NCT02489136

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2015

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
Last Updated

September 18, 2017

Status Verified

June 1, 2015

Enrollment Period

10 months

First QC Date

May 30, 2015

Last Update Submit

September 14, 2017

Conditions

Keywords

spiritist passelaying of handsnewbornadultconditions

Outcome Measures

Primary Outcomes (1)

  • Salivary cortisol

    Collection of salivary cortisol will be carried out using wads of cotton. On newborns it will be introduced in the mouth of the baby and left there for at around three minutes and after that, it will be put inside a kit salivette. Cortisol dosage will be by dependent sample.

    up to third days

Secondary Outcomes (1)

  • Anxiety and depression in adults.

    First and third days before and after the interventions

Other Outcomes (6)

  • Pain

    First and third days before and after the interventions

  • Physiological parameters

    First and third days before and after the interventions

  • Pain

    First and third days before and after the interventions

  • +3 more other outcomes

Study Arms (3)

Spirit Pass

OTHER

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.

Other: laying of hands (Spiritist "passe")

laying of hands by workes

PLACEBO COMPARATOR

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.

Other: laying of hands (Spiritist "passe")

No intervention

NO INTERVENTION

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

Interventions

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

Also known as: laying of hands
Spirit Passlaying of hands by workes

Eligibility Criteria

Age1 Hour+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals who will be excluded from the study:
  • Responsible for the NB or patient who refuses to give the consent, after have been informed;
  • Presence of metabolic diseases, which change the salivary cortisol secretion, verified in their register;
  • NB and adults in mechanical ventilation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas da UFTM

Uberaba, Minas Gerais, 38015170, Brazil

Location

Related Publications (7)

  • 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.

    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.

    PMID: 19142390BACKGROUND
  • Selye H. Stress and distress. Compr Ther. 1975 Dec;1(8):9-13.

    PMID: 1222562BACKGROUND
  • HOUAISS A.V.; SALLES M. Dicionário Houaiss da Língua. Rio de Janeiro: Editora Objetiva, 2009.

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

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

    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.

    BACKGROUND

MeSH Terms

Conditions

PainDisease

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Officials

  • Élida M Carneiro, Mrs.

    Religious and Spiritual Assistance Committee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Elida Mara Carneiro da Silva

Study Record Dates

First Submitted

May 30, 2015

First Posted

July 2, 2015

Study Start

July 1, 2014

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

September 18, 2017

Record last verified: 2015-06

Locations