Transformative Audio Storytelling

NCT05762315 | Completed

• 1 other identifier: 39C101
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Burden

Keywords

audio storytelling; informal caregivers; digital narratives

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Feedback on the perceived value of audio storytelling

  after 15 minutes intervention sessions

Study Arms (1)

Audio Storytelling

EXPERIMENTAL

15 minutes transformative audio storytelling session

Behavioral: Audio Storytelling

Interventions

Audio Storytelling BEHAVIORAL

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

Audio Storytelling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• European Union: collaborator

Study Sites (1)

Istituto Auxologico Italiano

Milan, Lombardy, 20145, Italy

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pre-post

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 9, 2023
• Study Start: November 26, 2021
• Primary Completion: June 10, 2022
• Study Completion: September 25, 2022
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

IT (1)