Health TrialsbyHealthPanel

Guided Distraction Movement

ConditionVenipuncture Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-3
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

aged 1 to 3 years

with a venipuncture prescribed within the first 48 hours of hospitalization in general paediatrics or during a consultation

Disqualifiers

motor disability of upper limbs

mental disability with neuromotor troubles

venipuncture or other invasive procedure (lumbar puncture or catheter insertion) within 2 hours prior to inclusion

more than 5 venipunctures within 48 hours prior to inclusion

Trial design

Design model

Parallel

Treatments tested in this trial

  • Guided movement

    Other intervention

    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

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Usual practiceNo intervention 0 interventions
Group B: Usual practice and active distraction.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pain score evaluated from the video recording of the procedure using the FLACC scale,

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.

Time frame
Day 1

Secondary outcomes

1

Restraint evaluated using PRIC scale

Time frame
Day 1
2

Immobility of the arm undergoing venipuncture evaluated using a numerical scale from 0 to 10 (in the absence of an internationally validated scale).

Time frame
Day 1
3

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).

Time frame
Day 1
4

Proportion of venipuncture successfully completed at the first attempt.

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: