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The Evaluation Complementary Spirit Therapy

Primary Purpose

Anxiety, Depression, Pain

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Complementary Spiritist Therapy
Prayer
Spiritist "passe"
laying on of hands with intent to heal
Fluid therapy.
No-fluid therapy.
Sponsored by
Universidade Federal do Triangulo Mineiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety focused on measuring Spiritist pass, adult, laying of hands

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Élida Mara CarneiroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

No Intervention

Experimental

Other

Other

Placebo Comparator

Other

Other

Arm Label

Control group

Complementary Spiritist Therapy

Prayer

Spiritist "passe"

Laying on of hands with intent to heal

Fluid water or magnetized water

Non-fluidic water

Arm Description

No intervention.

Prayer, Spirit education, Spiritist "passe" and magnetized water

Prayer during 1-2 minutes

Spiritist "passe" during 5-10 minutes.

laying on of hands with intent to heal during 5-10 minutes.

Spiritist healers laying on of hands hands on the glass of water and desire health, restoration of balance and health for the patient.

individuals receive water without fluidification (no laying on of hands hands on the glass of water).

Outcomes

Primary Outcome Measures

Change in Anxiety sympton.
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.

Secondary Outcome Measures

change in Depression.
The HAD subscale. Each of your items can be punctuated with zero to three, composing a maximum score of 21 points for each scale.
Change in Depression sympton.
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.
Change in Tension muscle.
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).
Change in wellness subjective.
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.
Change in wellness.
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).
Change in hematological and immunological responses.
Hemogram, immunoglobulin A , cortisol and Cytokine Doses.
Change in pain.
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).
Change in blood pressure
Blood pressure (mmHg) is assessed by blood pressure gauge.
Change in respiratory rate
Respiratory (ipm) rate is assessed by manual count.
Change in cardiac rate
Cardiac rate (bpm) is assessed by oximeter More Fitness.
Change in oxygen saturation
oxygen saturation (%) is assessed by oximeter More Fitness.
Change in Heart rate variability
Heart rate variability. It is measured by electrocardiogram (ECG) or frequency meter
Change in Burnout.
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).
Change in Quality of life
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.
Change in Stress score.
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.
Change in Stress.
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.
Change in perceived anxiety.
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).
Change in Anxiety.
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.

Full Information

First Posted
June 4, 2017
Last Updated
April 12, 2018
Sponsor
Universidade Federal do Triangulo Mineiro
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1. Study Identification

Unique Protocol Identification Number
NCT03356691
Brief Title
The Evaluation Complementary Spirit Therapy
Official Title
Effects of Complementary Spirit Therapy on Servers and Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2015 (Actual)
Primary Completion Date
April 9, 2018 (Actual)
Study Completion Date
December 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
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Pain, Well-being, Stress
Keywords
Spiritist pass, adult, laying of hands

