跳至主要内容
临床试验/NCT05623449
NCT05623449已完成不适用

Monocentric Pilot Study of the Feasibility of Teleconsultations Hypnosis Sessions Led by a Nurse for Patients With Peripheral Chronic Neuropathic Pain - HYPTEC

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年2月23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
发起方
入组人数
30
试验地点
2
主要终点
5 hypnosis consultations (in face-to-face and by teleconsultation).

研究概览

简要总结

The aim of this study is to assess the feasibility of hypnosis sessions performed in teleconsultations and led by a nurse, for patients with peripheral chronic neuropathic pain. Acceptability, satisfaction and effects (on pain and psychological distress) are also evaluated, comparing patients who have benefited from teleconsultations and those who did not.

详细描述

Factors explaining peripheral chronic neuropathic pains are complex ; they require a personalized therapeutic strategy and multidisciplinary management. Among the recommended management, psychocorporal approaches such as hypnosis, are subject of recent interest. At the CHU de Bordeaux, the management of patients suffering from such chronic pains, consists of 5 hypnosis sessions, conducted face-to-face, each performed one month apart : the first session is carried out by a doctor and a hypnotherapist nurse and the 4 following sessions by the hypnotherapist nurse alone. However, it seems that this usual management is not easily accessible for patients who are geographically distant and/or who are unable to move due to excessive pain. In such situations, teleconsultations would avoid travel for these patients with low mobility and then would an interesting alternative to face-to-face consultations. Few studies have been done on hypnosis sessions led by teleconsultations. So, the whole purpose of this study is to compare the management of 15 patients by teleconsultations (experimental arm) with 15 other patients seen in face-to-face (control arm) to evaluate feasibility of teleconsultation in hypnosis.

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

入选标准

  • Patient aged over 18 years old,
  • Patient suffering of from peripheral neuropathic pain for more than 1 year,
  • Patient referred for hypnosis management as part of a coordinated care support,
  • Patient who accepts teleconsultation, having the appropriate equipment to attend teleconsultations (computer, microphone, camera and stable internet connection with sufficient internet speed) and the ability to use it independently,
  • Patient having signed a free, informed and written consent,
  • Patient affiliated or beneficiary of the social security system.

排除标准

  • Patient with severe and unstable neurocognitive or psychiatric conditions (depression, psychoses, major cognitive impairments),
  • Patient with uncorrected deafness,
  • Patient with poor understanding of French
  • Patient placed under judicial safeguard, guardianship or curatorship.

研究组 & 干预措施

face-to-face hypnosis consultation

Active Comparator

5 face-to-face hypnosis sessions

干预措施: Anxiety and Depression Scale (HAD) (Other)

face-to-face hypnosis consultation

Active Comparator

5 face-to-face hypnosis sessions

干预措施: pain scale (Procedure)

combination of face-to-face and teleconsultation hypnosis consultation

Experimental

The first and the last hypnosis sessions in face-to-face, and the other 3 intermediate sessions being conducted by teleconsultation.

干预措施: Clinical examination (Other)

combination of face-to-face and teleconsultation hypnosis consultation

Experimental

The first and the last hypnosis sessions in face-to-face, and the other 3 intermediate sessions being conducted by teleconsultation.

干预措施: Anxiety and Depression Scale (HAD) (Other)

combination of face-to-face and teleconsultation hypnosis consultation

Experimental

The first and the last hypnosis sessions in face-to-face, and the other 3 intermediate sessions being conducted by teleconsultation.

干预措施: pain scale (Procedure)

combination of face-to-face and teleconsultation hypnosis consultation

Experimental

The first and the last hypnosis sessions in face-to-face, and the other 3 intermediate sessions being conducted by teleconsultation.

干预措施: hypnosis consultation (Procedure)

combination of face-to-face and teleconsultation hypnosis consultation

Experimental

The first and the last hypnosis sessions in face-to-face, and the other 3 intermediate sessions being conducted by teleconsultation.

干预措施: Maintenance (Procedure)

combination of face-to-face and teleconsultation hypnosis consultation

Experimental

The first and the last hypnosis sessions in face-to-face, and the other 3 intermediate sessions being conducted by teleconsultation.

干预措施: Data collection (Other)

face-to-face hypnosis consultation

Active Comparator

5 face-to-face hypnosis sessions

干预措施: Clinical examination (Other)

face-to-face hypnosis consultation

Active Comparator

5 face-to-face hypnosis sessions

干预措施: hypnosis consultation (Procedure)

face-to-face hypnosis consultation

Active Comparator

5 face-to-face hypnosis sessions

干预措施: Maintenance (Procedure)

face-to-face hypnosis consultation

Active Comparator

5 face-to-face hypnosis sessions

干预措施: Data collection (Other)

结局指标

主要结局

5 hypnosis consultations (in face-to-face and by teleconsultation).

时间窗: Month 8

The rate (%) of included patients who have completed the 5 hypnosis consultations (in face-to-face and by teleconsultation).

次要结局

  • Numerical Pain Assessme(Day 0, month 1, month 2, month 3 month 4 and montth 7)
  • Hospital Anxiety and Depression scale (HAD)(Day 0, month 4 and month 7)
  • Achievement/Acceptability(Month 8)
  • Learning self-hypnosis(Day 0, month 1, month 2, month 3 month 4 and montth 7)
  • Ssatisfaction scale(Month 7)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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