The Evaluation Complementary Spirit Therapy

Depression Clinical Trial

Official title:

Effects of Complementary Spirit Therapy on Servers and Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03356691
• Other study ID #: UFTM
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2017
• Last updated: April 12, 2018
• Start date: September 10, 2015
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2018
• Source: Universidade Federal do Triangulo Mineiro
• Contact: Élida M Carneiro, PhD
• Phone: 5134 99686 5988
• Email: elidamc16[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. Prayer: approximation of the person to God through words including gratitude, personal petition and intercession for others, about 2 to 3 minutes;

2. Spiritual education: reading and commentary of the Gospel according to Spiritism for about 10 minutes;

3. 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;

4. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 30, 2025
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Pain
• Stress
• Well-being

Intervention

Other:
• Complementary Spiritist Therapy
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.
• Prayer
Individuals will receive prayer during 1 to 2 minutes.
• Spiritist "passe"
Individuals will receive Spiritist "passe" during 5 to 10 minutes.
• laying on of hands with intent to heal
Individuals will receive laying on of hands with intent to heal during 5 to 10 minutes.
• Fluid therapy.
Individuals will receive fluid therapy.
• No-fluid therapy.
Individuals will receive no-fluid therapy.

Locations

Country	Name	City	State
Brazil	Élida Mara Carneiro	Uberaba	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Triangulo Mineiro

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Carneiro ÉM, 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 car — View Citation

Carneiro ÉM, 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. — View 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. — View Citation

Lucchetti G, de Oliveira RF, Gonçalves 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Secondary	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.	The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Secondary	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.	The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Secondary	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).	The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
Secondary	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.	The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Secondary	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).	The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
Secondary	Change in hematological and immunological responses.	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.
Secondary	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).	The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
Secondary	Change in blood pressure	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.
Secondary	Change in respiratory rate	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.
Secondary	Change in cardiac rate	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.
Secondary	Change in oxygen saturation	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.
Secondary	Change in Heart rate variability	Heart rate variability. It is measured by electrocardiogram (ECG) or frequency meter	The heart rate variability will be assessed on 1 day.
Secondary	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).	The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Secondary	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.	The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Secondary	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.	The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Secondary	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.	The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.
Secondary	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).	The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.
Secondary	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.	The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.