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NCT04901611: Petal

Parental Touch Trial (Petal)

Completed NA Last updated 28 February 2023
What this trial tests

NA trial testing Parental touch in Infant Development in 112 participants. Completed in 7 February 2023.

Timeline
1 September 2021
Primary endpoint
7 February 2023
7 February 2023

Quick facts

Lead sponsorPaediatric Neuroimaging Research Group
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment112
Start date1 September 2021
Primary completion7 February 2023
Estimated completion7 February 2023
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Paediatric Neuroimaging Research Group

Who can join

Adults 0 Days to 7 Days, any sex, with Infant Development or Pain, Procedural. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a two centre two-arm randomised controlled interventional trial. We aim to determine whether parental touch prior to a painful clinical procedure provides effective analgesia in neonates.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Multicentre, randomised controlled trial to investigate the effects of parental touch on relieving acute procedural pain in neonates (Petal).
    Cobo MM, Moultrie F, Hauck AGV, Crankshaw D, et al · · 2022 · cited 15× · PMID 36250332 · DOI 10.1136/bmjopen-2022-061841
  2. Effect of parental touch on relieving acute procedural pain in neonates and parental anxiety (Petal): a multicentre, randomised controlled trial in the UK.
    Hauck AGV, van der Vaart M, Adams E, Baxter L, et al · · 2024 · cited 11× · PMID 38373429 · DOI 10.1016/s2352-4642(23)00340-1
  3. Parental experience of neonatal pain research while participating in the Parental touch trial (Petal).
    van der Vaart M, Hauck AGV, Mansfield R, Adams E, et al · · 2024 · cited 8× · PMID 38284396 · DOI 10.1097/j.pain.0000000000003177
  4. Statistical analysis plan for the Petal trial: the effects of parental touch on relieving acute procedural pain in neonates.
    Baxter L, Hauck AGV, Bhatt A, Cobo MM, et al · · 2023 · cited 1× · PMID 40110538 · DOI 10.12688/wellcomeopenres.19819.3
  5. Statistical analysis plan for the Petal trial: the effects of parental touch on relieving acute procedural pain in neonates
    Baxter L, Hauck AG, Bhatt A, Cobo MM, et al · · 2024 · DOI 10.12688/wellcomeopenres.19819.3

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Data sources for this page

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