AzTrials
AzTrials

Infant DevelopmentPetalNCT04901611

Parental Touch Trial (Petal)

A study testing Parental touch in people with Infant Development and Pain, Procedural, run by Paediatric Neuroimaging Research Group at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 0 to 7 daysHealthy volunteers can take part
Conditions the study is for
Infant Development, Pain, Procedural, Parents
What is being tested?
Parental touch
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
1 siteUnited Kingdom
Study dates
1 Sep 2021to 7 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 7 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
Parental touch
Keywords
Parental touch, Brain activity, Stroking, Anxiety, Clinical pain score, Heart rate, Respiratory rate
Medical subject headings
Pain, Procedural, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parental touchBehavioural

    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

Study groups in NCT04901611
Study groupRoleWhat they receive
Parental touch (pre-procedural)ExperimentalParents 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.
Receives: Behavioral: Parental touch
Parental touch (post-procedural)Placebo comparatorParents 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.
Receives: Behavioral: Parental touch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Immediately after heel lance (within 1000ms)

Secondary outcomes (3)

  1. 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.

    Measured: During the 30s period after the heel lance

  2. 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).

    Measured: During the 30s period after the heel lance

  3. 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).

    Measured: At the end of the test occasion, within 30 minutes of the heel lance

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2021
  2. Study start1 Sep 2021
  3. Primary completion7 Feb 2023
  4. Study completion7 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04901611
Sponsor's protocol ID
Petal
Acronym
Petal
Status last verified
Feb 2023
First submitted
13 May 2021
Last updated
28 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data that support the findings of this study are available from the PI (rebeccah.slater@paediatrics.ox.ac.uk) 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.

Publications

  • Baxter L, Hauck AGV, Bhatt A, Cobo MM, Hartley C, Marchant S, Poorun R, van der Vaart M, Slater R. Statistical analysis plan for the Petal trial: the effects of parental touch on relieving acute procedural pain in neonates. Wellcome Open Res. 2024 Dec 18;8:402. doi: 10.12688/wellcomeopenres.19819.3. eCollection 2023.

    PubMed 40110538

  • Hauck AGV, van der Vaart M, Adams E, Baxter L, Bhatt A, Crankshaw D, Dhami A, Evans Fry R, Freire MBO, Hartley C, Mansfield RC, Marchant S, Monk V, Moultrie F, Peck M, Robinson S, Yong J, Poorun R, Cobo MM, Slater R. Effect of parental touch on relieving acute procedural pain in neonates and parental anxiety (Petal): a multicentre, randomised controlled trial in the UK. Lancet Child Adolesc Health. 2024 Apr;8(4):259-269. doi: 10.1016/S2352-4642(23)00340-1. Epub 2024 Feb 16.

    PubMed 38373429

  • van der Vaart M, Hauck AGV, Mansfield R, Adams E, Bhatt A, Cobo MM, Crankshaw D, Dhami A, Hartley C, Monk V, Evans Fry R, Moultrie F, Robinson S, Yong J, Poorun R, Baxter L, Slater R. Parental experience of neonatal pain research while participating in the Parental touch trial (Petal). Pain. 2024 Aug 1;165(8):1727-1734. doi: 10.1097/j.pain.0000000000003177. Epub 2024 Jan 25.

    PubMed 38284396

  • 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.

    PubMed 36250332

Questions about this trial

What is this clinical trial studying?

A study testing Parental touch in people with Infant Development and Pain, Procedural, run by Paediatric Neuroimaging Research Group at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Magnitude of noxious-evoked brain activity (time frame: Immediately after heel lance (within 1000ms)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04901611, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in