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Clinical Trials/NCT04152109
NCT04152109
Recruiting
N/A

Evaluation of Integrative and Complementary Practices in Health (PICS)

Universidade Federal do Triangulo Mineiro1 site in 1 country60 target enrollmentOctober 2, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Neoplasms
Sponsor
Universidade Federal do Triangulo Mineiro
Enrollment
60
Locations
1
Primary Endpoint
Depression
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Complementary medicine, considered an unconventional approach, is performed in conjunction with conventional medicine. In Brazil, Integrative and Complementary Practices in Health have been inserted by the National Ordinance of Integrative and Complementary Practices. The aim of this study is to evaluate the effects of laying on of hands with spiritual connection by the Spiritist Passe about mental and physical health and quality of life of individuals.

Detailed Description

Type of study: randomized controlled trial. The sample will consist of cancer and epileptic patients including individuals aged eigtheen years and over. Patients will be referred by health professionals and social workers from Lar da Charidade, Clinics Hospital and attachments, as well as from the general community and will be invited to participate in the study at the Center for Integrative and Complementary Practices of the Clinics Hospital. Participants will answer the questionnaires before the start of the study, after eight sessions and fiveteen days or the end of the research according to the group. The participants will be submitted to blood collection, when necessary.

Registry
clinicaltrials.gov
Start Date
October 2, 2019
End Date
December 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elida Mara Carneiro da Silva

Doctor of Health Sciences

Universidade Federal do Triangulo Mineiro

Eligibility Criteria

Inclusion Criteria

  • Cancer patients: diagnosis of neoplasia receiving parenteral chemotherapy.
  • Epileptic patients: clinical diagnosis of focal epilepsy

Exclusion Criteria

  • Cancer patients: pregnant women, unable to understand the questionnaires; non-attendance of 3 sessions of therapy application and refusal to sign the consent form.
  • Epileptic patients: people unable to understand the questionnaires; non-attendance of 3 sessions of therapy application and refusal to sign the consent form, as well as special groups (pregnant women, newly diagnosed epilepsy).

Outcomes

Primary Outcomes

Depression

Time Frame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.

Evaluation of Depression by by Depression, Anxiety and Stress Scale. Scores between 0-63. Higher score indicates greater severity.

Anxiety

Time Frame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.

Evaluation of Anxiety by Depression, Anxiety and Stress Scale. Scores between 0-63. Higher score indicates greater severity.

Stress

Time Frame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.

Evaluation of stress by Depression, Anxiety and Stress Scale. Scores between 0-63. Higher score indicates greater severity.

Secondary Outcomes

  • Fatigue cancer patients(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
  • Quality of life in cancer patients(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
  • Analysis of blood(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
  • Assessment of blood pressure(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
  • Assessment of peripheral oxygen saturation(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
  • Fatigue in epileptic and cancer patients(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
  • Assessment of heart rate(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
  • Quality of life in epileptic patients(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
  • Brain electrical activity in epileptic patients(Change from Baseline the results anxiety at 8 weeks.)
  • Pain intensity(Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.)
  • Autonomic Response in epileptic patients(Change from Baseline the results anxiety at 8 weeks.)

Study Sites (1)

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