NCT00067717

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2003

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2003

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

October 20, 2014

Status Verified

October 1, 2014

Enrollment Period

4.5 years

First QC Date

August 25, 2003

Last Update Submit

October 17, 2014

Conditions

Breast Reconstruction Surgery

Keywords

breast reconstruction surgeryprayerdistance healingwound healing

Outcome Measures

Primary Outcomes (1)

  • Collagen deposition in a surrogate wound

    8 days

Secondary Outcomes (1)

  • POMS normalized mood scores

    8 days

Other Outcomes (2)

  • SF-36 Mental Composite Score

    8 days

  • SF-36 Physical Composite Score

    8 days

Study Arms (3)

Distant Healing

EXPERIMENTAL

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

Behavioral: Distance healing

Non-blinded Distant Healing

PLACEBO COMPARATOR

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

Blinded Control

NO INTERVENTION

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

Interventions

Distance healingBEHAVIORAL
Distant HealingNon-blinded Distant Healing

Eligibility Criteria

Age34 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complementary Medicine Research Institute

San Francisco, California, 94115, United States

Location

Related 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.

    PMID: 22742672BACKGROUND

Study Officials

  • Marilyn J Schlitz, PhD

    California Pacific Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

August 25, 2003

First Posted

August 27, 2003

Study Start

November 1, 2003

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

October 20, 2014

Record last verified: 2014-10

Locations

US(1)