Clinical trial NCT02489136: Study of Spirit Pass in Newborn and Patient
Official title: Effect of Spirit Pass on Serum Cortisol Levels, Pain, Physiological Parameters and Haematologic Response in Newborn and Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Stress
Keywords: spiritist passe
laying of hands
newborn
adult
conditions
Lead sponsor: Universidade Federal do Triangulo Mineiro
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Salivary cortisol
timeFrame: up to third days
Secondary outcomes:
measure: Anxiety and depression in adults.
timeFrame: First and third days before and after the interventions
Other outcomes:
measure: Pain
timeFrame: First and third days before and after the interventions
measure: Physiological parameters
timeFrame: First and third days before and after the interventions
measure: Pain
timeFrame: First and third days before and after the interventions
measure: Physiological parameters
timeFrame: First and third days before and after the interventions
measure: Muscle tension in adults.
timeFrame: First and third days before and after the interventions
measure: Wellness in adults
timeFrame: First and third days before and after the interventions
Locations:
city: Uberaba
country: Brazil
facility: Hospital de Clínicas da UFTM
state: Minas Gerais
Study officials:
affiliation: Religious and Spiritual Assistance Committee
name: Élida M Carneiro, Mrs.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Selye H. Stress and distress. Compr Ther. 1975 Dec;1(8):9-13.
citation: HOUAISS A.V.; SALLES M. Dicionário Houaiss da Língua. Rio de Janeiro: Editora Objetiva, 2009.
citation: LUCCHETTI G. Efeitos do passe espírita no crescimento de culturas de bactérias. Complementary Therapies in Medicine2013;21:627-632.
citation: XAVIER F.C. O Consolador. Pelo Espírito Emmanuel. 28. ed. Rio de Janeiro: FEB, 2008.
citation: 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.