Integrative and Complementary Health Practices (PICS) (PICS)

Evaluation of Integrative and Complementary Practices in Health (PICS)

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Epilepsy
• Intervention / Treatment: Other: Without laying on of hands subgroup; Other: Laying on of hands without Spiritual connection; Other: Laying on of hands by Spiritual "Passe"

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Uberaba, Minas Gerais, Brazil, 381000 000
      • Recruiting
      • Núcleo de Praticas Integrativas e Complementares
      • Contact: Élida Silva, PhD; Phone Number: 34 99686 5988; Email: elidamc16@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Without laying on of hands; The patients will remain in bed supine with blindfolds. A volunteer will move close to the patient with hands behind and mentally repeat the alphabet or do count math during 5 minutes, around 8 weeks.	Other: Without laying on of hands subgroup; The patients will remain in bed supine with blindfolds. A volunteer will move close to the patient with hands behind and mentally repeat the alphabet or count during 5 minutes, around 8 weeks.
Sham Comparator: Laying on of hands with healing intent and without Spiritual connection; Participants included in this subgroup will be exposed to the laying on of hands with healing intent by volunteers. The patients will be blindfold in the supine bed during 5 minutes, 8 weeks.	Other: Laying on of hands without Spiritual connection; Participants included in this subgroup will be exposed to the laying on of hands with healing intent by volunteers. The patients will be blindfold in the supine bed during 5 minutes, around 8 weeks.
Experimental: Laying on of hands with healing intent and Spiritual connection by Spiritual "Passe"; The participants will be subjected application of the laying on of hands by the passistas who will give the Spiritist "passe". Patients remain in the supine bed blindfolded for 5 minutes, around 8 weeks.	Other: Laying on of hands by Spiritual "Passe"; The participants will be subjected application of the laying on of hands by the volunteer who will give the Spiritist "passe". Patients remain in the supine bed blindfolded for 5 minutes, around 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Evaluation of Anxiety by Depression, Anxiety and Stress Scale. Scores between 0-63. Higher score indicates greater severity.	Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Stress	Evaluation of stress by Depression, Anxiety and Stress Scale. Scores between 0-63. Higher score indicates greater severity.	Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Depression	Evaluation of Depression by by Depression, Anxiety and Stress Scale. Scores between 0-63. Higher score indicates greater severity.	Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue cancer patients	Functional Assessment of Chronic Illness Scale. Higher score on the scale indicates greater fatigue level.	Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Quality of life in cancer patients	Questionnaire developed to assess the quality of life of cancer patients. Lower score by scale indicates poorer quality of life.	Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Analysis of blood	Blood collection for complete blood count.	Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Assessment of blood pressure	Blood pressure, measured by the BPA 100 Microlife automatic oxygenation device	Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Assessment of peripheral oxygen saturation	Peripheral oxygen saturation by the fingertip handheld pulse oximeter	Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Assessment of heart rate	Heart rate (HR) by the fingertip handheld pulse oximeter.	Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Quality of life in epileptic patients	Quality of life in epileptic patients by EQ-5D	Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Fatigue in epileptic and cancer patients	Fatigue in epileptic and cancer patients by Fatigue pictogram. Scores between 0 - 4.	Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Brain electrical activity in epileptic patients	Assessment of brain electrical activity in epileptic patients by electroencephalogram.	Change from Baseline the results anxiety at 8 weeks.
Pain intensity	Assessment of pain by Visual pain scale (VAS). Scores between 0 - 10. High scores indicates worse pain intensity.	Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Autonomic Response in epileptic patients	Assessment of Heart rate variability by electrocardiogram with assessment of heart rate variability.	Change from Baseline the results anxiety at 8 weeks.

Collaborators and Investigators

• Sponsor: Universidade Federal do Triangulo Mineiro

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2019
• Primary Completion (Estimated): December 2, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: September 21, 2019
• First Submitted That Met QC Criteria: November 2, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: cancer; epilepsy; complementary therapies; complementary medicine; laying on of hands
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: Elida123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No