Parental Touch Trial (Petal)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infant Development, Pain, Procedural, Parents

Intervention / Treatment
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* Behavioral: Parental touch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parental touch (pre-procedural)<br>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. | Behavioral: Parental touch<br>* 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<br>|
| Placebo Comparator: Parental touch (post-procedural)<br>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. | Behavioral: Parental touch<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnitude of noxious-evoked brain activity | 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) | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parental touch, Brain activity, Stroking, Anxiety, Clinical pain score, Heart rate, Respiratory rate