Clinical trial NCT02716467: Effect of Intercessory Prayer in Patients With Breast Cancer in Radiotherapy Treatment: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: nursing
intercessory prayer
spirituality
clinical trials
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Spiritual Distress assessed using a scale
timeFrame: an average of 1 year
Secondary outcomes:
measure: Anxiety and Depression assessed using a scale
timeFrame: an average of 1 year
measure: anxiety assessed per physiological parameter using saliva
timeFrame: an average of 1 year
measure: Short Spiritual Religious Coping assessed using a scale
timeFrame: an average of 1 year
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Radiotherapy Clinic of the Hospital das Clínicas de Ribeirão Preto
state: São Paulo
Study officials:
affiliation: Ribeirão Preto College of Nursing
name: Emília C. Carvalho, PhD
role: STUDY_DIRECTOR
References: