Marfan SyndromeFOTOTEMANCT06872268
APPLICATION OF THERAPEUTIC PHOTOGRAPHY AND EXPRESSIVE WRITING IN THE MANAGEMENT OF PATIENTS WITH MARFAN SYNDROME
A study testing Therapeutic photography and expressive writing and Expressive writing in people with Marfan Syndrome, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
This study explores the efficacy of therapeutic photography and expressive writing as interventions in routine practice for patients with Marfan syndrome. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Marfan Syndrome
- What is being tested?
- Therapeutic photography and expressive writing and Expressive writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 2 Apr 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects with Marfan syndrome referred to the Cardiovascular genetic center in IRCCS Policlinico San Donato;
- Signed informed consent.
Who cannot join
- Patients who are currently going through a period of severe medical or psychological instability reported in medical history.
- Subjects who are unable to provide informed consent due to cognitive, language, or other limitations that prevent full understanding of the purpose and nature of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THERAPEUTIC PHOTOGRAPHY AND EXPRESSIVE WRITING: AN EXPLORATORY SEQUENTIAL MIXED-METHODS FEASIBILITY STUDY OF PATIENTS WITH MARFAN SYNDROME
This study explores the efficacy of therapeutic photography and expressive writing as interventions in routine practice for patients with Marfan syndrome.
Read the detailed description
The objective of the study is to assess the feasibility of including structured therapeutic photography and expressive writing activities in routine practice as an adjunct to standard treatment for patients with Marfan syndrome in a national Reference Centre for Rare Diseases. This will include measuring the adherence rate to the programme and evaluating the subjective experience of the patients involved.
- Conditions
- Marfan Syndrome
- Being tested
- Therapeutic photography and expressive writing, Expressive writing
- Keywords
- therapeutic photography, expressive writing activities, Marfan syndrome, standard practice, mixed methods study
- Medical subject headings
- Marfan Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic photography and expressive writingBehavioural
Therapeutic photography, unlike phototherapy, consists of a set of photography-based activities that are initiated independently as part of an organised group or project, but in which no formal therapy is taking place within a psychotherapeutic setting. This approach, too, can be used as a routine practice in treatment pathways. The subject deepens his or her self-awareness to improve the sense of being: images become a way to express oneself, to communicate what one is unable to verbalize. Therapeutic photography can be done independently and individually, or in the presence of other professionals (nurses, sociologists, teachers, facilitators, psychologists) who accompany the individual to the understanding and production of the activity.
Expressive writingBehavioural
Expressive writing is a technique that helps to understand and manage one's experiences and emotional tensions, contributes to mental and physical well-being, decreased stress, improved relationships, and the strengthening of the immune system.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Subjects with Marfan syndrome in follow-up at Cardiovascular Genetic Center, IRCCS Policlinico San Donato Receives: Behavioral: Therapeutic photography and expressive writing; Behavioral: Expressive writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of therapeutic photography in clinical practice
This approach will be assessed through semi-structured interviews and thematic analysis of photographs generated by participants to deepen their personal experience of living with a rare disease
Measured: 18 months
Efficacy of expressive writing in clinical practice
This approach will be assessed through semi-structured interviews and thematic analysis texts generated by participants to deepen their personal experience of living with a rare disease
Measured: 18 months
Secondary outcomes (5)
Impact of therapeutic photography
Detect and compare the impact of therapeutic photography activities on patients and their perception of its effect in their care. This approach will be assessed through semi-structured interviews and thematic analysis of photographs generated by participants to deepen their personal experience of living with a rare disease
Measured: 18 months
Impact of expressive writing
Detect and compare the impact of expressive writing activities on patients and their perception of its effect in their care. This approach will be assessed through semi-structured interviews and thematic analysis of texte written by participants to deepen their personal experience of living with a rare disease
Measured: 18 months
Pre- and post-activity effects of therapeutic photography: patients' perspective
Psychological General Well-Being Index (PGWBI) questionnaire will be applied for the evaluation of this outcome
Measured: 18 months
Pre- and post-activity effects of expressive writing: patients' perspective
Exploring patients' perceptions of attractiveness, efficiency, clarity, reliability, stimulation and originality of the program through standardized evaluations as a measure of proximity of feasibility.
Measured: 18 months
Qualitative analysis
Exploring the experience of the patients involved with qualitative analysis of interviews, texts and photographs.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start2 Apr 2024
- Primary completion1 Apr 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Marfan SyndromeStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- mixed-methods sequential exploratory study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Pini, IRCCS Policlinico S. Donato
- Investigators
- Nathasha Samali UDUGAMPOLAGE, MSN, Principal investigator, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872268
- Sponsor's protocol ID
- FOTOTEMA
- Acronym
- FOTOTEMA
- Status last verified
- Sep 2025
- First submitted
- 17 Jan 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared after study closure.
Publications
Panetta M, Bianchetti A, Udugampolage NS, Taurino J, Caruso R, Pini A, Callus E. Discussing psychological and psychotherapeutic support for patients with Marfan syndrome (MFS) and their family: an example of a structured program in Italy. Front Psychol. 2023 Jun 15;14:1176692. doi: 10.3389/fpsyg.2023.1176692. eCollection 2023. No abstract available.
PubMed 37397303Gibson, Neil. (2017). Therapeutic photography: enhancing patient communication. Journal of Kidney Care. 2. 46-47. 10.12968/jokc.2017.2.1.46.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THERAPEUTIC PHOTOGRAPHY AND EXPRESSIVE WRITING: AN EXPLORATORY SEQUENTIAL MIXED-METHODS FEASIBILITY STUDY OF PATIENTS WITH MARFAN SYNDROME
- ClinicalTrials.gov ID
- NCT06872268
- Acronym / sponsor ID
- FOTOTEMA / FOTOTEMA
- Conditions
- Marfan Syndrome
- Keywords
- therapeutic photography, expressive writing activities, Marfan syndrome, standard practice, mixed methods study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores the efficacy of therapeutic photography and expressive writing as interventions in routine practice for patients with Marfan syndrome.
Detailed description
The objective of the study is to assess the feasibility of including structured therapeutic photography and expressive writing activities in routine practice as an adjunct to standard treatment for patients with Marfan syndrome in a national Reference Centre for Rare Diseases. This will include measuring the adherence rate to the programme and evaluating the subjective experience of the patients involved.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- mixed-methods sequential exploratory study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Therapeutic photography and expressive writing, Behavioral: Expressive writingSubjects with Marfan syndrome in follow-up at Cardiovascular Genetic Center, IRCCS Policlinico San Donato |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with Marfan syndrome referred to the Cardiovascular genetic center in IRCCS Policlinico San Donato;
- Signed informed consent.
Key exclusion criteria (2 listed)
- Patients who are currently going through a period of severe medical or psychological instability reported in medical history.
- Subjects who are unable to provide informed consent due to cognitive, language, or other limitations that prevent full understanding of the purpose and nature of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic photography and expressive writingTherapeutic photography, unlike phototherapy, consists of a set of photography-based activities that are initiated independently as part of an organised group or project, but in which no formal therapy is taking place within a psychotherapeutic setting. This approach, too, can be used as a routine practice in treatment pathways. The subject deepens his or her self-awareness to improve the sense of being: images become a way to express oneself, to communicate what one is unable to verbalize. Therapeutic photography can be done independently and individually, or in the presence of other professionals (nurses, sociologists, teachers, facilitators, psychologists) who accompany the individual to the understanding and production of the activity. | Behavioural | Intervention group |
| Expressive writingExpressive writing is a technique that helps to understand and manage one's experiences and emotional tensions, contributes to mental and physical well-being, decreased stress, improved relationships, and the strengthening of the immune system. | Behavioural | Intervention group |
Primary outcome
Efficacy of therapeutic photography in clinical practice
Time frame: 18 months
This approach will be assessed through semi-structured interviews and thematic analysis of photographs generated by participants to deepen their personal experience of living with a rare disease
Efficacy of expressive writing in clinical practice
Time frame: 18 months
This approach will be assessed through semi-structured interviews and thematic analysis texts generated by participants to deepen their personal experience of living with a rare disease
5 secondary outcomes
Impact of therapeutic photography
Time frame: 18 months
Impact of expressive writing
Time frame: 18 months
Pre- and post-activity effects of therapeutic photography: patients' perspective
Time frame: 18 months
Pre- and post-activity effects of expressive writing: patients' perspective
Time frame: 18 months
Qualitative analysis
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 37397303Panetta M, Bianchetti A, Udugampolage NS, Taurino J, Caruso R, Pini A, Callus E. Discussing psychological and psychotherapeutic support for patients with Marfan syndrome (MFS) and their family: an example of a structured program in Italy. Front Psychol. 2023 Jun 15;14:1176692. doi: 10.3389/fpsyg.2023.1176692. eCollection 2023. No abstract available.
- BackgroundGibson, Neil. (2017). Therapeutic photography: enhancing patient communication. Journal of Kidney Care. 2. 46-47. 10.12968/jokc.2017.2.1.46.
- Individual participant dataSharing planned: No. IPD will be shared after study closure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathasha Samali UDUGAMPOLAGE, MSN principal investigator
IRCCS Policlinico S. Donato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic photography and expressive writing and Expressive writing in people with Marfan Syndrome, run by IRCCS Policlinico S. Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of therapeutic photography in clinical practice (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06872268, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.