NCT06893848

Brief Summary

A sedentary behavior in the postoperative phase has a negative impact on recovery from various types of surgery (e.g. abdominal, pulmonary, cardiac or esophageal). In fact, sedentary behavior in the days following surgery is associated with an increased risk of postoperative complications, longer hospital stays and, consequently, higher healthcare costs. Stimulating early mobilization and increasing the level of physical activity after surgery therefore remains a relevant current challenge. The Culture Care program will propose a new experience of the hospital towards an attractive and stimulating intrahospital environment, including art and culture. The hypothesis is that the innovative, positive hospital experience offered by the Culture Care program could contribute to increasing patients' mobility in the postoperative phase and thus reduce the sedentary behaviour compared with a control group included before the implementation of the program. The aim of this study is to explore the effect of the Culture Care program (Control group versus Culture Care group) on the mobility of patients hospitalized after thoracic or abdominal surgery, by determining the level of prediction in relation to the influencing covariates reported in the literature. The first quantitative part of this research project will compare the mobility of patients hospitalized after surgery, before (control group) and after the implementation of the Culture Care program (Culture Care group). Patients will be asked to wear an accelerometer for the first five post-operative days, and to complete three questionnaires (psychological well-being, physical recovery, perception of their mobility). Healthcare workers will be asked to complete a survey on their readiness to stimulate patients' mobility before and after the Culture Care program. The second part will be qualitative including individual semi-structured interviews with patients and healthcare workers during the Culture Care program, to gather their experiences.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress78%
Mar 2025Sep 2026

First Submitted

Initial submission to the registry

March 7, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

March 7, 2025

Last Update Submit

March 23, 2025

Conditions

Keywords

Physical activityPostoperative recoveryAccelerometerEarly mobilization

Outcome Measures

Primary Outcomes (2)

  • Daily time spent out of bed

    This outcome will be assessed by accelerometry

    From postoperative day 1 to postoperative day 3.

  • Daily steps number

    This outcome will be assessed by accelerometry

    From postoperative day 1 to postoperative day 3.

Secondary Outcomes (11)

  • Number of patients mobilized on the day of surgery

    The day of surgery (Day 0)

  • Daily steps number

    From postoperative day 1 to postoperative day 5.

  • Mean daily duration of physical inactivity, light physical activity and moderate-to-vigorous physical activity

    From postoperative day 1 to postoperative day 5.

  • Quality of recovery after surgery

    At postoperative day 2 and at discharge (maximum 1 day before)

  • Psychological well-being

    At postoperative day 2

  • +6 more secondary outcomes

Other Outcomes (2)

  • Patients experience of the Culture Care intervention

    Interviews will start after the end of the quantitative study, for a anticipated duration from 1 to 5 months, maximum 8 months). Interviews will be conducted with patients between postoperative day 2 and postoperative day 5.

  • Healthcare workers experience of the Culture Care intervention

    Interviews will start after the end of the quantitative study, for an anticipated duration from 1 to 5 months, maximum 8 months)

Study Arms (4)

Control group of patients

NO INTERVENTION

Patients hospitalized after thoracic or abdominal surgery in a conventional in-hospital environment (not modified, before the implementation of the Culture Care program). Patients will receive standard of care, including early mobilization prescribed by the physician according to the ERAS guidelines.

Culture Care group of patients

EXPERIMENTAL

Patients hospitalized after thoracic or abdominal surgery in an in-hospital environment modernized by the Culture Care program. As with control patients, patients in the Culture Care group will receive the similar standard of care, including early mobilization prescribed by the physician according to the ERAS guidelines.

Other: Culture Care program

Control group of healthcare workers

NO INTERVENTION

Healthcare workers working in the surgical units, with a conventional in-hospital environment (before implementation of the Culture Care program)

Culture Care group of healthcare workers

EXPERIMENTAL

Healthcare workers working in the surgical units, with an in-hospital environment modernized by the Culture Care program

Other: Culture Care program

Interventions

The Culture Care program modernizes the in-hospital environment by including art and culture proposed in the form of an individualized pathway. It will be offered primarily to hospitalized patients, but also available to families, caregivers and healthcare professionals. It will aim to create a new hospital experience, different from the one we've always known. The Culture Care program will display posters illustrating works of art (paintings, drawings, photographs, etc.) along the hallways. These posters will be interactive, so that a QR code can be scanned to access musical content and audio podcasts (interviews and documentaries) accessible via bone-conduction headphones. The Culture Care program is likely to reduce the sedentary behavior of hospitalized patients, by providing an attractive in-hospital environment that is likely to produce both physical and psychological benefits.

Culture Care group of healthcare workersCulture Care group of patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admission to Surgical Units in the Surgical Department of the Hôpital de Neuchâtel implementing the Culture Care program.
  • Elective thoracic or abdominal surgery with an expected hospital stay of at least 2 days (i.e. discharge on postoperative day 3).
  • Neurocognitive and physical ability to complete questionnaires and individual participation in the Culture Care program.
  • Full capacity of discernment and signed informed consent to participate in the study.

You may not qualify if:

  • Outpatient surgery.
  • Emergency surgery.
  • Mobility severely impaired prior to surgery: patients with 1 or 2 lower-limb amputations, patients with wheelchair mobility only, neurodegenerative diseases.
  • Bed restiction between POD 1 and POD 5 for medical reasons, i.e. surgery, post-operative complications or other pre-existing cardiorespiratory, neurological or orthopedic reasons.
  • Transfer to ICU
  • Only during the Culture Care phase, an unplanned transfer to another unit that does not have the Culture Care program (e.g. Medicine units).
  • Technical problem with the accelerometer (e.g. disfunctioning battery).
  • Allergic reaction to any dressing used to attach the accelerometer.
  • End-of-life patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de Neuchâtel

Neuchâtel, 2000, Switzerland

RECRUITING

MeSH Terms

Conditions

Mobility LimitationMotor Activity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Jonathan Dugernier, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The first part of this project is a quantitative monocentric, non-randomized controlled study comparing a group of participants before implementation of the Culture Care program (control group) with a group of participants after implementation of the Culture Care program (Culture Care group). Participants are hospitalized patients and the healthcare workers. The second part of this project is a qualitative study once the Culture Care program is implemented.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 25, 2025

Study Start

March 10, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations