NCT06617611

Brief Summary

Research show that between 48-97% of patients referred to surgery experience anxiety and fear related to the procedure. High levels of anxiety and fear lead to increased use of anesthetics and pain as well as increased morbidity after the surgical procedure. June 6 2024 is the international "What matters to you-day" and thus we mark this day in several Danish hospitals by asking patients referred to surgery: "What matters to you on the day of surgery"? This observational study has three goals:

  1. 1.To explore what matters to patients on the day of surgery
  2. 2.To explore associations between patients' degree-of-worry and their surgical fear on the day of surgery
  3. 3.To explore the characteristics and intensity of degree-of-worry
  4. 4.What matters to them on the day of surgery and why it matters
  5. 5.How worried they are about their situation using a scale from 1 to 10, and to state why they worry.
  6. 6.Eight questions about their fear related to anesthesia and surgery on a scale from 0-10

Trial Health

87
On Track

Trial Health Score

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

Enrollment
792

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

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

Study Start

First participant enrolled

June 6, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

Same day

First QC Date

September 25, 2024

Last Update Submit

March 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Degree of worry

    How worried are patients on the day of surgery on a scale from 1-10

    June 2024

Secondary Outcomes (1)

  • Surgical fear

    June 2024

Other Outcomes (3)

  • Agreement between degree of worry and surgical fear

    2024

  • What matters to you

    2025

  • Integration of the qualitative and quantitative data

    2025

Interventions

Any surgical procedure

Eligibility Criteria

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

Danish speaking adults referred to any type of planned surgery on June 6 2024

You may qualify if:

  • Danish speaking
  • years old or above

You may not qualify if:

  • Patients who are not cognitively intact
  • Do not consent to participation
  • Patients requiring immediate surgical intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gødstrup Hospital

Herning, Denmark

Location

MeSH Terms

Interventions

Surgical Procedures, OperativeAnesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Hejdi Gamst-Jensen, SR

    Rigshospitalet, Denmark

    STUDY DIRECTOR
  • Anne H Nielsen, Ass. prof.

    Gødstrup Hospital

    STUDY CHAIR
  • Lone Brix, Lecturer

    University of Aarhus

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 25, 2024

First Posted

September 27, 2024

Study Start

June 6, 2024

Primary Completion

June 6, 2024

Study Completion

June 6, 2024

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations