Study of Spirit Pass in Newborn and Patient
SSPNP
Effect of Spirit Pass on Serum Cortisol Levels, Pain, Physiological Parameters and Haematologic Response in Newborn and Patient
1 other identifier
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 2, 2015
CompletedSeptember 18, 2017
June 1, 2015
10 months
May 30, 2015
September 14, 2017
Conditions
Keywords
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
OTHERIt 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.
laying of hands by workes
PLACEBO COMPARATORLaying 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.
No intervention
NO INTERVENTIONNo 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.
Eligibility Criteria
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
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.
BACKGROUNDGomes 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: 19142390BACKGROUNDSelye H. Stress and distress. Compr Ther. 1975 Dec;1(8):9-13.
PMID: 1222562BACKGROUNDHOUAISS A.V.; SALLES M. Dicionário Houaiss da Língua. Rio de Janeiro: Editora Objetiva, 2009.
BACKGROUNDLUCCHETTI G. Efeitos do passe espírita no crescimento de culturas de bactérias. Complementary Therapies in Medicine2013;21:627-632.
BACKGROUNDXAVIER F.C. O Consolador. Pelo Espírito Emmanuel. 28. ed. Rio de Janeiro: FEB, 2008.
BACKGROUNDSILVA 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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Élida M Carneiro, Mrs.
Religious and Spiritual Assistance Committee
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