Guided Distraction Movement

Pharmacological methods can reduce the pain associated with venipuncture, but they do not address all aspects of pain. Complementary methods have been studied, such as distraction.

According to the literature, distraction interventions are effective in limiting self-reported or reported pain but not behavioural pain. The studies involved children aged 3 years and older who were distracted using passive methods such as reading, listening or watching a video.

On the other hand, in children aged 1 month to 3 years, no passive strategy was found to reduce pain.

Interventions in which the child actively participates, with motor action, have been little explored before 3 years of age.

Encouraging children aged 1 to 3 years to perform a movement using a maraca of the arm opposite to the one undergoing venipuncture, in synchronisation with the venipuncture, in addition to current pharmacological methods, would be a simple active intervention.

This distraction method has never been studied. It could reduce pain, withdrawal reactions and also the need for restraint by caregivers, leading to better acceptance of treatment and a higher success rate.

Based on studies demonstrating the effectiveness of active and multisensory distraction strategies, the hypothesis is based on the fact that voluntary movement, by simultaneously soliciting vision and hearing, captures the child's attention sufficiently to reduce the perception of pain and withdrawal reactions, thereby limiting restraint.

The aim of this study is to evaluate benefits of guided movement using a maraca of the arm opposite to the one undergoing venipuncture synchronised with venipuncture and combined with the usual practice, compared with the usual practice alone in children aged 1 to 3 years.

Two groups will be compared during a multicentre randomized controlled trial conducted in France. One group will receive usual practice with pharmacological analgesia (anaesthetic cream and/or nitroxus). In the other group, the usual practice will be combined with guided movement using a maraca of the arm opposite to the one undergoing venipuncture synchronised with venipuncture.

The evaluation will also include a qualitative analysis of the perceptions of the intervention by the parents and professionals involved.

• Restraint evaluated using PRIC scale [Срок оценки: Day 1]
• Immobility of the arm undergoing venipuncture evaluated using a numerical scale from 0 to 10 (in the absence of an internationally validated scale). [Срок оценки: Day 1]
• Intensity of the arm withdrawal reaction during venipuncture evaluated using a numerical scale from 0 to 10 (in the absence of an internationally validated scale). [Срок оценки: Day 1]
• Proportion of venipuncture successfully completed at the first attempt. [Срок оценки: Day 1]
• Acceptability of intervention from the child's perspective [Срок оценки: Day 1]
• Qualitative evaluation conducted through semi-structured interviews with 15 parents (or parental couples) and 15 nurses, nursing assistants or childcare assistants who participated in the intervention. [Срок оценки: Day 1]