NCT03679871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 22, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2019

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

September 17, 2018

Last Update Submit

December 4, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Psychometric properties of "Spiritual Resources and Distress" questionnaire

    Validity, internal consistency and stability of "Spiritual Resources and Distress" questionnaire

    8 months

Study Arms (1)

Questionnaire validation

OTHER

22-items questionnaire "Spiritual Resources and Distress"

Other: Questionnaire validation

Interventions

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)

Questionnaire validation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Life threatening diagnosis (e.g. cancer) that would introduce end-of-life topics as primary aspect
  • Cognitive disorders that would impair participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Klinik SGM Langenthal

Langenthal, Canton of Bern, 4900, Switzerland

Location

Schweizer Paraplegiker Zentrum, Zentrum für Schmerzmedizin

Nottwil, Canton of Lucerne, 2607, Switzerland

Location

Zürcher RehaZentrum Davos

Davos, Kanton Graubünden, 7272, Switzerland

Location

Arztpraxis Professor Sprott

Zurich, 8033, Switzerland

Location

Universitätsspital Zürich, Institut für Anästhesiologie, Schmerzambulatorium

Zurich, 8091, Switzerland

Location

Universitätsspital Zürich, Klinik für Konsiliarpsychiatrie und Psychosomatik

Zurich, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Rufer, Prof., MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 20, 2018

Study Start

October 22, 2018

Primary Completion

November 13, 2019

Study Completion

November 13, 2019

Last Updated

December 5, 2019

Record last verified: 2019-12

Locations