Recovering From Bariatric Surgery: the Effects of Early Initiated and Supervised Mobilization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Abdominal pain
研究概览
简要总结
The aim is to investigate the effect of early initiated and supervised mobilization continued after discharge as management of postoperative pain and recovery following obesity surgery, including patient experiences, pain coping, physical functionality and quality of life.
详细描述
Study aims;
- To investigate the effect of mobilization as pain management following obesity surgery.
- To investigate patient experiences with mobilization and postoperative pain, including the influence of mobilization on patients' ability to cope with pain and an identification of facilitating factors and barriers towards early mobilization.
- To assess the effect of mobilization on postoperative recovery, including the general physical activity level, physical function, and quality of life among patients discharged after obesity surgery.
The PhD study consists of two sub-studies. Study 1: Effect of early mobilization as pain management in patients recovering from obesity surgery. The study is a single center randomized controlled trial (RCT). Participants will be randomized with an allocation ratio of 1:1.
Study 2: Patient experiences with early mobilization and postoperative pain after surgery - An interview study Patients participating in both interventions (group A), will be invited to participate in two individual semi structured interviews.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The ability to read and understand the Danish language
排除标准
- •Preoperative dependence of walking aids
- •Vision impairment
- •Previous syncopes or epilepsy
- •Admission to the intensive care unit after surgery
- •Acute complications during hospital admission
- •Patients are excluded at baseline if they have an oxygen saturation below 90% or a systolic blood pressure above 180 mmHg
研究组 & 干预措施
A
Participates in intervention 1 and 2
干预措施: Intervention 1: Mobilization during hospitalization (Other)
A
Participates in intervention 1 and 2
干预措施: Intervention 2: Mobilization the first 4 postoperative weeks (Other)
B
Participates in intervention 1, control in intervention 2
干预措施: Control group (Other)
B
Participates in intervention 1, control in intervention 2
干预措施: Intervention 1: Mobilization during hospitalization (Other)
B
Participates in intervention 1, control in intervention 2
干预措施: Intervention 2: Mobilization the first 4 postoperative weeks (Other)
C
Participates in intervention 2, control in intervention 1
干预措施: Intervention 1: Mobilization during hospitalization (Other)
C
Participates in intervention 2, control in intervention 1
干预措施: Intervention 2: Mobilization the first 4 postoperative weeks (Other)
C
Participates in intervention 2, control in intervention 1
干预措施: Control group (Other)
D
Control in both intervention 1 and 2
干预措施: Control group (Other)
结局指标
主要结局
Abdominal pain
时间窗: 24 hours post surgery
Abdominal pain measured using a visual analog scale (VAS) of 0-10. A higher score indicates a worse pain.
Physical function
时间窗: Baseline, 1 month postoperative and 6 months postoperative
A 6 minute walk test measured in metres
次要结局
- Morphine equivalent consumption(At baseline, during intervention 1, at discharge (at the end of intervention 1), 1 month postoperative and 6 months postoperative)
- Patient reported pain experiences(At baseline, during intervention 1, 1 month postoperative and 6 months postoperative)
- Pain self-efficacy(At baseline, during intervention 1, 1 month postoperative and 6 months postoperative)
- Pain catastrophizing(At baseline, during intervention 1, 1 month postoperative and 6 months postoperative)
- Health related quality of life (SF-36)(At baseline, during intervention 1, 1 month postoperative and 6 months postoperative)
- Abdominal pain(At baseline, during intervention 1, 1 month postoperative and 6 months postoperative)
- Physical activity(At baseline, 1 month postoperative and 6 months postoperative)
- Postoperative nausea and vomiting(During intervention 1, at discharge (at the end of intervention 1), 1 month postoperative and 6 months postoperative)
- Readmission(1 month postoperative and 6 months postoperative)