Distance Healing in Wound Healing

October 17, 2014 updated by: Marilyn Schlitz, California Pacific Medical Center Research Institute

Placebo Effects in Distance Healing of Wounds

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • Complementary Medicine Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

34 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Collagen deposition in a surrogate wound
Time Frame: 8 days
8 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
POMS normalized mood scores
Time Frame: 8 days
Compared from baseline to end of distant healing period
8 days

Other Outcome Measures

Outcome Measure
Time Frame
SF-36 Mental Composite Score
Time Frame: 8 days
8 days
SF-36 Physical Composite Score
Time Frame: 8 days
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Pacific Medical Center Research Institute

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Marilyn J Schlitz, PhD, California Pacific Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

August 25, 2003

First Submitted That Met QC Criteria

August 26, 2003

First Posted (Estimate)

August 27, 2003

Study Record Updates

Last Update Posted (Estimate)

October 20, 2014

Last Update Submitted That Met QC Criteria

October 17, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R21AT001437 (U.S. NIH Grant/Contract)
  • SchlitzMJ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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