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Distance Healing in Wound Healing

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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

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.

Condition or disease Intervention/treatment Phase
Breast Reconstruction Surgery Behavioral: Distance healing Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo Effects in Distance Healing of Wounds
Study Start Date : November 2003
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Distant Healing
This group received distant healing but was blinded to the condition.
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.
Behavioral: Distance healing
No Intervention: Blinded Control
This group was blinded to the intervention condition and did not receive any distant healing.



Primary Outcome Measures :
  1. Collagen deposition in a surrogate wound [ Time Frame: 8 days ]

Secondary Outcome Measures :
  1. POMS normalized mood scores [ Time Frame: 8 days ]
    Compared from baseline to end of distant healing period


Other Outcome Measures:
  1. SF-36 Mental Composite Score [ Time Frame: 8 days ]
  2. SF-36 Physical Composite Score [ Time Frame: 8 days ]


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Ages Eligible for Study:   34 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067717


Locations
United States, California
Complementary Medicine Research Institute
San Francisco, California, United States, 94115
Sponsors and Collaborators
California Pacific Medical Center Research Institute
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Marilyn J Schlitz, PhD California Pacific Medical Center

Publications:
Responsible Party: Marilyn Schlitz, Senior Scientist, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00067717     History of Changes
Other Study ID Numbers: R21AT001437 ( U.S. NIH Grant/Contract )
R21AT001437 ( U.S. NIH Grant/Contract )
SchlitzMJ
First Posted: August 27, 2003    Key Record Dates
Last Update Posted: October 20, 2014
Last Verified: October 2014

Keywords provided by Marilyn Schlitz, California Pacific Medical Center Research Institute:
breast reconstruction surgery
prayer
distance healing
wound healing