The Danish Version of the Surgical Fear Questionnaire

Validation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06392698
• Other study ID #: 1-16-02-82-24.
• Status: Not yet recruiting
• Start date: June 10, 2024
• Est. completion date: June 20, 2025

Study information

• Verified date: April 2024
• Source: Gødstrup Hospital
• Contact: Brigitta R Villumsen, Postdoc
• Phone: +45 20487820
• Email: brigvill[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 20, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fear Anxiety
• Validation

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Gødstrup Hospital	Maastricht University, Maastricht University Medical Center, University of Aarhus

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: PLoS One. 2016;11(9):e0162737. — View Citation

Outcome

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