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Clinical Trials/NCT00067717
NCT00067717CompletedPhase 1

Placebo Effects in Distance Healing of Wounds

California Pacific Medical Center Research Institute2 sites in 1 country72 target enrollmentStarted: November 2003Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
72
Locations
2
Primary Endpoint
Collagen deposition in a surrogate wound
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
34 Years to 64 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Collagen deposition in a surrogate wound

Time Frame: 8 days

Secondary Outcomes

  • POMS normalized mood scores(8 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marilyn Schlitz

Senior Scientist

California Pacific Medical Center Research Institute

Study Sites (2)

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