Multicentre, randomised controlled trial to investigate the effects of parental touch on relieving acute procedural pain in neonates (Petal)
Introduction Newborn infants routinely undergo minor painful procedures as part of postnatal care, with infants born sick or premature requiring a greater number of procedures. As pain in early life can have long-term neurodevelopmental consequences and lead to parental anxiety and future avoidance...
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e061841.full |
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| author | Eleri Adams Daniel Crankshaw Ria Evans Fry Rebeccah Slater Caroline Hartley Maria M Cobo Fiona Moultrie Annalisa G V Hauck Vaneesha Monk Shellie Robinson Marianne van der Vaart Luke Baxter Ravi Poorun Aomesh Bhatt |
| author_facet | Eleri Adams Daniel Crankshaw Ria Evans Fry Rebeccah Slater Caroline Hartley Maria M Cobo Fiona Moultrie Annalisa G V Hauck Vaneesha Monk Shellie Robinson Marianne van der Vaart Luke Baxter Ravi Poorun Aomesh Bhatt |
| author_sort | Eleri Adams |
| collection | DOAJ |
| description | Introduction Newborn infants routinely undergo minor painful procedures as part of postnatal care, with infants born sick or premature requiring a greater number of procedures. As pain in early life can have long-term neurodevelopmental consequences and lead to parental anxiety and future avoidance of interventions, effective pain management is essential. Non-pharmacological comfort measures such as breastfeeding, swaddling and sweet solutions are inconsistently implemented and are not always practical or effective in reducing the transmission of noxious input to the brain. Stroking of the skin can activate C-tactile fibres and reduce pain, and therefore could provide a simple and safe parent-led intervention for the management of pain. The trial aim is to determine whether parental touch prior to a painful clinical procedure provides effective pain relief in neonates.Methods and analysis This is a multicentre randomised controlled trial. A total of 112 neonates born at 35 weeks’ gestation or more requiring a blood test in the first week of life will be recruited and randomised to receive parental stroking either preprocedure or postprocedure. We will record brain activity (EEG), cardiac and respiratory dynamics, oxygen saturation and facial expression to provide proxy pain outcome measures. The primary outcome will be the reduction of noxious-evoked brain activity in response to a heel lance. Secondary outcomes will be a reduction in clinical pain scores (Premature Infant Pain Profile-Revised), postprocedural tachycardia and parental anxiety.Ethics and dissemination The study has been approved by the London—South East Research Ethics Committee (ref: 21/LO/0523). The results will be widely disseminated through peer-reviewed publications, international conferences and via our partner neonatal charities Bliss and Supporting the Sick Newborn And their Parents (SSNAP). If the parental tactile intervention is effective, recommendations will be submitted via the National Health Service clinical guideline adoption process.Study status Commenced September 2021.Trial registration number NCT04901611; 14 135 962. |
| format | Article |
| id | doaj-art-195c3f3fa98844c4b09682832a300067 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-195c3f3fa98844c4b09682832a3000672025-01-31T19:05:11ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2022-061841Multicentre, randomised controlled trial to investigate the effects of parental touch on relieving acute procedural pain in neonates (Petal)Eleri Adams0Daniel Crankshaw1Ria Evans Fry2Rebeccah Slater3Caroline Hartley4Maria M Cobo5Fiona Moultrie6Annalisa G V Hauck7Vaneesha Monk8Shellie Robinson9Marianne van der Vaart10Luke Baxter11Ravi Poorun12Aomesh Bhatt13Newborn Care Unit, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UKDepartment of Paediatrics, University of Oxford, Oxford, UKDepartment of Paediatrics, University of Oxford, Oxford, UK3 Paediatrics, University of Oxford, Oxford, UKDepartment of Paediatrics, University of Oxford, Oxford, UKDepartment of Paediatrics, University of Oxford, Oxford, UKDepartment of Paediatrics, University of Oxford, Oxford, UKDepartment of Paediatrics, University of Oxford, Oxford, UK1 Department of Paediatrics, University of Oxford, Oxford, UKDepartment of Paediatrics, University of Oxford, Oxford, UKDepartment of Paediatrics, University of Oxford, Oxford, UK1 Department of Paediatrics, University of Oxford, Oxford, UKChildren’s Services, Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK1 Department of Paediatrics, University of Oxford, Oxford, UKIntroduction Newborn infants routinely undergo minor painful procedures as part of postnatal care, with infants born sick or premature requiring a greater number of procedures. As pain in early life can have long-term neurodevelopmental consequences and lead to parental anxiety and future avoidance of interventions, effective pain management is essential. Non-pharmacological comfort measures such as breastfeeding, swaddling and sweet solutions are inconsistently implemented and are not always practical or effective in reducing the transmission of noxious input to the brain. Stroking of the skin can activate C-tactile fibres and reduce pain, and therefore could provide a simple and safe parent-led intervention for the management of pain. The trial aim is to determine whether parental touch prior to a painful clinical procedure provides effective pain relief in neonates.Methods and analysis This is a multicentre randomised controlled trial. A total of 112 neonates born at 35 weeks’ gestation or more requiring a blood test in the first week of life will be recruited and randomised to receive parental stroking either preprocedure or postprocedure. We will record brain activity (EEG), cardiac and respiratory dynamics, oxygen saturation and facial expression to provide proxy pain outcome measures. The primary outcome will be the reduction of noxious-evoked brain activity in response to a heel lance. Secondary outcomes will be a reduction in clinical pain scores (Premature Infant Pain Profile-Revised), postprocedural tachycardia and parental anxiety.Ethics and dissemination The study has been approved by the London—South East Research Ethics Committee (ref: 21/LO/0523). The results will be widely disseminated through peer-reviewed publications, international conferences and via our partner neonatal charities Bliss and Supporting the Sick Newborn And their Parents (SSNAP). If the parental tactile intervention is effective, recommendations will be submitted via the National Health Service clinical guideline adoption process.Study status Commenced September 2021.Trial registration number NCT04901611; 14 135 962.https://bmjopen.bmj.com/content/12/7/e061841.full |
| spellingShingle | Eleri Adams Daniel Crankshaw Ria Evans Fry Rebeccah Slater Caroline Hartley Maria M Cobo Fiona Moultrie Annalisa G V Hauck Vaneesha Monk Shellie Robinson Marianne van der Vaart Luke Baxter Ravi Poorun Aomesh Bhatt Multicentre, randomised controlled trial to investigate the effects of parental touch on relieving acute procedural pain in neonates (Petal) BMJ Open |
| title | Multicentre, randomised controlled trial to investigate the effects of parental touch on relieving acute procedural pain in neonates (Petal) |
| title_full | Multicentre, randomised controlled trial to investigate the effects of parental touch on relieving acute procedural pain in neonates (Petal) |
| title_fullStr | Multicentre, randomised controlled trial to investigate the effects of parental touch on relieving acute procedural pain in neonates (Petal) |
| title_full_unstemmed | Multicentre, randomised controlled trial to investigate the effects of parental touch on relieving acute procedural pain in neonates (Petal) |
| title_short | Multicentre, randomised controlled trial to investigate the effects of parental touch on relieving acute procedural pain in neonates (Petal) |
| title_sort | multicentre randomised controlled trial to investigate the effects of parental touch on relieving acute procedural pain in neonates petal |
| url | https://bmjopen.bmj.com/content/12/7/e061841.full |
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