'I've Changed My Mind', Mindfulness-Based Childbirth and Parenting (MBCP) for pregnant women with a high level of fear of childbirth and their partners: study protocol of the quasi-experimental controlled trial
Approximately 25 % of pregnant women suffer from a high level of Fear of Childbirth (FoC), as assessed by the Wijma Delivery Expectancy Questionnaire (W-DEQ-A, score ≥66). FoC negatively affects pregnant women's mental health and adaptation to the perinatal period. Mindfulness-Based Childbirth...
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| Veröffentlicht in: | BMC psychiatry 2016-11, Vol.16 (1), p.377, Article 377 |
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| creator | Veringa, Irena K de Bruin, Esther I Bardacke, Nancy Duncan, Larissa G van Steensel, Francisca J A Dirksen, Carmen D Bögels, Susan M |
| description | Approximately 25 % of pregnant women suffer from a high level of Fear of Childbirth (FoC), as assessed by the Wijma Delivery Expectancy Questionnaire (W-DEQ-A, score ≥66). FoC negatively affects pregnant women's mental health and adaptation to the perinatal period. Mindfulness-Based Childbirth and Parenting (MBCP) seems to be potentially effective in decreasing pregnancy-related anxiety and stress. We propose a theoretical model of Avoidance and Participation in Pregnancy, Birth and the Postpartum Period in order to explore FoC and to evaluate the underlying mechanisms of change of MBCP.
The 'I've Changed My Mind' study is a quasi-experimental controlled trial among 128 pregnant women (week 16-26) with a high level of FoC, and their partners. Women will be allocated to MBCP (intervention group) or to Fear of Childbirth Consultation (FoCC; comparison group). Primary outcomes are FoC, labour pain, and willingness to accept obstetrical interventions. Secondary outcomes are anxiety, depression, general stress, parental stress, quality of life, sleep quality, fatigue, satisfaction with childbirth, birth outcome, breastfeeding self-efficacy and cost-effectiveness. The total study duration for women is six months with four assessment waves: pre- and post-intervention, following the birth and closing the maternity leave period.
Given the high prevalence and severe negative impact of FoC this study can be of major importance if statistically and clinically meaningful benefits are found. Among the strengths of this study are the clinical-based experimental design, the extensive cognitive-emotional and behavioural measurements in pregnant women and their partners during the entire perinatal period, and the representativeness of study sample as well as generalizability of the study's results. The complex and innovative measurements of FoC in this study are an important strength in clinical research on FoC not only in pregnant women but also in their partners.
Dutch Trial Register (NTR): NTR4302 , registration date the 3rd of December 2013. |
| doi_str_mv | 10.1186/s12888-016-1070-8 |
| format | Article |
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The 'I've Changed My Mind' study is a quasi-experimental controlled trial among 128 pregnant women (week 16-26) with a high level of FoC, and their partners. Women will be allocated to MBCP (intervention group) or to Fear of Childbirth Consultation (FoCC; comparison group). Primary outcomes are FoC, labour pain, and willingness to accept obstetrical interventions. Secondary outcomes are anxiety, depression, general stress, parental stress, quality of life, sleep quality, fatigue, satisfaction with childbirth, birth outcome, breastfeeding self-efficacy and cost-effectiveness. The total study duration for women is six months with four assessment waves: pre- and post-intervention, following the birth and closing the maternity leave period.
Given the high prevalence and severe negative impact of FoC this study can be of major importance if statistically and clinically meaningful benefits are found. Among the strengths of this study are the clinical-based experimental design, the extensive cognitive-emotional and behavioural measurements in pregnant women and their partners during the entire perinatal period, and the representativeness of study sample as well as generalizability of the study's results. The complex and innovative measurements of FoC in this study are an important strength in clinical research on FoC not only in pregnant women but also in their partners.
Dutch Trial Register (NTR): NTR4302 , registration date the 3rd of December 2013.</description><identifier>ISSN: 1471-244X</identifier><identifier>EISSN: 1471-244X</identifier><identifier>DOI: 10.1186/s12888-016-1070-8</identifier><identifier>PMID: 27821151</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Adult ; Anxiety ; Behavior modification ; Births ; Childbirth ; Childbirth & labor ; Clinical trials ; Cohen's d ; Delivery, Obstetric - psychology ; Fear ; Female ; Humans ; Medical referrals ; Methods ; Midwifery ; Mindfulness ; Mothers - psychology ; Obstetric Labor Complications - psychology ; Pain ; Parenting ; Parturition - psychology ; Patient Education as Topic - methods ; Postpartum Period - psychology ; Pregnancy ; Pregnancy Complications - psychology ; Pregnancy Outcome - psychology ; Pregnant women ; Pregnant Women - psychology ; Prenatal Care - methods ; Psychiatry ; Psychological aspects ; Quality of Life ; Self Efficacy ; Stress, Psychological - psychology ; Study Protocol ; Surveys and Questionnaires ; Womens health ; Young Adult</subject><ispartof>BMC psychiatry, 2016-11, Vol.16 (1), p.377, Article 377</ispartof><rights>COPYRIGHT 2016 BioMed Central Ltd.</rights><rights>Copyright BioMed Central 2016</rights><rights>The Author(s). 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c494t-13c1c89caee1e10733b792521499a86d8573e7f6ed4757906cd404944b4b39403</citedby><cites>FETCH-LOGICAL-c494t-13c1c89caee1e10733b792521499a86d8573e7f6ed4757906cd404944b4b39403</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5100329/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5100329/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27903,27904,53770,53772</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27821151$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Veringa, Irena K</creatorcontrib><creatorcontrib>de Bruin, Esther I</creatorcontrib><creatorcontrib>Bardacke, Nancy</creatorcontrib><creatorcontrib>Duncan, Larissa G</creatorcontrib><creatorcontrib>van Steensel, Francisca J A</creatorcontrib><creatorcontrib>Dirksen, Carmen D</creatorcontrib><creatorcontrib>Bögels, Susan M</creatorcontrib><title>'I've Changed My Mind', Mindfulness-Based Childbirth and Parenting (MBCP) for pregnant women with a high level of fear of childbirth and their partners: study protocol of the quasi-experimental controlled trial</title><title>BMC psychiatry</title><addtitle>BMC Psychiatry</addtitle><description>Approximately 25 % of pregnant women suffer from a high level of Fear of Childbirth (FoC), as assessed by the Wijma Delivery Expectancy Questionnaire (W-DEQ-A, score ≥66). FoC negatively affects pregnant women's mental health and adaptation to the perinatal period. Mindfulness-Based Childbirth and Parenting (MBCP) seems to be potentially effective in decreasing pregnancy-related anxiety and stress. We propose a theoretical model of Avoidance and Participation in Pregnancy, Birth and the Postpartum Period in order to explore FoC and to evaluate the underlying mechanisms of change of MBCP.
The 'I've Changed My Mind' study is a quasi-experimental controlled trial among 128 pregnant women (week 16-26) with a high level of FoC, and their partners. Women will be allocated to MBCP (intervention group) or to Fear of Childbirth Consultation (FoCC; comparison group). Primary outcomes are FoC, labour pain, and willingness to accept obstetrical interventions. Secondary outcomes are anxiety, depression, general stress, parental stress, quality of life, sleep quality, fatigue, satisfaction with childbirth, birth outcome, breastfeeding self-efficacy and cost-effectiveness. The total study duration for women is six months with four assessment waves: pre- and post-intervention, following the birth and closing the maternity leave period.
Given the high prevalence and severe negative impact of FoC this study can be of major importance if statistically and clinically meaningful benefits are found. Among the strengths of this study are the clinical-based experimental design, the extensive cognitive-emotional and behavioural measurements in pregnant women and their partners during the entire perinatal period, and the representativeness of study sample as well as generalizability of the study's results. The complex and innovative measurements of FoC in this study are an important strength in clinical research on FoC not only in pregnant women but also in their partners.
