Parental Touch Trial (Petal)

Infant Development Clinical Trial

— Petal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04901611
• Other study ID #: Petal
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: February 7, 2023

Study information

• Verified date: February 2023
• Source: Paediatric Neuroimaging Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: February 7, 2023
• Est. primary completion date: February 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Days to 7 Days

Eligibility

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.

Related Conditions & MeSH terms

• Infant Development
• Pain, Procedural
• Parents

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford

Sponsors (4)

Lead Sponsor	Collaborator
Paediatric Neuroimaging Research Group	BLISS charity, University of Oxford, Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory outcome: changes in brain activity 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
Other	Exploratory outcome: time taken for heart rate to return to baseline post-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
Other	Exploratory outcome: post-procedural variability in respiratory rate, incidence of apnoea, and change in respiratory stability	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
Other	Exploratory outcome: parental views	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
Primary	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	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
Secondary	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
Secondary	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