NeoplasmsPICSNCT04152109
Integrative and Complementary Health Practices (PICS)
A study testing Without laying on of hands subgroup, Laying on of hands without Spiritual connection and Laying on of hands by Spiritual "Passe" in people with Neoplasms and Epilepsy, run by Universidade Federal do Triangulo Mineiro at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Without laying on of hands subgroup, Laying on of hands without Spiritual connection and Laying on of hands by Spiritual "Passe"
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Oct 2019to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients: diagnosis of neoplasia receiving parenteral chemotherapy.
- Epileptic patients: clinical diagnosis of focal epilepsy
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Núcleo de Praticas Integrativas e Complementares
Uberaba, Minas Gerais, 381000 000
Élida Silva, PhD, 34 99686 5988, elidamc16@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Without laying on of hands subgroup, Laying on of hands without Spiritual connection, Laying on of hands by Spiritual "Passe"
- Keywords
- complementary medicine, laying on of hands, cancer, epilepsy, complementary therapies
- Medical subject headings
- Neoplasms, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Without laying on of hands subgroupOther
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 connectionOther
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"Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Without laying on of hands | Other | 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. Receives: Other: Without laying on of hands subgroup |
| Laying on of hands with healing intent and without Spiritual connection | Sham comparator | 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. Receives: Other: Laying on of hands without Spiritual connection |
| Laying on of hands with healing intent and Spiritual connection by Spiritual "Passe" | Experimental | 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. Receives: Other: Laying on of hands by Spiritual "Passe" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Evaluation of Anxiety by Depression, Anxiety and Stress Scale. Scores between 0-63. Higher score indicates greater severity.
Measured: 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.
Measured: 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.
Measured: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Secondary outcomes (11)
Fatigue cancer patients
Functional Assessment of Chronic Illness Scale. Higher score on the scale indicates greater fatigue level.
Measured: 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.
Measured: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Analysis of blood
Blood collection for complete blood count.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline the results anxiety at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start2 Oct 2019
- Primary completion2 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Triangulo Mineiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elida Mara Carneiro da Silva, Universidade Federal do Triangulo Mineiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152109
- Sponsor's protocol ID
- Elida123
- Acronym
- PICS
- Status last verified
- May 2024
- First submitted
- 21 Sep 2019
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Integrative and Complementary Practices in Health (PICS)
- ClinicalTrials.gov ID
- NCT04152109
- Acronym / sponsor ID
- PICS / Elida123
- Keywords
- complementary medicine, laying on of hands, cancer, epilepsy, complementary therapies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade Federal do Triangulo MineiroUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 2 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Without laying on of hands | Other | Other: Without laying on of hands subgroupThe 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. |
| Laying on of hands with healing intent and without Spiritual connection | Sham comparator | Other: Laying on of hands without Spiritual connectionParticipants 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. |
| Laying on of hands with healing intent and Spiritual connection by Spiritual "Passe" | Experimental | Other: Laying on of hands 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cancer patients: diagnosis of neoplasia receiving parenteral chemotherapy.
- Epileptic patients: clinical diagnosis of focal epilepsy
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Without laying on of hands subgroupThe 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. | Other | Without laying on of hands |
| Laying on of hands without Spiritual connectionParticipants 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. | Other | Laying on of hands with healing intent and without Spiritual connection |
| 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. | Other | Laying on of hands with healing intent and Spiritual connection by Spiritual "Passe" |
Primary outcome
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.
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.
11 secondary outcomes
Fatigue cancer patients
Time frame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Quality of life in cancer patients
Time frame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Analysis of blood
Time frame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Assessment of blood pressure
Time frame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Assessment of peripheral oxygen saturation
Time frame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Assessment of heart rate
Time frame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Quality of life in epileptic patients
Time frame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Fatigue in epileptic and cancer patients
Time frame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Brain electrical activity in epileptic patients
Time frame: Change from Baseline the results anxiety at 8 weeks.
Pain intensity
Time frame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Autonomic Response in epileptic patients
Time frame: Change from Baseline the results anxiety at 8 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Without laying on of hands subgroup, Laying on of hands without Spiritual connection and Laying on of hands by Spiritual "Passe" in people with Neoplasms and Epilepsy, run by Universidade Federal do Triangulo Mineiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.