Psychological StressNCT02801045
Art Therapy in Palliative Care: Study of Identification and Understanding of the Mechanisms of Change in the Patient
A study testing art therapy in people with Psychological Stress and Suffering, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
This study evaluates from the patient's perspective which elements of the own artistic creative process are the source of a beneficial change for him/her and how those elements influence in their end of life experience. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Stress, Suffering, Advanced Cancers
- What is being tested?
- art therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteSpain
- Study dates
- 20 Oct 2016to 31 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- advanced-cancer adult inpatients of the Palliative Care Unit
- informed consent
Who cannot join
- altered cognitive function (Mini-Mental Test < 24)
- physical decline (palliative care team's criteria) that impedes the art therapy process
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates from the patient's perspective which elements of the own artistic creative process are the source of a beneficial change for him/her and how those elements influence in their end of life experience.
Read the detailed description
In previous quantitative studies about the effect of an art therapy intervention in adult cancer inpatients of the Palliative Care Unit, the investigators evidenced significant improvements in the symptom control of malaise, anxiety, depression and pain.
This study is designed to deepen the understanding of specific action mechanisms which lead to those therapeutic benefits and quality of life implications for patients with life-threatening illness in which a situation of suffering is frequently detected.
The investigators will determine from the subjective patient's experience which specific elements of the artistic creative process (including production of art and art products) may lead to changes in the symptom perception, in meaning and healing process and in the personal perspective about the end of life situation.
- Conditions
- Psychological Stress, Suffering, Advanced Cancers
- Being tested
- art therapy
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
art therapyBehavioural
Patient's creativity is stimulated by visual arts materials and various art therapy techniques including punctual use of music, poetry and body expression. The intervention, based on the investigators previous experience, is founded on:
- humanistic phenomenological focus
- transpersonal therapeutic bound
- transdisciplinarity in the artistic approach
- integrative-relational specialized counseling of the grief, loss and trauma aspects.
| Study group | Role | What they receive |
|---|---|---|
| art therapy | Experimental | Individual 30-60 minutes art therapy sessions, twice a week, offering visual arts materials. Receives: Behavioral: art therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflect Interview (RI) using audio recording.
An art based interview is administered and involves the patients selecting 2 significant artworks from their art therapy productions. The patient is asked by the art therapist for a narrative of how one artwork relates to the other in the context of his/her lived experience. The art therapy dialogue from the RI is transcribed and subjected to thematic analysis.
Measured: After the making of a minimum of 5 art pieces, an average of 2 weeks
Secondary outcomes (1)
Art therapy process from the art therapist perspective.
Detailed notes and photographical register.
Measured: Every day of art therapy session, with an average of 2 sessions a week, over a period of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start20 Oct 2016
- Primary completion30 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Pascual, MD, Principal investigator, Palliative Care Unit, Sant Pau Hospital, Barcelona, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801045
- Sponsor's protocol ID
- IIBSP-ART-2016-14
- Status last verified
- Mar 2022
- First submitted
- 30 May 2016
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Art Therapy in Palliative Care: Study of Identification and Understanding of the Mechanisms of Change in the Patient
- ClinicalTrials.gov ID
- NCT02801045
- Acronym / sponsor ID
- IIBSP-ART-2016-14
- Conditions
- Psychological Stress, Suffering, Advanced Cancers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 Jun 2016 (estimated)
- 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 evaluates from the patient's perspective which elements of the own artistic creative process are the source of a beneficial change for him/her and how those elements influence in their end of life experience.
Detailed description
In previous quantitative studies about the effect of an art therapy intervention in adult cancer inpatients of the Palliative Care Unit, the investigators evidenced significant improvements in the symptom control of malaise, anxiety, depression and pain.
This study is designed to deepen the understanding of specific action mechanisms which lead to those therapeutic benefits and quality of life implications for patients with life-threatening illness in which a situation of suffering is frequently detected.
The investigators will determine from the subjective patient's experience which specific elements of the artistic creative process (including production of art and art products) may lead to changes in the symptom perception, in meaning and healing process and in the personal perspective about the end of life situation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| art therapy | Experimental | Behavioral: art therapyIndividual 30-60 minutes art therapy sessions, twice a week, offering visual arts materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- advanced-cancer adult inpatients of the Palliative Care Unit
- informed consent
Key exclusion criteria (2 listed)
- altered cognitive function (Mini-Mental Test < 24)
- physical decline (palliative care team's criteria) that impedes the art therapy process
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 |
|---|---|---|
| art therapyPatient's creativity is stimulated by visual arts materials and various art therapy techniques including punctual use of music, poetry and body expression. The intervention, based on the investigators previous experience, is founded on: * humanistic phenomenological focus * transpersonal therapeutic bound * transdisciplinarity in the artistic approach * integrative-relational specialized counseling of the grief, loss and trauma aspects. | Behavioural | art therapy |
Primary outcome
Reflect Interview (RI) using audio recording.
Time frame: After the making of a minimum of 5 art pieces, an average of 2 weeks
An art based interview is administered and involves the patients selecting 2 significant artworks from their art therapy productions. The patient is asked by the art therapist for a narrative of how one artwork relates to the other in the context of his/her lived experience. The art therapy dialogue from the RI is transcribed and subjected to thematic analysis.
1 secondary outcome
Art therapy process from the art therapist perspective.
Time frame: Every day of art therapy session, with an average of 2 sessions a week, over a period of 2 years.
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 24 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Antonio Pascual, MD principal investigator
Palliative Care Unit, Sant Pau Hospital, Barcelona, Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing art therapy in people with Psychological Stress and Suffering, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 24 Mar 2022. 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 Spain. 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?
Reflect Interview (RI) using audio recording. (time frame: After the making of a minimum of 5 art pieces, an average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2022.