xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05993663</url>
    </required_header>
    <id_info>
      <org_study_id>23/133-P</org_study_id>
      <nct_id>NCT05993663</nct_id>
    </id_info>
    <brief_title>Effectiveness of an Intervention Based on Arts In Health in the Quality of Life of People With Fibromyalgia.</brief_title>
    <official_title>Museums as Health Spaces: Design and Evaluation of the Effectiveness of an Arts in Health Intervention to Improve the Quality of Life and Functional Capacity Regarding the Pain of People With Fibromyalgia. Mixed Methodology Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Agència de Salut Pública de Catalunya (ASPCAT)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Institut Català de la Salut</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Servei de Museus i Protecció de Béns Mobles</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Museu de l'Empordà</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Adhoc Cultura</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this intervention is to measure the impact of a 12-session intervention with Arts&#xD;
        in Health methodology on the quality of life of the population with fibromyalgia.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  To know if the methodology of Arts in Health is effective for the improvement of the&#xD;
             functional capacity of people with fibromyalgia&#xD;
  &#xD;
          -  Which are the most effective techniques within this intervention&#xD;
  &#xD;
        During the intervention, the participants will take part in mindfulness sessions, dance,&#xD;
        visual thinking strategies, aimed at a greater understanding of the disease and the&#xD;
        development of healthy habits.&#xD;
  &#xD;
        The results of this intervention are compared with a control group, in which the same scales&#xD;
        and instruments will be passed in the same period of time. To complete the information&#xD;
        gathering, a focus group will be held to obtain qualitative information about the experience&#xD;
        of the participants.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Arts in Health is a methodology that seeks to use the power of arts and culture to improve&#xD;
        people's health and well-being. To develop it, collaboration is promoted between health&#xD;
        professionals and those in the artistic and cultural fields.&#xD;
  &#xD;
        In accordance with the Arts in Health strategy of the Catalan Health Institute, the primary&#xD;
        health care professionals in Figueres have started a joint project along Museu de l'Empordà,&#xD;
        a local museum, to address fibromyalgia from this perspective.&#xD;
  &#xD;
        The objectives are to quantitatively analyze the effectiveness of an Arts in Health&#xD;
        intervention to improve the functional capacity with respect to pain and the quality of life&#xD;
        of people with fibromyalgia. Also, qualitatively assess the experience of the participants&#xD;
        and explore how they value the impact of cultural activities on health.&#xD;
  &#xD;
        Joint work has been carried out to produce a guide where, through different modalities of&#xD;
        Art, the symptoms and needs of people suffering from fibromyalgia will be addressed. Affected&#xD;
        people have also collaborated in this process. With the results of this work, the content of&#xD;
        the Intervention has been designed.&#xD;
  &#xD;
        From here, a mixed methodology study is proposed through a randomized clinical trial for&#xD;
        people affected by fibromyalgia. For the quantitative analysis, quality of life tests and a&#xD;
        disability perception test due to pain, (FIQ-R), will be taken before, at the end and 6&#xD;
        months after the intervention. For the qualitative analysis, focus groups will be formed at&#xD;
        the end of the intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">October 2, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 15, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Single intervention will be carried out for the 60 people who are part of the intervention groups, which will be 4 in total</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>No masking</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Functional capacity</measure>
      <time_frame>The first and last days of the intervention and 6 months after intervention.</time_frame>
      <description>Functional capacity with respect to pain management, measured with the Revised Fibromyalgia Impact Questionnaire (FIQ-R)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Life quality</measure>
      <time_frame>The first and last days of the intervention and 6 months after intervention.</time_frame>
      <description>Quality of life perceived by the participants, measured with the EUROQOL</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anxiety</measure>
      <time_frame>1 month before the intervention, last intervention day and 6 months after intervention.</time_frame>
      <description>Assessment of anxiety with the Goldberg scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emotional well-being</measure>
      <time_frame>1 month before the intervention, last intervention day and 6 months after intervention.</time_frame>
      <description>Assessment of emotional well-being with the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression</measure>
      <time_frame>1 month before the intervention, last intervention day and 6 months after intervention.</time_frame>
      <description>Depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Social support</measure>
      <time_frame>1 month before the intervention, last intervention day and 6 months after intervention.</time_frame>
      <description>Assessment of perceived social support with the Oslo Social Support Scale (OSLO-3) scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Drug consumption</measure>
      <time_frame>During the 6 months before the intervention and the 6 months after the intervention.</time_frame>
      <description>Painkillers and psychotropic drugs consumed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health care professional appointments.</measure>
