Chronic PainNCT03679871
Spiritual Assessment in Chronic Pain Patients
A study testing Questionnaire validation in people with Chronic Pain and Spirituality, run by University of Zurich at 6 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Spirituality
- What is being tested?
- Questionnaire validation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 6 sitesSwitzerland
- Study dates
- 22 Oct 2018to 13 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Life threatening diagnosis (e.g. cancer) that would introduce end-of-life topics as primary aspect
- Cognitive disorders that would impair participation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Switzerland6 sites
Zürcher RehaZentrum Davos
Davos, Kanton Graubünden, 7272
Klinik SGM Langenthal
Langenthal, Canton of Bern, 4900
Schweizer Paraplegiker Zentrum, Zentrum für Schmerzmedizin
Nottwil, Canton of Lucerne, 2607
Arztpraxis Professor Sprott
Zurich, 8033
Universitätsspital Zürich, Institut für Anästhesiologie, Schmerzambulatorium
Zurich, 8091
Universitätsspital Zürich, Klinik für Konsiliarpsychiatrie und Psychosomatik
Zurich
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain, Spirituality
- Being tested
- Questionnaire validation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire validationOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire validation | Other | 22-items questionnaire "Spiritual Resources and Distress" Receives: Other: Questionnaire validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric properties of "Spiritual Resources and Distress" questionnaire
Validity, internal consistency and stability of "Spiritual Resources and Distress" questionnaire
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start22 Oct 2018
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Michael Rufer, Prof., MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679871
- Sponsor's protocol ID
- Spiritual Care & Chronic Pain
- Status last verified
- Dec 2019
- First submitted
- 17 Sep 2018
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34039337
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spiritual Assessment in Chronic Pain Patients: Construction and Validation of a Screening Tool in Health Care
- ClinicalTrials.gov ID
- NCT03679871
- Acronym / sponsor ID
- Spiritual Care & Chronic Pain
- Conditions
- Chronic Pain, Spirituality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 20 Sep 2018 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire validation | Other | Other: Questionnaire validation22-items questionnaire "Spiritual Resources and Distress" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Life threatening diagnosis (e.g. cancer) that would introduce end-of-life topics as primary aspect
- Cognitive disorders that would impair participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire validationParticipants 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) | Other | Questionnaire validation |
Primary outcome
Psychometric properties of "Spiritual Resources and Distress" questionnaire
Time frame: 8 months
Validity, internal consistency and stability of "Spiritual Resources and Distress" questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Derived from this study: PubMed 34039337Perrin 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.
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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. This study is not recruiting at the moment.
Michael Rufer, Prof., MD principal investigator
University of Zurich
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire validation in people with Chronic Pain and Spirituality, run by University of Zurich at 6 sites in Switzerland.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometric properties of "Spiritual Resources and Distress" questionnaire (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03679871, which also lists 1 linked publication.
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 5 Dec 2019.