Birth ball for pregnant women in labour research protocol: a multi-centre randomised controlled trial
Abstract Background Birth ball is one of the non-pharmacologic pain relief methods to help mothers cope with the labouring process. A randomised controlled trial (RCT) is conducted to evaluate the effectiveness, safety and harm of birth ball use by pregnant women in labour compared to treatment as u...
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2019-05-01
|
| Series: | BMC Pregnancy and Childbirth |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12884-019-2305-8 |
| _version_ | 1819153288577155072 |
|---|---|
| author | May Pui Shan Yeung Katrina Wai Kay Tsang Benjamin Hon Kei Yip Wing Hung Tam Wan Yim Ip Florence Wai Lei Hau Margaret Kit Wah Wong Judy Wai Ying Ng Sau Ha Liu Sophia Shu Wing Chan Chi Kin Law Samuel Yeung Shan Wong |
| author_facet | May Pui Shan Yeung Katrina Wai Kay Tsang Benjamin Hon Kei Yip Wing Hung Tam Wan Yim Ip Florence Wai Lei Hau Margaret Kit Wah Wong Judy Wai Ying Ng Sau Ha Liu Sophia Shu Wing Chan Chi Kin Law Samuel Yeung Shan Wong |
| author_sort | May Pui Shan Yeung |
| collection | DOAJ |
| description | Abstract Background Birth ball is one of the non-pharmacologic pain relief methods to help mothers cope with the labouring process. A randomised controlled trial (RCT) is conducted to evaluate the effectiveness, safety and harm of birth ball use by pregnant women in labour compared to treatment as usual group. Methods A prospective multi-centre randomised controlled trial (RCT) will be conducted in Obstetrics and Gynaecological units of five public hospitals in Hong Kong, China. Data will be collected from March 2016 onward for 2 years. The target population is Chinese women with an uncomplicated singleton pregnancy at gestational age of 37 to 42 weeks. Participants are randomised based on parity (nulliparous and multiparous) and type of labour onset (spontaneous and induced). Women in the intervention group are actively offered and taught how to use a birth ball; those in the control group receive the usual midwifery care. The target sample size is 512. The primary outcome measures are maternal pain intensity, satisfaction with pain relief, sense of control in labour, assisted delivery and satisfaction with childbirth experience. Labour pain relief is measured by visual analogue scale (VAS). Other outcomes will be measured through four different validated questionnaires. To control for potential cluster effects, a linear mixed model will be used. An intention-to-treat analysis is adopted and performed by researchers unknown to subjects’ group allocation. Discussion Results will provide rigorous scientific evidence for policy development and practice. We are using stratified randomisation according to potential confounders of parity and type of labour onset to give four possible combinations. If the results are favourable, it will facilitate systematic implementation to promote birth ball use for women in labour. Trial registration Chinese Clinical Trial Register (ChiCTR), Registration number: ChiCTR-IIC-16008275, Date of registration 12 April 2016 (retrospectively registered), Date of enrolment of the first participant to the trial 1 March 2016. |
| first_indexed | 2024-12-22T15:02:48Z |
| format | Article |
| id | doaj.art-773937037a354b588e58fa9105ad41b8 |
| institution | Directory Open Access Journal |
| issn | 1471-2393 |
| language | English |
| last_indexed | 2024-12-22T15:02:48Z |
| publishDate | 2019-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pregnancy and Childbirth |
| spelling | doaj.art-773937037a354b588e58fa9105ad41b82022-12-21T18:22:05ZengBMCBMC Pregnancy and Childbirth1471-23932019-05-011911610.1186/s12884-019-2305-8Birth ball for pregnant women in labour research protocol: a multi-centre randomised controlled trialMay Pui Shan Yeung0Katrina Wai Kay Tsang1Benjamin Hon Kei Yip2Wing Hung Tam3Wan Yim Ip4Florence Wai Lei Hau5Margaret Kit Wah Wong6Judy Wai Ying Ng7Sau Ha Liu8Sophia Shu Wing Chan9Chi Kin Law10Samuel Yeung Shan Wong11Jockey Club School of Public Health and Primary Care (JCSPHPC), The Chinese University of Hong Kong (CUHK), Prince of Wales HospitalJockey Club School of Public Health and Primary Care (JCSPHPC), The Chinese University of Hong Kong (CUHK), Prince of Wales HospitalJockey Club School of Public Health and Primary Care (JCSPHPC), The Chinese University of Hong Kong (CUHK), Prince of Wales HospitalDepartment of Obstetrics & Gynaecology, The Chinese University of Hong KongNew Asia College, The Chinese University of Hong KongSchool of Midwifery, Prince of Wales HospitalDepartment of Obstetrics & Gynaecology, Prince of Wales HospitalDepartment of Obstetrics & Gynaecology, Princess Margaret HospitalDepartment of Obstetrics & Gynaecology, Pamela Youde Nethersole Eastern HospitalJockey Club School of Public Health and Primary Care (JCSPHPC), The Chinese University of Hong Kong (CUHK), Prince of Wales HospitalCentre