Dutch Trial Register (NTR): NTR4302 , registration date the 3rd of December 2013.</description><subject>Adult</subject><subject>Anxiety</subject><subject>Behavior modification</subject><subject>Births</subject><subject>Childbirth</subject><subject>Childbirth & labor</subject><subject>Clinical trials</subject><subject>Cohen's d</subject><subject>Delivery, Obstetric - psychology</subject><subject>Fear</subject><subject>Female</subject><subject>Humans</subject><subject>Medical referrals</subject><subject>Methods</subject><subject>Midwifery</subject><subject>Mindfulness</subject><subject>Mothers - psychology</subject><subject>Obstetric Labor Complications - psychology</subject><subject>Pain</subject><subject>Parenting</subject><subject>Parturition - psychology</subject><subject>Patient Education as Topic - methods</subject><subject>Postpartum Period - psychology</subject><subject>Pregnancy</subject><subject>Pregnancy Complications - psychology</subject><subject>Pregnancy Outcome - psychology</subject><subject>Pregnant women</subject><subject>Pregnant Women - psychology</subject><subject>Prenatal Care - methods</subject><subject>Psychiatry</subject><subject>Psychological aspects</subject><subject>Quality of Life</subject><subject>Self Efficacy</subject><subject>Stress, Psychological - psychology</subject><subject>Study Protocol</subject><subject>Surveys and Questionnaires</subject><subject>Womens health</subject><subject>Young Adult</subject><issn>1471-244X</issn><issn>1471-244X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNptUl1v0zAUjRCIjcIP4AVZ4qFDIsOOncbZA9JW8TFpFXsAiTfLdW4ST67d2U5H_ya_CGcd1YqQH6517znnfuhk2WuCTwnhsw-BFJzzHJNZTnCFc_4kOyasInnB2M-nj_5H2YsQbjAmFS_J8-yoqHhBSEmOs9_Ty-kG0LyXtoMGLbZooW0zfX8f2sFYCCG_kCHV5r02zVL72CNpG3QtPdiobYdOFhfz63eodR6tPXRW2oju3AosutMjGPW665GBDRjkWtSC9GNUh3qxB50EpI8WfDhDIQ7NNgm66JS7JyYEuh1k0Dn8WoPXqUOUBilno3fGpBGj19K8zJ610gR49RAn2Y_Pn77Pv-ZX375czs-vcsVqFnNCFVG8VhKAQDofpcuqLsqCsLqWfNbwsqJQtTNoWFVWNZ6phuHEZEu2pDXDdJJ93Omuh-UKGpWm8dKIdRpM-q1wUovDitW96NxGlARjWtRJ4ORBwLvbAUIUKx0UGCMtuCEIwmlVcMbo2OvtP9AbN3ib1ksoVlJGaNpgj-qkAaFt61JfNYqKc1bhkpezpDnJTv-DSq-BlU7HhFan_AGB7AjKuxA8tPsdCRajEcXOiCIZUYxGFCPnzePj7Bl_nUf_ALXs2eA</recordid><startdate>20161107</startdate><enddate>20161107</enddate><creator>Veringa, Irena K</creator><creator>de Bruin, Esther I</creator><creator>Bardacke, Nancy</creator><creator>Duncan, Larissa G</creator><creator>van Steensel, Francisca J A</creator><creator>Dirksen, Carmen D</creator><creator>Bögels, Susan M</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20161107</creationdate><title>'I've Changed My Mind', Mindfulness-Based Childbirth and Parenting (MBCP) for pregnant women with a high level of fear of childbirth and their partners: study protocol of the quasi-experimental controlled trial</title><author>Veringa, Irena K ; de Bruin, Esther I ; Bardacke, Nancy ; Duncan, Larissa G ; van Steensel, Francisca J A ; Dirksen, Carmen D ; Bögels, Susan M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c494t-13c1c89caee1e10733b792521499a86d8573e7f6ed4757906cd404944b4b39403</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Anxiety</topic><topic>Behavior modification</topic><topic>Births</topic><topic>Childbirth</topic><topic>Childbirth & labor</topic><topic>Clinical trials</topic><topic>Cohen's d</topic><topic>Delivery, Obstetric - psychology</topic><topic>Fear</topic><topic>Female</topic><topic>Humans</topic><topic>Medical referrals</topic><topic>Methods</topic><topic>Midwifery</topic><topic>Mindfulness</topic><topic>Mothers - psychology</topic><topic>Obstetric Labor Complications - psychology</topic><topic>Pain</topic><topic>Parenting</topic><topic>Parturition - psychology</topic><topic>Patient Education as Topic - methods</topic><topic>Postpartum Period - psychology</topic><topic>Pregnancy</topic><topic>Pregnancy Complications - psychology</topic><topic>Pregnancy Outcome - psychology</topic><topic>Pregnant women</topic><topic>Pregnant Women - psychology</topic><topic>Prenatal Care - methods</topic><topic>Psychiatry</topic><topic>Psychological aspects</topic><topic>Quality of Life</topic><topic>Self Efficacy</topic><topic>Stress, Psychological - psychology</topic><topic>Study Protocol</topic><topic>Surveys and Questionnaires</topic><topic>Womens health</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Veringa, Irena