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
The investigators did not know which group the patients were allocated.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention.
Arm Title
Complementary Spiritist Therapy
Arm Type
Experimental
Arm Description
Prayer, Spirit education, Spiritist "passe" and magnetized water
Arm Title
Prayer
Arm Type
Other
Arm Description
Prayer during 1-2 minutes
Arm Title
Spiritist "passe"
Arm Type
Other
Arm Description
Spiritist "passe" during 5-10 minutes.
Arm Title
Laying on of hands with intent to heal
Arm Type
Placebo Comparator
Arm Description
laying on of hands with intent to heal during 5-10 minutes.
Arm Title
Fluid water or magnetized water
Arm Type
Other
Arm Description
Spiritist healers laying on of hands hands on the glass of water and desire health, restoration of balance and health for the patient.
Arm Title
Non-fluidic water
Arm Type
Other
Arm Description
individuals receive water without fluidification (no laying on of hands hands on the glass of water).
Intervention Type
Other
Intervention Name(s)
Complementary Spiritist Therapy
Other Intervention Name(s)
Integrative medicine
Intervention Description
Complementary Spiritist Therapy: Prayer: for 1 to 2 minutes. Spiritual education: reading and commentary of the Gospel according to Spiritism, about 7 minutes. Spiritist "passe, for 2-min. Fluid therapy.
Intervention Type
Other
Intervention Name(s)
Prayer
Intervention Description
Individuals will receive prayer during 1 to 2 minutes.
Intervention Type
Other
Intervention Name(s)
Spiritist "passe"
Intervention Description
Individuals will receive Spiritist "passe" during 5 to 10 minutes.
Intervention Type
Other
Intervention Name(s)
laying on of hands with intent to heal
Intervention Description
Individuals will receive laying on of hands with intent to heal during 5 to 10 minutes.
Intervention Type
Other
Intervention Name(s)
Fluid therapy.
Intervention Description
Individuals will receive fluid therapy.
Intervention Type
Other
Intervention Name(s)
No-fluid therapy.
Intervention Description
Individuals will receive no-fluid therapy.
Primary Outcome Measure Information:
Title
Change in Anxiety sympton.
Description
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.
Time Frame
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Secondary Outcome Measure Information:
Title
change in Depression.
Description
The HAD subscale. Each of your items can be punctuated with zero to three, composing a maximum score of 21 points for each scale.
Time Frame
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Title
Change in Depression sympton.
Description
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.
Time Frame
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Title
Change in Tension muscle.
Description
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).
Time Frame
The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
Title
Change in wellness subjective.
Description
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.
Time Frame
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Title
Change in wellness.
Description
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).
Time Frame
The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
Title
Change in hematological and immunological responses.
Description
Hemogram, immunoglobulin A , cortisol and Cytokine Doses.
Time Frame
The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
Title
Change in pain.
Description
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).
Time Frame
The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
Title
Change in blood pressure
Description
Blood pressure (mmHg) is assessed by blood pressure gauge.
Time Frame
The blood pressure will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Title
Change in respiratory rate
Description
Respiratory (ipm) rate is assessed by manual count.
Time Frame
The respiratory rate will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Title
Change in cardiac rate
Description
Cardiac rate (bpm) is assessed by oximeter More Fitness.
Time Frame
The cardiac rate will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Title
Change in oxygen saturation
Description
oxygen saturation (%) is assessed by oximeter More Fitness.
Time Frame
The oxygen saturation will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Title
Change in Heart rate variability
Description
Heart rate variability. It is measured by electrocardiogram (ECG) or frequency meter
Time Frame
The heart rate variability will be assessed on 1 day.
Title
Change in Burnout.
Description
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).
Time Frame
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Title
Change in Quality of life
Description
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.
Time Frame
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Title
Change in Stress score.
Description
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.
Time Frame
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Title
Change in Stress.
Description
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.
Time Frame
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Title
Change in perceived anxiety.
Description
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).
Time Frame
The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
Title
Change in Anxiety.
Description
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.
Time Frame
The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Élida M Carneiro, PhD
Phone
5134 99686 5988
Email
elidamc16@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Hospital Federal University of Triângulo Mineiro
Phone
5134 33185000
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Élida M Carneiro, PhD
Organizational Affiliation
Spiritist Medical Association of Uberaba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Élida Mara Carneiro
City
Uberaba
State/Province
Minas Gerais
ZIP/Postal Code
38015-170
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ÉLIDA D CARNEIRO, PhD
Phone
3433134624
Email
elidamc16@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27515871
Citation
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.
Results Reference
background
PubMed Identifier
27874837
Citation
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.
Results Reference
result
PubMed Identifier
24280471
Citation
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.
Results Reference
result
PubMed Identifier
28137530
Citation
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.
Results Reference
result
PubMed Identifier
35611849
Citation
Carneiro EM, Avezum Oliveira LF, Alves da Silva DA, da Silva Catarino J, Timoteo RP, Desiderio CS, Rodrigues Junior V, de Fatima 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;20(2):471-480. doi: 10.1515/jcim-2020-0305. eCollection 2023 Jun 1.
Results Reference
derived
PubMed Identifier
31119515
Citation
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.
Results Reference
derived

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The Evaluation Complementary Spirit Therapy

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