Effect of Woman-Centered Care on Anxiety and Comfort Levels
14 de fevereiro de 2022 atualizado por: Kutahya Health Sciences University
Evaluation of the Effect of Woman-Centered Care Given in the Early Postpartum Period on Anxiety and Comfort Levels
H1a: There is a statistically significant difference in anxiety levels between women who received woman-centered care in the early postpartum period and women who received standard care.
H1b: There is a statistical difference in terms of comfort levels between women who received woman-centered care in the early postpartum period and women who received standard care.
H0a: There is no statistically significant difference in anxiety levels between women who received woman-centered care in the early postpartum period and women who received standard care.
H0b: There is no statistical difference in terms of comfort levels between women who receive female-centered care in the early postpartum period and women who receive standard care.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The research was carried out as a single-blind and block randomized control. The research was conducted in a tertiary hospital in Turkey between February, 2019 and February 2020. The universe of the research consisted of women who gave birth by cesarean section. In the power analysis, the sample size was calculated as a minimum of 105 for each group, according to α:0.05 and 1-β= 0.95. Considering the possibility of loss or separation of the selected specimens during the conduct of the study, 240 women who met the inclusion criteria were assigned to the experimental (120) and control (120) groups.Due to the nature of the study, it was conducted as a single-blind randomized controlled trial.
The pre-test procedure was performed when the mothers' statuses were stabilized two hour after the admittance to the maternity service. The post-test procedure was conducted one hour before the discharge. Woman-centered care was provided to the experimental group, and standard care was provided to the control group.The women in the experimental and control groups were not told which group they were in. Each woman in the experimental group was given woman-centered care from the 2nd hour postpartum, and this process continued until the mother was discharged (mothers are discharged after 24 hours). The standard care provided by the hospital covers the basic postpartum care components. These components are the nutrition of the newborn and the protection of maternal and newborn health. A dynamic interaction was established between the women in the experimental group and the researcher in which woman-centered care was applied. Each woman in the experimental group was responsible for explaining herself, her own health behaviors, and her own needs and values.
"Descriptive Information Form", "Postpartum Comfort Scale" and "State-Trait Anxiety Inventory" were used as data collection tools.
Statistical analyses were performed using IBM SPSS (Statistical Package for Social Sciences) Statistics 22 software. Descriptive statistics (mean, standard deviation, frequency and percentage values) were used to assess the results. Kolmogorov-Smirnov test was used to review the goodness of fit to normal distribution.
Tipo de estudo
Intervencional
Inscrição (Real)
218
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Kütahya, Peru, 43000
- Kütahya Health Science University
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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
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- To receive woman-centered care
- To have cesarian section
- To have singleton birth
- To be within the early postpartum period (the first 24 hours)
- Not have complications childbirth
- Not have chronic diseases or mental disorders
- Older than 18 years
- To voluntary to participate
- To know how to read, write and speak in Turkish
- To stay within this study until the end
- To fully complete questionnaire
- To have a newborn with no complications
- To have a healthy baby
Exclusion Criteria:
- To receive standart care
- Not have cesarian section
- Having multiple birth
- Not to be within the early postpartum period (the first 24 hours)
- Having complications childbirth
- Having chronic diseases or mental disorders
- Younger than 18 years
- To refuse to participate
- Not knowing how to read, write and speak Turkish
- To leave early this study
- Not fill the questionnaire
- Having a newborn with complications
- Having a baby in need of medical care
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 |
|---|---|
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Experimental: Woman-Centered Care Group
Woman-centered care was given to the experimental group.
At the time of the study, 6 women were discharged early, 4 women did not want to continue the study, and the babies of 1 women were admitted to the neonatal intensive care unit due to complications so these women were excluded from the study.
The study was completed with 109 women in the experimental group.
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Each woman in the experimental group was given woman-centered care as from 2 hours postpartum and this process continued until 24 hours postpartum.
Physiological parameters (systolic-diastolic blood pressure, pulse, body temperature) of women assigned either to the experimental group or the control group were measured at 2 hrs postpartum.
