Distance Healing in Wound Healing

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marilyn Schlitz, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00067717
First received: August 25, 2003
Last updated: October 17, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Breast Reconstruction Surgery
Behavioral: Distance healing
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo Effects in Distance Healing of Wounds

Resource links provided by NLM:


Further study details as provided by California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • Collagen deposition in a surrogate wound [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • POMS normalized mood scores [ Time Frame: 8 days ] [ Designated as safety issue: No ]
    Compared from baseline to end of distant healing period


Other Outcome Measures:
  • SF-36 Mental Composite Score [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • SF-36 Physical Composite Score [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: November 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   34 Years to 64 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067717

Locations
United States, California
Complementary Medicine Research Institute
San Francisco, California, United States, 94115
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Investigators
Principal Investigator: Marilyn J Schlitz, PhD California Pacific Medical Center
  More Information

No publications provided

Responsible Party: Marilyn Schlitz, Senior Scientist, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00067717     History of Changes
Other Study ID Numbers: R21 AT001437, R21AT001437, SchlitzMJ
Study First Received: August 25, 2003
Last Updated: October 17, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 23, 2014