Table 1

Objectives and outcome measures

ObjectivesOutcome measures
Primary objective
  1. To test whether parental touch prior to the clinical procedure reduces noxious-evoked brain activity following a heel lance.

Primary outcome measure
  1. Magnitude of noxious-evoked brain activity following a heel lance (EEG data recorded in the 1000 ms period following each heel lance).

Secondary objectives
  1. To test whether parental touch prior to the clinical procedure reduces clinical pain scores (PIPP-R) during the 30 s period after the heel lance.

  2. To test whether parental touch prior to the clinical procedure reduces incidence of postprocedural tachycardia following a heel lance.

  3. To test whether parental touch prior to the clinical procedure reduces parental anxiety, compared with postprocedural touch.

Secondary outcome measures
  1. PIPP-R score during the 30 s period after the heel lance.

  2. Percentage of neonates who develop tachycardia in the 30 s post heel lance.

  3. Difference in STAI-S scores preprocedure and postprocedure.

Exploratory objectives
  1. To explore how parental touch impacts background brain activity.

  2. To explore whether parental touch prior to the clinical procedure reduces the duration of time for heart rate to return to baseline after a heel lance.

  3. To explore how parental touch prior to the clinical procedure affects respiratory stability.

  4. To explore parental anxiety and distress, and their experience of the trial and infant research.

Exploratory outcome measures
  1. Changes in brain activity during the touch intervention.

  2. Time taken for heart rate to return to baseline post heel lance.

  3. Postprocedural respiratory dynamics and incidence of apnoea.

  4. Scores for individual parameters from the STAI-T and STAI-S; four-point distress questionnaire score; responses to survey about participation in Petal and infant research.

  • EEG, Electroencephalography; PIPP-R, Premature Infant Pain Profile-Revised; STAI-S, State-Trait Anxiety Inventory-State; STAI-T, State-Trait Anxiety Inventory-Trait.