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Parental Touch Trial (Petal)

NCT04901611 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2023-02-28

No results posted yet for this study

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.

Conditions

  • Infant Development
  • Pain, Procedural
  • Parents

Interventions

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

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • University of Oxford

    collaborator OTHER

  • Bliss Charity

    collaborator OTHER

  • Paediatric Neuroimaging Research Group

    lead OTHER

Principal Investigators

  • Eleri Adams · Oxford University Hospitals NHS Trust

  • Ravi Poorun · Royal Devon and Exeter NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2023-02-07
Completion
2023-02-07

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04901611 on ClinicalTrials.gov