The State, Trait Anxiety, and Postpartum Comfort Scales were pretested.
A dynamic interaction was ensured between the researcher and the women in the experimental group who received woman-centered care.
In the processes of determining and meeting the care needs of women in the early postpartum period, both the women and the researcher took equal responsibilities and the common goal of achieving safe results was shared.
Clinical guidelines were used while providing woman-centered care.
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Sem intervenção: Control Group
Standard care was given to the control group.
At the time of the study, 2 women were discharged early, 7 women did not want to continue the study, and the babies of 2 women were admitted to the neonatal intensive care unit due to complications so these women were excluded from the study.
The study was completed with 218 mothers, with 109 women in the control group.
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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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Pre-Test State, Trait Anxiety
Prazo: 2nd postpartum hour
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The State, Trait Anxiety Inventory consists of two subscales, being state and trait anxiety subscales, and 40 items.
The State Anxiety Inventory determines how an individual feels at a certain moment and under certain conditions, and the Trait Anxiety Inventory on the other hand, generally determines how one feels.
High scores indicate a high level of anxiety.
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2nd postpartum hour
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Postpartum Comfort Scale
Prazo: 2nd postpartum hour
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It is a five-point Likert-type scale that evaluates the physical, psychological, sociocultural and environmental comfort of mothers who had cesarean section and normal spontaneous delivery.
The lowest and the highest scores that can be obtained from the 34-item scale are 34 and 170, respectively.
High scores obtained from the scale indicate that the level of comfort increases.
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2nd postpartum hour
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Systolic blood pressure
Prazo: 2nd postpartum hour
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All of women were measured from the cubital fossa area using a digital sphygmomanometer.
In order to ensure consistency in the measurement of physiological parameters, measurements were conducted on the women using the same devices.
The first measurement of the physiological parameters of the women in both the experimental and control groups was recorded when they agreed to participate in the study.
The measurement taken at the 2nd postpartum hour will be accepted.
It will not be combined with the value measured at another time.
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2nd postpartum hour
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Diastolic blood pressure
Prazo: 2nd postpartum hour
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All of women were measured from the cubital fossa area using a digital sphygmomanometer.
In order to ensure consistency in the measurement of physiological parameters, measurements were conducted on the women using the same devices.
The first measurement of the physiological parameters of the women in both the experimental and control groups was recorded when they agreed to participate in the study.
The measurement taken at the 2nd postpartum hour will be accepted.
It will not be combined with the value measured at another time.
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2nd postpartum hour
|
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Pulse
Prazo: 2nd postpartum hour
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Pulse was measured using a digital sphygmomanometer.
In order to ensure consistency in the measurement of physiological parameters, measurements were conducted on the women using the same devices.
The first measurement of the physiological parameters of the women in both the experimental and control groups was recorded when they agreed to participate in the study.
The measurement taken at the 2nd postpartum hour will be accepted.
It will not be combined with the value measured at another time.
|
2nd postpartum hour
|
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Body temperature
Prazo: 2nd postpartum hour
|
Body temperature was measured from the forehead using a non-contact thermometer.
In order to ensure consistency in the measurement of physiological parameters, measurements were conducted on the women using the same devices.
The first measurement of the physiological parameters of the women in both the experimental and control groups was recorded when they agreed to participate in the study.
The measurement taken at the 2nd postpartum hour will be accepted.
It will not be combined with the value measured at another time.
|
2nd postpartum hour
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Post-Test State, Trait Anxiety
Prazo: 24th postpartum hour
|
The State, Trait Anxiety Inventory consists of two subscales, being state and trait anxiety subscales, and 40 items.
The State Anxiety Inventory determines how an individual feels at a certain moment and under certain conditions, and the Trait Anxiety Inventory on the other hand, generally determines how one feels.
High scores indicate a high level of anxiety.
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24th postpartum hour
|
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Post-Test postpartum Comfort Scale
Prazo: 24th postpartum hour
|
It is a five-point Likert-type scale that evaluates the physical, psychological, sociocultural and environmental comfort of mothers who had cesarean section and normal spontaneous delivery.
The lowest and the highest scores that can be obtained from the 34-item scale are 34 and 170, respectively.
High scores obtained from the scale indicate that the level of comfort increases.
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24th postpartum hour
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Systolic blood pressure
Prazo: 20th postpartum hour
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All of women were measured from the cubital fossa area using a digital sphygmomanometer.
In order to ensure consistency in the measurement of physiological parameters, measurements were conducted on the women using the same devices.
The measurement taken at the 20th postpartum hour will be accepted.
It will not be combined with the value measured at another time.
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20th postpartum hour
|
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Diastolic blood pressure
Prazo: 20th postpartum hour
|
All of women were measured from the cubital fossa area using a digital sphygmomanometer.
In order to ensure consistency in the measurement of physiological parameters, measurements were conducted on the women using the same devices.
The measurement taken at the 20th postpartum hour will be accepted.
It will not be combined with the value measured at another time.
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20th postpartum hour
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Pulse
Prazo: 20th postpartum hour
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Pulse was measured using a digital sphygmomanometer.
In order to ensure consistency in the measurement of physiological parameters, measurements were conducted on the women using the same devices.
The measurement taken at the 20th postpartum hour will be accepted.
It will not be combined with the value measured at another time.
|
20th postpartum hour
|
|
Body temperature
Prazo: 20th postpartum hour
|
Body temperature was measured from the forehead using a non-contact thermometer.
In order to ensure consistency in the measurement of physiological parameters, measurements were conducted on the women using the same devices.
The measurement taken at the 20th postpartum hour will be accepted.
It will not be combined with the value measured at another time.
|
20th postpartum hour
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Aysegul Durmaz, Ph.D., Kütahya Health Science University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Ceylan B, Eser I. Assessment of individualized nursing care in hospitalized patients in a university hospital in Turkey. J Nurs Manag. 2016 Oct;24(7):954-961. doi: 10.1111/jonm.12400. Epub 2016 Jun 14.
- Finlayson K, Crossland N, Bonet M, Downe S. What matters to women in the postnatal period: A meta-synthesis of qualitative studies. PLoS One. 2020 Apr 22;15(4):e0231415. doi: 10.1371/journal.pone.0231415. eCollection 2020.
- Durmaz A, Komurcu N. Relationship Between Maternal Characteristics and Postpartum Hemorrhage: A Meta-Analysis Study. J Nurs Res. 2018 Oct;26(5):362-372. doi: 10.1097/jnr.0000000000000245.
- Verbiest S, Tully K, Simpson M, Stuebe A. Elevating mothers' voices: recommendations for improved patient-centered postpartum. J Behav Med. 2018 Oct;41(5):577-590. doi: 10.1007/s10865-018-9961-4. Epub 2018 Aug 9.
- Fontein-Kuipers Y, de Groot R, van Staa A. Woman-centered care 2.0: Bringing the concept into focus. Eur J Midwifery. 2018 May 30;2:5. doi: 10.18332/ejm/91492. eCollection 2018.
- Verbiest S, Bonzon E, Handler A. Postpartum Health and Wellness: A Call for Quality Woman-Centered Care. Matern Child Health J. 2016 Nov;20(Suppl 1):1-7. doi: 10.1007/s10995-016-2188-5.
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 (Real)
11 de fevereiro de 2019
Conclusão Primária (Real)
31 de agosto de 2019
Conclusão do estudo (Real)
11 de fevereiro de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
2 de fevereiro de 2022
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de fevereiro de 2022
Primeira postagem (Real)
24 de fevereiro de 2022
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de fevereiro de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de fevereiro de 2022
Última verificação
1 de fevereiro de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Woman-Cent. Care on Anx.
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
all IPD that underlie results in a publication
Prazo de Compartilhamento de IPD
Starting 6 months after publication
Critérios de acesso de compartilhamento IPD
If study' IPD are used, my article should be cited.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
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Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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