Effect of Intercessory Prayer in Patients With Breast Cancer in Radiotherapy Treatment: Clinical Trial

Breast Cancer 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716467
• Other study ID #: EERP/USP
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: May 15, 2016

Study information

• Verified date: November 2020
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 15, 2016
• Est. primary completion date: July 15, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• intercessory prayer
Intercessory prayer will be offered by a group of six Christian people.

Radiation:
• Radiotherapy
All participants will receive treatment by radiotherapy

Locations

Country	Name	City	State
Brazil	Radiotherapy Clinic of the Hospital das Clínicas de Ribeirão Preto	Ribeirão Preto	São Paulo

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	Spiritual Distress assessed using a scale	spiritual distress	an average of 1 year
Secondary	Anxiety and Depression assessed using a scale	anxiety and depression	an average of 1 year
Secondary	anxiety assessed per physiological parameter using saliva	anxiety	an average of 1 year
Secondary	Short Spiritual Religious Coping assessed using a scale	Short Spiritual Religious Coping	an average of 1 year