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临床试验/NCT04168983
NCT04168983已完成不适用

Study of the Impact of Sophrology on the Pain Felt During a Bone Marrow Aspiration and Biopsy

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Visual analog scale (VAS) score of the pain felt by the patient during the gesture of performing the BMAB

研究概览

简要总结

The bone marrow aspiration and biopsy (BMAB) is an essential and indispensable examination for the diagnosis and the follow-up of the hematological diseases but which remains painful and dread by the patients. Until then it was performed manually using a trocar. It is now practiced most often using a tool (like a small drill), device that pierces through the external iliac bone to extract a bone cylinder that will be analyzed

If the gesture is faster than with the manual method, it remains overall painful and the noise generated by the drill that passes through the periosteum of the iliac bone is impressive for the patient.

Prevention measures to limit pain and anxiety are put in place during the examination: local anesthesia, with or without a lidocaine patch, as well as inhalation of a mixture of nitrous oxide and oxygen (MEOPA®). These, recommended by the "Standards, Options, Recommendation" (SOR) often remain insufficient and are not devoid of undesirable effects.

Despite these precautions, several studies show that the action remains painful and anxiety-provoking.

An exploratory survey carried out in the hematology department of the François Baclesse Center in 2013 confirms these results and specifies that the pain remains present for another 30 minutes after the examination.

The investigators believe that associating a psycho-corporeal technique, as is sophrology, with the usual care, could contribute to the decrease of the threshold of pain and anxiety during the BMAB and avoid the use of a premedication.

The effectiveness of sophrology as a complementary technique in the field of pain prevention in invasive procedures is recognized by observations and clinical results. This complementary therapy, among others, has its place in the hospital.

To date, to investigator's knowledge, there is no published, randomized study evaluating the effectiveness of sophrology on pain in invasive procedures.

The investigators propose a study whose main objective is to evaluate the effectiveness of a session of sophrology on the pain felt during the realization of the BMAB, in patients with hematological malignancy. This session will be provided by a sophrologist nurse This study should include 90 patients undergoing a BMAB over a 24-month period.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient over 18 years old who has been informed of the study and has signed the consent form of the study
  • •Patient with a malignant hemopathy requiring a BMAB as part of a diagnostic assessment
  • •Patient who has never had a BMAB before
  • •Patient affiliated to a social security scheme

排除标准

  • •Patient requiring oral premedication
  • •Patient with contraindications or intolerance to MEOPA®
  • •Patient with a history of allergy to local anesthetics
  • •Patient not understanding French
  • •Patient with deafness
  • •Patient with severe cognitive impairment
  • •Patient under legal protection

研究组 & 干预措施

Control

No Intervention

Usual care: local anesthesia + nitrous oxide and oxygen administration

Experimental

Experimental

Usual care: local anesthesia + nitrous oxide and oxygen administration

In this arm : sophrology is added

干预措施: sophrology (Other)

结局指标

主要结局

Visual analog scale (VAS) score of the pain felt by the patient during the gesture of performing the BMAB

时间窗: Baseline

This is a self-assessment. This scale has two sides. On one side, the patient identifies his pain with a ruler, left (no pain) right (the strongest pain he has ever felt). On the other hand, the caregiver raises the corresponding score from 0 to 10. Pain will bemeasured a posteriori (not possible to evaluate during the sophrology sesssion)

次要结局

  • Numerical score (NS) of anxiety of the patient before the BMAB(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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