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Fear AnxietyNCT06392698

The Danish Version of the Surgical Fear Questionnaire

An observational study of Fear Anxiety and Validation, run by Gødstrup Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fear Anxiety, Validation
How many people
236 participants
Where
1 siteDenmark
Study dates
4 Oct 2024to 3 Apr 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients referred to surgery at Gødstrup Hospital

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Gødstrup Hospital

    Herning

Other trials in Denmark

About this study

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

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.

Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlations between the SFQ and the PCS and SFQ and the anxiety subscale of the HADS

    Assement will be conducted using Spearman correlation analysis

    Measured: 2025

  2. Internal consistency

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

    Measured: 2025

  3. Confirmatory factor analysis

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

    Measured: 2025

  4. 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.

    Measured: 2025

Secondary outcomes (16)

  1. Frequency distribution

    For each of the 8 items on the Surgical Fear Questionnaire minimum and maximum score, mean, median and Interquartile Range (IQR) will be calculated.

    Measured: 2025

  2. Floor and ceiling effect

    Number and percentages of respondents who score the lowest value (=0) and highest value (=10) on each individual item on the Surgical Fear Questionnaire

    Measured: 2025

  3. Fear of short-term consequences of surgery

    The first 4 items on the Surgical Fear Questionnaire constitue a subscale related to the fear of short-term consequences of surgery. Each item is rated on a numerical rating scale 0-10 where 0 is the lowest and 10 the highest level of fear. The score on the subscale ranges from 0-40.

    Minimum, maximun, meand, standard deviation, median and Interquartile Range will be calculated.

    Measured: 2025

  4. Fear of long-term consequences of surgery

    The last 4 items on the Surgical Fear Questionnaire constitute a subscale related to the fear of long-term consequences of surgery. Each item is rated on a numeric rating scale ranging from 0-10 where 0 is = not afraid and 10 = very afraid. The score on the subscale range from 0-40.

    Minimum, maximum, meand, standard deviation, median and Interquartile Range will be calculated.

    Measured: 2025

  5. Scores on the Surgical Fear Questionnaire

    The questionnaire contains 8 items and each item is rated on a numeric rating scale ranging from 0 (not afraid) to 10 (very afraid). The total score ranges from 0 to 80, where higher score means higher level of fear.

    Minimum, maximum, meand, standard deviation, median and Interquartile Range will be calculated.

    Measured: 2025

  6. Scores on the Pain Catastrophizing Scale (PCS)

    Pain Catastrophizing consists of three distinct, but interrelated concepts: rumination, magnification and helplessness which construct are assessed with three subscales on the 13-item Pain Catastrophizing Scale (PCS). Respondents provide answers on a 5-point Likert scales ranging from 0 (not at all) to 4 (all the time). Higher score indicate higher level of pain catastrophizing. The scale ranges from 0-52 Minimum, maximum, mean, standard deviation, median and Interquartile Range will be calculated.

    Measured: 2025

  7. Scores on the Hospital Depression and Anxiety Scale (HADS)

    The HADS is commonly used in non-psychiatric hospital settings to identify anxiety disorders and depression. It comprises two subscales, Anxiety and Depression, each consisting of 7 items. Respondents provide answers on a 4-point Likert scale ranging from 0 to 3. Separate scores are computed for the Anxiety and Depression subscales, with higher scores indicating greater symptom severity. The scores range from 0-21 on each subscale.

    Minimum, maximum, mean, standard deviation, median and Interquartile Range will be calculated

    Measured: 2025

  8. The association between surgical fear and gender

    The Kruskal-Wallis test will be applied to calculated the association.

    Measured: 2025

  9. The correlation between surgical fear and age

    The Spearman rank correlation will be applied to calculate the association.

    Measured: 2025

  10. The association between surgical fear and educational level

    The Kruskal-Wallis test will be applied to calculate the association.

    Measured: 2025

  11. The association between surgical fear and civil status

    The Kruskal-Wallis test will be applied to calculate the association.

    Measured: 2025

  12. The association between surgical fear and type of admission (day surgery versus hospitalised overnight)

    The Mann-Whitney U Test will be applied to calculate the association

    Measured: 2025

  13. The association between surgical fear and cancer versus non-cancer surgery

    The Kruskal-Wallis test will be applied to calculate the association

    Measured: 2025

  14. The association between surgical fear and previous surgery versus no previous surgery

    The Mann-Whitney U Test will be applied to calculate the association.

    Measured: 2025

  15. The association between surgical fear and type of anaesthesia

    Three groups of anaesthesia:

    1. General alone, vs
    2. General plus regional with or without sedation vs
    3. Regional or local with or without sedation The Kruskal-Wallis Test will be applied for the calculations. In case of significant results the test will be followed by Dunn's test with Bonferroni correction to determine which specific groups are different.

    Measured: 2025

  16. The association between surgical fear and postoperative pain

    A logistic regression analysis will be applied to calculate the likelihood of postoperative pain score based on preoperative surgical fear.

    Measured: 2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2024
  2. Study start4 Oct 2024
  3. Primary completion3 Apr 2025
  4. Study completion3 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06392698
Sponsor's protocol ID
1-16-02-82-24.
Status last verified
Sep 2025
First submitted
26 Apr 2024
Last updated
23 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 24960025

  • 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.

    PubMed 11832252

  • 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.

    PubMed 22115922

  • 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.

    PubMed 17442038

Questions about this trial

What is this clinical trial studying?

An observational study of Fear Anxiety and Validation, run by Gødstrup Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlations between the SFQ and the PCS and SFQ and the anxiety subscale of the HADS (time frame: 2025). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06392698, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.

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