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Clinical Trials/NCT07020481
NCT07020481Not yet recruitingNot Applicable

Spiritual Needs of Patients With Inflammatory Bowel Disease and Their Caregivers: a European Cross-sectional Nursing Study

University of Padova0 sites1,000 target enrollmentStarted: September 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
1,000
Primary Endpoint
Spiritual Needs Questionnaire (SpNQ-EV)

Study Overview

Brief 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 (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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •adolescents and adults of all ages clinically diagnosed with CD, UC, or any other form of IBD (such as indeterminate colitis or IBD unclassified).

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Padova
Sponsor Class
Other
Responsible Party
Sponsor

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