Distance Healing in Wound Healing

Breast Reconstruction Surgery Clinical Trial

Official title:

Placebo Effects in Distance Healing of Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067717
• Other study ID #: R21AT001437
• Secondary ID: R21AT001437Schli
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 25, 2003
• Last updated: October 17, 2014
• Start date: November 2003
• Est. completion date: May 2008

Study information

• Verified date: October 2014
• Source: California Pacific Medical Center Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 34 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Reconstruction Surgery

Intervention

Behavioral:
• Distance healing

Locations

Country	Name	City	State
United States	Complementary Medicine Research Institute	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
California Pacific Medical Center Research Institute	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SF-36 Mental Composite Score		8 days	No
Other	SF-36 Physical Composite Score		8 days	No
Primary	Collagen deposition in a surrogate wound		8 days	No
Secondary	POMS normalized mood scores	Compared from baseline to end of distant healing period	8 days	No