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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
| University of Oxford | OTHER |
| Bliss Charity | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parental touch (pre-procedural) | Experimental | 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. |
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| Parental touch (post-procedural) | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parental touch | Behavioral | 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 |
|
| 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) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eleri Adams | Oxford University Hospitals NHS Trust | Principal Investigator |
| Ravi Poorun | Royal Devon and Exeter NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford University Hospitals NHS Foundation Trust | Oxford | OX3 9DU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40110538 | Derived | 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. | |
| 38373429 | Derived |
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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.
Available after the publication of final results.
PI will have discretion to share data with potential collaborators.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 16, 2024 | |
| Reset | Nov 18, 2024 | |
| Release | Feb 6, 2025 | |
| Reset | Feb 27, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 16, 2024 | Nov 18, 2024 | |||
| Feb 6, 2025 |
| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 38284396 | Derived | 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. |
| 36250332 | Derived | 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. |
| Feb 27, 2025 |
| D001523 | Mental Disorders |