K</creatorcontrib><creatorcontrib>de Bruin, Esther I</creatorcontrib><creatorcontrib>Bardacke, Nancy</creatorcontrib><creatorcontrib>Duncan, Larissa G</creatorcontrib><creatorcontrib>van Steensel, Francisca J A</creatorcontrib><creatorcontrib>Dirksen, Carmen D</creatorcontrib><creatorcontrib>Bögels, Susan M</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Neurosciences Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMC psychiatry</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Veringa, Irena K</au><au>de Bruin, Esther I</au><au>Bardacke, Nancy</au><au>Duncan, Larissa G</au><au>van Steensel, Francisca J A</au><au>Dirksen, Carmen D</au><au>Bögels, Susan M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>'I've Changed My Mind', Mindfulness-Based Childbirth and Parenting (MBCP) for pregnant women with a high level of fear of childbirth and their partners: study protocol of the quasi-experimental controlled trial</atitle><jtitle>BMC psychiatry</jtitle><addtitle>BMC Psychiatry</addtitle><date>2016-11-07</date><risdate>2016</risdate><volume>16</volume><issue>1</issue><spage>377</spage><pages>377-</pages><artnum>377</artnum><issn>1471-244X</issn><eissn>1471-244X</eissn><abstract>Approximately 25 % of pregnant women suffer from a high level of Fear of Childbirth (FoC), as assessed by the Wijma Delivery Expectancy Questionnaire (W-DEQ-A, score ≥66). FoC negatively affects pregnant women's mental health and adaptation to the perinatal period. Mindfulness-Based Childbirth and Parenting (MBCP) seems to be potentially effective in decreasing pregnancy-related anxiety and stress. We propose a theoretical model of Avoidance and Participation in Pregnancy, Birth and the Postpartum Period in order to explore FoC and to evaluate the underlying mechanisms of change of MBCP.
The 'I've Changed My Mind' study is a quasi-experimental controlled trial among 128 pregnant women (week 16-26) with a high level of FoC, and their partners. Women will be allocated to MBCP (intervention group) or to Fear of Childbirth Consultation (FoCC; comparison group). Primary outcomes are FoC, labour pain, and willingness to accept obstetrical interventions. Secondary outcomes are anxiety, depression, general stress, parental stress, quality of life, sleep quality, fatigue, satisfaction with childbirth, birth outcome, breastfeeding self-efficacy and cost-effectiveness. The total study duration for women is six months with four assessment waves: pre- and post-intervention, following the birth and closing the maternity leave period.
Given the high prevalence and severe negative impact of FoC this study can be of major importance if statistically and clinically meaningful benefits are found. Among the strengths of this study are the clinical-based experimental design, the extensive cognitive-emotional and behavioural measurements in pregnant women and their partners during the entire perinatal period, and the representativeness of study sample as well as generalizability of the study's results. The complex and innovative measurements of FoC in this study are an important strength in clinical research on FoC not only in pregnant women but also in their partners.
Dutch Trial Register (NTR): NTR4302 , registration date the 3rd of December 2013.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>27821151</pmid><doi>10.1186/s12888-016-1070-8</doi><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Anxiety Behavior modification Births Childbirth Childbirth & labor Clinical trials Cohen's d Delivery, Obstetric - psychology Fear Female Humans Medical referrals Methods Midwifery Mindfulness Mothers - psychology Obstetric Labor Complications - psychology Pain Parenting Parturition - psychology Patient Education as Topic - methods Postpartum Period - psychology Pregnancy Pregnancy Complications - psychology Pregnancy Outcome - psychology Pregnant women Pregnant Women - psychology Prenatal Care - methods Psychiatry Psychological aspects Quality of Life Self Efficacy Stress, Psychological - psychology Study Protocol Surveys and Questionnaires Womens health Young Adult |
| title | 'I've Changed My Mind', Mindfulness-Based Childbirth and Parenting (MBCP) for pregnant women with a high level of fear of childbirth and their partners: study protocol of the quasi-experimental controlled trial |
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