Effect of the Nursing Intervention "Spiritual Support"

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01866670
• Other study ID #: 00896312.0.0000.5393
• Status: Recruiting
• Phase: Phase 2
• First received: May 17, 2013
• Last updated: May 30, 2013
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: May 2013
• Source: University of Sao Paulo
• Contact: Caroline Guilherme, PhD student
• Phone: 055(16)3602-3475
• Email: carolg[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Condition: patients with breast cancer. Intervention: spiritual support (relaxation + image guided + meditation) or relaxation in three consecutive meetings (day 2, 3 and 4), three days of intervention in the same week. The first day the participants will be evaluated if she meets the needs of the research and will answer questions about their indentification and spirituality.

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of breast cancer (record of inclusion and monitoring);

• 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 history of psychiatric disorders involving hallucinations (record of inclusion and monitoring).

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Behavioral:
• spiritual support
-Spiritual Support: deep breathing + guided image + meditation
• relaxation therapy
Relaxation Therapy: deep breathing

Locations

Country	Name	City	State
Brazil	REMA - Center for Education, Research and Rehabilitation assistence mastectomy	Ribeirão Preto	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spirituality	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); these questions also will be made at the end of the study, 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). 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).	Spirituality Scale of Pinto and Pais-Ribeiro assessed at up to 1 week	Yes