Study of Spirit Pass in Newborn and Patient

Pain Clinical Trial

— SSPNP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489136
• Other study ID #: EMC123
• Status: Completed
• Phase: N/A
• First received: May 30, 2015
• Last updated: September 14, 2017
• Start date: July 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Universidade Federal do Triangulo Mineiro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Stress

Intervention

Other:
• laying of hands (Spiritist "passe")
In a distance of 10 cm and to apply the spiritist passe for 10 minutes.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas da UFTM	Uberaba	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Triangulo Mineiro

Country where clinical trial is conducted

Brazil, 

References & 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.

Gomes VM, Silva MJ, Araújo EA. [Gradual effects of therapeutic touch in reducing anxiety in university students]. Rev Bras Enferm. 2008 Nov-Dec;61(6):841-6. Portuguese. — View Citation

HOUAISS A.V.; SALLES M. Dicionário Houaiss da Língua. Rio de Janeiro: Editora Objetiva, 2009.

Lucchetti G, de Oliveira RF, Gonçalves JP, Ueda SM, Mimica LM, Lucchetti AL. Effect of Spiritist "passe" (Spiritual healing) on growth of bacterial cultures. Complement Ther Med. 2013 Dec;21(6):627-32. doi: 10.1016/j.ctim.2013.08.012. Epub 2013 Aug 31. — View Citation

Pereira Da Silva T, Justo Da Silva L. [Pain scales used in the newborn infant: a systematic review]. Acta Med Port. 2010 May-Jun;23(3):437-54. Epub 2010 Jun 14. Review. Portuguese. — View Citation

Selye H. Stress and distress. Compr Ther. 1975 Dec;1(8):9-13. — View Citation

XAVIER F.C. O Consolador. Pelo Espírito Emmanuel. 28. ed. Rio de Janeiro: FEB, 2008.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain	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
Other	Physiological parameters	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
Other	Pain	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
Other	Physiological parameters	Physiological parameters such as heart frequency and oxygen saturation through Dixtal 2022 monitor in adults.	First and third days before and after the interventions
Other	Muscle tension in adults.	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
Other	Wellness in adults	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
Primary	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	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