- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03356691
The Evaluation Complementary Spirit Therapy
Effects of Complementary Spirit Therapy on Servers and Patients
Background: Complementary Spiritist Therapy (ECT) based on a range of therapeutic resources including prayer, spiritist "passe", fluidotherapy (fluidic water or magnetized water), spirit education. The aim of this study was to evaluate the effects of ECT in individuals at UFTM Hospital de Clínicas.
Methods: Randomized controlled trial, patients were randomly. Patients will then be allocated into groups:
- The group submitted to ECT (prayer, spiritual education, spiritist "passe" and fluidized water or prayer or spiritist "passe" or laying on of hands with intent to heal or laying on of hands with intent to heal or fluidized water or no-fluidized water or Control group (CG) will not be submitted to any intervention.
Study Overview
Status
Conditions
Detailed Description
Distribution of subjects according to the group to be worked and place of data collection:
Group to be worked:
patients hospitalized in the medical and surgical clinic, orthopedics, neurology, emergency adult , gynecology and obstetrics and employees of the clinic hospital
After randomization, participants included in the study will be allocated to one of the groups:
The group submitted to ECT:
- Prayer: approximation of the person to God through words including gratitude, personal petition and intercession for others, about 2 to 3 minutes;
- Spiritual education: reading and commentary of the Gospel according to Spiritism for about 10 minutes;
- Spiritist "passe": to carry out the spiritist pass, the passers-by will be asked to position themselves in front of the bed, to place their hands on the head of the person alternating with passing their hands repeatedly on or over the person, positioned lying in the dorsal position, distance about 10 to 15 cm and apply the spiritist pass for 2 to 3 minutes. Individuals will be directed to direct the thoughts in heath during the intervention;
- Fluid Therapy by means of magnetized or fluidized water: you will be asked to stand in front of the table containing a tray with 20 ml water cups, to place hands on the cups wishing health and healing intentions, for approximately 2 minutes .
The total time of interventions will be about 10-15 minutes.
- The control group (CG) will not be submitted to any intervention.
- The Spiritist "passe" be submitted to Spiritist "passe": To carry out the spiritist pass, the passers-by will be asked to position themselves in front of the participant, to place their hands on the head of the person alternating with passing their hands repeatedly on or over the person, distance about 10 to 15 cm and apply the spiritist pass between 5-10 minutes. Individuals will be directed the thoughts in heath during the intervention.
- The laying on of hands with intent to heal: To carry out the volunteers, the passers-by will be asked to position themselves in front of the participant, to place their hands on the head of the person alternating with passing their hands repeatedly on or over the person, distance about 10 to 15 cm and apply the spiritist pass between 5-10 minutes. Individuals will be directed the thoughts in heath during the intervention.
- The Fluid Therapy: Fluid Therapy by means of magnetized or fluidized water: you will be asked to stand in front of the table containing a tray with water cups, to place hands on the cups wishing health and healing intentions, for approximately 10 minutes.
- The No-Fluid Therapy: individuals will receive non-fluidic water.
- The Prayer group:
After intervention blood collection will be performed and the questionnaires will be applied again.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Élida M Carneiro, PhD
- Phone Number: 5134 99686 5988
- Email: elidamc16@gmail.com
Study Contact Backup
- Name: Clinical Hospital Federal University of Triângulo Mineiro
- Phone Number: 5134 33185000
Study Locations
-
-
Minas Gerais
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Uberaba, Minas Gerais, Brazil, 38015-170
- Recruiting
- Élida Mara Carneiro
-
Contact:
- ÉLIDA D CARNEIRO, PhD
- Phone Number: 3433134624
- Email: elidamc16@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The patients with the ability to understand the questionnaires.
