跳至主要内容
临床试验/NCT06846944
NCT06846944招募中不适用

Mixed-method Research Protocol: Evaluation of a Relaxation Technique for Anxiety Management in Pre-surgical Pediatric Patients

Meyer Children's Hospital IRCCS1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Percentage reduction in anxiety score

研究概览

简要总结

Children exhibit anxiety before surgery: in particular, the literature reports that younger children have a higher level of preoperative anxiety than older children. Preoperative anxiety has been associated with side effects such as postoperative pain and emergence delirium (ED), which are generally treated with the administration of analgesics but can cause nausea, vomiting, and drowsiness.

In addition to pharmacological strategies, there are behavioral and psychological techniques commonly referred to as nonpharmacological techniques to reduce preoperative anxiety. These are a broad set of strategies and methods, more or less complex, that can be applied to children and adolescents to help them cope with preoperative agitation and for pain control.

Nonpharmacological techniques include distraction techniques that have shown promise in reducing pediatric anxiety and include listening to music , the use of humor, and the use of games . Several researchers have found active distraction to be an effective preoperative anxiolytic in children. Of relevant importance for reducing preoperative anxiety are relaxation techniques as shown in the literature and in particular by a randomized trial that demonstrated the effectiveness of this type of proposed nonpharmacological technique for reducing anxiety and pain in pediatric patients in a preoperative setting.

This study plan to investigate the effectiveness of a breathing/relaxation intervention (Ladybug/Sunshine method) on pediatric patients' anxiety levels before surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 5 years and 15 years;
  • •Admission for minor surgical conditions of low intensity, such as inguinal hernia, phimosis, sebaceous cysts, vascular malformations, skin lesions, ankyloglossus, afferent to the unified pediatric surgery day-surgery service of AOU Meyer;
  • •Knowledge of the Italian language and ability to express oneself;

排除标准

  • •Presence of cognitive impairment reported in history

研究组 & 干预措施

Ladybug and Sunrise breathing/relaxation technique

Experimental

Ladybug TECHNIQUE is a breathing/relaxation intervention performed in children aged 5 to 10 years and consists of telling the story of a ladybug performing 4 moves and visualizing and performing breathing techniques independently. Afterwards, a drawing is invited.

SUNRISE TECHNIQUE is a breathing/relaxation intervention performed in children aged 10 to 15 years and consists of having the child imagine a favorite place. Then they are invited to reflect on the experience either verbally or through writing or drawing.

干预措施: Breathing/relaxation intervention (Other)

Standard of care

No Intervention

结局指标

主要结局

Percentage reduction in anxiety score

时间窗: From recruitment to end of surgery

次要结局

未报告次要终点

研究者

发起方
Meyer Children's Hospital IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriella Barresi

Nurse

Meyer Children's Hospital IRCCS

研究点 (1)

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