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

Effect of Intercessory Prayer on the Levels of Psychological Variables, Spiritual and Biological of Patients With Breast Cancer in Radiotherapy Treatment: Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: intercessory prayer; Radiation: 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14040-902
      • Radiotherapy Clinic of the Hospital das Clínicas de Ribeirão Preto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intercessory prayer group; Patients in the experimental group receive prayer of intercession during radiotherapy treatment.	Other: intercessory prayer; Intercessory prayer will be offered by a group of six Christian people.; Radiation: Radiotherapy; All participants will receive treatment by radiotherapy
Active Comparator: Radiotherapy Treatment; Patients in the radiotherapy group not receive prayer of intercession during radiotherapy treatment.	Radiation: Radiotherapy; All participants will receive treatment by radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spiritual Distress assessed using a scale	spiritual distress	an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety and Depression assessed using a scale	anxiety and depression	an average of 1 year
anxiety assessed per physiological parameter using saliva	anxiety	an average of 1 year
Short Spiritual Religious Coping assessed using a scale	Short Spiritual Religious Coping	an average of 1 year

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Director: Emília C. Carvalho, PhD, Ribeirão Preto College of Nursing

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): July 15, 2015
• Study Completion (Actual): May 15, 2016

Study Registration Dates

• First Submitted: March 6, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: clinical trials; nursing; spirituality; intercessory prayer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: EERP/USP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO