Distance Healing in Wound Healing

NCT ID: NCT00067717

Last Updated: 2014-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2008-05-31

Brief Summary

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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

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Conditions

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Breast Reconstruction Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Distant Healing

This group received distant healing but was blinded to the condition.

Group Type EXPERIMENTAL

Distance healing

Intervention Type BEHAVIORAL

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.

Group Type PLACEBO_COMPARATOR

Distance healing

Intervention Type BEHAVIORAL

Blinded Control

This group was blinded to the intervention condition and did not receive any distant healing.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Distance healing

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

34 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

California Pacific Medical Center Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Marilyn Schlitz

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marilyn J Schlitz, PhD

Role: PRINCIPAL_INVESTIGATOR

California Pacific Medical Center

Locations

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Complementary Medicine Research Institute

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22742672 (View on PubMed)

Other Identifiers

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R21AT001437

Identifier Type: NIH

Identifier Source: secondary_id

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SchlitzMJ

Identifier Type: -

Identifier Source: secondary_id

R21AT001437

Identifier Type: NIH

Identifier Source: org_study_id

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