Guided Distraction Movement

NCT ID: NCT07248852

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-10-31

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

Detailed Description

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.

Conditions

Venipuncture Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual practice

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Usual practice and active distraction.

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

Group Type: EXPERIMENTAL

Guided movement

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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
• clinical condition requiring emergency venous access

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bénédicte LOMBART, Paramedical coordinator

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Direction de la recherche et de l'innovation

Paris, , France

Countries

France

Central Contacts

Bénédicte LOMBART, Paramedical coordinator

Role: CONTACT

benedicte.lombart@aphp.fr

0033171970607

Judith LEBLANC, Associate professor

Role: CONTACT

judith.leblanc@aphp.fr

0033171970555

Facility Contacts

Bénédicte LOMBART, Paramedical coordinator

Role: primary

benedicte.lombart@aphp.fr

0033171970607

Judith LEBLANC, Associate professor

Role: backup

judith.leblanc@aphp.fr

0033171970555

Other Identifiers

IDRCB 2025-A00034-45

Identifier Type: OTHER

Identifier Source: secondary_id

APHP241783

Identifier Type: -

Identifier Source: org_study_id