- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07234643
What Matters to You When You Prepare for Surgery and How Does Surgical Preparedness Influence Postoperative Outcome
What Matters to You When You Prepare for Surgery and How Does Surgical Preparedness Influence Postoperative Outcome - a Flashmob Study
On the occasion of the international What Matters To You-day 2025 the goal of this Danish, multicenter flashmob study with follow up is to investigate what matters to adult patients when they prepare for surgery or colonoscopy.
Aim
The study has the following aims:
- To explore and describe what matters to patients when preparing for surgery and to explore how patients prepare before surgery and assess their perceived level of readiness.
- To examine how the patient's preparation is associated with the quality of their postoperative recovery at home.
- To examine the associations between Degree of Worry (DOW)/postoperative quality of recovery (QoR-15), and preoperative preparedness/postoperative quality of recovery (QoR-15).
On the day of surgery, patients will be invited to fill out an online questionnaire. At the same time they will be invited to participate in the follow-up on postoperative day 3 (survey link via text message).
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Copenhagen, Denmark
- Rigshospitalet
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Herning, Denmark, 7400
- Gødstrup Hospital
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Horsens, Denmark
- Horsens Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing surgical procedures in general anaesthesia, regional anaesthesia, or nerve blocks on June 3th or 6th, 2025, between 7:00 in the morning and 4:00 in the afternoon
- Patients expected to be discharged to their homes the same day.
- ≥18 years old and able to speak and understand Danish.
- For a separate analysis, patients undergoing colonoscopy
Exclusion Criteria:
- Cognitive or psychiatric conditions that impede ability to give informed consent and complete the surveys,
- Non-surgical procedures such as diagnostic endoscopies (with or without biopsy)
- Injection treatments, endovascular treatments or smaller surgical procedures requiring only infiltration analgesia.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Surgery
Adult patients undergoing surgery
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Colonoscopy
Adult patients undergoing colonoscopy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Correlation between preoperative preparedness and degree of worry
Time Frame: From enrollment on the day of surgery to postoperative day 3
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The correlation between patients' selfreported preparedness (0 = Not at all prepared, 10 = Very prepared) and the Degree of Worry (0-10 numeric scale, 0 = not all worried and 10 = very worried).
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From enrollment on the day of surgery to postoperative day 3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pre-operative preparation strategies
Time Frame: Baseline
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Multiple choice questions regarding preparation strategies will be asked:
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Baseline
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Patient preparedness (pre- and postoperatively)
Time Frame: From enrollment on the day of surgery to postoperative day 3
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Patient preparedness (pre- and post-operatively) will be investigated using a numeric rating scale (0 = not at all prepared, 10 = very prepared).
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From enrollment on the day of surgery to postoperative day 3
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The association between pre-operatively patient preparedness and age
Time Frame: Baseline
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The association between pre-operatively preparedness and age.
Patient preparedness will be investigated using a numeric rating scale (0 = Not at all prepared, 10 = Very prepared).
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Baseline
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The association between pre-operatively preparedness and gender
Time Frame: Baseline
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The association between pre-operatively preparedness and gender.
Patient preparedness will be investigated using a numeric rating scale (0 = not at all prepared, 10 = very prepared).
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Baseline
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The association between pre-operatively preparedness and surgical status
Time Frame: Baseline
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The association between pre-operatively preparedness and surgical status will be investigated using a numeric rating scale (0= not at all prepared, 10 = very prepared) and surgical status (elective or acute).
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Baseline
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The association between pre-operatively preparedness and living situation
Time Frame: Baseline
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The association between pre-operatively preparedness and living situation (alone/cohabiting).
Patient preparedness will be investigated using a numeric rating scale (0 = not at all prepared, 10 = very prepared.
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Baseline
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The correlation between pre-operative preparedness and postoperative recovery
Time Frame: From enrollment on the day of surgery to postoperative day 3
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The correlation between pre-operative preparedness shown by a numeric rating scale (0-10) where 0 = "Not a all prepared" and 10 = "Very prepared" and total Quality of Recovery score (QoR-15 score), a 15-item numeric rating scale (0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent]).
