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A feasibility study for a randomised controlled trial of the Positive Reappraisal Coping Intervention, a novel supportive technique for recurrent miscarriage.
BMJ Open. 2015 Apr 15; 5(4):e007322.BO

Abstract

INTRODUCTION

Recurrent miscarriage (RM) is diagnosed when a woman has had three or more miscarriages. Increased levels of distress and anxiety are common during the waiting period of any subsequent pregnancies, posing a significant threat to psychological well-being. However, only limited support and therapy are available for these women, and many are left to cope alone. The Positive Reappraisal Coping Intervention (PRCI) is a novel self-administered supportive technique which has been shown to be effective in patients awaiting the outcome of in vitro fertilisation treatment. The primary objective of this study is to assess the feasibility and effectiveness of the PRCI in improving quality of life in the difficult waiting period which women with previous RM endure before an ongoing pregnancy can be confirmed.

METHODS AND ANALYSIS

A randomised controlled trial (RCT) feasibility study will establish the viability of conducting a multicentre RCT to definitively test the effects of the PRCI on the psychological well-being of women who have experienced RM during the initial waiting period of a subsequent pregnancy. A second component consists of a qualitative process evaluation exploring the initial experience of pregnancy following repeated miscarriages. Participants (n=50) will be randomised into one of two groups. The PRCI intervention group will receive the PRCI card and weekly questionnaires to assess their psychological well-being during the waiting period of their new pregnancy. The non-intervention group will be asked to complete the same weekly questionnaires. The qualitative process analysis will employ semistructured interviews (n=20) to address relevant aspects of the study objectives.

ETHICS AND DISSEMINATION

Ethics approval has been obtained from the National Research Ethics Service Committee South Central-Hampshire A. Participating centres have given National Health Service R&D approval. Study findings will be disseminated through peer reviewed journals, national and international conferences and lay user groups.

TRIAL REGISTRATION NUMBER

ISRCTN43571276. This study was registered with the ISRCTN 18/02/2014 following adoption onto the United Kingdom Clinical Research Network (UKCRN) portfolio. Recruitment of the first participant occurred 04/02/2014.

Authors+Show Affiliations

Faculty of Health Sciences, University of Southampton, Southampton, UK.Faculty of Health Sciences, University of Southampton, Southampton, UK.School of Psychology, Cardiff University, Cardiff, UK.Department of Obstetrics and Gynaecology, Academic Unit of Human Development and Health, University of Southampton, Southampton, UK.Faculty of Medicine, University of Southampton, Southampton, UK.Department of Obstetrics and Gynaecology, Academic Unit of Human Development and Health, University of Southampton, Southampton, UK.

Pub Type(s)

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

Language

eng

PubMed ID

25877278

Citation

Bailey, Sarah, et al. "A Feasibility Study for a Randomised Controlled Trial of the Positive Reappraisal Coping Intervention, a Novel Supportive Technique for Recurrent Miscarriage." BMJ Open, vol. 5, no. 4, 2015, pp. e007322.
Bailey S, Bailey C, Boivin J, et al. A feasibility study for a randomised controlled trial of the Positive Reappraisal Coping Intervention, a novel supportive technique for recurrent miscarriage. BMJ Open. 2015;5(4):e007322.
Bailey, S., Bailey, C., Boivin, J., Cheong, Y., Reading, I., & Macklon, N. (2015). A feasibility study for a randomised controlled trial of the Positive Reappraisal Coping Intervention, a novel supportive technique for recurrent miscarriage. BMJ Open, 5(4), e007322. https://doi.org/10.1136/bmjopen-2014-007322
Bailey S, et al. A Feasibility Study for a Randomised Controlled Trial of the Positive Reappraisal Coping Intervention, a Novel Supportive Technique for Recurrent Miscarriage. BMJ Open. 2015 Apr 15;5(4):e007322. PubMed PMID: 25877278.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A feasibility study for a randomised controlled trial of the Positive Reappraisal Coping Intervention, a novel supportive technique for recurrent miscarriage. AU - Bailey,Sarah, AU - Bailey,Chris, AU - Boivin,Jacky, AU - Cheong,Ying, AU - Reading,Isabel, AU - Macklon,Nick, Y1 - 2015/04/15/ PY - 2015/4/17/entrez PY - 2015/4/17/pubmed PY - 2015/12/29/medline KW - GYNAECOLOGY SP - e007322 EP - e007322 JF - BMJ open JO - BMJ Open VL - 5 IS - 4 N2 - INTRODUCTION: Recurrent miscarriage (RM) is diagnosed when a woman has had three or more miscarriages. Increased levels of distress and anxiety are common during the waiting period of any subsequent pregnancies, posing a significant threat to psychological well-being. However, only limited support and therapy are available for these women, and many are left to cope alone. The Positive Reappraisal Coping Intervention (PRCI) is a novel self-administered supportive technique which has been shown to be effective in patients awaiting the outcome of in vitro fertilisation treatment. The primary objective of this study is to assess the feasibility and effectiveness of the PRCI in improving quality of life in the difficult waiting period which women with previous RM endure before an ongoing pregnancy can be confirmed. METHODS AND ANALYSIS: A randomised controlled trial (RCT) feasibility study will establish the viability of conducting a multicentre RCT to definitively test the effects of the PRCI on the psychological well-being of women who have experienced RM during the initial waiting period of a subsequent pregnancy. A second component consists of a qualitative process evaluation exploring the initial experience of pregnancy following repeated miscarriages. Participants (n=50) will be randomised into one of two groups. The PRCI intervention group will receive the PRCI card and weekly questionnaires to assess their psychological well-being during the waiting period of their new pregnancy. The non-intervention group will be asked to complete the same weekly questionnaires. The qualitative process analysis will employ semistructured interviews (n=20) to address relevant aspects of the study objectives. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the National Research Ethics Service Committee South Central-Hampshire A. Participating centres have given National Health Service R&D approval. Study findings will be disseminated through peer reviewed journals, national and international conferences and lay user groups. TRIAL REGISTRATION NUMBER: ISRCTN43571276. This study was registered with the ISRCTN 18/02/2014 following adoption onto the United Kingdom Clinical Research Network (UKCRN) portfolio. Recruitment of the first participant occurred 04/02/2014. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/25877278/A_feasibility_study_for_a_randomised_controlled_trial_of_the_Positive_Reappraisal_Coping_Intervention_a_novel_supportive_technique_for_recurrent_miscarriage_ L2 - https://bmjopen.bmj.com/lookup/pmidlookup?view=long&pmid=25877278 DB - PRIME DP - Unbound Medicine ER -