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

Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT02716467
Collaborator
(none)
30
1
2
13.5
2.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: intercessory prayer
  • Radiation: Radiotherapy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
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 Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Jul 15, 2015
Actual Study Completion Date :
May 15, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Spiritual Distress assessed using a scale [an average of 1 year]

    spiritual distress

Secondary Outcome Measures

  1. Anxiety and Depression assessed using a scale [an average of 1 year]

    anxiety and depression

  2. anxiety assessed per physiological parameter using saliva [an average of 1 year]

    anxiety

  3. Short Spiritual Religious Coping assessed using a scale [an average of 1 year]

    Short Spiritual Religious Coping

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Radiotherapy Clinic of the Hospital das Clínicas de Ribeirão Preto Ribeirão Preto São Paulo Brazil 14040-902

Sponsors and Collaborators

  • University of Sao Paulo

Investigators

  • Study Director: Emília C. Carvalho, PhD, Ribeirão Preto College of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Talita Prado Simão, Student of the Nursing Doctoral, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT02716467
Other Study ID Numbers:
  • EERP/USP
First Posted:
Mar 23, 2016
Last Update Posted:
Nov 27, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Talita Prado Simão, Student of the Nursing Doctoral, University of Sao Paulo
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 27, 2020