A high score indicates a good quality of recovery.
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From enrollment on the day of surgery to postoperative day 3
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Correlation between preoperative preparedness and degree of Worry
Time Frame: Baseline
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The correlation between pre-operative preparedness shown by a numeric rating scale (0-10) where 0 = "Not a all prepared" and 10 = "Very prepared" and Degree of Worry scale (0-10) where 0 = Not worried at all and 10 = very worried.
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Baseline
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What matters when preparing for surgery and was there anything the patient would have known or done differently
Time Frame: From enrollment on the day of surgery to postoperative day 3
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For this outcome a qualitative research approach will be applied.
Open-ended responses about What matters when preparing for surgery and was there anything the patient would have known or done differently will be analysed using content analysis focusing on the manifest content
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From enrollment on the day of surgery to postoperative day 3
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The association between the preparation strategy Read informational material/watched videos and postoperative outcomes
Time Frame: From enrollment on the day of surgery to postoperative day 3
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The association between preparation strategy Read informational material/watched videos and postoperative outcomes: Quality of Recovery - 15 (QoR-15) score and sub scores for Q7 (support from healthcare professionals), Q9 (feel in control), Q14 (anxiety) and Section B of the QoR-15. The scale will be used with each item ranging from 0 to 10 with higher score indicating better QoR. 0 = none of the time [poor] and 10 = all of the time [excellent]). The following covariates will be used for the analysis: age, sex, Degree of worry score, surgical status and cohabiting status. |
From enrollment on the day of surgery to postoperative day 3
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The association between the preparation strategy Spoke with healthcare professionals (surgeon, anesthesiologist/nurse anesthetist, others) and postoperative outcome
Time Frame: From enrollment on the day of surgery to postoperative day 3
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The association between preparation strategy Spoke with healthcare professionals (surgeon, anesthesiologist/nurse anesthetist, others) and postoperative outcomes: Quality of Recovery - 15 (QoR-15) score and sub scores for Q7 (support from healthcare professionals), Q9 (feel in control), Q14 (anxiety) and Section B of the QoR-15. The scale will be used with each item ranging from 0 to 10 with higher score indicating better QoR. 0 = none of the time [poor] and 10 = all of the time [excellent]). The following covariates will be used for the analysis: age, sex, Degree of worry score, surgical status and cohabiting status. |
From enrollment on the day of surgery to postoperative day 3
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The association between the preparation strategy Spoke with other patients and postoperative outcome
Time Frame: From enrollment on the day of surgery to postoperative day 3
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The association between preparation strategy Spoke with other patients and postoperative outcomes: Quality of Recovery - 15 (QoR-15) score and sub scores for Q7 (support from healthcare professionals), Q9 (feel in control), Q14 (anxiety) and Section B of the QoR-15. The scale will be used with each item ranging from 0 to 10 with higher score indicating better QoR. 0 = none of the time [poor] and 10 = all of the time [excellent]). The following covariates will be used for the analysis: age, sex, Degree of worry score, surgical status and cohabiting status. |
From enrollment on the day of surgery to postoperative day 3
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The association between the preparation strategy Discussed with family or friends and postoperative outcome
Time Frame: From enrollment on the day of surgery to postoperative day 3
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The association between preparation strategy Discussed with family or friends and postoperative outcomes: Quality of Recovery - 15 (QoR-15) score and sub scores for Q7 (support from healthcare professionals), Q9 (feel in control), Q14 (anxiety) and Section B of the QoR-15. The scale will be used with each item ranging from 0 to 10 with higher score indicating better QoR. 0 = none of the time [poor] and 10 = all of the time [excellent]). The following covariates will be used for the analysis: age, sex, Degree of worry score, surgical status and cohabiting status. |
From enrollment on the day of surgery to postoperative day 3
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The association between the preparation strategy Researched the procedure online and postoperative outcome
Time Frame: From enrollment of the day of surgery to postoperative day 3
