Study of Spirit Pass in Newborn and Patient

Study Overview
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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.

Official Title
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Effect of Spirit Pass on Serum Cortisol Levels, Pain, Physiological Parameters and Haematologic Response in Newborn and Patient

Conditions
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Pain, Stress

Intervention / Treatment
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* Other: laying of hands (Spiritist passe)


Participation Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 1 Hour

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Spirit Pass<br>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)<br>* In a distance of 10 cm and to apply the spiritist passe for 10 minutes.<br>* Other names: laying of hands;|
| Placebo Comparator: laying of hands by workes<br>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)<br>* In a distance of 10 cm and to apply the spiritist passe for 10 minutes.<br>* Other names: laying of hands;|
| No Intervention: No intervention<br>No intervention during, in adults before and after ten minutes for 3 days. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and depression in adults. | Anxiety and depression in patients will be applied in the questionnaire: Hospital Scale of Anxiety of depression HAD, consisted of 14 items, divided into 7 items of anxiety assessment and 7 of depression. | First and third days before and after the interventions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spiritist passe, laying of hands, newborn, adult, conditions