Distance Healing in Wound Healing - Tabular View

Tracking Information

First Received Date ^ICMJE

August 25, 2003

Last Updated Date

August 4, 2008

Start Date ^ICMJE

November 2003

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00067717 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Breast Reconstruction Surgery

Intervention ^ICMJE

Behavioral: Distance healing
Behavioral: Prayer

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

116

Completion Date

May 2008

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

Gender

Female

Ages

34 Years to 64 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00067717

Responsible Party

Study ID Numbers ^ICMJE

R21 AT001437, SchlitzMJ

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Marilyn J Schlitz, PhD

California Pacific Medical Center

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

August 2008

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