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Spiritual Assessment in Chronic Pain Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03679871
Recruitment Status : Not yet recruiting
First Posted : September 20, 2018
Last Update Posted : September 20, 2018
Swiss National Science Foundation
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
The WHO understanding of health(care) is incrementally incorporating the spiritual dimensionas 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Spirituality Other: Questionnaire validation Not Applicable

Detailed Description:
Adressing spiritual concerns and needs in chronic pain therapy is in line with the WHO understanding of health(care) and would improve health care for this patient group. An applicable screening tool for chronic pain patients' spritual 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-patient and out-patient settings.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Spiritual Assessment in Chronic Pain Patients: Construction and Validation of a Screening Tool in Health Care
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Questionnaire validation
22-items questionnaire "Spiritual Ressources and Distress"
Other: Questionnaire validation
Particpiants 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 Measures :
  1. Psychometric properties [ Time Frame: 8 months ]
    Validity, internal consistency and stability

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Sufficent 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 threating diagnosis (e.g. cancer) that would introduce end-of-life topicas as Primary aspect
  • Cognitive disorders that would impair participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03679871

Contact: Horst Rettke, PhD, RN +41442552568

Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
Principal Investigator: Michael Rufer, Prof., MD University of Zurich

Responsible Party: University of Zurich Identifier: NCT03679871     History of Changes
Other Study ID Numbers: Spiritual Care & Chronic Pain
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chronic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms