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- Ensaio Clínico NCT07566962
Effect of Mechanical Massage Cushion on Labor Pain and Comfort
Effect of Mechanical Massage Cushion on Labor Pain and Comfort: A Randomized Controlled Trial
This study was conducted to examine the effect of mechanical massage applied with a mechanical massage cushion during labor on labor pain and comfort.
This research is a randomized controlled experimental study. The universe of the study consisted of primiparous women who gave birth normally in a state hospital between November 2021 and February 2022, and the sample consisted of 70 pregnant women (35 pregnant women in the experimental group and 35 pregnant women in the control group) who met the selection criteria. Data were collected face-to-face with the Personal Information Form, Visual Analog Scale (VAS), Verbal Category Scale (VCS), and Childbirth Comfort Questionnaire (CCQ). Data were analyzed using the SPSS 22.0 package program.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Massage applied during birth provides relaxation to the pregnant woman, reduces pain, anxiety, agitation, and depressive mood, relaxes muscle spasms, and reduces the duration of birth and hospital stay. There are a limited number of studies in the literature on mechanical massage during birth. This study was conducted to examine the effect of mechanical massage applied with a mechanical massage cushion during labor on labor pain and comfort.
This research is a randomized controlled experimental study. The universe of the study consisted of primiparous women who gave birth normally in a state hospital between November 2021 and February 2022, and the sample consisted of 70 pregnant women (35 pregnant women in the experimental group and 35 pregnant women in the control group) who met the selection criteria. Data were collected face-to-face with the Personal Information Form, Visual Analog Scale (VAS), Verbal Category Scale (VCS), and Childbirth Comfort Questionnaire (CCQ). Data were analyzed using the SPSS 22.0 package program. The normal distribution of the data was evaluated using the number, percentage, mean, chi-square, and t-test.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Mersin, Turquia (Türkiye)
- Tarsus University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- At least a primary school graduate, no communication problems, healthy at term pregnancies, primiparous pregnants, in the latent phase of labor (cervical dilation 0-3 cm).
Exclusion Criteria:
- Foreign pregnant women, multiparous pregnants, pregnant women who dropped out of the study, pregnant women who experienced complications and required a cesarean section, pregnant women who were admitted to the delivery room while using an automatic massage cushion on another pregnant woman.
Plano de estudo
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 |
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Experimental: massage
During the active phase, the pregnant woman was asked to manage the mechanical massage cushion and massage the desired areas at the desired intensity until the end of the phase.
Pain scales (VAS, VCS) were administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm).
The Childbirth Comfort Questionnaire was administered at the end of the first hour after birth.
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The mechanical massage cushion was introduced to the pregnant woman and its use was explained.
In addition to routine hospital procedures, during the latent phase, a custom-made bed protector and towel were placed on the mechanical massage cushion, and the researcher accompanied the pregnant woman during the first massage application.
The bed protector and towel were changed as needed when soiled.
During the active phase, the pregnant woman was asked to manage the mechanical massage cushion and massage the desired areas at the desired intensity until the end of the phase.
Pain scales (VAS, VCS) were administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm).
The Childbirth Comfort Questionnaire was administered at the end of the first hour after birth.
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Sem intervenção: control
Standard care was applied to the control group.
Pain scales (VAS, VCS) were administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm).
The Childbirth Comfort Questionnaire was administered at the end of the first hour after birth.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Assessment of childbirth comfort
Prazo: The Childbirth Comfort Questionnaire was administered at the end of the first hour after birth.
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Childbirth Comfort Questionnaire (CCQ): The scale was developed by Schuiling in 2003.
The Turkish validity and reliability of the scale were examined by Coskuner et al. in 2015.
The scale is a 5-point Likert-type instrument, consisting of 9 items and 3 sub-dimensions.
The minimum score is 9 and the maximum score is 45.
A high score indicates high comfort.
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The Childbirth Comfort Questionnaire was administered at the end of the first hour after birth.
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Assessment of labor pain
Prazo: VAS was administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm).
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Visual Analog Scale (VAS): It is a scale where painlessness and unbearable pain are indicated on a 10 cm ruler, and the individual marks the pain they perceive.
When evaluating the scale, the distance between the beginning and the marked part is measured with the ruler and the distances are determined as 0-2 cm; 3-4 cm; 5-6 cm; 7-8 cm and 9-10 cm and should be interpreted as no pain; mild pain, moderate pain; severe pain and unbearable pain, respectively.
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VAS was administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm).
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Assessment of labor pain
Prazo: VCS was administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm).
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Verbal Category Scale (VCS): It is a one-dimensional scale that defines the severity of pain.
Pain is divided into categories from mild to unbearable.
The individual marks the part of the scale that corresponds to their pain.
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VCS was administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm).
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Hava Özkan, PhD, Prof. Dr.
Publicações e links úteis
Publicações Gerais
- Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.
- Poppendieck W, Wegmann M, Ferrauti A, Kellmann M, Pfeiffer M, Meyer T. Massage and Performance Recovery: A Meta-Analytical Review. Sports Med. 2016 Feb;46(2):183-204. doi: 10.1007/s40279-015-0420-x.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Tarsus University
- Project number 10119 (Número de outro subsídio/financiamento: Atatürk University Scientific Research Projects Office)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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Ensaios clínicos em Dor de parto
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Aydin Adnan Menderes UniversityConcluídoDuração do Trabalho | Labor Bain | e Satisfação com o Parto Durante o Parto Vaginal FisiológicoTurquia (Türkiye)