Parental Touch Trial (Petal) (Petal)

February 27, 2023 updated by: Rebeccah Slater, Paediatric Neuroimaging Research Group

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 week (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parental touch (pre-procedural)
Parents will stroke their baby on the posterior lower limb of the leg where the heel lance will be administered, at a speed of 3cm/s for 10 seconds using the whole hand and in one direction down the limb towards the foot. This will happen just before the control procedure and clinical heel lance.
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
Placebo Comparator: Parental touch (post-procedural)
Parents will stroke their baby on the posterior lower limb of the leg where the heel lance was administered, at a speed of 3cm/s for 10 seconds using the whole hand and in one direction down the limb towards the foot. This will happen just after the control procedure and clinical heel lance.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnitude of noxious-evoked brain activity
Time Frame: Immediately after heel lance (within 1000ms)
An electroencephalography (EEG) template based on the Principal Component that reflects the noxious-evoked brain activity in neonates has been defined and validated in independent data sets (Hartley 2017). This template will be projected onto the EEG data recorded in the 1000ms period following each heel lance and heel lance control stimulus and the relative weight of the component calculated for each neonate. A greater weight indicates a stronger noxious-evoked response.
Immediately after heel lance (within 1000ms)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Premature Infant Pain Profile - Revised score (PIPP-R score)
Time Frame: During the 30s period after the heel lance
PIPP-R is a composite measure encompassing behavioural, physiological and contextual indicators involved in the pain response. These include gestational age, behavioural state, heart rate, oxygen saturation, and duration of brow bulge, eye squeeze, and nasolabial furrow. Each indicator in the PIPP-R is rated on a 4-point scale (0, 1, 2, and 3); these are summed together to produce a maximum possible score of 21, and minimum possible score of 0. In the revised PIPP-R, the scores for the contextual indicators (gestational age and behavioural state) are only included if a non-zero score is recorded for either the physiological or behavioural variables (Stevens et al., 2014). A higher score suggests a greater pain response.
During the 30s period after the heel lance
Percentage of neonates who develop tachycardia
Time Frame: During the 30s period after the heel lance
Percentage of neonates who develop post-procedural tachycardia (in the 30 seconds post-heel lance). Tachycardia will be defined as a heart rate >160 beats per minute as per Advanced Paediatric Life Support guidelines, reflecting heart rate values >90th centile for newborns in the first week of life (Fleming et al., 2011; Schwartz et al., 2002).
During the 30s period after the heel lance
Parental anxiety
Time Frame: At the end of the test occasion, within 30 minutes of the heel lance
Anxiety score from the 20-point Stait Trait Anxiety Inventory (STAI), the gold standard for state anxiety. It is well validated and publicly available. The STAI has a trait (STAI-T) and a state version (STAI-S). The STAI-T scale consists of 20 statements that ask people to describe how they generally feel. The STAI-S scale also consists of 20 statements, but the instructions require subjects to indicate how they feel at a particular moment in time. The STAI-S scale can be used to determine the actual levels of anxiety intensity induced by stressful procedures. Each question is rated on a 4-point scale (not at all, somewhat, moderately so, very much so). The range of possible scores for form Y of the STAI varies from a minimum score of 20 to a maximum score of 80 on both the STAI-T and STAI-S subscales. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
At the end of the test occasion, within 30 minutes of the heel lance

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory outcome: changes in brain activity during parental touch intervention
Time Frame: During parental touch intervention
Changes in brain activity recorded using EEG, which are elicited during the parental touch intervention. This is an exploratory outcome, therefore data will be investigated with a pragmatic approach.
During parental touch intervention
Exploratory outcome: time taken for heart rate to return to baseline post-heel lance
Time Frame: 30 min time period after the clinical heel lance
Impact of parental touch prior to the clinical procedure on reducing the duration of time for heart rate to return to baseline after a clinically-essential heel lance, compared with post-procedural touch.
30 min time period after the clinical heel lance
Exploratory outcome: post-procedural variability in respiratory rate, incidence of apnoea, and change in respiratory stability
Time Frame: 30 min time period after the clinical heel lance
Changes in respiratory rate and respiratory stability recorded using electrocardiogram (ECG). The data will also identify incidence of apnoea; an episode of apnoea will be defined as the cessation in breathing for at least 20s. This is an exploratory outcome, therefore data will be investigated with a pragmatic approach. Variability in respiratory rate, incidence of apnoea and change in respiratory stability are considered as one exploratory outcome as they are recorded using the same measurement techniques and interrelated.
30 min time period after the clinical heel lance
Exploratory outcome: parental views
Time Frame: At the end of the test occasion, within 30 minutes of the heel lance
Scores for each emotion, experienced by the parent during the heel lance, using a 4-point distress score (worried/upset/anxious/sad), and responses to a questionnaire about participating in this study and general infant research.
At the end of the test occasion, within 30 minutes of the heel lance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eleri Adams, Oxford University Hospitals NHS Trust
  • Principal Investigator: Ravi Poorun, Royal Devon University Healthcare NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

February 7, 2023

Study Completion (Actual)

February 7, 2023

Study Registration Dates

First Submitted

May 13, 2021

First Submitted That Met QC Criteria

May 20, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data that support the findings of this study are available from the PI ([email protected]) listed on clinicaltrials.gov. The Study Protocol, Informed Consent Form and Statistical Analysis Plan will be available to download as a supplement to the final publication of the results.

IPD Sharing Time Frame

Available after the publication of final results.

IPD Sharing Access Criteria

PI will have discretion to share data with potential collaborators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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