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AnxietyNCT03356691

The Evaluation Complementary Spirit Therapy

A study testing Complementary Spiritist Therapy, Prayer and Spiritist "passe" in people with Anxiety and Depression, run by Universidade Federal do Triangulo Mineiro at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Anxiety, Depression, Pain
What is being tested?
Complementary Spiritist Therapy, Prayer and Spiritist "passe"
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
1 siteBrazil
Study dates
10 Sep 2015to 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The patients with the ability to understand the questionnaires.

Who cannot join

  • Patients expected to be discharged in less than 4 days
  • Lowering the level of consciousness.

Trial locations and contacts

1 site in 1 country.

Élida M Carneiro, PhD contact

5134 99686 5988

elidamc16@gmail.com

Clinical Hospital Federal University of Triângulo Mineiro contact

5134 33185000

Brazil1 site, 1 recruiting
  • Élida Mara Carneiro

    Uberaba, Minas Gerais, 38015-170

    ÉLIDA D CARNEIRO, PhD, 3433134624, elidamc16@gmail.com

    Recruiting

Other trials in Brazil

About this study

Official title: 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.
Read the 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:
  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.

Being tested
Complementary Spiritist Therapy, Prayer, Spiritist "passe", laying on of hands with intent to heal, Fluid therapy.
Keywords
Spiritist pass, adult, laying of hands
Medical subject headings
Anxiety Disorders, Depression, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Complementary Spiritist TherapyOther

    Also called Integrative medicine

    Complementary Spiritist Therapy:

    1. Prayer: for 1 to 2 minutes.
    2. Spiritual education: reading and commentary of the Gospel according to Spiritism, about 7 minutes.
    3. Spiritist "passe, for 2-min.
    4. Fluid therapy.
  • PrayerOther

    Individuals will receive prayer during 1 to 2 minutes.

  • Spiritist "passe"Other

    Individuals will receive Spiritist "passe" during 5 to 10 minutes.

  • laying on of hands with intent to healOther

    Individuals will receive laying on of hands with intent to heal during 5 to 10 minutes.

  • Fluid therapy.Other

    Individuals will receive fluid therapy.

  • No-fluid therapy.Other

    Individuals will receive no-fluid therapy.

Study groups in NCT03356691
Study groupRoleWhat they receive
Control groupNo interventionNo intervention.
Complementary Spiritist TherapyExperimentalPrayer, Spirit education, Spiritist "passe" and magnetized water
Receives: Other: Complementary Spiritist Therapy
PrayerOtherPrayer during 1-2 minutes
Receives: Other: Prayer
Spiritist "passe"OtherSpiritist "passe" during 5-10 minutes.
Receives: Other: Spiritist "passe"
Laying on of hands with intent to healPlacebo comparatorlaying on of hands with intent to heal during 5-10 minutes.
Receives: Other: laying on of hands with intent to heal
Fluid water or magnetized waterOtherSpiritist healers laying on of hands hands on the glass of water and desire health, restoration of balance and health for the patient.
Receives: Other: Fluid therapy.
Non-fluidic waterOtherindividuals receive water without fluidification (no laying on of hands hands on the glass of water).
Receives: Other: No-fluid therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.

Secondary outcomes (18)
  1. 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.

    Measured: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.

  2. 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.

    Measured: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.

  3. 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).

    Measured: The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.

  4. 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.

    Measured: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.

  5. 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).

    Measured: The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.

  6. Change in hematological and immunological responses.

    Hemogram, immunoglobulin A , cortisol and Cytokine Doses.

    Measured: The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.

  7. 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).

    Measured: The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.

  8. Change in blood pressure

    Blood pressure (mmHg) is assessed by blood pressure gauge.

    Measured: The blood pressure will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.

  9. Change in respiratory rate

    Respiratory (ipm) rate is assessed by manual count.

    Measured: The respiratory rate will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.

  10. Change in cardiac rate

    Cardiac rate (bpm) is assessed by oximeter More Fitness.

    Measured: The cardiac rate will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.

  11. Change in oxygen saturation

    oxygen saturation (%) is assessed by oximeter More Fitness.

    Measured: The oxygen saturation will be evaluated an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.

  12. Change in Heart rate variability

    Heart rate variability. It is measured by electrocardiogram (ECG) or frequency meter

    Measured: The heart rate variability will be assessed on 1 day.

  13. 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).

    Measured: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.

  14. 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.

    Measured: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.

  15. 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.

    Measured: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.

  16. 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.

    Measured: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.

  17. 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).

    Measured: The instrument will be applied an average on 1 day, 2 days, 3 days, 1 week, 15 days, 2 mounths.

  18. 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.

    Measured: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2017
  2. Study start10 Sep 2015
  3. Primary completion9 Apr 2018
  4. Study completion30 Dec 2025 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03356691
Sponsor's protocol ID
UFTM
Status last verified
Apr 2018
First submitted
4 Jun 2017
Last updated
17 Apr 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 27515871
  • 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.

    PubMed 27874837
  • 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.

    PubMed 24280471
  • 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.

    PubMed 28137530
  • 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.

    PubMed 31119515

Questions about this trial

What is this clinical trial studying?

A study testing Complementary Spiritist Therapy, Prayer and Spiritist "passe" in people with Anxiety and Depression, 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 1 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 17 Apr 2018. 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?

Contact Élida M Carneiro, PhD (5134 99686 5988, elidamc16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Anxiety sympton. (time frame: The instrument will be applied an average on 1 day, 3 days, 1 week, 15 days, 2 mounths.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03356691, which also lists 5 linked publications.

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 17 Apr 2018.

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