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临床试验/NCT05762315
NCT05762315已完成不适用

Un Protocollo di Studio Per l'Assessment Dell'Efficacia Dello Storytelling Audio Trasformativo Per Caregiver Informale (A Protocol for Assessing the Feasibility of Transformative Audio Storytelling for Informal Caregivers)

Istituto Auxologico Italiano2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2021年11月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Sense of Coherence Scale revised (SOC-R)

研究概览

简要总结

Pilot testing the feasibility of the Transformative Audio Storytelling approach for informal caregivers, as an innovative method for delivering potentially empowering mental health narratives.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • Informal caregiver (family members or significant other person who provides primary care for the patients visiting or being hospitalized in the Rehabilitation Ward)
  • Age ≥18 years
  • Native speaker of the Italian language
  • Having voluntarily agreed to participate in the study and having signed the informed consent in all its points.

排除标准

  • Informal caregiver for children
  • Informal caregiver who does not personally play this role (primary caregiver)
  • Informal caregiver of adults with a tumor pathological condition

结局指标

主要结局

Sense of Coherence Scale revised (SOC-R)

时间窗: pre-post (15 minutes) intervention

The SOC-R is a tool composed of 13 items on a 5-point Likert scale ranging from 1 - "Not at all true" to 5 - "Extremely true".

Meaning in Life (MLQ)

时间窗: pre-post (15 minutes) intervention

The MLQ is a questionnaire composed of 10 items to evaluate meaning of life. The MLQ uses 7-step Likert scales from 1 "Absolutely true" to "Absolutely not true".

Perceived Stress Scale

时间窗: pre-post (15 minutes) intervention

The PSS is a questionnaire consisting of 10 items, on a 5-step Likert scale, ranging from 0, "Never" to 4, "Very Often". A total score of the 10 items provides a general measure of perceived stress. PPS items rate thoughts and feelings about the past month.

Cognitive Emotion Regulation Questionnaire (CERQ)

时间窗: pre-post (15 minutes) intervention

The CERQ is a questionnaire composed of 27 items, consisting of 5-step Likert scales, from 1 - "almost never" to 5 "almost always"

Burden Scale for Family Caregivers - Short Form (BSFC-s)

时间窗: pre-post (15 minutes) intervention

The BSFC-s is a 10-item 4-step Likert scale ranging from (0) "Strongly disagree" to (4) Strongly agree.

Facial expressions responses (Noldus FaceReader)

时间窗: during 15 minutes intervention session

this facial expression recognition software includes the evaluation of six basic expressions and then calculates the drive, valence, arousal, gaze direction, head orientation and other additional characteristics such as age and the sex

次要结局

  • Feedback on the perceived value of audio storytelling(after 15 minutes intervention sessions)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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