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临床试验/NCT06893848
NCT06893848招募中不适用

Culture Care Program: a Mixed-methods Study Evaluating the Effect of an Innovative In-hospital Experience on Patient Mobility After Thoracic or Abdominal Surgery

Haute Ecole ARC Sante2 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2025年3月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
204
试验地点
2
主要终点
Daily time spent out of bed

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Culture Care program (Other)

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

干预措施: Culture Care program (Other)

结局指标

主要结局

Daily time spent out of bed

时间窗: From postoperative day 1 to postoperative day 3.

This outcome will be assessed by accelerometry

Daily steps number

时间窗: From postoperative day 1 to postoperative day 3.

This outcome will be assessed by accelerometry

次要结局

  • 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)
  • Experience of in-hospital mobility(At postoperative day 2)
  • Postoperative complications rate(From the day of surgery to hospital discharge (from maximum 1 day before discharge to 2 days after discharge))
  • Length of hospital stay(At hospital discharge (from maximum 1 day before discharge to 2 days after discharge))
  • Number of patients with adverse events(At hospital discharge (from maximum 1 day before discharge to 2 days after discharge))
  • Number of adverse events per patients(At hospital discharge (from maximum 1 day before discharge to 2 days after discharge))
  • Perception of the work environment and readiness to stimulate the mobility of hospitalized patients after surgery(During the 2 month period before the implementation of the Culture Care. This outcome will be assessed 3 month after the implementation of the Culture Care program.)

研究者

发起方
Haute Ecole ARC Sante
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dugernier Jonathan

Dr

Haute Ecole ARC Sante

研究点 (2)

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