Trials / Completed
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.