Exclusion Criteria:
- Patients expected to be discharged in less than 4 days
- Lowering the level of consciousness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
No intervention.
|
|
|
Experimental: Complementary Spiritist Therapy
Prayer, Spirit education, Spiritist "passe" and magnetized water
|
Complementary Spiritist Therapy:
Other Names:
|
|
Other: Prayer
Prayer during 1-2 minutes
|
Individuals will receive prayer during 1 to 2 minutes.
|
|
Other: Spiritist "passe"
Spiritist "passe" during 5-10 minutes.
|
Individuals will receive Spiritist "passe" during 5 to 10 minutes.
|
|
Placebo Comparator: Laying on of hands with intent to heal
laying on of hands with intent to heal during 5-10 minutes.
|
Individuals will receive laying on of hands with intent to heal during 5 to 10 minutes.
|
|
Other: Fluid water or magnetized water
Spiritist healers laying on of hands hands on the glass of water and desire health, restoration of balance and health for the patient.
|
Individuals will receive fluid therapy.
|
|
Other: Non-fluidic water
individuals receive water without fluidification (no laying on of hands hands on the glass of water).
|
Individuals will receive no-fluid therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Anxiety sympton.
Time Frame: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
The Depression Anxiety and Stress Scale (DASS-21).
This scale is a Likert 4-point scale between 0 (not applicable to me) and 3 (applies to me a lot, or most of the time).
Scores for depression, anxiety and stress are determined by summing the scores of the 21 items.
|
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in Depression.
Time Frame: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
The HAD subscale.
Each of your items can be punctuated with zero to three, composing a maximum score of 21 points for each scale.
|
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
|
Change in Depression sympton.
Time Frame: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
The Depression Anxiety and Stress Scale (DASS-21).
This scale is a Likert 4-point scale between 0 (not applicable to me) and 3 (applies to me a lot, or most of the time).
Scores for depression, anxiety and stress are determined by summing the scores of the 21 items.
|
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
|
Change in Tension muscle.
Time Frame: The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
|
The visual analog scale of tension muscle.
The most simple VAS is a straight horizontal line of fixed length, usually 100 mm.
The ends are defined as the extreme limits of the parameter to be measured (symptom) orientated from the left (worst) to the right (best).
|
The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
|
|
Change in wellness subjective.
Time Frame: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
The wellness subjective scale.
This scale is is composed of 21 items of evaluation of positive affect, 26 items of negative affect and satisfaction with life consists of 15 items.
|
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
|
Change in wellness.
Time Frame: The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
|
The visual analog scale of wellness.
The most simple VAS is a straight horizontal line of fixed length, usually 100 mm.
The ends are defined as the extreme limits of the parameter to be measured (symptom) orientated from the left (worst) to the right (best).
|
The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
|
|
Change in hematological and immunological responses.
Time Frame: The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
|
Hemogram, immunoglobulin A , cortisol and Cytokine Doses.
|
The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
|
|
Change in pain.
Time Frame: The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
|
The visual analog scale of Pain.
The most simple Visual Analog Pain Scale is a straight horizontal line of fixed length, usually 100 mm.
The ends are defined as the extreme limits of the parameter to be measured (symptom) orientated from the left (worst) to the right (best).
|
The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
|
|
Change in blood pressure
Time Frame: The blood pressure will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
Blood pressure (mmHg) is assessed by blood pressure gauge.
|
The blood pressure will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
|
Change in respiratory rate
Time Frame: The respiratory rate will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
Respiratory (ipm) rate is assessed by manual count.
|
The respiratory rate will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
|
Change in cardiac rate
Time Frame: The cardiac rate will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
Cardiac rate (bpm) is assessed by oximeter More Fitness.
|
The cardiac rate will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
|
Change in oxygen saturation
Time Frame: The oxygen saturation will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
oxygen saturation (%) is assessed by oximeter More Fitness.
|
The oxygen saturation will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
|
Change in Heart rate variability
Time Frame: The heart rate variability will be assessed on 1 day.
|
Heart rate variability.
It is measured by electrocardiogram (ECG) or frequency meter
|
The heart rate variability will be assessed on 1 day.
|
|
Change in Burnout.
Time Frame: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
Maslach Burnout Inventory.
The instrument consists of 15 questions that are subdivided into three subscales: Emotional Exhaustion (EE) (5 items); Disbelief (DE) (4 items) and Professional Efficacy (EP) (6 items).
All items are evaluated on a 7-point Likert scale, ranging from 0 (never) to 6 (always).
|
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
|
Change in Quality of life
Time Frame: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
Whoqol.
The instrument module consists of 26 questions (being question number 1 and 2 on general quality of life), the answers follow a Likert scale (from 1 to 5, the higher the score the better the quality of life).
