跳至主要内容
临床试验/NCT06839950
NCT06839950招募中不适用

Sensory Profile and Early Clinical Signs of Calm Room Users

Centre Hospitalier Esquirol1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Scores of Sensory Sensitivity from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room

研究概览

简要总结

This descriptive study aims primarily to characterize the sensory profile of patients in a closed psychiatric hospital unit who use a calming room.

The main questions it aims to answer are :

  • Could sensory information processing disorders be the cause of distress and tension in these patients?
  • Could users of the calming room present extreme sensory processing profiles, characterized by either hypersensitivity or hyposensitivity ?

Participants will answer a survey to determine their the sensory profile. Participants can already use the calming room as part of their regular medical care and they will answer surveys before and after each use.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Gender and Age: Male or female, aged 18 to 65
  • •Hospitalization: Admitted to the closed hospitalization unit for less than 10 days
  • •Social security: Affiliated or beneficiary of a social security system
  • •Consent: Free, informed, and written consent, signed by the participant and/or their legal representative (for participants under protection measures) and the investigator (at the latest on the day of inclusion and before any research-related examination).

排除标准

  • •Inability to understand information related to the study
  • •Proven sensory disability
  • •Pregnancy
  • •Lack of social protection
  • •Previous Participation in this research protocol (in the case of a new hospitalization)
  • •Expression abilities incompatible with completing the AASP Scale (e.g., french language comprehension issues, mute individuals, patients in restraint and/or therapeutic isolation)

结局指标

主要结局

Scores of Sensory Sensitivity from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room

时间窗: At enrollment

The sensory profile scores will be obtained through the Adolescent/Adult Sensory Profile (AASP) scale during an individual interview following the participant inclusion. The following Sensory Sensitivity sub-score will be collected. The minimum and maximum values are from 15 to 75. A high score indicate a high sensory sensitivity.

次要结局

  • Frequency of use of the calming room(From enrollment to the end of observation at 2 weeks)
  • Scores of the Sensation Seeking from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room(At enrollment)
  • Initiative for the use of the calming room(From enrollment to the end of observation at 2 weeks)
  • Autonomy for the use of the calming room(From enrollment to the end of observation at 2 weeks)
  • Scores of the Low Registration from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room(At enrollment)
  • Anxiety for users or non-user of the calming room(From enrollment to the end of observation at 2 weeks)
  • Scores of the Sensation Avoiding from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room(At enrollment)
  • Comparison of Adolescent/Adult Sensory Profile score between the user and non-user of the calming room(From enrollment to the end of observation at 2 weeks)
  • Reason for resquesting of the calming room(From enrollment to the end of observation at 2 weeks)
  • User frenquecy of the calming room(From enrollment to the end of observation at 2 weeks)
  • Description of anxiety leading to the use of the calming room among patients who use this room.(From enrollment to the the end of observation at 2 weeks)
  • Description of well-being leading to the use of the calming room among patients who use this room.(From enrollment to the the end of observation at 2 weeks)
  • Description of physical tension leading to the use of the calming room among patients who use this room.(From enrollment to the the end of observation at 2 weeks)

研究者

发起方
Centre Hospitalier Esquirol
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aude Paquet

Psychomotor Therapist, Doctor in Psychology

Centre Hospitalier Esquirol

研究点 (1)

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