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NCT Number: NCT07248852

Guided Distraction Movement

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

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Key information

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 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.

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

  5. Acceptability of intervention from the child's perspective

    Time frame: Day 1

    Acceptability of intervention from the child's perspective, evaluated by parents and attending professionals (nurses, nursing assistants and childcare assistants ) using a numerical scale from 0 to 10.

  6. 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.

    Time frame: Day 1

Study contacts

Contact information is provided by the study sponsor or research team.

Bénédicte LOMBART, Paramedical coordinator

CONTACT

[email protected]

0033171970607

Judith LEBLANC, Associate professor

CONTACT

[email protected]

0033171970555

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Benefits of Guided Movement Using a Maraca of the Arm Opposite to the One Undergoing Venipuncture to Reduce Pain in Children Aged 1-3 Years: a Multicentre Randomized Controlled Trial

Acronym: MOVING

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 25, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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