RBR-464nctz Integrative medicine Pranic Healing as adjuvant and effective treatment therapy: reduce the Chronic Pain

Date of registration: 11/25/2020 ^(mm/dd/yyyy)
Last approval date : 11/25/2020 ^(mm/dd/yyyy)

Study type:

Observational

Scientific title:

Trial identification

• UTN code: U1111-1234-3742

• Public title:

  en

  Integrative medicine Pranic Healing as adjuvant and effective treatment therapy: reduce the Chronic Pain

  pt-br

  Medicina integrativa Pranic Healing como um coadjuvante e terapia eficaz: reduz a Dor Crônica

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 79342617.6.8084
    Issuing authority: Plataforma Brasil
  • 2.439.317
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Cruzeiro do Sul

Sponsors

• Primary sponsor: Ruth Nobuko Nakabayashi
• Secondary sponsor:
  • Institution: Ruth Nobuko Nakabayashi
• Supporting source:
  • Institution: Ruth Nobuko Nakabayashi

Health conditions

• Health conditions:

  en

  Chronic pain, Integrative medicine, Complementary and Integrative Practices, Alternative Therapies

  pt-br

  Dor cronica, Medicina Integrativa, Práticas Complementares e Integrativas, Terapias Alternativas

  es

  Dolor crónico, Medicina Integrativa, Prácticas Complementarias e Integrativas, Terapias Alternativas

• General descriptors for health conditions:

  en

  C23.888.592.612.274 Chronic pain

  en

  H02.403.400 Integrative medicine

  en

  HP3.018 Complementary and Integrative Practices

  en

  HP3.018 Alternative Therapies

• Specific descriptors:

  en

  55208 Muscle Pain

Interventions

• Interventions:

  en

  Study group selected from January 2011 to December 2013, including male and female subjects between 10 and 90 years old. A total of 534 subjects were collected and 331 were excluded for not correctly completing the Confidential Treatment Form of the Pranic Healing Certification program (FTC-CPH) and signed, before and after receiving Pranic Healing care. For the assessment of pain, the Visual Analog Scale - VAS was used, on an intensity scale from 0 to 10, where zero is the total absence of pain and 10 is the maximum pain limit. Two hundred and three (203) individuals were included in the criterion, one hundred and seventy-seven (177) subjects were classified according to gender and reported having pain symptoms: thirty-two (32) subjects reported moderate pain, one hundred and forty-five (145) severe chronic pain and twenty-two six (26) subjects reported other symptoms - obesity, anxiety and stress.

  pt-br

  Grupo de estudo selecionado dentro do período de Janeiro 2011 a Dezembro 2013, incluídos sujeitos masculinos e femininos entre 10 e 90 anos. Foram coletados 534 sujeitos e 331 foram excluídos por não preencherem corretamente o Formulário de Tratamento Confidencial do programa de Certificação de Pranic Healing (FTC-CPH) e assinado, antes e depois de receber um atendimento de Pranic Healing. Para a avaliação da dor, foi utilizado a Escala Visual Analógica – EVA, em uma escala de intensidade de 0 a 10, onde zero e a ausência total da dor e 10 o limite máximo de dor. Duzentos e três (203) indivíduos foram incluídos no critério, cento e setenta e sete (177) sujeitos foram classificados de acordo com gênero e reportaram apresentar sintomas de dor: trinta e dois (32) sujeitos reportaram dor moderada, cento e quarenta e cinco (145) dor crônica intensa e vinte e seis (26) sujeitos reportaram outros sintomas – obesidade, ansiedade e estresse.

• Descriptors:

  en

  E02.190 Complementary Therapies

  en

  H02.403.400 Integrative Medicine

Recruitment

• Study status: Data analysis completed
• Countries
  • Brazil
• Date first enrollment: 01/01/2011 ^(mm/dd/yyyy)
• Date last enrollment: 12/20/2013 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  534	B	0	0

• Inclusion criteria:

  en

  534 subjects between 10 and 90 years. 203 subjects filled the inclusion criteria, 177 subjects reported pain symptoms: 32 subjects with medium pain and 145 subjects with high chronic pain The Confidential Treatment Form of the Institute for Inner Studies, Inc (IIS) Pranic Healing Certification (FTC-CPH) program is completed and signed, before and after receiving PH care. For the assessment of pain, the Visual Analog Scale – EVA was used, on an intensity scale from 0 to 10, where zero is the total absence of pain and 10 is the maximum pain limit.

  pt-br

  534 sujeitos entre 10 a 90 anos. 203 indivíduos incluídos no critério, 177 indivíduos relataram sintomas de dor: 32 indivíduos com dor média e 145 indivíduos com dor crônica alta. O Formulário de Tratamento Confidencial do programa de Certificação de Pranic Healing (FTC-CPH) do Institute for Inner Studies, Inc (IIS) estar preenchido e assinado, antes e depois de receber um atendimento de PH. Para a avaliação da dor, foi utilizado a Escala Visual Analógica – EVA, em uma escala de intensidade de 0 a 10, onde zero é a ausência total da dor e 10 o limite máximo de dor.