      <time_frame>During the 6 months before the intervention, during the interventions and the 6 months after the intervention.</time_frame>
      <description>Assistance to health services</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">121</enrollment>
    <condition>Fibromyalgia</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intervention groups that will receive 12 Arts in Health session. There will be four groups of 15 individuals for reaching the needed sample size.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Control groups. Participants in these groups won't receive any group intervention, just regular health care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Arts in health group intervention</intervention_name>
      <description>12 sessions using the Arts in Health methodology with the aim of having a better understanding of the disease, developing healthy lifestyle habits and greater emotional intelligence. Visual thinking strategies, game based activities, mindfulness and dance will be used</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Individuals diagnosed with fibromyalgia (M79.1) or diagnosed with fibromyalgia and&#xD;
               chronic fatigue syndrome (T78.40 and M79.7)&#xD;
  &#xD;
            2. Over 18 years old.&#xD;
  &#xD;
            3. They agree to participate in the study and sign the informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Serious concomitant rheumatological pathology, that is to say, that this involves a&#xD;
               much more important functional disability than that caused by the fibromyalgia&#xD;
               pathology itself.&#xD;
  &#xD;
            2. Serious psychiatric pathology [according to V Diagnostical and Statical Manual of&#xD;
               Mental Disorders (DSM-V) criteria] that could make it difficult to participate in the&#xD;
               sessions and follow the study. Or that due to his psychiatric diagnosis, participation&#xD;
               in a group was not advisable because of the negative impact it could cause.&#xD;
  &#xD;
            3. Having previously participated in the group education project for people with&#xD;
               fibromyalgia in Figueres Health Care Center.&#xD;
  &#xD;
            4. Users who present a language barrier that makes good communication impossible.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Judit Ferragutcasas Butiña</last_name>
      <phone>600234302</phone>
      <email>jferragutcasa.girona.ics@gencat.cat</email>
    </overall_contact>
    <location>
      <facility>
        <name>ABS Figueres</name>
        <address>
          <city>Figueres</city>
          <state>Girona</state>
          <zip>17600</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maria Carrillo, Manager</last_name>
        <phone>972 67 76 31</phone>
        <email>eap_figueres.girona.ics@gencat.cat</email>
      </contact>
      <investigator>
        <last_name>Judit Ferragutcasas Butiñà, physician</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Xavier López Blánquez, psychologist</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Clàudia Molina-Martínez, psychologist</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Agustina Cros Peñalba, nurse</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Marta Roura Fausellas, nurse</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Eloisa Gómez Garcia, nurse</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
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      <citation>Bosman JT, Bood ZM, Scherer-Rath M, Dorr H, Christophe N, Sprangers MAG, van Laarhoven HWM. The effects of art therapy on anxiety, depression, and quality of life in adults with cancer: a systematic literature review. Support Care Cancer. 2021 May;29(5):2289-2298. doi: 10.1007/s00520-020-05869-0. Epub 2020 Nov 13.</citation>
      <PMID>33188476</PMID>
    </reference>
    <reference>
      <citation>Young R, Camic PM, Tischler V. The impact of community-based arts and health interventions on cognition in people with dementia: a systematic literature review. Aging Ment Health. 2016;20(4):337-51. doi: 10.1080/13607863.2015.1011080. Epub 2015 Feb 16.</citation>
      <PMID>25683767</PMID>
    </reference>
    <reference>
      <citation>Onieva-Zafra MD, Castro-Sanchez AM, Mataran-Penarrocha GA, Moreno-Lorenzo C. Effect of music as nursing intervention for people diagnosed with fibromyalgia. Pain Manag Nurs. 2013 Jun;14(2):e39-46. doi: 10.1016/j.pmn.2010.09.004. Epub 2010 Nov 26.</citation>
      <PMID>23108015</PMID>
    </reference>
    <reference>
      <citation>Macnaughton, J., White, M., &amp; Stacy, R. Researching the benefits of Arts in Health. Health Education, 2005; 105(5), 332-339.</citation>
    </reference>
    <reference>
      <citation>Camic PM, Baker EL, Tischler V. Theorizing How Art Gallery Interventions Impact People With Dementia and Their Caregivers. Gerontologist. 2016 Dec;56(6):1033-1041. doi: 10.1093/geront/gnv063. Epub 2015 Jul 16.</citation>
      <PMID>26185152</PMID>
    </reference>
    <reference>
      <citation>Daykin N, Mansfield L, Meads C, Julier G, Tomlinson A, Payne A, Grigsby Duffy L, Lane J, D'Innocenzo G, Burnett A, Kay T, Dolan P, Testoni S, Victor C. What works for wellbeing? A systematic review of wellbeing outcomes for music and singing in adults. Perspect Public Health. 2018 Jan;138(1):39-46. doi: 10.1177/1757913917740391. Epub 2017 Nov 13.</citation>
      <PMID>29130840</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Fibromyalgia</keyword>
    <keyword>Arts in Health</keyword>
    <keyword>Mindfulness</keyword>
    <keyword>Visual Thinking Strategies</keyword>
    <keyword>Revised Fibromyalgia Impact Questionnaire (FIQ-R)</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fibromyalgia</mesh_term>
      <mesh_term>Myofascial Pain Syndromes</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05993663
  org study id: 23/133-P
  nct id: NCT05993663
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this intervention is to measure the impact of a 12-session intervention with Arts
        in Health methodology on the quality of life of the population with fibromyalgia.
  
