Study of Spirit Pass in Newborn and Patient

NCT ID: NCT02489136

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-06-30

Brief Summary

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Stress is a multiple variable and an inevitable aspect of life. Any change that affects the life of a person is a stressful agent, being possible to widely vary its nature and may be formed by several components, since psychosocial and behavioral factors, such as frustration, anxiety and overload. The goal is to assess the effects of laying on of hands on newborns and patients without direct physical contact. Newborns are allocated in two three groups: G1 - group submitted to imposition of hands by workers, for a period of 10 minutes; G2 group submitted to laying on of hands for 10 minutes; and adults are allocated three groups: G1 - group submitted to imposition of hands by workers, for a period of 10 minutes; G2 group submitted to laying on of hands for 10 minutes; in G3: group without intervention, for a period of 10 minutes.

Detailed Description

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Individuals responsible for NB will be invited to participate in the research and, after they have signed the informed term of consent, NB will be allocated into two groups (G1 and G2):

G1: group submitted to hand imposition by the workers, for 10 minutes; G2: group submitted to the laying on of hands (spiritist passe), for 10 minutes.

In hospitalized adults, after they have signed the informed term of consent, they will be allocated into three groups:

G1: group submitted to hand imposition by workers and volunteers, not belonging to Spiritism, for 10 minutes; G2: group submitted to the laying on of hands (spiritist passe), for 10 minutes; G3: group with no intervention, for 10 minutes. All interventions will be performed in 3 consecutive days. In group 1 (G1) it will consist of: asking workers and individuals who do not belong to Spiritism to place themselves In front of the incubators or the bed, lay on their hands over the NB or the patient in dorsal decubitus (left hand over the head and the right hand over the chest), in a distance of 10 cm, and emit sincere wishes of improvement to the patient, aiming the healing, for 10 minutes, regardless their belief or religion. Patients will be oriented to direct their thoughts to Jesus during the intervention. For the laying on of hands, Salivary cortisol collection in NB will be carried out in the days: D1 (1st day) and D3 (3rd day). It will be a blind evaluation and allocation of NB and adults in each group. • Anxiety, depression, muscle tension and wellness in adults. \[Time Frame: First and third days before and after the interventions.

Diagnosis of each patient included in the study, their beliefs and religions, as well as the characteristics of the passe givers , such as age, gender, time of experience as a passe givers will be analyzed in the characterization of the sample and discussion.

Conditions

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Pain Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Spirit Pass

It is a transfusion of psychic energies. Laying of hands to be in front of the incubator or on bed, at a distance at around 10 to 15 cm, during 10 minutes. Evaluate the effects of spirit passe in newborn and adults before and after ten minutes for 3 days.

Group Type OTHER

laying of hands (Spiritist "passe")

Intervention Type OTHER

In a distance of 10 cm and to apply the spiritist passe for 10 minutes.

laying of hands by workes

Laying of hand by workers and volunteers, not belonging to Spiritism.Laying of hands to be in front of the incubator or on bed, at a distance at around 10 to 15 cm, during 10 minutes. Evaluate the effects of spirit passe in newborn and adults before and after ten minutes for 3 days.

Group Type PLACEBO_COMPARATOR

laying of hands (Spiritist "passe")

Intervention Type OTHER

In a distance of 10 cm and to apply the spiritist passe for 10 minutes.

No intervention

No intervention during, in adults before and after ten minutes for 3 days.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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laying of hands (Spiritist "passe")

In a distance of 10 cm and to apply the spiritist passe for 10 minutes.

Intervention Type OTHER

Other Intervention Names

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laying of hands

Eligibility Criteria

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Inclusion Criteria

• It will be included in the study newborns (NB) hospitalized in the nursery and patients aged 18 or over, male and female, conscious and oriented, presenting Glasgow coma scale of 15, hospitalized at the Clinical Hospital of UFTM, who will not be discharged from it for at around the 3 following days.

Exclusion Criteria

• Individuals who will be excluded from the study:

1. Responsible for the NB or patient who refuses to give the consent, after have been informed;
2. Presence of metabolic diseases, which change the salivary cortisol secretion, verified in their register;
3. NB and adults in mechanical ventilation.
Minimum Eligible Age

1 Hour

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal do Triangulo Mineiro

OTHER

Sponsor Role lead

Responsible Party

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Elida Mara Carneiro da Silva

Elida Mara Carneiro da Silva

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Élida M Carneiro, Mrs.

Role: PRINCIPAL_INVESTIGATOR

Religious and Spiritual Assistance Committee

Locations

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Hospital de Clínicas da UFTM

Uberaba, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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CASTRO M.; MOREIRA A.C. Análise Crítica do Cortisol Salivar na Avaliação do eixo Hipotálamo-Hipófise-Adrenal. Arquivo Brasileiro de Endocrinologia & Metabologia, v. 47, p. 358-367, 2003.

Reference Type BACKGROUND

Gomes VM, Silva MJ, Araujo EA. [Gradual effects of therapeutic touch in reducing anxiety in university students]. Rev Bras Enferm. 2008 Nov-Dec;61(6):841-6. doi: 10.1590/s0034-71672008000600008. Portuguese.

Reference Type BACKGROUND
PMID: 19142390 (View on PubMed)

Selye H. Stress and distress. Compr Ther. 1975 Dec;1(8):9-13.

Reference Type BACKGROUND
PMID: 1222562 (View on PubMed)

HOUAISS A.V.; SALLES M. Dicionário Houaiss da Língua. Rio de Janeiro: Editora Objetiva, 2009.

Reference Type BACKGROUND

LUCCHETTI G. Efeitos do passe espírita no crescimento de culturas de bactérias. Complementary Therapies in Medicine2013;21:627-632.

Reference Type BACKGROUND

XAVIER F.C. O Consolador. Pelo Espírito Emmanuel. 28. ed. Rio de Janeiro: FEB, 2008.

Reference Type BACKGROUND

SILVA T.P.; SILVA L.J. Escalas de avaliação da dor utilizadas no recém-nascido. Revisão sistemática. Acta Médica Portuguesa, v. 23, n. 3, p. 437-454, 2010.

Reference Type BACKGROUND

Other Identifiers

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EMC123

Identifier Type: -

Identifier Source: org_study_id