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CompletedNCT06392698

The Danish Version of the Surgical Fear Questionnaire

Translation and Validation of the Dutch Surgical Fear Questionnaire in a Danish Population

Status
Completed
Phase
Study type
Observational
Enrollment
236 (actual)
Sponsor
Gødstrup Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The aim of this translation and validation study is to make the The Dutch Surgical Fear Questionnaire (SFQ) applicable in adult Danish speaking patients referred to surgery. 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.

Detailed description

Some of the instruments for assessing surgical fear are the Amsterdam Preoperative Anxiety and Information Scale (APAIS), the Hospital anxiety and depression scale (HADS), the State-Trait Anxiety Inventory (STAI) and the Visual Analog Scale assessing Anxiety (VAS-A). However, HADS, STAI and VAS-A ask questions not particular related to perioperative procedures and thus seem too generic and APAIS seems unspecific despite questions directly related to anaesthesia and the surgical procedure. The Dutch Surgical Fear Questionnaire (SFQ) was developed to be suitable for general use among all types of adult surgery patients to assess self-reported surgical fear, and to cover a broad range of short-term and long-term surgery-related fears. 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

Timeline

Start date
2024-10-04
Primary completion
2025-04-03
Completion
2025-04-03
First posted
2024-04-30
Last updated
2025-09-23

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT06392698. Inclusion in this directory is not an endorsement.