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Completed

NCT Number: NCT02489136

Study of Spirit Pass in Newborn and Patient

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.

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Key information

Conditions

Pain Disease Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress

Age range

1 hour and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas da UFTM

Uberaba, Minas Gerais, 38015170, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laying of hands (Spiritist "passe")

Other

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

Other names: laying of hands

Primary outcomes

  1. Salivary cortisol

    Time frame: up to third days

    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.

Secondary outcomes

  1. Anxiety and depression in adults.

    Time frame: First and third days before and after the interventions

    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.

Other outcomes

  1. Pain

    Time frame: First and third days before and after the interventions

    It will be adopted the Infant Pain Scale (NIPS) in newborns. This scale assesses facial expression, crying, breathing, arms, legs and consciousness. Maximum score is 7 and it is considered pain when all the values are equal or higher than 4.

  2. Physiological parameters

    Time frame: First and third days before and after the interventions

    Physiological parameters such as respiratory frequency, heart frequency and oxygen saturation through Dixtal 2022 monitor in newborn.

  3. Pain

    Time frame: First and third days before and after the interventions

    In adults, it will be adopted the Analogical Visual Scale (AVS), which consists of a horizontal line with 10 centimeters length. In one extremity there is the classification "NO PAIN" and, in the other, "MAXIMUM PAIN".

  4. Physiological parameters

    Time frame: First and third days before and after the interventions

    Physiological parameters such as heart frequency and oxygen saturation through Dixtal 2022 monitor in adults.

  5. Muscle tension in adults.

    Time frame: First and third days before and after the interventions

    Perception of muscle tension in patients will be applied in the questionnaire Analogical scale: analogical visual scale for identification of self-perception of Muscle Tension, individual tension, in which 0 means absence of muscle tension perception and 10 the level of maximum tension perception.

  6. Wellness in adults

    Time frame: First and third days before and after the interventions

    Sense of wellness in patients will be applied in the questionnaire: Analogical scale: analogical visual scale for identification of self-perception of wellness; in which 0 means the absence of wellness perception and 10 the level of maximum wellness perception.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Triangulo Mineiro

Other

Registry information

Official study title

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

Acronym: SSPNP

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 2, 2015
Registry last updated
Sep 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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