NCT06392698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

October 4, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2025

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

April 26, 2024

Last Update Submit

September 17, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • Internal consistency

    The Cronbach's alpha test will be employed to assess the internal consistency of the SFQ

    2025

  • Confirmatory factor analysis

    A confirmatory factor analysis (CFA) will be conducted to investigate whether the factor structure confirms the original Dutch version.

    2025

  • Cut-off values for item-specific clinically significant surgical fear

    For each of the 8 items on the Surgical Fear Questionnaire, a cut-off value between 0-10 will be calculated to determine clinically relevant surgical fear.

    2025

Secondary Outcomes (16)

  • Frequency distribution

    2025

  • Floor and ceiling effect

    2025

  • Fear of short-term consequences of surgery

    2025

  • Fear of long-term consequences of surgery

    2025

  • Scores on the Surgical Fear Questionnaire

    2025

  • +11 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients referred to surgery at Gødstrup Hospital

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gødstrup Hospital

Herning, Denmark

Location

Related Publications (4)

  • 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.

    PMID: 24960025BACKGROUND
  • 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.

    PMID: 11832252BACKGROUND
  • 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.

    PMID: 22115922BACKGROUND
  • 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.

    PMID: 17442038BACKGROUND

Study Officials

  • Brigitta R Villumsen, Postdoc

    Gødstrup Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 26, 2024

First Posted

April 30, 2024

Study Start

October 4, 2024

Primary Completion

April 3, 2025

Study Completion

April 3, 2025

Last Updated

September 23, 2025

Record last verified: 2025-09

Locations