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The association between preparation strategy Researched the procedure online and postoperative outcomes: Quality of Recovery - 15 (QoR-15) score and sub scores for Q7 (support from healthcare professionals), Q9 (feel in control), Q14 (anxiety) and Section B of the QoR-15. The scale will be used with each item ranging from 0 to 10 with higher score indicating better QoR. 0 = none of the time [poor] and 10 = all of the time [excellent]). The following covariates will be used for the analysis: age, sex, Degree of worry score, surgical status and cohabiting status. |
From enrollment of the day of surgery to postoperative day 3
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The association between the preparation strategy purchased groceries/medications and postoperative outcome
Time Frame: From enrollment on the day of surgery to postoperative day 3
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The association between preparation strategy purchased groceries/medications and postoperative outcomes: Quality of Recovery - 15 (QoR-15) score and sub scores for Q7 (support from healthcare professionals), Q9 (feel in control), Q14 (anxiety) and Section B of the QoR-15. The scale will be used with each item ranging from 0 to 10 with higher score indicating better QoR. 0 = none of the time [poor] and 10 = all of the time [excellent]). The following covariates will be used for the analysis: age, sex, Degree of worry score, surgical status and cohabiting status. |
From enrollment on the day of surgery to postoperative day 3
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The association between the preparation strategy Changed medications and postoperative outcome
Time Frame: From enrollment on the day of surgery to postoperative day 3
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The association between preparation strategy Changed medications and postoperative outcomes: Quality of Recovery - 15 (QoR-15) score and sub scores for Q7 (support from healthcare professionals), Q9 (feel in control), Q14 (anxiety) and Section B of the QoR-15. The scale will be used with each item ranging from 0 to 10 with higher score indicating better QoR. 0 = none of the time [poor] and 10 = all of the time [excellent]). The following covariates will be used for the analysis: age, sex, Degree of worry score, surgical status and cohabiting status. |
From enrollment on the day of surgery to postoperative day 3
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The association between the preparation strategy Stopped smoking and postoperative outcome
Time Frame: From enrollment on the day of surgery to postoperative day 3
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The association between preparation strategy Stopped smoking and postoperative outcomes: Quality of Recovery - 15 (QoR-15) score and sub scores for Q7 (support from healthcare professionals), Q9 (feel in control), Q14 (anxiety) and Section B of the QoR-15. The scale will be used with each item ranging from 0 to 10 with higher score indicating better QoR. 0 = none of the time [poor] and 10 = all of the time [excellent]). The following covariates will be used for the analysis: age, sex, Degree of worry score, surgical status and cohabiting status. |
From enrollment on the day of surgery to postoperative day 3
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The association between the preparation strategy Exercised and postoperative outcome
Time Frame: From enrollment on the day of surgery to postoperative day 3
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The association between preparation strategy Exercised and postoperative outcomes: Quality of Recovery - 15 (QoR-15) score and sub scores for Q7 (support from healthcare professionals), Q9 (feel in control), Q14 (anxiety) and Section B of the QoR-15. The scale will be used with each item ranging from 0 to 10 with higher score indicating better QoR. 0 = none of the time [poor] and 10 = all of the time [excellent]). The following covariates will be used for the analysis: age, sex, Degree of worry score, surgical status and cohabiting status. |
From enrollment on the day of surgery to postoperative day 3
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The association between the preparation strategy Avoided infections and postoperative outcome
Time Frame: From enrollment on the day of surgery to postoperative day 3
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The association between preparation strategy Avoided infections and postoperative outcomes: Quality of Recovery - 15 (QoR-15) score and sub scores for Q7 (support from healthcare professionals), Q9 (feel in control), Q14 (anxiety) and Section B of the QoR-15. The scale will be used with each item ranging from 0 to 10 with higher score indicating better QoR. 0 = none of the time [poor] and 10 = all of the time [excellent]). The following covariates will be used for the analysis: age, sex, Degree of worry score, surgical status and cohabiting status. |
From enrollment on the day of surgery to postoperative day 3
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The association between the preparation strategy Arranged for assistance/support from family or friends and postoperative outcome
Time Frame: From enrollment on the day of surgery to postoperative day 3
