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Clinical Trials/NCT05762315
NCT05762315CompletedNot Applicable

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 Italiano1 site in 1 country21 target enrollmentStarted: November 26, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Sense of Coherence Scale revised (SOC-R)

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

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

Arms & Interventions

Audio Storytelling

Experimental

15 minutes transformative audio storytelling session

Intervention: Audio Storytelling (Behavioral)

Outcomes

Primary Outcomes

Sense of Coherence Scale revised (SOC-R)

Time Frame: 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)

Time Frame: 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

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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