NCT04901611

Parental Touch Trial (Petal)

A Randomised Controlled Trial to Investigate the Effects of Parental Touch on Relieving Acute Procedural Pain in Neonates

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Paediatric Neuroimaging Research Group · Academic / Other
• Sex: All
• Age: 0 Days – 7 Days
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a multicentre randomised-controlled interventional trial, with two research sites (John Radcliffe Hospital, Oxford, and Royal Devon and Royal Devon and Exeter Hospital, Devon). In this study we aim to determine whether parental touch prior to a painful clinical procedure provides effective analgesia. The primary objective is to determine whether parental touch reduces noxious-evoked brain activity following a heel lance. In addition, our secondary and exploratory objectives include investigating the effect of touch on behavioural and electrophysiological measures evoked by a heel lance. Neonates will be randomised to receive parental touch either prior to or post a clinically required heel lance. We will also investigate how parental touch impacts post-procedural clinical stability and explore whether this intervention affects parental anxiety. Neonates will be recruited during a 9-month period. Participants will be studied on a single test occasion while they are in hospital, when they require a clinical heel lance. No extra blood tests or noxious procedures will be performed for the purpose of the study. Participants will be included in the study for approximately an hour period. This will be approximately 30 min before and after the time when the heel lance is performed. Individual babies will only be included in the trial once. If a neonate requires additional heel lances to acquire sufficient blood for clinical assessment at the time of the test occasion, we will also record the responses to this.

Conditions

• Infant Development
• Pain, Procedural
• Parents

Interventions

Type	Name	Description
BEHAVIORAL	Parental touch	Parental touch in the form of stroking at 3cm/s for 10 seconds on the posterior lower limb where the heel lance will be/has been administered

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-02-07
• Completion: 2023-02-07
• First posted: 2021-05-25
• Last updated: 2023-02-28

Locations

1 site across 1 country: United Kingdom