Effect of Intercessory Prayer in Patients With Breast Cancer in Radiotherapy Treatment: Clinical Trial
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
intercessory prayer
Radiotherapy
Sponsored by

About this trial
This is an interventional other trial for Breast Cancer focused on measuring nursing, intercessory prayer, spirituality, clinical trials
Eligibility Criteria
Inclusion Criteria:
- Individuals diagnosed with breast cancer in adjuvant and neoadjuvant radiotherapy treatment;
- Both female and male participants are being studiedolder;
- Minimum age of participants is 18 years.
Exclusion Criteria:
- Not being with consciousness, memory and orientation preserved;
- Patients with clinical conditions that affect the continuity in the study or express request not to continue participating in the study.
Sites / Locations
- Radiotherapy Clinic of the Hospital das Clínicas de Ribeirão Preto
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
intercessory prayer group
Radiotherapy Treatment
Arm Description
Patients in the experimental group receive prayer of intercession during radiotherapy treatment.
Patients in the radiotherapy group not receive prayer of intercession during radiotherapy treatment.
Outcomes
Primary Outcome Measures
Spiritual Distress assessed using a scale
spiritual distress
Secondary Outcome Measures
Anxiety and Depression assessed using a scale
anxiety and depression
anxiety assessed per physiological parameter using saliva
anxiety
Short Spiritual Religious Coping assessed using a scale
Short Spiritual Religious Coping
Full Information
NCT ID
NCT02716467
First Posted
March 6, 2016
Last Updated
November 23, 2020
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02716467
Brief Title
Effect of Intercessory Prayer in Patients With Breast Cancer in Radiotherapy Treatment: Clinical Trial
Official Title
Effect of Intercessory Prayer on the Levels of Psychological Variables, Spiritual and Biological of Patients With Breast Cancer in Radiotherapy Treatment: Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
July 15, 2015 (Actual)
Study Completion Date
May 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Living with breast cancer and forms of treatment, among them radiation therapy can cause both side effects such as pain, fatigue and skin changes that affect the well-being, as anxiety, feelings of isolation and changes in routine, which generate existential conflicts and allow the origin of the spiritual anguish phenomenon, which in turn, aggravates the physical and emotional symptoms and the ability to fight the disease. Thus, this study aims to evaluate the effect of intercessory prayer on levels of spiritual distress, religious / spiritual coping, psychological morbidity (anxiety and depression) and amylase levels salivary present in patients with breast cancer radiotherapy.
Detailed Description
Reflection on the existence and the meaning of life, common among people with breast cancer radiotherapy generates a suffering that, when directed to the spiritual dimension, results in spiritual distress. In addition, combined with the presence of this phenomenon can flourish during this phase psychological morbidity such as anxiety and depression. In order to face this situation, each person uses cognitive and behavioral strategy according to their beliefs and their meaning of life (religious / spiritual coping). The use of intercessory prayer, where an individual asks a higher being for the benefit of someone seen as receiver, is a strategy that can help people cope with the situation of illness and restore your health. Prayer is one of these activities in the nursing intervention "spiritual support" (5420) proposed by the Nursing Interventions Classification (NIC). a complementary alternative therapy is considered and can be used as an adjuvant in radiotherapy. Therefore, the aim of this study is to verify that the intercession of prayer cause positive effects on levels of spiritual distress, religious coping / spiritual and psychological morbidity (anxiety and depression) present in patients with breast cancer radiotherapy. Thus, a clinical trial will be used randomized controlled and mascaraed. Intervention group will receive the prayer of intercession and control groups (positive and negative) usual care. The data will be analyzed using the Statistical Package for the Social Sciences version 20.0 and will be adopted as the reference value p <0.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
nursing, intercessory prayer, spirituality, clinical trials
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intercessory prayer group
Arm Type
Experimental
Arm Description
Patients in the experimental group receive prayer of intercession during radiotherapy treatment.
Arm Title
Radiotherapy Treatment
Arm Type
Active Comparator
Arm Description
Patients in the radiotherapy group not receive prayer of intercession during radiotherapy treatment.
Intervention Type
Other
Intervention Name(s)
intercessory prayer
Intervention Description
Intercessory prayer will be offered by a group of six Christian people.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
All participants will receive treatment by radiotherapy
Primary Outcome Measure Information:
Title
Spiritual Distress assessed using a scale
Description
spiritual distress
Time Frame
an average of 1 year
Secondary Outcome Measure Information:
Title
Anxiety and Depression assessed using a scale
Description
anxiety and depression
Time Frame
an average of 1 year
Title
anxiety assessed per physiological parameter using saliva
Description
anxiety
Time Frame
an average of 1 year
Title
Short Spiritual Religious Coping assessed using a scale
Description
Short Spiritual Religious Coping
Time Frame
an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Individuals diagnosed with breast cancer in adjuvant and neoadjuvant radiotherapy treatment;
Both female and male participants are being studiedolder;
Minimum age of participants is 18 years.
Exclusion Criteria:
Not being with consciousness, memory and orientation preserved;
Patients with clinical conditions that affect the continuity in the study or express request not to continue participating in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emília C. Carvalho, PhD
Organizational Affiliation
Ribeirão Preto College of Nursing
Official's Role
Study Director
Facility Information:
Facility Name
Radiotherapy Clinic of the Hospital das Clínicas de Ribeirão Preto
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14040-902
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Intercessory Prayer in Patients With Breast Cancer in Radiotherapy Treatment: Clinical Trial
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