Clinical trial NCT06392698: The Danish Version of the Surgical Fear Questionnaire
Official title: Translation and Validation of the Dutch Surgical Fear Questionnaire in a Danish Population
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fear Anxiety
Validation
Lead sponsor: Gødstrup Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: Maastricht University Medical Center
name: Maastricht University
First posted: 2024-04-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients referred to surgery at 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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlations between the SFQ and the PCS and SFQ and the anxiety subscale of the HADS
timeFrame: 2025
measure: Internal consistency
timeFrame: 2025
measure: Confirmatory factor analysis
timeFrame: 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Gødstrup Hospital
Study officials:
affiliation: Gødstrup Hospital
name: Brigitta R Villumsen, Postdoc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Audley I. A case of sea-snake envenomation. Med J Aust. 1985 Nov 25;143(11):532. doi: 10.5694/j.1326-5377.1985.tb119935.x. No abstract available.
citation: 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.
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.
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.