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

NCT ID: NCT02716467

Last Updated: 2020-11-27

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-05-15

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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nursing intercessory prayer spirituality clinical trials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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intercessory prayer group

Patients in the experimental group receive prayer of intercession during radiotherapy treatment.

Group Type EXPERIMENTAL

intercessory prayer

Intervention Type OTHER

Intercessory prayer will be offered by a group of six Christian people.

Radiotherapy

Intervention Type RADIATION

All participants will receive treatment by radiotherapy

Radiotherapy Treatment

Patients in the radiotherapy group not receive prayer of intercession during radiotherapy treatment.

Group Type ACTIVE_COMPARATOR

Radiotherapy

Intervention Type RADIATION

All participants will receive treatment by radiotherapy

Interventions

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intercessory prayer

Intercessory prayer will be offered by a group of six Christian people.

Intervention Type OTHER

Radiotherapy

All participants will receive treatment by radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Talita Prado Simão

Student of the Nursing Doctoral

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emília C. Carvalho, PhD

Role: STUDY_DIRECTOR

Ribeirão Preto College of Nursing

Locations

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Radiotherapy Clinic of the Hospital das Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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EERP/USP

Identifier Type: -

Identifier Source: org_study_id