The goal of this Phase 1 clinical study is to evaluate the impact of patients' knowledge and expectancy that healing efforts on their behalf are being made from a distance on objective and subjective measures of wound healing, psychosocial functioning, and physiological symptoms following breast reconstruction surgery. People undergoing surgery are among those who make frequent use of distant healing modalities. Patients undergoing elective reconstructive surgery will be randomized into three groups (n=26 in each group), which will be compared with each other and with a normative comparison sample. The first two groups will follow a standard double blind randomized trial model assessing the effects of Distant Healing (DH) on wound healing as measured by collagen deposition. This design will allow for traditional assessment of the effects of DH on wound healing by comparing a blinded treatment group with a blinded no-treatment placebo group. The third group will be an open label treatment arm in which patients receive DH and are told directly that they are receiving it. Subjects will be assessed at baseline and 14 days post-surgical follow-up. Baseline attitudes toward the efficacy of DH will be assessed, as will belief about assignment of treatment condition (in blind groups) and confidence that DH is actually occurring on their behalf. If direct knowledge of healing efforts is beneficial, the open-label treatment group should fare better than both blind groups and the normative comparison sample. If DH has an effect, the blind treatment group should show more healing than the blind no-treatment placebo group and the normative comparison sample. If expectancy and DH have an additive booster effect, differences between the open-label vs. blind treatment group should exceed those of the blind treatment vs. blind no-treatment group. Finally, if attitudes toward DH and confidence in being healed are associated with greater healing, these measures should correlate with healing in all groups.
|Schlitz, Marilyn; Hopf, Harriet W; Eskenazi, Loren et al. (2012) Distant healing of surgical wounds: an exploratory study. Explore (NY) 8:223-30|