Back to resultsTransformative Audio Storytelling (HealingStories)
Primary Purpose
Caregiver Burden
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Audio Storytelling
Sponsored by
About this trial
This is an interventional supportive care trial for Caregiver Burden focused on measuring audio storytelling, informal caregivers, digital narratives
Eligibility Criteria
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
Sites / Locations
- Istituto Auxologico Italiano
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Audio Storytelling
Arm Description
15 minutes transformative audio storytelling session
Outcomes
Primary Outcome Measures
Perceived Stress Scale
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.
Sense of Coherence Scale revised (SOC-R)
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)
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".
Cognitive Emotion Regulation Questionnaire (CERQ)
The CERQ is a questionnaire composed of 27 items, consisting of 5-step Likert scales, from 1 - "almost never" to 5 "almost always"
Facial expressions responses (Noldus FaceReader)
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
Burden Scale for Family Caregivers - Short Form (BSFC-s)
The BSFC-s is a 10-item 4-step Likert scale ranging from (0) "Strongly disagree" to (4) Strongly agree.
Secondary Outcome Measures
Feedback on the perceived value of audio storytelling
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
Full Information
NCT ID
NCT05762315
First Posted
February 28, 2023
Last Updated
March 9, 2023
Sponsor
Istituto Auxologico Italiano
Collaborators
European Union
1. Study Identification
Unique Protocol Identification Number
NCT05762315
Brief Title
Transformative Audio Storytelling
Acronym
HealingStories
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 26, 2021 (Actual)
Primary Completion Date
June 10, 2022 (Actual)
Study Completion Date
September 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Auxologico Italiano
Collaborators
European Union
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden
Keywords
audio storytelling, informal caregivers, digital narratives
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
pre-post
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Audio Storytelling
Arm Type
Experimental
Arm Description
15 minutes transformative audio storytelling session
Intervention Type
Behavioral
Intervention Name(s)
Audio Storytelling
Intervention Description
The audio session is designed to deliver audio narrative developed following the Transformative Storytelling Technique and provide re-structurization of internal caregiver self-stories.
Primary Outcome Measure Information:
Title
Perceived Stress Scale
Description
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.
Time Frame
pre-post (15 minutes) intervention
Title
Sense of Coherence Scale revised (SOC-R)
Description
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".
Time Frame
pre-post (15 minutes) intervention
Title
Meaning in Life (MLQ)
Description
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".
Time Frame
pre-post (15 minutes) intervention
Title
Cognitive Emotion Regulation Questionnaire (CERQ)
Description
The CERQ is a questionnaire composed of 27 items, consisting of 5-step Likert scales, from 1 - "almost never" to 5 "almost always"
Time Frame
pre-post (15 minutes) intervention
Title
Facial expressions responses (Noldus FaceReader)
Description
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
Time Frame
during 15 minutes intervention session
Title
Burden Scale for Family Caregivers - Short Form (BSFC-s)
Description
The BSFC-s is a 10-item 4-step Likert scale ranging from (0) "Strongly disagree" to (4) Strongly agree.
Time Frame
pre-post (15 minutes) intervention
Secondary Outcome Measure Information:
Title
Feedback on the perceived value of audio storytelling
Description
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
Time Frame
after 15 minutes intervention sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Istituto Auxologico Italiano
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20145
Country
Italy
12. IPD Sharing Statement
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Transformative Audio Storytelling
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