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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Utrecht, Países Bajos, : PO Box 85500
- University Medical Center Utrecht
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patient in IVF/ICSI treatment
Exclusion Criteria:
- Patient who do not speak the dutch language
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: PRCI-monitoring
Coping intervention, Daily Record Keeping, Questionnaires
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Positive reappraisal coping intervention
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|
Sin intervención: Routine care control
Questionnaires
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|
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Sin intervención: Monitoring control
DRK and Questionnaires
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Anxiety
Periodo de tiempo: 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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Depression
Periodo de tiempo: 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
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PRCI study
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