        The main questions it aims to answer are:
  
          -  To know if the methodology of Arts in Health is effective for the improvement of the
             functional capacity of people with fibromyalgia
  
          -  Which are the most effective techniques within this intervention
  
        During the intervention, the participants will take part in mindfulness sessions, dance,
        visual thinking strategies, aimed at a greater understanding of the disease and the
        development of healthy habits.
  
        The results of this intervention are compared with a control group, in which the same scales
        and instruments will be passed in the same period of time. To complete the information
        gathering, a focus group will be held to obtain qualitative information about the experience
        of the participants.
  Arts in Health is a methodology that seeks to use the power of arts and culture to improve
        people's health and well-being. To develop it, collaboration is promoted between health
        professionals and those in the artistic and cultural fields.
  
        In accordance with the Arts in Health strategy of the Catalan Health Institute, the primary
        health care professionals in Figueres have started a joint project along Museu de l'Empordà,
        a local museum, to address fibromyalgia from this perspective.
  
        The objectives are to quantitatively analyze the effectiveness of an Arts in Health
        intervention to improve the functional capacity with respect to pain and the quality of life
        of people with fibromyalgia. Also, qualitatively assess the experience of the participants
        and explore how they value the impact of cultural activities on health.
  
        Joint work has been carried out to produce a guide where, through different modalities of
        Art, the symptoms and needs of people suffering from fibromyalgia will be addressed. Affected
        people have also collaborated in this process. With the results of this work, the content of
        the Intervention has been designed.
  
