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Integrative and Complementary Health Practices (PICS) (PICS)

Primary Purpose

Neoplasms, Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Without laying on of hands subgroup
Laying on of hands without Spiritual connection
Laying on of hands by Spiritual "Passe"
Sponsored by
Universidade Federal do Triangulo Mineiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring complementary medicine, laying on of hands, cancer, epilepsy, complementary therapies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Núcleo de Praticas Integrativas e ComplementaresRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Sham Comparator

Experimental

Arm Label

Without laying on of hands

Laying on of hands with healing intent and without Spiritual connection

Laying on of hands with healing intent and Spiritual connection by Spiritual "Passe"

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 21, 2019
Last Updated
May 9, 2023
Sponsor
Universidade Federal do Triangulo Mineiro
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1. Study Identification

Unique Protocol Identification Number
NCT04152109
Brief Title
Integrative and Complementary Health Practices (PICS)
Acronym
PICS
Official Title
Evaluation of Integrative and Complementary Practices in Health (PICS)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2019 (Actual)
Primary Completion Date
October 2, 2023 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Triangulo Mineiro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Epilepsy
Keywords
complementary medicine, laying on of hands, cancer, epilepsy, complementary therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The investigators and outcome evaluators will be blind to interventions that participants receive (do not know participants' allocation) and participants will be blind to subgroups without laying on of hands, laying on of hands with and without Spiritual connection (Spirit "passe"), not knowing which group they were allocated to.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Without laying on of hands
Arm Type
Other
Arm Description
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.
Arm Title
Laying on of hands with healing intent and without Spiritual connection
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Laying on of hands with healing intent and Spiritual connection by Spiritual "Passe"
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Without laying on of hands subgroup
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Laying on of hands without Spiritual connection
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Laying on of hands by Spiritual "Passe"
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety
Description
Evaluation of Anxiety by Depression, Anxiety and Stress Scale. Scores between 0-63. Higher score indicates greater severity.
Time Frame
Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Title
Stress
Description
Evaluation of stress by Depression, Anxiety and Stress Scale. Scores between 0-63. Higher score indicates greater severity.
Time Frame
Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Title
Depression
Description
Evaluation of Depression by by Depression, Anxiety and Stress Scale. Scores between 0-63. Higher score indicates greater severity.
Time Frame
Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Secondary Outcome Measure Information:
Title
Fatigue cancer patients
Description
Functional Assessment of Chronic Illness Scale. Higher score on the scale indicates greater fatigue level.
Time Frame
Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Title
Quality of life in cancer patients
Description
Questionnaire developed to assess the quality of life of cancer patients. Lower score by scale indicates poorer quality of life.
Time Frame
Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Title
Analysis of blood
Description
Blood collection for complete blood count.
Time Frame
Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Title
Assessment of blood pressure
Description
Blood pressure, measured by the BPA 100 Microlife automatic oxygenation device
Time Frame
Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Title
Assessment of peripheral oxygen saturation
Description
Peripheral oxygen saturation by the fingertip handheld pulse oximeter
Time Frame
Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Title
Assessment of heart rate
Description
Heart rate (HR) by the fingertip handheld pulse oximeter.
Time Frame
Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Title
Quality of life in epileptic patients
Description
Quality of life in epileptic patients by EQ-5D
Time Frame
Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Title
Fatigue in epileptic and cancer patients
Description
Fatigue in epileptic and cancer patients by Fatigue pictogram. Scores between 0 - 4.
Time Frame
Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Title
Brain electrical activity in epileptic patients
Description
Assessment of brain electrical activity in epileptic patients by electroencephalogram.
Time Frame
Change from Baseline the results anxiety at 8 weeks.
Title
Pain intensity
Description
Assessment of pain by Visual pain scale (VAS). Scores between 0 - 10. High scores indicates worse pain intensity.
Time Frame
Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Title
Autonomic Response in epileptic patients
Description
Assessment of Heart rate variability by electrocardiogram with assessment of heart rate variability.
Time Frame
Change from Baseline the results anxiety at 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Núcleo de Praticas Integrativas e Complementares
City
Uberaba
State/Province
Minas Gerais
ZIP/Postal Code
381000 000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Élida Silva, PhD
Phone
34 99686 5988
Email
elidamc16@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Integrative and Complementary Health Practices (PICS)

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