NCT03356691

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2018

Completed
7.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

2.6 years

First QC Date

June 4, 2017

Last Update Submit

April 12, 2018

Conditions

AnxietyDepressionPainWell-beingStress

Keywords

Spiritist passadultlaying of hands

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (18)

  • change in Depression.

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

  • Change in Depression sympton.

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

  • Change in Tension muscle.

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

  • Change in wellness subjective.

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

  • Change in wellness.

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

  • +13 more secondary outcomes

Study Arms (7)

Control group

NO INTERVENTION

No intervention.

Complementary Spiritist Therapy

EXPERIMENTAL

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

Other: Complementary Spiritist Therapy

Prayer

OTHER

Prayer during 1-2 minutes

Other: Prayer

Spiritist "passe"

OTHER

Spiritist "passe" during 5-10 minutes.

Other: Spiritist "passe"

Laying on of hands with intent to heal

PLACEBO COMPARATOR

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

Other: laying on of hands with intent to heal

Fluid water or magnetized water

OTHER

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

Other: Fluid therapy.

Non-fluidic water

OTHER

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

Other: No-fluid therapy.

Interventions

Complementary Spiritist TherapyOTHER

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.

Also known as: Integrative medicine
Complementary Spiritist Therapy
PrayerOTHER

Individuals will receive prayer during 1 to 2 minutes.

Prayer
Spiritist "passe"OTHER

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

Spiritist "passe"
laying on of hands with intent to healOTHER

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

Laying on of hands with intent to heal
Fluid therapy.OTHER

Individuals will receive fluid therapy.

Fluid water or magnetized water
No-fluid therapy.OTHER

Individuals will receive no-fluid therapy.

Non-fluidic water

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients with the ability to understand the questionnaires.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Élida Mara Carneiro

Uberaba, Minas Gerais, 38015-170, Brazil

RECRUITING

Related Publications (5)

  • 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.

    PMID: 27515871BACKGROUND

  • 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.

    PMID: 27874837RESULT

  • 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.

    PMID: 24280471RESULT

  • 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.

    PMID: 28137530RESULT

  • 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.

    PMID: 31119515DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepressionPain

Interventions

Faith HealingTherapeutic TouchFluid Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spiritual TherapiesComplementary TherapiesTherapeuticsMind-Body TherapiesDrug Therapy

Study Officials

  • Élida M Carneiro, PhD

    Spiritist Medical Association of Uberaba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Élida M Carneiro, PhD

CONTACT

5134 99686 5988elidamc16@gmail.com

Clinical Hospital Federal University of Triângulo Mineiro

CONTACT

5134 33185000

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The investigators did not know which group the patients were allocated.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinic Physiotherapist

Study Record Dates

First Submitted

June 4, 2017

First Posted

November 29, 2017

Study Start

September 10, 2015

Primary Completion

April 9, 2018

Study Completion

December 30, 2025

Last Updated

April 17, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)