Study of Spirit Pass in Newborn and Patient (SSPNP)

September 14, 2017 updated by: Elida Mara Carneiro da Silva, Universidade Federal do Triangulo Mineiro

Effect of Spirit Pass on Serum Cortisol Levels, Pain, Physiological Parameters and Haematologic Response 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Uberaba, Minas Gerais, Brazil, 38015170
        • Hospital de Clínicas da UFTM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Spirit Pass
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")
In a distance of 10 cm and to apply the spiritist passe for 10 minutes.
Other Names:
  • laying of hands
Placebo Comparator: laying of hands by workes
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")
In a distance of 10 cm and to apply the spiritist passe for 10 minutes.
Other Names:
  • laying of hands
No Intervention: No intervention
No intervention during, in adults before and after ten minutes for 3 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to third days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First and third days before and after the interventions

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First and third days before and after the interventions
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.
First and third days before and after the interventions
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".
First and third days before and after the interventions
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.
First and third days before and after the interventions
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.
First and third days before and after the interventions
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.
First and third days before and after the interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Triangulo Mineiro

Investigators

  • Principal Investigator: Élida M Carneiro, Mrs., Religious and Spiritual Assistance Committee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

May 30, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (Estimate)

July 2, 2015

Study Record Updates

Last Update Posted (Actual)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 14, 2017

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EMC123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on laying of hands (Spiritist "passe")

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe