Coping Intervention After Embryo Transfer
Study of the Effectiveness of a Coping Selfhelp Intervention for Women in the Waiting Period After an Embryo Transfer During an IVF/ISCI Treatment
Background of the study:
Undergoing an IVF or ICSI treatment is an emotional and physical burden for both the woman and her partner. Most stressful for the couple is waiting for the result of the treatment, the period after the embryotransfer until the pregnancy test or menstruation and an unsuccessful treatment. Symptoms of anxiety and depression have been identified in couples during the waitingperiod after an embryotransfer. For this waitingperiod a short selfhelp copingintervention has been developed based on the stress theory of Lazarus for women to use at home. Goal of the instrument is to stimulate the copingstyle positive reappraisal. Research has demonstrated that using this copingstyle can have a positive impact in health related circumstances.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Objective of the study:
To investigate if a short copingintervention reduces anxiety in patients undergoing an IVF or ICSI treatment in the UMCU during the waitingperiod after an embryotransfer.
Study design:
In this research a randomised controlled trial (RCT) will be used for three groups. The choice for three groups has been based on earlier research with a daily record keeping (DRK). The DRK is a daily measurement for emotions, copingstyle and physical complaints. Previous research with the DRK showed an increase of anxiety. More research must be done of the impact of the DRK. Group 1: Positive Reappraisal Coping Intervention (PRCI) & DRK & questionnaires Group 2: DRK & questionnaires Group 3: Standard care & questionnaires
Study population:
Patients undergoing an IVF or ICSI treatment in the UMCU.
Intervention (if applicable):
A selfhelp coping intervention
Primary study parameters/outcome of the study:
Anxiety
Secondary study parameters/outcome of the study (if applicable):
Risk of emotional problems copingstyle depression vital pregnancy quality of life
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
Using the coping intervention may reduce anxiety for the patient. The use of this instrument is not a burden for patients. The burden for patients is to complete questionnaires before, during and six weeks after the embryotransfer. Partners are asked to fill in a questionnaire at three times.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Utrecht, Holanda, : PO Box 85500
- University Medical Center Utrecht
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patient in IVF/ICSI treatment
Exclusion Criteria:
- Patient who do not speak the dutch language
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: PRCI-monitoring
Coping intervention, Daily Record Keeping, Questionnaires
|
Positive reappraisal coping intervention
|
|
Sem intervenção: Routine care control
Questionnaires
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|
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Sem intervenção: Monitoring control
DRK and Questionnaires
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Anxiety
Prazo: T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer
|
The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983).
TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale.
The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21).
Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.
|
T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Depression
Prazo: T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer
|
The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983).
TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale.
The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21).
Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.
|
T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: N.S. Macklon, MD, PhD, University of Southampton
- Investigador principal: J Boivin, PhD, Cardiff University
Publicações e links úteis
Publicações Gerais
- Ockhuijsen H, van den Hoogen A, Eijkemans M, Macklon N, Boivin J. The impact of a self-administered coping intervention on emotional well-being in women awaiting the outcome of IVF treatment: a randomized controlled trial. Hum Reprod. 2014 Jul;29(7):1459-70. doi: 10.1093/humrep/deu093. Epub 2014 May 7.
- Ockhuijsen HD, van den Hoogen A, Macklon NS, Boivin J. The PRCI study: design of a randomized clinical trial to evaluate a coping intervention for medical waiting periods used by women undergoing a fertility treatment. BMC Womens Health. 2013 Sep 3;13:35. doi: 10.1186/1472-6874-13-35.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
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
- PRCI study
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