Parental touch trial (Petal)
Research type
Research Study
Full title
A randomised controlled trial to investigate the effects of parental touch on relieving acute procedural pain in neonates
IRAS ID
291213
Contact name
N/A CTRG
Contact email
Sponsor organisation
University of Oxford
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
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. Infants 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.
Infants 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 an infant 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.
Summary of study results:
There is evidence that gentle touch by parents can provide comfort to babies during painful procedures. In adults, stroking the skin at a caress-like speed can help reduce pain by activating special nerves. We wanted to understand if parental stroking could reduce the pain experienced by newborn babies during a clinically-required blood test. Half the babies in our study were stroked on their leg by their parent before a blood test, the other half were stroked after the blood test.
We were interested in the brain response to the procedure, as well as changes in heart rate and facial expression that are relevant to pain. We also asked parents how they felt taking part and what motivated them to participate in the study.
We did not find that stroking babies before the blood test reduce brain activity, heart rate or facial expression markers of pain compared to stroking babies after the blood test. However, trying to reproduce the stroking movement applied in previous studies might have changed the way parents naturally stroke their child, which might have masked the benefits of parental touch on reducing pain.
Parents reported that they were happy to participate in soothing their baby during the painful procedure, commonly reporting feeling “reassured”, “calm”, and “useful”. This supports the notion that parents want to be involved in, and experience positive emotions when caring for their baby during a painful procedure. Most parents reported feeling pleased to have participated in the trial; the main motivation stated was to improve future care for babies, and many parents felt that being involved during the procedure might benefit their own baby.
We have shown that parental involvement during procedures can be beneficial for parents. Gentle parental touch-related interventions can be easily adopted and practised during babies’ painful procedures.
REC name
London - South East Research Ethics Committee
REC reference
21/LO/0523
Date of REC Opinion
28 Jul 2021
REC opinion
Favourable Opinion