Clinical trial NCT04152109: Integrative and Complementary Health Practices (PICS)
Official title: Evaluation of Integrative and Complementary Practices in Health (PICS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Epilepsy
Keywords: complementary medicine
laying on of hands
cancer
epilepsy
complementary therapies
Lead sponsor: Universidade Federal do Triangulo Mineiro
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Anxiety
timeFrame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
measure: Stress
timeFrame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
measure: Depression
timeFrame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
Secondary outcomes:
measure: Fatigue cancer patients
timeFrame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
measure: Quality of life in cancer patients
timeFrame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
measure: Analysis of blood
timeFrame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
measure: Assessment of blood pressure
timeFrame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
measure: Assessment of peripheral oxygen saturation
timeFrame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
measure: Assessment of heart rate
timeFrame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
measure: Quality of life in epileptic patients
timeFrame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
measure: Fatigue in epileptic and cancer patients
timeFrame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
measure: Brain electrical activity in epileptic patients
timeFrame: Change from Baseline the results anxiety at 8 weeks.
measure: Pain intensity
timeFrame: Change from Baseline the results anxiety at 8 weeks and maintained at 10 weeks.
measure: Autonomic Response in epileptic patients
timeFrame: Change from Baseline the results anxiety at 8 weeks.
Other outcomes:
Locations:
city: Uberaba
country: Brazil
facility: Núcleo de Praticas Integrativas e Complementares
state: Minas Gerais
Study officials:
References: