Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Study aims;
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Participates in intervention 1 and 2 |
|
| B | Other | Participates in intervention 1, control in intervention 2 |
|
| C | Other | Participates in intervention 2, control in intervention 1 |
|
| D | Active Comparator | Control in both intervention 1 and 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention 1: Mobilization during hospitalization | Other | Surgical ICU Optimal Mobilization Score (SOMS) will be used to initiate early mobilization. SOMS consists of five levels of mobilization reaching from no activity to ambulation. Thirty minutes after PACU-arrival, the patient will be asked to do lower leg exercises. If this is possible, the patient will advance to the next level of mobilization. If not possible, level zero is recorded and the patient rests for another 30 minutes before attempting level one again. This continues until the patient succeeds with level four. Safety criteria for advancing to the next level of mobilization are based on criteria for mobilizing patients in the ICU. The intervention group will receive standard care with additional supervised mobilization while hospitalized. This mobilization consist of walking 1000 steps on postoperative day (POD) 0 and 500 steps on POD1 before discharge. Step counts are measured using pedometers. |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal pain | Abdominal pain measured using a visual analog scale (VAS) of 0-10. A higher score indicates a worse pain. | 24 hours post surgery |
| Physical function | A 6 minute walk test measured in metres | Baseline, 1 month postoperative and 6 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal pain | Abdominal pain measured using a visual analog scale (VAS) of 0-10. A higher score indicates a worse pain. | At baseline, during intervention 1, 1 month postoperative and 6 months postoperative |
| Morphine equivalent consumption |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nanna Marie Christiansen | Contact | +45 20670937 | nanna.marie.christiansen2@rsyd.dk | |
| Bibi Gram | Contact | +45 79182356 | bgram@health.sdu.dk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Esbjerg Hospital, University Hospital of Southern Denmark | Recruiting | Esbjerg | Region Syddanmark | 6700 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41421861 | Derived | Christiansen NMN, Oxlund J, Dreyer P, Gram B. Recovery After Bariatric Surgery: The effects of Mobilization-A Study Protocol. Pain Manag Nurs. 2026 Jun;27(3):e486-e492. doi: 10.1016/j.pmn.2025.11.017. Epub 2025 Dec 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The patients will be randomized into the intervention or control group. To assess the effect of the two interventions separately and independent of each other and to avoid inequality at the starting point of intervention 1 and 2, the patients will at the starting point be randomized into four different groups: A) Intervention 1/Intervention 2, B) Intervention 1/Control 2, C) Control 1/ Intervention 2 D) Control 1/Control 2 (Figure 1). This procedure will enable evaluation of one intervention group versus one control group who are different at each time point.
Not provided
Not provided
Not provided
Not provided
|
| Intervention 2: Mobilization the first 4 postoperative weeks | Other | Intervention 2 will start the first weekday after discharge and continue for 4 weeks. Four supervised physical activity sessions and 8 sessions using telerehabilitation. The activities are low-intensity exercises (walking and lightly strength training using resistance bands) with progressed intensity throughout the weeks. The exercises will be individually progressed to meet the participant's level of activity, as it is important the participants benefit as much as possible from the intervention. The participants will receive information about different possibilities for leisure activities, for motivation to continue physical activity after the first 4 weeks. |
|
| Control group | Other | The control group receives standard care. Patients are mobilized to sit at the bedside before being transferred to the surgical ward. However, it is not used as prophylactic pain management nor is there a structured evidence based protocol with regard to mobilization. The control group will also be equipped with pedometers. They are encouraged to mobilize, and they receive a form in which they can write down mobilization for each hour. There is no planned supervised mobilization. As patients in the control group are assigned to standard care, they will not receive any supervised physical activity after discharge. |
|
Measured in milligram intravenous
| At baseline, during intervention 1, at discharge (at the end of intervention 1), 1 month postoperative and 6 months postoperative |
| Patient reported pain experiences | APS-POQ-R-D questionnaire. | At baseline, during intervention 1, 1 month postoperative and 6 months postoperative |
| Pain self-efficacy | PSEQ-DK questionnaire. Pain self-efficacy is measured on a score of 0-60. A higher score indicates a greater pain self-efficacy. | At baseline, during intervention 1, 1 month postoperative and 6 months postoperative |
| Pain catastrophizing | Pain Catastrophizing Scale questionnaire. Pain Catastrophizing is measured on a score of 0-52. A higher score indicates a higher pain catastrophizing. | At baseline, during intervention 1, 1 month postoperative and 6 months postoperative |
| Postoperative nausea and vomiting | On a visual analog scale (VAS) of 0-10. A higher score indicates worse nausea. | During intervention 1, at discharge (at the end of intervention 1), 1 month postoperative and 6 months postoperative |
| Health related quality of life (SF-36) | 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. | At baseline, during intervention 1, 1 month postoperative and 6 months postoperative |
| Physical activity | 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 | At baseline, 1 month postoperative and 6 months postoperative |
| Readmission | Readmissions during study period | 1 month postoperative and 6 months postoperative |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
Not provided
Not provided