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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Pain score evaluated from the video recording of the procedure using the FLACC scale,
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 1 to 3 years
- •with a venipuncture prescribed within the first 48 hours of hospitalization in general paediatrics or during a consultation
排除标准
- •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
研究组 & 干预措施
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.
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
干预措施: Guided movement (Other)
结局指标
主要结局
Pain score evaluated from the video recording of the procedure using the FLACC scale,
时间窗: 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.
次要结局
- 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)
- 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)