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Completed

NCT Number: NCT06392698

The Danish Version of the Surgical Fear Questionnaire

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.

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Key information

Conditions

Fear Anxiety Validation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gødstrup Hospital

Herning, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 2025

    Assement will be conducted using Spearman correlation analysis

  2. Internal consistency

    Time frame: 2025

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

  3. Confirmatory factor analysis

    Time frame: 2025

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

  4. Cut-off values for item-specific clinically significant surgical fear

    Time frame: 2025

    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.

Secondary outcomes

  1. Frequency distribution

    Time frame: 2025

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

  2. Floor and ceiling effect

    Time frame: 2025

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

  3. Fear of short-term consequences of surgery

    Time frame: 2025

    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.

  4. Fear of long-term consequences of surgery

    Time frame: 2025

    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.

  5. Scores on the Surgical Fear Questionnaire

    Time frame: 2025

    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.

  6. Scores on the Pain Catastrophizing Scale (PCS)

    Time frame: 2025

    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.

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

    Time frame: 2025

    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

  8. The association between surgical fear and gender

    Time frame: 2025

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

  9. The correlation between surgical fear and age

    Time frame: 2025

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

  10. The association between surgical fear and educational level

    Time frame: 2025

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

  11. The association between surgical fear and civil status

    Time frame: 2025

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

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

    Time frame: 2025

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

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

    Time frame: 2025

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

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

    Time frame: 2025

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

  15. The association between surgical fear and type of anaesthesia

    Time frame: 2025

    Three groups of anaesthesia:

    • General alone, vs
    • General plus regional with or without sedation vs
    • 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.

  16. The association between surgical fear and postoperative pain

    Time frame: 2025

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

Sponsors and collaborators

Lead sponsor

Gødstrup Hospital

Other

Collaborators

  • Maastricht University
  • Maastricht University Medical Center
  • University of Aarhus

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2024
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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