Breast Reconstruction Surgery
Conditions
Keywords
breast reconstruction surgery, prayer, distance healing, wound healing
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.
Interventions
BEHAVIORALDistance healing
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
California Pacific Medical Center Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
34 Years to 64 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Collagen deposition in a surrogate wound | 8 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| POMS normalized mood scores | 8 days | Compared from baseline to end of distant healing period |
Other
| Measure | Time frame |
|---|---|
| SF-36 Mental Composite Score | 8 days |
| SF-36 Physical Composite Score | 8 days |
Countries
United States
Outcome results
None listed