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- Ensaio Clínico NCT06628986
MBSR e PNL, amamentação pós-parto e depressão (postpartum)
o efeito das aplicações de MBSR e PNL na fadiga, qualidade do sono, lactação e depressão pós-parto no período pós-parto após cesariana
The postnatal period is a risky period in which mothers experience regressive and progressive changes and rapid biopsychosocial changes. Since this process affects not only the mother but also the family, mothers are under intense stress due to adaptation to the changes that occur in this period.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The postnatal period is a risky period in which retrogressive and progressive changes and rapid biopsychosocial changes occur in mothers. Since this process affects not only the mother but also the family, mothers are under intense stress due to adaptation to the changes occurring in this period. Studies have reported that the most common physical problems in the early postpartum period after caesarean section are pain in the incision area, difficulty in caring for the baby alone, activity intolerance, fatigue, insomnia, breastfeeding problems (such as nipple or lack of milk), mastitis and abdominal tension/gas. As important as it is to reduce postpartum symptoms after caesarean section, it is also important to support and maintain breastfeeding. However, postpartum symptoms such as pain, fatigue and negative effects of anaesthesia after caesarean section negatively affect the breastfeeding process and lead to a delay in the onset of lactation.
When the literature was examined, no study was found that examined the effects of mindfulness-based stress reduction programme and neurolinguistic programme on fatigue, sleep quality, lactation and depression in the postpartum long term.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Eyalet/Yerleşke
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Sanliurfa, Eyalet/Yerleşke, Turquia (Türkiye), 63000
- Şanlıurfa training and research hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 19-35 years old
- caesarean section
- primiparous
- breastfeeding women
Exclusion Criteria:
- women who refused to participate in the research.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Mindfulness-based stress reduction program
MBSR; Mindfulness-based stress reduction program. 8 weeks of practice once a week for 20 minutes each. Mindfulness-based stress reduction practices will be carried out online. Mothers will actively participate. |
20 minutes once a week for 8 weeks
Outros nomes:
|
|
Experimental: Neurolinguistic programming
NLP; Neurolinguistic programming 8 weeks of practice once a week for 20 minutes each. Neurolinguistic programming will be carried out online. Mothers will actively participate. |
NLP Neurolinguistic programming, 20 minutes once a week for 8 weeks
Outros nomes:
|
|
Experimental: control
control; MBSR and NLP applications will not be performed. Mothers will be monitored online every week. |
control group, no practice,
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Visual Analogue Scale for Fatigue (VAS-F)
Prazo: before the first application
|
Visual Analogue Scale for Fatigue (VAS-F), The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10, the most negative expression of the energy sub-dimension is 0 and the most positive expression is 10. |
before the first application
|
|
Visual Analogue Scale for Fatigue (VAS-F)
Prazo: Week 4, following the intervention administered on that day
|
Visual Analogue Scale for Fatigue (VAS-F) The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10, the most negative expression of the energy sub-dimension is 0 and the most positive expression is 10. |
Week 4, following the intervention administered on that day
|
|
Visual Analogue Scale for Fatigue (VAS-F)
Prazo: Week 8, following the final intervention
|
Visual Analogue Scale for Fatigue (VAS-F) The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10, the most negative expression of the energy sub-dimension is 0 and the most positive expression is 10. |
Week 8, following the final intervention
|
|
Pittsburgh Sleep Quality Index (PSQI)
Prazo: before the first application
|
Pittsburgh Sleep Quality Index (PSQI) Each item is evaluated as 0-3 points and the sum of the 7 subcomponents constitutes the PDQI score. The lowest score of the scale is 0 and the highest score is 21. A total PDQI score of ≤5 indicates good sleep and >5 indicates poor sleep. |
before the first application
|
|
Pittsburgh Sleep Quality Index (PSQI)
Prazo: week 4, following the intervention administered on that day
|
Pittsburgh Sleep Quality Index (PSQI) Each item is evaluated as 0-3 points and the sum of the 7 subcomponents constitutes the PDQI score. The lowest score of the scale is 0 and the highest score is 21. A total PDQI score of ≤5 indicates good sleep and >5 indicates poor sleep. |