        From here, a mixed methodology study is proposed through a randomized clinical trial for
        people affected by fibromyalgia. For the quantitative analysis, quality of life tests and a
        disability perception test due to pain, (FIQ-R), will be taken before, at the end and 6
        months after the intervention. For the qualitative analysis, focus groups will be formed at
        the end of the intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Single intervention will be carried out for the 60 people who are part of the intervention groups, which will be 4 in total
  primary purpose: Supportive Care
  masking: None (Open Label)
  masking description: No masking
  measure: Functional capacity
  time frame: The first and last days of the intervention and 6 months after intervention.
  description: Functional capacity with respect to pain management, measured with the Revised Fibromyalgia Impact Questionnaire (FIQ-R)
  measure: Life quality
  time frame: The first and last days of the intervention and 6 months after intervention.
  description: Quality of life perceived by the participants, measured with the EUROQOL
  measure: Anxiety
  time frame: 1 month before the intervention, last intervention day and 6 months after intervention.
  description: Assessment of anxiety with the Goldberg scale
  measure: Emotional well-being
  time frame: 1 month before the intervention, last intervention day and 6 months after intervention.
  description: Assessment of emotional well-being with the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS)
  measure: Depression
  time frame: 1 month before the intervention, last intervention day and 6 months after intervention.
  description: Depression
  measure: Social support
  time frame: 1 month before the intervention, last intervention day and 6 months after intervention.
  description: Assessment of perceived social support with the Oslo Social Support Scale (OSLO-3) scale
  measure: Drug consumption
  time frame: During the 6 months before the intervention and the 6 months after the intervention.
  description: Painkillers and psychotropic drugs consumed
  measure: Health care professional appointments.
  time frame: During the 6 months before the intervention, during the interventions and the 6 months after the intervention.
  description: Assistance to health services
  arm group label: Intervention group
  arm group type: Experimental
  description: Intervention groups that will receive 12 Arts in Health session. There will be four groups of 15 individuals for reaching the needed sample size.
  arm group label: Control group
  arm group type: No Intervention
  description: Control groups. Participants in these groups won't receive any group intervention, just regular health care.
  intervention type: Behavioral
  intervention name: Arts in health group intervention
  description: 12 sessions using the Arts in Health methodology with the aim of having a better understanding of the disease, developing healthy lifestyle habits and greater emotional intelligence. Visual thinking strategies, game based activities, mindfulness and dance will be used
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Judit Ferragutcasas Butiña
  phone: 600234302
  email: jferragutcasa.girona.ics@gencat.cat
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Spain
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  PMID: 31106558
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  PMID: 33188476
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  PMID: 25683767
  citation: Onieva-Zafra MD, Castro-Sanchez AM, Mataran-Penarrocha GA, Moreno-Lorenzo C. Effect of music as nursing intervention for people diagnosed with fibromyalgia. Pain Manag Nurs. 2013 Jun;14(2):e39-46. doi: 10.1016/j.pmn.2010.09.004. Epub 2010 Nov 26.
  PMID: 23108015
  citation: Macnaughton, J., White, M., & Stacy, R. Researching the benefits of Arts in Health. Health Education, 2005; 105(5), 332-339.
  citation: Camic PM, Baker EL, Tischler V. Theorizing How Art Gallery Interventions Impact People With Dementia and Their Caregivers. Gerontologist. 2016 Dec;56(6):1033-1041. doi: 10.1093/geront/gnv063. Epub 2015 Jul 16.
  PMID: 26185152
  citation: Daykin N, Mansfield L, Meads C, Julier G, Tomlinson A, Payne A, Grigsby Duffy L, Lane J, D'Innocenzo G, Burnett A, Kay T, Dolan P, Testoni S, Victor C. What works for wellbeing? A systematic review of wellbeing outcomes for music and singing in adults. Perspect Public Health. 2018 Jan;138(1):39-46. doi: 10.1177/1757913917740391. Epub 2017 Nov 13.
  PMID: 29130840
  responsible party type: Sponsor
  mesh term: Fibromyalgia
  mesh term: Myofascial Pain Syndromes
  sharing ipd: No