NCT07234643

Brief Summary

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:

  1. 1.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.
  2. 2.To examine how the patient's preparation is associated with the quality of their postoperative recovery at home.
  3. 3.To examine the associations between Degree of Worry (DOW)/postoperative quality of recovery (QoR-15), and preoperative preparedness/postoperative quality of recovery (QoR-15).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
830

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2025

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
Last Updated

November 18, 2025

Status Verified

August 1, 2025

Enrollment Period

6 days

First QC Date

July 28, 2025

Last Update Submit

November 14, 2025

Conditions

Day Surgery

Keywords

Surgical preparednessPreoperative worryPostoperative recovery

Outcome Measures

Primary Outcomes (1)

  • Correlation between preoperative preparedness and degree of worry

    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).

    From enrollment on the day of surgery to postoperative day 3

Secondary Outcomes (23)

  • Pre-operative preparation strategies

    Baseline

  • Patient preparedness (pre- and postoperatively)

    From enrollment on the day of surgery to postoperative day 3

  • The association between pre-operatively patient preparedness and age

    Baseline

  • The association between pre-operatively preparedness and gender

    Baseline

  • The association between pre-operatively preparedness and surgical status

    Baseline

  • +18 more secondary outcomes

Other Outcomes (1)

  • Quality of Recovery score (QoR-15)

    On postoperative day 3

Study Arms (2)

Surgery

Adult patients undergoing surgery

Colonoscopy

Adult patients undergoing colonoscopy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients referred to ambulatory surgery or colonoscopy in Danish hospitals on June 3rd og June 6th 2025

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rigshospitalet

Copenhagen, Denmark

Location

Gødstrup Hospital

Herning, 7400, Denmark

Location

Horsens Hospital

Horsens, Denmark

Location

Study Officials

  • Anne H Nielsen, PhD

    Gødstrup Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2025

First Posted

November 18, 2025

Study Start

June 3, 2025

Primary Completion

June 9, 2025

Study Completion

June 9, 2025

Last Updated

November 18, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Start date: June 3 2025 End date: January 2026
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.

Locations

DK(3)