week 4, following the intervention administered on that day
|
|
Pittsburgh Sleep Quality Index (PSQI)
Prazo: week 8, , following the final intervention
|
Pittsburgh Sleep Quality Index (PSQI) Each item is evaluated as 0-3 points and the sum of the 7 subcomponents constitutes the PDQI score. The lowest score of the scale is 0 and the highest score is 21. A total PDQI score of ≤5 indicates good sleep and >5 indicates poor sleep. |
week 8, , following the final intervention
|
|
Edinburgh Postpartum Depression Scale (EPDS)
Prazo: before the first application
|
Edinburgh Postpartum Depression Scale (EPDS) The scale is a 4-point Likert-type scale consisting of 10 items. Responses consisting of four options are scored between 0 and 3. A minimum of 0 and a maximum of 30 points can be obtained from the scale. The cut-off point of the scale is 13 points and above for women and 10 points and above for men, and above this point indicates the presence of depression. |
before the first application
|
|
Edinburgh Postpartum Depression Scale (EPDS)
Prazo: week 4, following the intervention administered on that day
|
Edinburgh Postpartum Depression Scale (EPDS) The scale is a 4-point Likert-type scale consisting of 10 items. Responses consisting of four options are scored between 0 and 3. A minimum of 0 and a maximum of 30 points can be obtained from the scale. The cut-off point of the scale is 13 points and above for women and 10 points and above for men, and above this point indicates the presence of depression. |
week 4, following the intervention administered on that day
|
|
Edinburgh Postpartum Depression Scale (EPDS)
Prazo: week 8, following the final intervention
|
Edinburgh Postpartum Depression Scale (EPDS) The scale is a 4-point Likert-type scale consisting of 10 items. Responses consisting of four options are scored between 0 and 3. A minimum of 0 and a maximum of 30 points can be obtained from the scale. The cut-off point of the scale is 13 points and above for women and 10 points and above for men, and above this point indicates the presence of depression. |
week 8, following the final intervention
|
|
Breastfeeding Self-Efficacy Scale (BSES)
Prazo: before the first application
|
Breastfeeding Self-Efficacy Scale (BSES) The scale consists of 14 items, five-point Likert type. The items of the scale are evaluated on a scale from '1=never sure' to 5=always sure'. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy. |
before the first application
|
|
Breastfeeding Self-Efficacy Scale (BSES)
Prazo: week 4, following the intervention administered on that day
|
Breastfeeding Self-Efficacy Scale (BSES) The scale consists of 14 items, five-point Likert type. The items of the scale are evaluated on a scale from '1=never sure' to 5=always sure'. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy. |
week 4, following the intervention administered on that day
|
|
Breastfeeding Self-Efficacy Scale (BSES)
Prazo: week 8, following the final intervention
|
Breastfeeding Self-Efficacy Scale (BSES) The scale consists of 14 items, five-point Likert type. The items of the scale are evaluated on a scale from '1=never sure' to 5=always sure'. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy. |
week 8, following the final intervention
|
|
Exclusive breastfeeding status
Prazo: before the first application
|
Exclusive breastfeeding status (yes or no) |
before the first application
|
|
Exclusive breastfeeding status
Prazo: week 4, following the intervention administered on that day
|
Exclusive breastfeeding status (yes or no) |
week 4, following the intervention administered on that day
|
|
Exclusive breastfeeding status
Prazo: week 8, following the final intervention
|
Exclusive breastfeeding status (yes or no) |
week 8, following the final intervention
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: AYŞEGÜL KILIÇLI, Dr., Muş Alparslan University
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
- Doenças urogenitais
- Transtornos Mentais, Desordem Mental
- Doenças urogenitais femininas e complicações na gravidez
- Complicações na Gravidez
- Transtornos de Humor
- Distúrbios puerperais
- Desordem depressiva
- Condições Patológicas, Sinais e Sintomas
- Comportamento
- Sinais e sintomas
- Comportamento Alimentar
- Fadiga
- Depressão, Pós-parto
- Amamentação
- Técnicas de investigação
- Design de pesquisa epidemiológica
- Métodos epidemiológicos
- Design de pesquisa
- Métodos
- Grupos de controle
Outros números de identificação do estudo
- Mauniv
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
All
Prazo de Compartilhamento de IPD
8 October 2024 - 30 October 2025
Critérios de acesso de compartilhamento IPD
8 October 2024 - 30 October 2025
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
- CSR
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