Trial Information

Effect of the Nursing Intervention "Spiritual Support" in the Level of Spirituality and Clinical Parameters in Women With Breast Cancer: a Randomized Clinical Trial

People who attend the study sessions will participate in sessions of relaxation or of
spiritual support depending on the group in which they were selected.

One way to see if there was influence of these activities for the person is measuring some
factors such as heart rate, oxygen saturation and blood pressure. The interventions will be
conducted by the researcher and the data will be collected by a research assistant.

Before being accepted to participate in the study each participant will be evaluated if
he/she meets the needs of the research (day 1); thus it will be observed if she has or not
no physical condition to perform normal activities of daily life (Eastern Cooperative
Oncology Group - ECOG/Scale Zubrod) like this and your cognitive ability ((Mini-Mental State
Examination MMSE/Brucki et al. 2003); if the patient is performing another type of
complementary therapy will be considered his/her temporary interruption during the study
period (Sheet inclusion and monitoring).

After this assessment, women who can participate in the research will answer questions about
their identification (Identification Card of the study participants). They will answer five
questions about spirituality (Pinto; Pais-Ribeiro, 2007).On the day 2, 3 and 4, during
relaxation or spiritual support,the study participants should allow being recorded heart
rate, oxygen saturation and blood pressure (ANOVA); this will be done by means of a sensor
(or electrode) as those used for ECG and results will appear on a monitor (monitor BM5).

The sessions of relaxation or of spiritual support will be scheduled in three consecutive
meetings in the same week, during the activities of the Teaching, Research and
Rehabilitation Center for Mastectomized Women (REMA) of the University of São Paulo at
Ribeirão Preto College of Nursing (EERP-USP).

The questionnaires also will be made at the end of the study (day 4), after sessions of
relaxation or spiritual support to see if there was any change in the two stages and between
the two groups (ANOVA). At the end they will give a score from 0 to 10, or give their
opinion on the experience of the meetings (Experience Rating Scale).

Women who are selected to the sessions of relaxation may perform the activity of spiritual
support in future schedules, if they want. It is necessary to participate of the selected
activity, i.e., relaxation or spiritual support, and they cannot switch groups during the
research.

The research ends in 2014 jun.