Clinical trial NCT04901611: Parental Touch Trial (Petal)
Official title: A Randomised Controlled Trial to Investigate the Effects of Parental Touch on Relieving Acute Procedural Pain in Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Pain, Procedural
Parents
Keywords: Parental touch
Brain activity
Stroking
Anxiety
Clinical pain score
Heart rate
Respiratory rate
Lead sponsor: Paediatric Neuroimaging Research Group
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: University of Oxford
name: Bliss Charity
First posted: 2021-05-25
Enrollment: 112
Sex: ALL
Minimum age (years): 0
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Participants born at the John Radcliffe Hospital, Oxford or the Royal Devon and Exeter Hospital, Devon
* Neonates born at or after 35+0 weeks gestation
* Neonates with a postnatal age of 7 days or less
* Neonates who clinically require a heel lance
* Neonates for whom parents/guardians have given written informed consent for inclusion in the trial

Exclusion Criteria:

* Intraventricular haemorrhage (IVH) \> grade II
* Received any analgesics or sedatives in the last 24 hours
* Congenital malformation or genetic condition known to affect neurological development
* Born to mothers who have a history of substance abuse.

Primary outcomes:
measure: Magnitude of noxious-evoked brain activity
timeFrame: Immediately after heel lance (within 1000ms)
Secondary outcomes:
measure: Premature Infant Pain Profile - Revised score (PIPP-R score)
timeFrame: During the 30s period after the heel lance
measure: Percentage of neonates who develop tachycardia
timeFrame: During the 30s period after the heel lance
measure: Parental anxiety
timeFrame: At the end of the test occasion, within 30 minutes of the heel lance
Other outcomes:
measure: Exploratory outcome: changes in brain activity during parental touch intervention
timeFrame: During parental touch intervention
measure: Exploratory outcome: time taken for heart rate to return to baseline post-heel lance
timeFrame: 30 min time period after the clinical heel lance
measure: Exploratory outcome: post-procedural variability in respiratory rate, incidence of apnoea, and change in respiratory stability
timeFrame: 30 min time period after the clinical heel lance
measure: Exploratory outcome: parental views
timeFrame: At the end of the test occasion, within 30 minutes of the heel lance
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Eleri Adams
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Devon and Exeter NHS Foundation Trust
name: Ravi Poorun
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cobo MM, Moultrie F, Hauck AGV, Crankshaw D, Monk V, Hartley C, Evans Fry R, Robinson S, van der Vaart M, Baxter L, Adams E, Poorun R, Bhatt A, Slater R. Multicentre, randomised controlled trial to investigate the effects of parental touch on relieving acute procedural pain in neonates (Petal). BMJ Open. 2022 Jul 19;12(7):e061841. doi: 10.1136/bmjopen-2022-061841.