The Danish Version of the Surgical Fear Questionnaire

Active, not recruiting

• Conditions: Validation; Fear Anxiety

• Registration Number: NCT06392698
• Lead Sponsor: Gødstrup Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-04-26
• Study First Posted: 2024-04-30
• Study Start: 2024-10-04
• Status Verified: 2025-04
• Primary Completion: 2025-04-03
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 18 years or older
• Able to read and understand Danish
• Cognitive well-functioning
• No previously or ongoing diagnosed mental disorders
• Consent to participate in the study.

Exclusion Criteria

• Any patient who in the opinion of the investigator does not comply with the inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlations between the SFQ and the PCS and SFQ and the anxiety subscale of the HADS	2025	Assement will be conducted using Spearman correlation analysis
Internal consistency	2025	The Cronbach's alpha test will be employed to assess the internal consistency of the SFQ
Confirmatory factor analysis	2025	A confirmatory factor analysis (CFA) will be conducted to investigate whether the factor structure confirms the original Dutch version.

Trial Locations

Locations (1)

Gødstrup Hospital; 🇩🇰 Herning, Denmark