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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Utrecht, Pays-Bas, : PO Box 85500
- University Medical Center Utrecht
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patient in IVF/ICSI treatment
Exclusion Criteria:
- Patient who do not speak the dutch language
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: PRCI-monitoring
Coping intervention, Daily Record Keeping, Questionnaires
|
Positive reappraisal coping intervention
|
|
Aucune intervention: Routine care control
Questionnaires
|
|
|
Aucune intervention: Monitoring control
DRK and Questionnaires
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Anxiety
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Depression
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: N.S. Macklon, MD, PhD, University of Southampton
- Chercheur principal: J Boivin, PhD, Cardiff University
Publications et liens utiles
Publications générales
- 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.
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PRCI study
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .