Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392698
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-26
Brief Title:
The Danish Version of the Surgical Fear Questionnaire
Sponsor:
Gødstrup Hospital
Organization:
Gødstrup Hospital
Study Overview
Official Title:
Translation and Validation of the Dutch Surgical Fear Questionnaire in a Danish Population
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Cronbachs 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
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 Cronbachs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None