Recovering From Bariatric Surgery: the Effects of Early Initiated and Supervised Mobilization
- Conditions
- Postoperative Pain, AcuteBariatric SurgeryMobilizationPhysical ActivityPostoperative Pain, Chronic
- Interventions
- Other: Control group
- Registration Number
- NCT06222151
- Lead Sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Brief Summary
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.
- Detailed Description
Study aims;
1. To investigate the effect of mobilization as pain management following obesity surgery.
2. 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.
3. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 112
- The ability to read and understand the Danish language
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Control group Participates in intervention 1, control in intervention 2 C Control group Participates in intervention 2, control in intervention 1 D Control group Control in both intervention 1 and 2
- Primary Outcome Measures
Name Time Method Abdominal pain 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 Baseline, 1 month postoperative and 6 months postoperative A 6 minute walk test measured in metres
- Secondary Outcome Measures
Name Time Method Morphine equivalent consumption At baseline, during intervention 1, at discharge (at the end of intervention 1), 1 month postoperative and 6 months postoperative Measured in milligram intravenous
Patient reported pain experiences At baseline, during intervention 1, 1 month postoperative and 6 months postoperative APS-POQ-R-D questionnaire.
Health related quality of life (SF-36) At baseline, during intervention 1, 1 month postoperative and 6 months postoperative Questionnaire SF-36. Health related quality of life is measured at a scale of 0-100. A higher score indicates a greater quality of life.
Pain self-efficacy At baseline, during intervention 1, 1 month postoperative and 6 months postoperative PSEQ-DK questionnaire. Pain self-efficacy is measured on a score of 0-60. A higher score indicates a greater pain self-efficacy.
Pain catastrophizing At baseline, during intervention 1, 1 month postoperative and 6 months postoperative Pain Catastrophizing Scale questionnaire. Pain Catastrophizing is measured on a score of 0-52. A higher score indicates a higher pain catastrophizing.
Abdominal pain At baseline, during intervention 1, 1 month postoperative and 6 months postoperative Abdominal pain measured using a visual analog scale (VAS) of 0-10. A higher score indicates a worse pain.
Physical activity At baseline, 1 month postoperative and 6 months postoperative Measured using accelerometers - minutes low/medium/high activity performed per hour. Measured for 7 days at baseline, 7 days 1 month postoperative and 7 days 7 months postoperative
Postoperative nausea and vomiting During intervention 1, at discharge (at the end of intervention 1), 1 month postoperative and 6 months postoperative On a visual analog scale (VAS) of 0-10. A higher score indicates worse nausea.
Readmission 1 month postoperative and 6 months postoperative Readmissions during study period
Trial Locations
- Locations (1)
Esbjerg Hospital, University Hospital of Southern Denmark
🇩🇰Esbjerg, Region Of Southern Denmark, Denmark