Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)Spirit@IBDNCT07020481
Spiritual Needs of European Patients With Inflammatory Bowel Disease and Their Caregivers
An observational study of Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), run by University of Padova.
Trial summary
A European-wide cross-sectional non-interventional study, initiated by a pilot study in Italy, will be conducted. The first phase of the pilot study is a 6-step translation, adaptation, and validation of the extended version of the Spiritual Needs Questionnaire (SpNQ-EV) and the Interpretation of Illness Questionnaire… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adolescents and adults of all ages clinically diagnosed with CD, UC, or any other form of IBD (such as indeterminate colitis or IBD unclassified)
Who may be able to join
- adolescents and adults of all ages clinically diagnosed with CD, UC, or any other form of IBD (such as indeterminate colitis or IBD unclassified).
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Spiritual Needs of Patients With Inflammatory Bowel Disease and Their Caregivers: a European Cross-sectional Nursing Study
A European-wide cross-sectional non-interventional study, initiated by a pilot study in Italy, will be conducted. The first phase of the pilot study is a 6-step translation, adaptation, and validation of the extended version of the Spiritual Needs Questionnaire (SpNQ-EV) and the Interpretation of Illness Questionnaire (IIQ) adopting the methodology [3] described in figure 1. To ensure they are both valid and user-friendly, the Thinking Out Loud (TOL) technique (think-aloud method) will pre-test their self-administration and provide fine tuning of the secondary objectives of the study. TOL involves participants verbalizing their thoughts while completing the questionnaires, allowing to capture real-time insights into their understanding, interpretation, and potential challenges with questionnaires' items. The second phase will consist of an anonymous e-survey consisting of the six questionnaires described in table 1 including the translated and validated SPNQ-EV and IIQ developed in phase 1. The European study will employ a multilingual anonymous e-survey developed to ensure accessibility in participants' native languages, eventually preceded by country-based pilot studies. Eligible participants include adolescents and adults with IBD, as well as their caregivers, recruited via nurses and patient associations.
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
Spiritual Needs Questionnaire (SpNQ-EV)
To assess the spiritual needs among European IBD patients and their caregivers
Measured: Day 1 (From enrollment to the end of data collection (end of questionnaire completion) - same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020481
- Sponsor's protocol ID
- SpNs-IBD-01
- Acronym
- Spirit@IBD
- Status last verified
- Jun 2025
- First submitted
- 20 Nov 2024
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spiritual Needs of Patients With Inflammatory Bowel Disease and Their Caregivers: a European Cross-sectional Nursing Study
- ClinicalTrials.gov ID
- NCT07020481
- Acronym / sponsor ID
- Spirit@IBD / SpNs-IBD-01
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Jun 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.
A European-wide cross-sectional non-interventional study, initiated by a pilot study in Italy, will be conducted. The first phase of the pilot study is a 6-step translation, adaptation, and validation of the extended version of the Spiritual Needs Questionnaire (SpNQ-EV) and the Interpretation of Illness Questionnaire (IIQ) adopting the methodology [3] described in figure 1. To ensure they are both valid and user-friendly, the Thinking Out Loud (TOL) technique (think-aloud method) will pre-test their self-administration and provide fine tuning of the secondary objectives of the study. TOL involves participants verbalizing their thoughts while completing the questionnaires, allowing to capture real-time insights into their understanding, interpretation, and potential challenges with questionnaires' items. The second phase will consist of an anonymous e-survey consisting of the six questionnaires described in table 1 including the translated and validated SPNQ-EV and IIQ developed in phase 1. The European study will employ a multilingual anonymous e-survey developed to ensure accessibility in participants' native languages, eventually preceded by country-based pilot studies. Eligible participants include adolescents and adults with IBD, as well as their caregivers, recruited via nurses and patient associations.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adolescents and adults of all ages clinically diagnosed with CD, UC, or any other form of IBD (such as indeterminate colitis or IBD unclassified)
Key inclusion criteria (1 listed)
- adolescents and adults of all ages clinically diagnosed with CD, UC, or any other form of IBD (such as indeterminate colitis or IBD unclassified).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spiritual Needs Questionnaire (SpNQ-EV)
Time frame: Day 1 (From enrollment to the end of data collection (end of questionnaire completion) - same day
To assess the spiritual needs among European IBD patients and their caregivers
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), run by University of Padova.
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 1 inclusion and 0 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: opening soon, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo Martinato (+39 3358769308, matteo.martinato@ubep.unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spiritual Needs Questionnaire (SpNQ-EV) (time frame: Day 1 (From enrollment to the end of data collection (end of questionnaire completion) - same day). 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 13 Jun 2025.