• Exclusion criteria:

  en

  331 individuals who did not complete the Pranic Healing Certification Program (FTC-CPH) Confidential Treatment Form (FTC-CPH) of the Institute for Inner Studies, Inc (IIS) correctly, or did not sign and did not report after receiving treatment with Pranic Healing

  pt-br

  331 indivíduos que não preencheram o Formulário de Tratamento Confidencial do programa de Certificação de Pranic Healing (FTC-CPH) do Institute for Inner Studies, Inc (IIS) corretamente, ou não assinaram e não relataram após receberem um tratamento com a Pranic Healing

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Other	N/A	0	N/A	N/A	N/A

Outcomes

• Primary outcomes:

  en

  Expected outcome 1 PH decreases chronic pain

  pt-br

  Desfecho esperado 1 A PH diminui a dor crônica

  en

  Found outcome PH decreases chronic pain and can be used as an adjunctive and effective treatment in reducing chronic pain symptoms

  pt-br

  Desfecho encontrado A PH diminui a dor crônica e pode ser utilizada como tratamento coadjuvante e eficaz na diminuição dos sintomas da dor crônica

• Secondary outcomes:

  en

  Expected Outcome 2 The total group of patients (male and female), showed statistical significance before and immediately after PH in the total group of patients

  pt-br

  Desfecho esperado 2 O grupo total de pacientes (masculino e feminino, apresentou redução da Dor Crônica imediatamente após a PH no grupo total de pacientes.

  en

  Outcome found 2 The total group of patients (male and female) showed a considerable reduction in chronic pain. The paired T-test showed statistical significance before and immediately after PH in the total group of patients (p <0.001) Group of patients separated by sex (male and female), before and immediately after PH. The figure shows a statistically significant difference (P = <0.001) between the pre and post PH groups, both male and female When compared before the female PH group versus the male PH group (p equal to 0.743) and after the female PH group versus the male PH group (p equal to 0.340), both did not show statistically significant differences Patients divided by age group before and after PH. There was a statistically significant difference when individuals were analyzed separately by age in both groups (p <0.001) One-way ANOVA showed statistical significance in all groups when compared before and after PH, regardless of gender or age (p less than 0.001). There was no statistically significant difference when comparing the female group versus the male group before (p = 0.743) and after PH (p = 0.340)

  pt-br

  Desfecho encontrado 2 O grupo total de pacientes (masculino e feminino), apresentou considerável redução da Dor Crônica. O teste T-pareado apresentou significância estatística antes e imediatamente após a PH no grupo total de pacientes (p <0,001) Grupo de pacientes separados por sexo (masculino e feminino), antes e imediatamente após a PH. A figura mostra uma diferença estatisticamente significativa (P = <0,001) entre os grupos pré e pós PH, tanto masculino quanto feminino Quando comparados antes do grupo PH feminino versus grupo masculino PH (p igual a 0,743) e após grupo feminino PH versus grupo masculino PH (p igual a 0,340), ambos não apresentaram diferenças estatisticamente significantes Os pacientes divididos por faixa etária antes e após a PH. Houve diferença estatisticamente significante quando analisados indivíduos separadamente por idade nos ambos quatro grupos (p <0,001). A ANOVA one-way mostrou significância estatística em todos os grupos quando comparada antes e depois da PH, independentemente do sexo ou idade (p menor que 0,001) Não houve diferença estatística significativa quando comparados o grupo feminino versus o masculino pré (p=0,743) e pós PH (p=0,340).

Contacts

• Public contact
  • Full name: Ruth Nobuko Nakabayashi
  • • Address: Rua Jorge Secco, 110. Jardim Alice.
    • City: Taubate / Brazil
    • Zip code: 12062--25
  • Phone: +55-012-991187568
  • Email: ruth@ruthprana.com.br
  • Affiliation: IAMSPE - Instituto de Assistencia Medica ao Servidor Publico Estadual.
   
• Scientific contact
  • Full name: Viviani Barnabé
  • • Address: Rua Butanta, 285
    • City: São Paulo / Brazil
    • Zip code: 05424-140
  • Phone: +55-011-988679669
  • Email: vivianibarnabe@gmail.com
  • Affiliation: UNICID - Universidade Cidade de São Paulo
   
• Site contact
  • Full name: Ruth Nobuko Nakabayashi
  • • Address: Rua Jorge Secco, 110. Jardim Alice.
    • City: Taubate / Brazil
    • Zip code: 12062--25
  • Phone: +55-012-991187568
  • Email: ruth@ruthprana.com.br
  • Affiliation: IAMSPE - Instituto de Assistencia Medica ao Servidor Publico Estadual.
   

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