- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06617611
What Matters to You on the Day of Surgery 2024? (WMTY2024)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Herning, Denmark
- Gødstrup Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Danish speaking
- 18 years old or above
Exclusion Criteria:
- Patients who are not cognitively intact
- Do not consent to participation
- Patients requiring immediate surgical intervention.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of worry
Time Frame: June 2024
|
How worried are patients on the day of surgery on a scale from 1-10
|
June 2024
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical fear
Time Frame: June 2024
|
How fearful are patients based on an 8-item scale with total score ranging from 0-80
|
June 2024
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement between degree of worry and surgical fear
Time Frame: 2024
|
Measure of agreement using Cohen's kappa
|
2024
|
|
What matters to you
Time Frame: 2025
|
A thematic analysis of the answers to the question what matters to you
|
2025
|
|
Integration of the qualitative and quantitative data
Time Frame: 2025
|
Mixed methods analysis
|
2025
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hejdi Gamst-Jensen, SR, Rigshospitalet, Denmark
- Study Chair: Anne H Nielsen, Ass. prof., Gødstrup Hospital
- Study Director: Lone Brix, Lecturer, University of Aarhus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-16-02-118-24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Surgical Fear and Worrying
-
Bingol UniversityNot yet recruitingPatient Education | Surgical Stress Response | Medical-surgical Nursing | Surgical Fear and WorryingTurkey
-
Nermin OcaktanCompletedTotal Knee Arthroplasty | Kinesiophobia | Surgical Fear and WorryingTurkey (Türkiye)
-
Nigde Omer Halisdemir UniversityCompletedSurgical Anxiety Scale for Adult Patients | Surgical Fear Scale | Postpartum Comfort ScaleTurkey (Türkiye)
-
Dr. Negrin University HospitalRecruitingAnxiety | Pain Management | Fear | Complications of Surgical Procedures or Medical CareSpain
-
KK Women's and Children's HospitalRecruitingAnxiety | Pregnancy Related | Fear | Fear of Childbirth | Anxiety and FearSingapore
-
Balikesir UniversityNot yet recruitingPain | Child Behavior | Fear | Fear of Pain | Vaccination
-
Nagihan AcetCompletedFear of Falling | Fear of MovementTurkey
-
University of PennsylvaniaCompleted
-
Burdur Mehmet Akif Ersoy UniversityCompletedPain | Children | Fear | Virtual Reality | Fear of Pain | VaccinationTurkey
-
Aydin Adnan Menderes UniversityCompletedPain | Allergy | Fear | Child, Only | Fear of PainTurkey
Clinical Trials on Surgical intervention and anesthesia
-
Kasr El Aini HospitalCompleted
-
Abramson Cancer Center at Penn MedicineRecruitingSkin Cancer Face | Skin Cancer ScalpUnited States
-
Mayo Hospital LahoreNot yet recruitingBlood Pressure After Nerve Block | Hemodynamic Stability During Awake IntubationPakistan
-
Kasr El Aini HospitalNot yet recruiting
-
Aarhus University HospitalOdense University Hospital; Zealand University Hospital; Rigshospitalet, Denmark and other collaboratorsNot yet recruiting
-
HealthCore-NERIUniversity of California, San Diego; University of Maryland; University of Alabama... and other collaboratorsTerminated
-
International Spine Study Group FoundationOrthofix Inc.; DePuy SynthesRecruitingCervical DeformityUnited States
-
SI-BONE, Inc.TerminatedOsteoporosis | Fragility Fracture | Insufficiency Fractures | Sacral Fracture | Sacroiliac; Fusion | Fracture;PelvisUnited States
-
Washington University School of MedicineUniversity Health Network, Toronto; Northwestern University; National Institute... and other collaboratorsCompletedScoliosisUnited States, Canada