Guided Distraction Movement

NCT07248852 | Not Yet Recruiting

• 2 other identifiers: APHP241783IDRCB 2025-A00034-45
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Venipuncture Pain

Keywords

Active distraction; Venipuncture; Children; Pain

Outcome Measures

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.

  Day 1

Secondary Outcomes (6)

• Restraint evaluated using PRIC scale

  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).

  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).

  Day 1

• Proportion of venipuncture successfully completed at the first attempt.

  Day 1

• Acceptability of intervention from the child's perspective

  Day 1

Study Arms (2)

Usual practice

NO INTERVENTION

In this arm, venipuncture will be performed according to usual care. The usual care recommended for young children is as follows: * The child is lying down, sitting or in a semi-setting position or in the arms of an adult (parent or health professional). * Parents are present if they wish. The child may have his or her cuddly toy. * Analgesia is administered using anaesthetic cream and, depending on the child and the department's routine, anaesthetic cream and/or nitroxusmay be added. * No distracting objects are used apart from the voice (whispers, unsung words) or reassuring gestures as in usual practice (e. g. caresses, gentle rocking ). No active distraction with a toy or a screen are offered. * The child's gestures may be restrained by the professional(s) if necessary, in accordance with the department's policies and current practices. 62 caractères maximum. Facultatif si la description de l'intervention (cf. ci-dessous) décrit suffisamment le bras.

Usual practice and active distraction.

EXPERIMENTAL

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 shake the maraca. If the venipun

Other: Guided movement

Interventions

Guided movement OTHER

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

Usual practice and active distraction.

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• aged 1 to 3 years
• with a venipuncture prescribed within the first 48 hours of hospitalization in general paediatrics or during a consultation

You may not qualify if:

• motor disability of upper limbs
• mental disability with neuromotor troubles
• clinical condition requiring emergency venous access

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Direction de la recherche et de l'innovation

Paris, 75012, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bénédicte LOMBART, Paramedical coordinator

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bénédicte LOMBART, Paramedical coordinator

CONTACT

0033171970607; benedicte.lombart@aphp.fr

Judith LEBLANC, Associate professor

CONTACT

0033171970555; judith.leblanc@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

FR (1)