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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

A feasibility study for a randomised controlled trial of the Positive Reappraisal Coping Intervention, a novel supportive technique for recurrent miscarriage
A feasibility study for a randomised controlled trial of the Positive Reappraisal Coping Intervention, a novel supportive technique for recurrent miscarriage
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
e007322-e007322
Bailey, S.
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Bailey, C.
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Boivin, J.
b99698f8-bfae-4d46-b0cb-69bd1c7b2a11
Cheong, Y.
4efbba2a-3036-4dce-82f1-8b4017952c83
Reading, I.
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Macklon, N.
7db1f4fc-a9f6-431f-a1f2-297bb8c9fb7e
Bailey, S.
60a95335-0ecb-419a-bb32-d61da0f1db2b
Bailey, C.
af803055-3a2d-42cf-813c-47558ca0a3e5
Boivin, J.
b99698f8-bfae-4d46-b0cb-69bd1c7b2a11
Cheong, Y.
4efbba2a-3036-4dce-82f1-8b4017952c83
Reading, I.
6f832276-87b7-4a76-a9ed-b4b3df0a3f66
Macklon, N.
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Bailey, S., Bailey, C., Boivin, J., Cheong, Y., Reading, I. and 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-e007322. (doi:10.1136/bmjopen-2014-007322).

Record type: Article

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

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More information

Accepted/In Press date: 13 January 2015
e-pub ahead of print date: 15 April 2015
Published date: 15 April 2015
Organisations: Faculty of Medicine

Identifiers

Local EPrints ID: 376155
URI: http://eprints.soton.ac.uk/id/eprint/376155
PURE UUID: 2fa33d1e-0c9f-41d8-9f90-c2a49a897269
ORCID for C. Bailey: ORCID iD orcid.org/0000-0002-7528-6264
ORCID for Y. Cheong: ORCID iD orcid.org/0000-0001-7687-4597
ORCID for I. Reading: ORCID iD orcid.org/0000-0002-1457-6532

Catalogue record

Date deposited: 16 Apr 2015 10:07
Last modified: 29 Oct 2019 01:59

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