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Non-pharmacological Resources in Assisting Labor

8 de maio de 2019 atualizado por: Silvana Maria Quintana, University of Sao Paulo

Application of Non-pharmacological Resources in Assisting Labor: Randomized Controlled Trial

The proposed project will be conducted to evaluate the influence of application resources associated with non-pharmacological during labor for pain relief and accelerated phase of expansion. Although mothers' access to resources for non-pharmacological pain relief during labor is recommended, is not seen as the application of routine obstetric practice, although it has been demonstrated benefits and scientific evidence with your application. It is believed that the implementation of associated application of non-pharmacological resources in assisting the labor can be introduced into daily practice in various hospitals in the country, minimizing pain and favoring the shorter duration of labor, decrease in use of painkillers and inductors, resulting in a reduction of complications, improves the comfort of the mother making her birth experience more satisfying and rewarding, being assisted with security and trained by multidisciplinary teams.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

The current model of care delivery has demanded a technical-assistance approach that prioritizes the quality of care, as indissolubly concerns the employment of technology, knowledge, the centrality of dialogue between professionals and patients and individualized choice resources deemed suitable for safe delivery. Seeking to implement a less interventionist care with evidence-based practice and greater incentive to vaginal delivery, the programs were created humanization of labor and birth, with the use of various non-pharmacological resources. This study aimed to evaluate the effectiveness of the combination of non-pharmacological resources during the dilation in relieving the pain of the mothers. The research will be of type randomized controlled trial, consisting of low-risk primigravidae admitted at the Reference Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups (intervention protocol features non-drug) and Control (routine maternity) and will be evaluated before and after application of each resource, and the control group in the same time according to cervical dilation. Evaluation will be conducted by a visual analog scale and / or facial pain and pain location diagram and postpartum will be applied a validated questionnaire Experience and Satisfaction with childbirth. After collecting the data, the groups are statistically analyzed using the linear regression model with mixed effects (fixed and random), taking into account a value of p <0.05 to obtain the statistical significance of 5%.

Tipo de estudo

Intervencional

Inscrição (Real)

80

Estágio

  • Não aplicável

Contactos e Locais

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Locais de estudo

  • Brasil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brasil
        • Referral Center Women's Health - Mater

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

15 anos a 40 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:- Agreed to participate in the study after reading and signing the consent form;

  • Primigravida;
  • Pregnancy only;
  • Gestational age ≥ 37 weeks;
  • Presentation fetal head
  • Chorioamniotic intact membranes
  • Working with spontaneous onset of labor
  • Admission at the beginning of active phase dilation (4-5 cm)
  • Lack of maternal and fetal pathologies
  • Literacy - primary education
  • Absence of cognitive problems

Exclusion Criteria:

  • Pregnant women admitted for induction of labor
  • Rupture premature or early of chorioamniotic membranes
  • Use of uterotonic drugs before the active phase

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Control Group
Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group.
Outro: Routine care
Routine care of the institution performed by the staff, without the presence of the researcher that included offering a balanced meal, continuous support with the presence of a partner or family throughout labor, use of oxytocin when prescribed by the staff, use of drug analgesia when requested by the patient.
Experimental: Intervention Group
Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: pelvic mobility , lumbosacral massage and warm shower.
Outro: Non-pharmacological resources

A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows:

  • Pelvic mobility on the exercise ball oriented and accompanied by the researcher for 40 minutes;
  • Lumbosacral massage for a period of 40 minutes, when dilation was between 5 and 6 cm. During the procedure, the woman in labor was allowed to freely choose the most comfortable position; and,
  • Warm shower with the water flow directed to the lower-back of the woman in labor, for 40 minutes, when uterine cervical dilation was equal to or higher than 7cm.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Pain Relief
Prazo: ten hours

The Visual Analogue Scale - VAS - was used to measure the intensity of the pain described by the patients during the study. The patient was requested do mark a dot in a straight line, measuring 100mm, being a 0 (Zero) no pain and 100 the most intense pain. The researcher then would measure the estimated pain intensity in millimeters. The pain intensity was measured in all three phases before and after each procedure assigned to each group. The phases and their respective procedures were:

  • Phase I: 4-5cm of cervical dilation (pelvic mobility in exercise ball)
  • Phase II: 5-6cm of cervical dilation (lumbosacral massage)
  • Phase III: 7cm or higher cervical dilation (warm shower)
ten hours

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Evolution of Labor
Prazo: 10 hours
Amount of minutes, from admission to labor.
10 hours
Moment That Women Requested Analgesia During the Active Phase of Labor
Prazo: 10 hours
Mean uterine cervical dilation at the moment the patient requested analgesia for pain relief. Data obtained from medical record
10 hours
Number of Women Who Received Pharmacological Analgesia
Prazo: 10 hours
Determine the number of women who where submitted to pharmacological analgesia, either prescribed by the attending physician ou requested by the patient herself.
10 hours
Type of Delivery
Prazo: 10 hours
Type of delivery at the end of the active phase of labor.
10 hours
Number of Participants Whose Neonates Had:
Prazo: 10 hours
Number and type of neonatal complications as reported in medical chart
10 hours
Number of Participants With:
Prazo: 10 hours
Number and type of maternal complications as reported in medical chart
10 hours

Colaboradores e Investigadores

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Patrocinador

University of Sao Paulo

Investigadores

  • Investigador principal: Silvana M Quintana, professor, Faculty of Medicine of São Paulo University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de outubro de 2011

Conclusão Primária (Real)

1 de julho de 2012

Conclusão do estudo (Real)

1 de julho de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

30 de junho de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de julho de 2011

Primeira postagem (Estimativa)

7 de julho de 2011

Atualizações de registro de estudo

Última Atualização Postada (Real)

19 de julho de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de maio de 2019

Última verificação

1 de maio de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • FR443033

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