- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03679871
Spiritual Assessment in Chronic Pain Patients
December 4, 2019 updated by: University of Zurich
Spiritual Assessment in Chronic Pain Patients: Construction and Validation of a Screening Tool in Health Care
The World Health Organization's (WHO) understanding of health(care) is incrementally incorporating the spiritual dimensions equivalent to the physical, psychological and social ones.
Yet, it remains widely neglected in multi-modal, interprofessional chronic pain therapy.
To support gaining access to chronic pain patients' spiritual needs and concerns within therapy, a screening tool has been constructed based on foregoing qualitative research and literature.
The screening tool is to be validated with chronic pain patients in clinical settings.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Addressing spiritual concerns and needs in chronic pain therapy is in line with the World Health Organization's (WHO) understanding of health(care) and would improve health care for this patient group.
An applicable screening tool for chronic pain patients' spiritual concerns and needs must be empirically based.
Based on preceding focus group interviews with patients and with health care professionals in various clinical settings and literature analysis, a screening tool has been constructed.
This tool aims at supporting health care professionals as well as chronic pain patients in gaining access to spiritual concerns and needs for incorporation in multi-modal, interprofessional pain therapy.
In this project the screening tools' psychometric properties will be tested with in five distinct clinical in- and out-patient settings.
Study Type
Interventional
Enrollment (Actual)
225
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Zürich, Switzerland, 8033
- Arztpraxis Professor Sprott
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Zürich, Switzerland, 8091
- Universitätsspital Zürich, Institut für Anästhesiologie, Schmerzambulatorium
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Zürich, Switzerland
- Universitätsspital Zürich, Klinik für Konsiliarpsychiatrie und Psychosomatik
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Bern
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Langenthal, Bern, Switzerland, 4900
- Klinik SGM Langenthal
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Graubünden
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Davos, Graubünden, Switzerland, 7272
- Zürcher RehaZentrum Davos
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Luzern
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Nottwil, Luzern, Switzerland, 2607
- Schweizer Paraplegiker Zentrum, Zentrum für Schmerzmedizin
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Sufficient command of German language as assessed by local study coordinator
- Confirmed medical and/or nursing diagnosis of chronic pain
- Suffering pain for ≥ 6 months
- Pain intensity was≥ 5 on a 11-point numeric Rating scale (NRS; 0 = no pain, 10 = worst pain imaginable) during the last episode of pain
Exclusion Criteria:
- Life threatening diagnosis (e.g. cancer) that would introduce end-of-life topics as primary aspect
- Cognitive disorders that would impair participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Questionnaire validation
22-items questionnaire "Spiritual Resources and Distress"
|
Participants will fill in the questionnaire "Spiritual Resources and Distress"plus additional questionnaires required for validation purposes.
Three weeks later, a sub-sample will fill in the questionnaire one more time for consistency testing (test-retest)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychometric properties of "Spiritual Resources and Distress" questionnaire
Time Frame: 8 months
|
Validity, internal consistency and stability of "Spiritual Resources and Distress" questionnaire
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Rufer, Prof., MD, University of Zurich
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 22, 2018
Primary Completion (Actual)
November 13, 2019
Study Completion (Actual)
November 13, 2019
Study Registration Dates
First Submitted
September 17, 2018
First Submitted That Met QC Criteria
September 19, 2018
First Posted (Actual)
September 20, 2018
Study Record Updates
Last Update Posted (Actual)
December 5, 2019
Last Update Submitted That Met QC Criteria
December 4, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Spiritual Care & Chronic Pain
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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