Transformative Audio Storytelling

Caregiver Burden Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05762315
• Other study ID #: 39C101
• Status: Completed
• Phase: N/A
• Start date: November 26, 2021
• Est. completion date: September 25, 2022

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 25, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Burden

Intervention

Behavioral:
• Audio Storytelling
The audio session is designed to deliver audio narrative developed following the Transformative Storytelling Technique and provide re-structurization of internal caregiver self-stories.

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano	Milan	Lombardia

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano	European Union

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	pre-post (15 minutes) intervention
Primary	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".	pre-post (15 minutes) intervention
Primary	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".	pre-post (15 minutes) intervention
Primary	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"	pre-post (15 minutes) intervention
Primary	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	during 15 minutes intervention session
Primary	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.	pre-post (15 minutes) intervention
Secondary	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	after 15 minutes intervention sessions