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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB 2025-A00034-45 | Other Identifier | ANSM |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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.
If the venipun |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bénédicte LOMBART, Paramedical coordinator | Contact | 0033171970607 | benedicte.lombart@aphp.fr | |
| Judith LEBLANC, Associate professor | Contact | 0033171970555 | judith.leblanc@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Bénédicte LOMBART, Paramedical coordinator | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Direction de la recherche et de l'innovation | Paris | 75012 | France |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 | 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. | Day 1 |
| 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. | Day 1 |