Esbjerg Hospital, University Hospital of Southern Denmark
Esbjerg, Region Syddanmark, 6700, Denmark
Location status: Recruiting
Location contact
Bibi Gram
CONTACT
Nanna Marie Christiansen
CONTACT
NCT Number: NCT06222151
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Esbjerg, Region Syddanmark, 6700, Denmark
Location status: Recruiting
Bibi Gram
CONTACT
Nanna Marie Christiansen
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 24 hours post surgery
Abdominal pain measured using a visual analog scale (VAS) of 0-10. A higher score indicates a worse pain.
Time frame: Baseline, 1 month postoperative and 6 months postoperative
A 6 minute walk test measured in metres
Time frame: 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.
Time frame: At baseline, during intervention 1, at discharge (at the end of intervention 1), 1 month postoperative and 6 months postoperative
Measured in milligram intravenous
Time frame: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
APS-POQ-R-D questionnaire.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 1 month postoperative and 6 months postoperative
Readmissions during study period
Contact information is provided by the study sponsor or research team.
Bibi Gram
CONTACT
Nanna Marie Christiansen
CONTACT
Esbjerg Hospital - University Hospital of Southern Denmark
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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