Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Distance Healing in Wound Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00067717
Recruitment Status : Completed
First Posted : August 27, 2003
Last Update Posted : October 20, 2014
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Marilyn Schlitz, California Pacific Medical Center Research Institute

Tracking Information
First Submitted Date  ICMJE August 25, 2003
First Posted Date  ICMJE August 27, 2003
Last Update Posted Date October 20, 2014
Study Start Date  ICMJE November 2003
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2014)
Collagen deposition in a surrogate wound [ Time Frame: 8 days ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00067717 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2014)
POMS normalized mood scores [ Time Frame: 8 days ]
Compared from baseline to end of distant healing period
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: October 17, 2014)
  • SF-36 Mental Composite Score [ Time Frame: 8 days ]
  • SF-36 Physical Composite Score [ Time Frame: 8 days ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Distance Healing in Wound Healing
Official Title  ICMJE Placebo Effects in Distance Healing of Wounds
Brief Summary This trial examines the impact of patients' knowledge of an experienced distant healer's efforts to heal them on measures of wound healing, psychosocial functioning, and physiological symptoms after plastic surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Reconstruction Surgery
Intervention  ICMJE Behavioral: Distance healing
Study Arms  ICMJE
  • Experimental: Distant Healing
    This group received distant healing but was blinded to the condition.
    Intervention: Behavioral: Distance healing
  • Placebo Comparator: Non-blinded Distant Healing
    This group received the distant healing intervention and was called every day they were receiving to be told they were receiving it, therefore enhancing expectancy.
    Intervention: Behavioral: Distance healing
  • No Intervention: Blinded Control
    This group was blinded to the intervention condition and did not receive any distant healing.
Publications * Schlitz M, Hopf HW, Eskenazi L, Vieten C, Radin D. Distant healing of surgical wounds: an exploratory study. Explore (NY). 2012 Jul-Aug;8(4):223-30. doi: 10.1016/j.explore.2012.04.004.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2014)
72
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
116
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women undergoing major plastic surgery (> 2 hours in length)
  • Health status is excellent with no systemic disease, no limitation on activity, no danger of death or disease of one body system, well-controlled underlying disease

Exclusion Criteria:

  • Remove history of breast or other cancers
  • History of radiation therapy to the abdomen or any radiation within the past three months
  • Non-English speaking
  • Unable or unwilling to fill out questionnaires
  • Current smoker
  • Morbid obesity
  • Circulatory inadequacies (i.e., diabetes, hypovolemia)
  • Nutritional deficits as evidenced by neutropenia (WBC <2500/ml) or hypoalbuminemia (albumin <3.3mmg/dl) / chart review
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 34 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00067717
Other Study ID Numbers  ICMJE R21AT001437( U.S. NIH Grant/Contract )
R21AT001437 ( U.S. NIH Grant/Contract )
SchlitzMJ
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marilyn Schlitz, California Pacific Medical Center Research Institute
Study Sponsor  ICMJE California Pacific Medical Center Research Institute
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Marilyn J Schlitz, PhD California Pacific Medical Center
PRS Account California Pacific Medical Center Research Institute
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP