Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
25 participants
INTERVENTIONAL
2013-03-31
2014-06-30
Brief Summary
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Type of study: intervention Study design: randomized controlled trial Masking: blind study. Randomization: sequence generated by SPSS (Statistical Package for the Social Sciences) version 15, organized in sealed envelopes by another qualified professional.
The research ends in 2014 jun.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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spiritual support
-Spiritual Support: deep breathing + guided image + meditation
Each patient will participate individually in three sequential meetings (A1, A2 and A3).
In the experimental group, it will be developed the support spiritual intervention in all three meetings.
In all meetings, namely A1, A2 and A3 the physiological parameters will be recorded (PA, SpO2, HR) through the monitor BM5.
spiritual support
-Spiritual Support: deep breathing + guided image + meditation
relaxation therapy
Relaxation Therapy Each patient will participate individually in three sequential meetings (A1, A2 and A3).
In the control group, it will be performed just relaxing in all three meetings. In all meetings, namely A1, A2 and A3 the physiological parameters will be recorded (PA, SpO2, HR) through the monitor BM5.
relaxation therapy
Relaxation Therapy: deep breathing
Interventions
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spiritual support
-Spiritual Support: deep breathing + guided image + meditation
relaxation therapy
Relaxation Therapy: deep breathing
Eligibility Criteria
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Inclusion Criteria
* Patients in follow up treatment for breast cancer (record of inclusion and monitoring);
* Have more than 18 years (record of inclusion and monitoring);
Exclusion Criteria
* Present energy-reduction (Eastern Cooperative Oncology Group - ECOG/Zubrod Scale) - ECOG greater than 3
* Present decreased cognition (Mini-Mental State Examination MMSE/Brucki et al. 2003) - lower sum related to grade school.
18 Years
FEMALE
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Caroline Guilherme
PhD student
Locations
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REMA - Center for Education, Research and Rehabilitation assistence mastectomy
Ribeirão Preto, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Ana Maria Almeida, PhD
Role: primary
Other Identifiers
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00896312.0.0000.5393
Identifier Type: -
Identifier Source: org_study_id