Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
236 participants
OBSERVATIONAL
2024-10-04
2025-04-03
Brief Summary
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After succesful translation of the SFQ, 200 adult patients referred to surgery at Gødstrup Hospital will be invited to answer the SFQ as well as two other questionnaires for the validation: The Pain Catastrophizing Scale (PCS) and The Hospital Anxiety and Depression Scale (HADS).
Statistical analysis will be performed to assess the correlation between the scales and thus the validity of the SFQ.
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Detailed Description
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The translation and validation follows the standardized multistep process outlined by Cha, Kim, and Erlen: 1) forward translation, 2) backward translation by native speakers, 3) a test of the translation in a pilot population of adults referred to surgery at Gødstrup Hospital, and 4) validation in a clinical population.
For the validation of quantitatively measured clinical variables (clinimetric validation), convergent validity will be assessed between SFQ, the Pain Catastrophizing Scale (PCS) and the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The Cronbach's alpha test will be employed to assess the internal consistency of the SFQ subscales and the overall score.
Approval of the study has been obtained from the Institutional Review Board at Central Denmark Region. Informed consent will be obtained from all participants prior to inclusion.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Able to read and understand Danish
* Cognitive well-functioning
* No previously or ongoing diagnosed mental disorders
* Consent to participate in the study.
18 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Maastricht University Medical Center
OTHER
Maastricht University
OTHER
Gødstrup Hospital
OTHER
Responsible Party
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Brigitta Rasmussen Villumsen
Principal Investigator
Principal Investigators
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Brigitta R Villumsen, Postdoc
Role: PRINCIPAL_INVESTIGATOR
Gødstrup Hospital
Locations
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Gødstrup Hospital
Herning, , Denmark
Countries
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References
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Theunissen M, Peters ML, Schouten EG, Fiddelers AA, Willemsen MG, Pinto PR, Gramke HF, Marcus MA. Validation of the surgical fear questionnaire in adult patients waiting for elective surgery. PLoS One. 2014 Jun 24;9(6):e100225. doi: 10.1371/journal.pone.0100225. eCollection 2014.
Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
Pinto PR, McIntyre T, Almeida A, Araujo-Soares V. The mediating role of pain catastrophizing in the relationship between presurgical anxiety and acute postsurgical pain after hysterectomy. Pain. 2012 Jan;153(1):218-226. doi: 10.1016/j.pain.2011.10.020. Epub 2011 Nov 23.
Cha ES, Kim KH, Erlen JA. Translation of scales in cross-cultural research: issues and techniques. J Adv Nurs. 2007 May;58(4):386-95. doi: 10.1111/j.1365-2648.2007.04242.x. Epub 2007 Apr 17.
Other Identifiers
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1-16-02-82-24.
Identifier Type: -
Identifier Source: org_study_id
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