跳至主要内容
临床试验/NCT06392698
NCT06392698已完成不适用

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

Gødstrup Hospital1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2024年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
236
试验地点
1
主要终点
Cut-off values for item-specific clinically significant surgical fear

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

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

时间窗: 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.

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

时间窗: 2025

Assement will be conducted using Spearman correlation analysis

Internal consistency

时间窗: 2025

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

Confirmatory factor analysis

时间窗: 2025

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

次要结局

  • 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)
  • Scores on the Pain Catastrophizing Scale (PCS)(2025)
  • Scores on the Hospital Depression and Anxiety Scale (HADS)(2025)
  • The association between surgical fear and gender(2025)
  • The correlation between surgical fear and age(2025)
  • The association between surgical fear and educational level(2025)
  • The association between surgical fear and civil status(2025)
  • The association between surgical fear and type of admission (day surgery versus hospitalised overnight)(2025)
  • The association between surgical fear and cancer versus non-cancer surgery(2025)
  • The association between surgical fear and previous surgery versus no previous surgery(2025)
  • The association between surgical fear and type of anaesthesia(2025)
  • The association between surgical fear and postoperative pain(2025)

研究者

发起方
Gødstrup Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Brigitta Rasmussen Villumsen

Principal Investigator

Gødstrup Hospital

研究点 (1)

Loading locations...

相似试验