Integrative and Complementary Health Practices (PICS)

Epilepsy Clinical Trial

— PICS  

Official title:

Evaluation of Integrative and Complementary Practices in Health (PICS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04152109
• Other study ID #: Elida123
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2019
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2024
• Source: Universidade Federal do Triangulo Mineiro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2025
• Est. primary completion date: December 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Epilepsy
• Neoplasms

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Núcleo de Praticas Integrativas e Complementares	Uberaba	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Triangulo Mineiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	Analysis of blood	Blood collection for complete blood count.	Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.