Apart from these two questions (1 and 2), the instrument has 24 facets which comprise 4 domains that are: PHYSICAL, PSYCHOLOGICAL, SOCIAL RELATIONS and ENVIRONMENT.
|
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
|
Change in Stress score.
Time Frame: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
The scale of stress.
This assessment is a questionnaire that evaluates stress in four levels - alert, resistance, almost exhaustion and exhaustion.
The instrument assesses the presence of symptoms and how the individual has felt in the last 24 h, in the last month and in the last 3 months.
For each period of time, a set of 15 physical and emotional symptoms is evaluated for the first 2 periods and 23 symptoms are evaluated for the last period.
|
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
|
Change in Stress.
Time Frame: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
The Depression Anxiety and Stress Scale (DASS-21).
This scale is a Likert 4-point scale between 0 (not applicable to me) and 3 (applies to me a lot, or most of the time).
Scores for depression, anxiety and stress are determined by summing the scores of the 21 items.
|
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
|
Change in perceived anxiety.
Time Frame: The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
|
Visual analog scale.
The most simple VAS is a straight horizontal line of fixed length, usually 100 mm.
The ends are defined as the extreme limits of the parameter to be measured (symptom) orientated from the left (worst) to the right (best).
|
The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
|
|
Change in Anxiety.
Time Frame: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
The Hospital Anxiety and Depression Scale.
It has 14 items, seven of which are for evaluation of anxiety (HADS-A) and seven for depression (HADS-D).
Each of your items can be punctuated with zero to three, composing a maximum score of 21 points for each scale.
|
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Élida M Carneiro, PhD, Spiritist Medical Association of Uberaba
Publications and helpful links
General Publications
- de Souza Cavalcante R, Banin VB, de Moura Ribeiro Paula NA, Daher SR, Habermann MC, Habermann F, Bravin AM, da Silva CE, de Andrade LG. Effect of the Spiritist "passe" energy therapy in reducing anxiety in volunteers: A randomized controlled trial. Complement Ther Med. 2016 Aug;27:18-24. doi: 10.1016/j.ctim.2016.05.002. Epub 2016 May 6.
- Carneiro EM, Moraes GV, Terra GA. Effectiveness of Spiritist Passe (Spiritual Healing) on the Psychophysiological Parameters in Hospitalized Patients. Adv Mind Body Med. 2016 Summer;30(3):4-10.
- Lucchetti G, de Oliveira RF, Goncalves JP, Ueda SM, Mimica LM, Lucchetti AL. Effect of Spiritist "passe" (Spiritual healing) on growth of bacterial cultures. Complement Ther Med. 2013 Dec;21(6):627-32. doi: 10.1016/j.ctim.2013.08.012. Epub 2013 Aug 31.
- Carneiro EM, Barbosa LP, Marson JM, Terra JA Junior, Martins CJ, Modesto D, Resende LA, Borges MF. Effectiveness of Spiritist "passe" (Spiritual healing) for anxiety levels, depression, pain, muscle tension, well-being, and physiological parameters in cardiovascular inpatients: A randomized controlled trial. Complement Ther Med. 2017 Feb;30:73-78. doi: 10.1016/j.ctim.2016.11.008. Epub 2016 Nov 24.
- Carneiro ÉM, Avezum Oliveira LF, Alves da Silva DA, da Silva Catarino J, Timóteo RP, Desidério CS, Rodrigues Junior V, de Fátima Borges M. Effects of complementary spiritual therapy on stress, anxiety, burnout syndrome and hematological parameters of professionals in a public hospital: a randomized controlled trial. J Complement Integr Med. 2022 May 26. doi: 10.1515/jcim-2020-0305. [Epub ahead of print]
- Carneiro EM, Tosta AM, Antonelli IBS, Soares VM, Oliveira LFA, Borges RMC, da Silva AP, Borges MF. Effect of Spiritist "Passe" on Preoperative Anxiety of Surgical Patients: A Randomized Controlled Trial, Double-Blind. J Relig Health. 2020 Aug;59(4):1728-1739. doi: 10.1007/s10943-019-00841-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFTM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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