Transformative Audio Storytelling

Not Applicable

Completed

• Conditions: Caregiver Burden
• Interventions: Behavioral: Audio Storytelling

• Registration Number: NCT05762315
• Lead Sponsor: Istituto Auxologico Italiano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-26
• Primary Completion: 2022-06-10
• Study Completion: 2022-09-25
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Status Verified: 2023-03
• Study First Posted: 2023-03-09
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Audio Storytelling	Audio Storytelling	15 minutes transformative audio storytelling session

Primary Outcome Measures

Name	Time	Method
Sense of Coherence Scale revised (SOC-R)	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)	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	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)	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)	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)	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 Outcome Measures

Name	Time	Method
Feedback on the perceived value of audio storytelling	after 15 minutes intervention sessions	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

Trial Locations

Locations (1)

Istituto Auxologico Italiano; 🇮🇹 Milan, Lombardia, Italy