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The association between preparation strategy Arranged for assistance/support from family or friends and postoperative outcomes: Quality of Recovery - 15 (QoR-15) score and sub scores for Q7 (support from healthcare professionals), Q9 (feel in control), Q14 (anxiety) and Section B of the QoR-15. The scale will be used with each item ranging from 0 to 10 with higher score indicating better QoR. 0 = none of the time [poor] and 10 = all of the time [excellent]). The following covariates will be used for the analysis: age, sex, Degree of worry score, surgical status and cohabiting status. |
From enrollment on the day of surgery to postoperative day 3
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The association between the preparation strategy Planned leave with employer and postoperative outcome
Time Frame: From enrollment on the day of surgery to postoperative day 3
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The association between preparation strategy Planned leave with employer and postoperative outcomes: Quality of Recovery - 15 (QoR-15) score and sub scores for Q7 (support from healthcare professionals), Q9 (feel in control), Q14 (anxiety) and Section B of the QoR-15. The scale will be used with each item ranging from 0 to 10 with higher score indicating better QoR. 0 = none of the time [poor] and 10 = all of the time [excellent]). The following covariates will be used for the analysis: age, sex, Degree of worry score, surgical status and cohabiting status. |
From enrollment on the day of surgery to postoperative day 3
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The association between other preparation strategies and postoperative outcome
Time Frame: From enrollment on the day of surgery to postoperative day 3
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The association between other preparation strategies and postoperative outcomes: Quality of Recovery - 15 (QoR-15) score and sub scores for Q7 (support from healthcare professionals), Q9 (feel in control), Q14 (anxiety) and Section B of the QoR-15. The scale will be used with each item ranging from 0 to 10 with higher score indicating better QoR. 0 = none of the time [poor] and 10 = all of the time [excellent]). The following covariates will be used for the analysis: age, sex, Degree of worry score, surgical status and cohabiting status. |
From enrollment on the day of surgery to postoperative day 3
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The correlation between Degree of Worry and Quality of Recovery (QoR-15)
Time Frame: From enrollment on the day of surgery to postoperative day 3
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The correlation between the degree of worry shown by the Degree of Worry scale (0-10 numeric scale, 0 = not all worried and 10 = very worried) and QoR-15 scale with each item ranging from 0 to 10 with higher score indicating better QoR (0 = none of the time [poor] and 10 = all of the time [excellent]).
The total QoR-15 score and the following individual items will be used:Q7 (support from healthcare professionals), Q9 (feel in control), Q10 (feeling of well-being), Q14 (anxiety) as well as section B.
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From enrollment on the day of surgery to postoperative day 3
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Recovery score (QoR-15)
Time Frame: On postoperative day 3
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Quality of Recovery score (QoR-15), a 15-item numeric rating scale (0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent]).
A high score indicates a good quality of recovery.
Results will be summarized using percentages, means with standard deviations, or medians with interquartile ranges (IQR) for the entire population.
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On postoperative day 3
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Anne H Nielsen, PhD, Gødstrup Hospital
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
Other Study ID Numbers
- 1-16-02-262-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Demographics:
Age, gender, status of procedure (emergency/planned), surgical specialty, hospital, living situation (alone/cohabiting), phone number for survey distribution via text message.
Preparation-related questions:
- What matters to you when preparing for surgery? Open ended response
- How have you prepared for the surgery? Response format: Multiple-choice checkboxes
- How worried are you about the first few post-operative days? Response format: Degree of Worry, 0-10 numeric rating scale
Quality of Recovery score (QoR-15)
Retrospective preparation assessment:
- Looking back, how well-prepared were you for surgery? Response format: 0-10 numeric rating scale
- Was there anything you wish you had known or done? Response format: Multiple choice categories + option for open ended response
IPD Sharing Time Frame
IPD Sharing Access Criteria
Data will be collected through the REDCap database. Collaborators in the steering group will be granted access to all data in the REDCap database.
Collaborators who enroll patients to the study from various Danish locations will be provided with data from their specific location/site. They will not be provided with access to REDCap but will receive data in a data file.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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