for Applied Health Economics (CAHE), School of Medicine, University of GriffithJockey Club School of Public Health and Primary Care (JCSPHPC), The Chinese University of Hong Kong (CUHK), Prince of Wales HospitalAbstract Background Birth ball is one of the non-pharmacologic pain relief methods to help mothers cope with the labouring process. A randomised controlled trial (RCT) is conducted to evaluate the effectiveness, safety and harm of birth ball use by pregnant women in labour compared to treatment as usual group. Methods A prospective multi-centre randomised controlled trial (RCT) will be conducted in Obstetrics and Gynaecological units of five public hospitals in Hong Kong, China. Data will be collected from March 2016 onward for 2 years. The target population is Chinese women with an uncomplicated singleton pregnancy at gestational age of 37 to 42 weeks. Participants are randomised based on parity (nulliparous and multiparous) and type of labour onset (spontaneous and induced). Women in the intervention group are actively offered and taught how to use a birth ball; those in the control group receive the usual midwifery care. The target sample size is 512. The primary outcome measures are maternal pain intensity, satisfaction with pain relief, sense of control in labour, assisted delivery and satisfaction with childbirth experience. Labour pain relief is measured by visual analogue scale (VAS). Other outcomes will be measured through four different validated questionnaires. To control for potential cluster effects, a linear mixed model will be used. An intention-to-treat analysis is adopted and performed by researchers unknown to subjects’ group allocation. Discussion Results will provide rigorous scientific evidence for policy development and practice. We are using stratified randomisation according to potential confounders of parity and type of labour onset to give four possible combinations. If the results are favourable, it will facilitate systematic implementation to promote birth ball use for women in labour. Trial registration Chinese Clinical Trial Register (ChiCTR), Registration number: ChiCTR-IIC-16008275, Date of registration 12 April 2016 (retrospectively registered), Date of enrolment of the first participant to the trial 1 March 2016.http://link.springer.com/article/10.1186/s12884-019-2305-8Birth ballNon-pharmacologicalPain reliefPregnant womenRCT |
| spellingShingle | May Pui Shan Yeung Katrina Wai Kay Tsang Benjamin Hon Kei Yip Wing Hung Tam Wan Yim Ip Florence Wai Lei Hau Margaret Kit Wah Wong Judy Wai Ying Ng Sau Ha Liu Sophia Shu Wing Chan Chi Kin Law Samuel Yeung Shan Wong Birth ball for pregnant women in labour research protocol: a multi-centre randomised controlled trial BMC Pregnancy and Childbirth Birth ball Non-pharmacological Pain relief Pregnant women RCT |
| title | Birth ball for pregnant women in labour research protocol: a multi-centre randomised controlled trial |
| title_full | Birth ball for pregnant women in labour research protocol: a multi-centre randomised controlled trial |
| title_fullStr | Birth ball for pregnant women in labour research protocol: a multi-centre randomised controlled trial |
| title_full_unstemmed | Birth ball for pregnant women in labour research protocol: a multi-centre randomised controlled trial |
| title_short | Birth ball for pregnant women in labour research protocol: a multi-centre randomised controlled trial |
| title_sort | birth ball for pregnant women in labour research protocol a multi centre randomised controlled trial |
| topic | Birth ball Non-pharmacological Pain relief Pregnant women RCT |
| url | http://link.springer.com/article/10.1186/s12884-019-2305-8 |
| work_keys_str_mv | AT maypuishanyeung birthballforpregnantwomeninlabourresearchprotocolamulticentrerandomisedcontrolledtrial AT katrinawaikaytsang birthballforpregnantwomeninlabourresearchprotocolamulticentrerandomisedcontrolledtrial AT benjaminhonkeiyip birthballforpregnantwomeninlabourresearchprotocolamulticentrerandomisedcontrolledtrial AT winghungtam birthballforpregnantwomeninlabourresearchprotocolamulticentrerandomisedcontrolledtrial AT wanyimip birthballforpregnantwomeninlabourresearchprotocolamulticentrerandomisedcontrolledtrial AT florencewaileihau birthballforpregnantwomeninlabourresearchprotocolamulticentrerandomisedcontrolledtrial AT margaretkitwahwong birthballforpregnantwomeninlabourresearchprotocolamulticentrerandomisedcontrolledtrial AT judywaiyingng birthballforpregnantwomeninlabourresearchprotocolamulticentrerandomisedcontrolledtrial AT sauhaliu birthballforpregnantwomeninlabourresearchprotocolamulticentrerandomisedcontrolledtrial AT sophiashuwingchan birthballforpregnantwomeninlabourresearchprotocolamulticentrerandomisedcontrolledtrial AT chikinlaw birthballforpregnantwomeninlabourresearchprotocolamulticentrerandomisedcontrolledtrial AT samuelyeungshanwong birthballforpregnantwomeninlabourresearchprotocolamulticentrerandomisedcontrolledtrial |