapoBianco P, Barnett SD. Guided imagery in cardiac surgery. Outcomes Manag. 2002 Jul-Sep;6(3):132-7.

    PMID: 12134377BACKGROUND

  • 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. doi: 10.1126/science.7031901.

    PMID: 7031901BACKGROUND

  • Holden-Lund C. Effects of relaxation with guided imagery on surgical stress and wound healing. Res Nurs Health. 1988 Aug;11(4):235-44. doi: 10.1002/nur.4770110405.

    PMID: 3043570BACKGROUND

  • 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. doi: 10.1016/S0140-6736(00)02162-0.

    PMID: 10801169BACKGROUND

  • 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. doi: 10.1001/archpsyc.56.5.450.

    PMID: 10232300BACKGROUND

  • 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.

    PMID: 10069091BACKGROUND

  • 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. doi: 10.1080/00029157.2003.10403546.

    PMID: 12722936BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Susan L Troyan, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology in the Department of Psychiatry

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

March 1, 2005

Primary Completion

March 27, 2008

Study Completion

March 27, 2008

Last Updated

March 24, 2017

Record last verified: 2017-03

Locations

US(1)