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Completed

NCT Number: NCT02716467

Effect of Intercessory Prayer in 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radiotherapy Clinic of the Hospital das Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, 14040-902, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intercessory Prayer

Other

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

Radiotherapy

Radiation

All participants will receive treatment by radiotherapy

Primary outcomes

  1. Spiritual Distress assessed using a scale

    Time frame: an average of 1 year

    spiritual distress

Secondary outcomes

  1. Anxiety and Depression assessed using a scale

    Time frame: an average of 1 year

    anxiety and depression

  2. anxiety assessed per physiological parameter using saliva

    Time frame: an average of 1 year

    anxiety

  3. Short Spiritual Religious Coping assessed using a scale

    Time frame: an average of 1 year

    Short Spiritual Religious Coping

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Mar 23, 2016
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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