Spiritual Assessment in Chronic Pain Patients
Primary Purpose
Chronic Pain, Spirituality
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Questionnaire validation
Sponsored by
About this trial
This is an interventional other trial for Chronic Pain
Eligibility Criteria
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
Sites / Locations
- Klinik SGM Langenthal
- Zürcher RehaZentrum Davos
- Schweizer Paraplegiker Zentrum, Zentrum für Schmerzmedizin
- Arztpraxis Professor Sprott
- Universitätsspital Zürich, Institut für Anästhesiologie, Schmerzambulatorium
- Universitätsspital Zürich, Klinik für Konsiliarpsychiatrie und Psychosomatik
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Questionnaire validation
Arm Description
22-items questionnaire "Spiritual Resources and Distress"
Outcomes
Primary Outcome Measures
Psychometric properties of "Spiritual Resources and Distress" questionnaire
Validity, internal consistency and stability of "Spiritual Resources and Distress" questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT03679871
First Posted
September 17, 2018
Last Updated
December 4, 2019
Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03679871
Brief Title
Spiritual Assessment in Chronic Pain Patients
Official Title
Spiritual Assessment in Chronic Pain Patients: Construction and Validation of a Screening Tool in Health Care
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
November 13, 2019 (Actual)
Study Completion Date
November 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Spirituality
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Questionnaire validation
Arm Type
Other
Arm Description
22-items questionnaire "Spiritual Resources and Distress"
Intervention Type
Other
Intervention Name(s)
Questionnaire validation
Intervention Description
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)
Primary Outcome Measure Information:
Title
Psychometric properties of "Spiritual Resources and Distress" questionnaire
Description
Validity, internal consistency and stability of "Spiritual Resources and Distress" questionnaire
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Rufer, Prof., MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik SGM Langenthal
City
Langenthal
State/Province
Bern
ZIP/Postal Code
4900
Country
Switzerland
Facility Name
Zürcher RehaZentrum Davos
City
Davos
State/Province
Graubünden
ZIP/Postal Code
7272
Country
Switzerland
Facility Name
Schweizer Paraplegiker Zentrum, Zentrum für Schmerzmedizin
City
Nottwil
State/Province
Luzern
ZIP/Postal Code
2607
Country
Switzerland
Facility Name
Arztpraxis Professor Sprott
City
Zürich
ZIP/Postal Code
8033
Country
Switzerland
Facility Name
Universitätsspital Zürich, Institut für Anästhesiologie, Schmerzambulatorium
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Universitätsspital Zürich, Klinik für Konsiliarpsychiatrie und Psychosomatik
City
Zürich
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
34039337
Citation
Perrin J, Streeck N, Naef R, Rufer M, Peng-Keller S, Rettke H. Comparing perspectives: patients' and health care professionals' views on spiritual concerns and needs in chronic pain care - a qualitative study. BMC Health Serv Res. 2021 May 26;21(1):504. doi: 10.1186/s12913-021-06508-y.
Results Reference
derived
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Spiritual Assessment in Chronic Pain Patients
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