Surgical Fear and WorryingWMTY2024NCT06617611
What Matters to You on the Day of Surgery 2024?
An observational study of Surgical Fear and Worrying and Person-centered Care, run by Gødstrup Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Fear and Worrying, Person-centered Care
- What is being tested?
- Surgical intervention and anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 792 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Jun 2024to 6 Jun 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Danish speaking adults referred to any type of planned surgery on June 6 2024
Who may be able to join
- Danish speaking
- 18 years old or above
Who cannot join
- Patients who are not cognitively intact
- Do not consent to participation
- Patients requiring immediate surgical intervention.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- To explore what matters to patients on the day of surgery
- To explore associations between patients' degree-of-worry and their surgical fear on the day of surgery
- To explore the characteristics and intensity of degree-of-worry
From 7.00 AM to 11.00 PM patients will be invited to answer:
- What matters to them on the day of surgery and why it matters
- How worried they are about their situation using a scale from 1 to 10, and to state why they worry.
- Eight questions about their fear related to anesthesia and surgery on a scale from 0-10
In the analysis we will investigate the possible association between patients' degree of worry and fear related to anesthesia and surgery. Secondly, we analyse the prevalence of degree of worry and fear according to gender, age, type of surgery and medical speciality.
Finally, we will investigate what themes appear when we analyse the answers to what matters and why patients' worry.
- Conditions
- Surgical Fear and Worrying, Person-centered Care
- Being tested
- Surgical intervention and anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical intervention and anesthesiaProcedure or surgery
Any surgical procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of worry
How worried are patients on the day of surgery on a scale from 1-10
Measured: June 2024
Secondary outcomes (1)
Surgical fear
How fearful are patients based on an 8-item scale with total score ranging from 0-80
Measured: June 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start6 Jun 2024
- Primary completion6 Jun 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Fear and WorryingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 792 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gødstrup Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brigitta Rasmussen Villumsen, Gødstrup Hospital
- Investigators
- Hejdi Gamst-Jensen, SR, Study director, Copenhagen University Hospital, RigshospitaletAnne H Nielsen, Ass. prof., Study chair, Gødstrup HospitalLone Brix, Lecturer, Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617611
- Sponsor's protocol ID
- 1-16-02-118-24
- Acronym
- WMTY2024
- Status last verified
- Mar 2025
- First submitted
- 25 Sep 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Matters to You on the Day of Surgery 2024?
- ClinicalTrials.gov ID
- NCT06617611
- Acronym / sponsor ID
- WMTY2024 / 1-16-02-118-24
- Conditions
- Surgical Fear and Worrying, Person-centered Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 792 participants (actual)
- Lead sponsor
- Gødstrup HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, University of Aarhus
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To explore what matters to patients on the day of surgery
- To explore associations between patients' degree-of-worry and their surgical fear on the day of surgery
- To explore the characteristics and intensity of degree-of-worry
From 7.00 AM to 11.00 PM patients will be invited to answer:
- What matters to them on the day of surgery and why it matters
- How worried they are about their situation using a scale from 1 to 10, and to state why they worry.
- Eight questions about their fear related to anesthesia and surgery on a scale from 0-10
In the analysis we will investigate the possible association between patients' degree of worry and fear related to anesthesia and surgery. Secondly, we analyse the prevalence of degree of worry and fear according to gender, age, type of surgery and medical speciality.
Finally, we will investigate what themes appear when we analyse the answers to what matters and why patients' worry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Danish speaking adults referred to any type of planned surgery on June 6 2024
Key inclusion criteria (2 listed)
- Danish speaking
- 18 years old or above
Key exclusion criteria (3 listed)
- Patients who are not cognitively intact
- Do not consent to participation
- Patients requiring immediate surgical intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical intervention and anesthesiaAny surgical procedure | Procedure or surgery | – |
Primary outcome
Degree of worry
Time frame: June 2024
How worried are patients on the day of surgery on a scale from 1-10
1 secondary outcome
Surgical fear
Time frame: June 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Surgical Fear and Worrying
Active, not recruitingObservational study
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The Effect of Video-Supported Online Preoperative Education on Fear, Anxiety, Sleep, and Stress
Patient Education, Surgical Fear and Worrying
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hejdi Gamst-Jensen, SR study director
Copenhagen University Hospital, Rigshospitalet
Anne H Nielsen, Ass. prof. study chair
Gødstrup Hospital
Lone Brix, Lecturer study director
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Fear and Worrying and Person-centered Care, 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 2 inclusion and 3 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 13 Mar 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?
Degree of worry (time frame: June 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2025.