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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 03; 13:35.BW

Abstract

BACKGROUND

Many medical situations necessitate a stressful period of waiting for potentially threatening test results. The medical waiting period is often associated with negative anticipatory anxiety and rumination about the outcome of treatment. Few evidence-based self-help coping interventions are available to assist individuals manage these periods. Theory and research suggest that positive reappraisal coping strategies may be particularly useful for this type of unpredictable and uncontrollable stressful context. The objective of this study is to investigate the effects of a Positive Reappraisal Coping Intervention (PRCI) on psychological well-being of women waiting for the outcome of their fertility treatment cycle.

METHODS/DESIGN

In a three-armed randomized controlled trial, the effectiveness of the PRCI will be tested. Consecutive patients undergoing in vitro fertilisation in a Dutch university hospital and meeting selection criteria will be invited to participate. Those who agree will be randomized to one of three experimental groups (N=372). The PRCI Intervention group will receive the intervention that comprises an explanatory leaflet and the 10 statements designed to promote positive reappraisal coping, to be read at least once in the morning, once in the evening. To capture the general impact of PRCI on psychological wellbeing patients will complete questionnaires before the waiting period (pre-intervention), on day ten of the 14-day waiting period (intervention) and six weeks after the start of the waiting period (post-intervention). To capture the specific effects of the PRCI during the waiting period, patients will also be asked to monitor daily their emotions and reactions during the 14-day waiting period. The primary outcome is general anxiety, measured by the Hospital Anxiety and Depression Scale. Secondary outcomes are positive and negative emotions during the waiting period, depression, quality of life, coping and treatment outcome. During recruitment for the RCT it was decided to add a fourth non-randomized group, a PRCI Control group that received the PRCI and completed the questionnaires but did not complete daily monitoring.

DISCUSSION

Positive reappraisal is one of the few ways of coping that has been shown to be associated with increased wellbeing during unpredictable and uncontrollable situations like medical waiting periods. A simple evidence based self-help intervention could facilitate coping during this common medical situation. This RCT study will evaluate the value of a self-help coping intervention designed for medical waiting periods in women undergoing fertility treatment.

TRIAL REGISTRATION

The study is registered at the Clinical Tials.gov (NCT01701011).

Authors+Show Affiliations

Department of Reproductive Medicine and Gynaecology, University Medical Centre Utrecht, Utrecht, the Netherlands. h.d.l.ockhuysen@umcutrecht.nl.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24004640

Citation

Ockhuijsen, Henrietta D L., et al. "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 Women's Health, vol. 13, 2013, p. 35.
Ockhuijsen HD, van den Hoogen A, Macklon NS, et al. 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;13:35.
Ockhuijsen, H. D., van den Hoogen, A., Macklon, N. S., & Boivin, J. (2013). 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 Women's Health, 13, 35. https://doi.org/10.1186/1472-6874-13-35
Ockhuijsen HD, et al. 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. PubMed PMID: 24004640.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Ockhuijsen,Henrietta D L, AU - van den Hoogen,Agnes, AU - Macklon,Nickolas S, AU - Boivin,Jacky, Y1 - 2013/09/03/ PY - 2013/02/11/received PY - 2013/08/30/accepted PY - 2013/9/6/entrez PY - 2013/9/6/pubmed PY - 2014/3/29/medline SP - 35 EP - 35 JF - BMC women's health JO - BMC Womens Health VL - 13 N2 - BACKGROUND: Many medical situations necessitate a stressful period of waiting for potentially threatening test results. The medical waiting period is often associated with negative anticipatory anxiety and rumination about the outcome of treatment. Few evidence-based self-help coping interventions are available to assist individuals manage these periods. Theory and research suggest that positive reappraisal coping strategies may be particularly useful for this type of unpredictable and uncontrollable stressful context. The objective of this study is to investigate the effects of a Positive Reappraisal Coping Intervention (PRCI) on psychological well-being of women waiting for the outcome of their fertility treatment cycle. METHODS/DESIGN: In a three-armed randomized controlled trial, the effectiveness of the PRCI will be tested. Consecutive patients undergoing in vitro fertilisation in a Dutch university hospital and meeting selection criteria will be invited to participate. Those who agree will be randomized to one of three experimental groups (N=372). The PRCI Intervention group will receive the intervention that comprises an explanatory leaflet and the 10 statements designed to promote positive reappraisal coping, to be read at least once in the morning, once in the evening. To capture the general impact of PRCI on psychological wellbeing patients will complete questionnaires before the waiting period (pre-intervention), on day ten of the 14-day waiting period (intervention) and six weeks after the start of the waiting period (post-intervention). To capture the specific effects of the PRCI during the waiting period, patients will also be asked to monitor daily their emotions and reactions during the 14-day waiting period. The primary outcome is general anxiety, measured by the Hospital Anxiety and Depression Scale. Secondary outcomes are positive and negative emotions during the waiting period, depression, quality of life, coping and treatment outcome. During recruitment for the RCT it was decided to add a fourth non-randomized group, a PRCI Control group that received the PRCI and completed the questionnaires but did not complete daily monitoring. DISCUSSION: Positive reappraisal is one of the few ways of coping that has been shown to be associated with increased wellbeing during unpredictable and uncontrollable situations like medical waiting periods. A simple evidence based self-help intervention could facilitate coping during this common medical situation. This RCT study will evaluate the value of a self-help coping intervention designed for medical waiting periods in women undergoing fertility treatment. TRIAL REGISTRATION: The study is registered at the Clinical Tials.gov (NCT01701011). SN - 1472-6874 UR - https://www.unboundmedicine.com/medline/citation/24004640/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_ L2 - https://bmcwomenshealth.biomedcentral.com/articles/10.1186/1472-6874-13-35 DB - PRIME DP - Unbound Medicine ER -