Guided Distraction Movement

Condition(s) studied

Investigational drug(s) / intervention(s)

Guided movement: Active distraction procedure: Venipuncture will be performed according to the usual care with the addition of active distraction using the maraca. Active distraction procedure: The nurse performing the venipuncture called the operator and a professional called the 'accompanying person' (nurse, nursing assistant or childcare assistant usually in charge of looking after or holding the child) sit on either side of the child. * At the start of the procedure, the accompanying person places the maraca in the child's hand and shows him/her that it makes a noise 30 seconds before the venipuncture. The accompanying person checks the movement of the child's hand by placing his/her own hand on the child's hand. He/she playfully suggests to the child to wait to make noise with the maraca by counting down 'on 3, we'll make noise'. This countdown allows coordination with the operator. * When the operator is ready to perform the venipuncture, the accompanying person invites the child to gently sha

Study summary

The aim of this research is to evaluate the benefits of using a maraca to guide movement in order to reduce pain during venipuncture for blood sampling or infusion (insertion of a peripheral venous line) in children aged 1 to 3 years.

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, 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.

During a multicentre randomized controlled trial conducted in France, the 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, will be compared with the usual practice alone. 5000 caractères maximum

Eligibility

Primary outcome measure(s)

• Pain score evaluated from the video recording of the procedure using the FLACC scale, — Day 1
  Pain score evaluated from the video recording of the procedure using the FLACC scale, completed between 2 minutes before the venipuncture and the end of the first venipuncture. The assessment will be performed remotely and independently by two expert professionals.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France