Venipuncture PainMOVINGNCT07248852
Guided Distraction Movement
A study testing Guided movement in people with Venipuncture Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Venipuncture Pain
- What is being tested?
- Guided movement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- aged 1 to 3 years
- with a venipuncture prescribed within the first 48 hours of hospitalization in general paediatrics or during a consultation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Direction de la recherche et de l'innovation
Paris, 75012
Bénédicte LOMBART, Paramedical coordinator, 0033171970607, benedicte.lombart@aphp.fr
Judith LEBLANC, Associate professor, 0033171970555, judith.leblanc@aphp.fr
About this study
Official 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
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.
Read more
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
Read the 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
- Being tested
- Guided movement
- Keywords
- Active distraction, Venipuncture, Children, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided movementOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Guided movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (6)
Restraint evaluated using PRIC scale
Measured: 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).
Measured: 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).
Measured: Day 1
Proportion of venipuncture successfully completed at the first attempt.
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study startFeb 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venipuncture PainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bénédicte LOMBART, Paramedical coordinator, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248852
- Sponsor's protocol ID
- APHP241783
- Other IDs
- IDRCB 2025-A00034-45
- Acronym
- MOVING
- Status last verified
- Feb 2026
- First submitted
- 18 Nov 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07248852
- Acronym / sponsor ID
- MOVING / APHP241783
- Conditions
- Venipuncture Pain
- Keywords
- Active distraction, Venipuncture, Children, Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Guided movementVenipuncture 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 |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- aged 1 to 3 years
- with a venipuncture prescribed within the first 48 hours of hospitalization in general paediatrics or during a consultation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided movementActive 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 | Other | Usual practice and active distraction. |
Primary outcome
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.
6 secondary outcomes
Restraint evaluated using PRIC scale
Time frame: 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).
Time frame: 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).
Time frame: Day 1
Proportion of venipuncture successfully completed at the first attempt.
Time frame: Day 1
Acceptability of intervention from the child's perspective
Time frame: 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.
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
Related trials for Venipuncture Pain
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Recruiting
Effectiveness of Multisensoral Nature-based Intervention in Hospitalized Children During Venous Blood Sampling
Anxiety, Fear
RecruitingPhase 1
Two Different Therapeutic Interventions Applied During Blood Sampling in Children
Blood Sampling, Child, Only
Not yet recruiting
Comparative Effectiveness of Yakson Touch and a Dextrose-Sweetened Pacifier for Reducing Phlebotomy-Induced Pain in Term Neonates
Hospital Acquired Infections
Active, not recruiting
Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants
Procedural Pain, Pre-Term
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bénédicte LOMBART, Paramedical coordinator principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided movement in people with Venipuncture Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bénédicte LOMBART, Paramedical coordinator (0033171970607, benedicte.lombart@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score evaluated from the video recording of the procedure using the FLACC scale, (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.