Effects of Postoperative Video-assisted Early Mobilization on Recovery Outcomes
ConditionCholelithiasis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMuş Alparslan University
About this trial
This randomized controlled trial aims to evaluate the effects of video-assisted early mobilization education on postoperative recovery in patients undergoing laparoscopic cholecystectomy. As part of the intervention, structured and professionally produced educational videos will be used to explain the physiological benefits of early mobilization in the preoperative period and to demonstrate step-by-step mobilization techniques in the postoperative period.
Patients in the intervention group will receive video-assisted mobilization education in addition to standard postoperative care, while patients in the control group will receive standard care alone. Physical activity levels will be objectively monitored using wearable activity tracking devices during the first 24 hours after surgery.
The study will assess the effects of video-assisted early mobilization education on postoperative physiological stress response, pain, nausea and vomiting, blood glucose levels, mobilization performance, gastrointestinal recovery, length of hospital stay, and patient satisfaction. In addition, postoperative complications, emergency department visits, and hospital readmissions within 30-days after surgery will be evaluated as exploratory outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 65 years.
Scheduled for elective laparoscopic cholecystectomy.
Classified as ASA I or ASA II according to the American Society of Anesthesiologists Physical Status Classification.
Ability to read and understand Turkish.
Disqualifiers
Chronic pain syndrome or severe chronic orthopedic/rheumatologic pain conditions.
Pre-existing mobility limitations.
Endocrine or metabolic diseases affecting cortisol or glucose (e.g., diabetes, thyroid disorders, Addison's disease, Cushing's syndrome).
Use of medications affecting the HPA axis (e.g., systemic corticosteroids, chronic opioids, high-dose benzodiazepines).
Trial design
Design model
Parallel
Treatments tested in this trial
Video-Assisted Early Mobilization Training
BehavioralA behavioral intervention consisting of a structured, professionally produced video-based early mobilization training program delivered preoperatively and postoperatively. The intervention aims to enhance patient engagement, improve mobilization performance, and reduce postoperative physiological stress responses.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Intervention Group (Video-Assisted Early Mobilization Training)Experimental treatment 1 intervention
Group B: Control Group (Standard Postoperative Care)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Salivary Cortisol Levels Over Time
This measure evaluates the effect of the intervention on the temporal change of salivary cortisol levels. Cortisol will be collected at four predefined time points (T0, T1, T2, T3), and the primary analysis will assess the group × time interaction to determine whether the intervention group demonstrates a different postoperative cortisol trajectory compared to the control group. Salivary cortisol is selected as the primary endpoint because it reflects surgical stress response and forms the basis of the sample size calculation.
Time frame
Preoperative baseline (time point 0), and at 3 hours (time point 1), 6 hours (time point 2), and 24 hours (time point 3) after surgery.Secondary outcomes
1
Change in Blood Glucose Levels Over Time
Capillary glucose measurements will be compared between groups across four time points to assess metabolic stress response.
Time frame
Preoperative baseline (time point 0), and at 3 hours (time point 1), 6 hours (time point 2), and 24 hours (time point 3) after surgery.2
Postoperative Pain Intensity
Pain will be evaluated using the Visual Analogue Scale (VAS) to determine differences in symptom severity between groups. The scale consists of a 10 cm horizontal line where 0 represents "no pain" and 10 represents "unbearable pain." Patients mark the point that best reflects their pain intensity. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. A higher score indicates a worse outcome (greater pain intensity). For clinical significance, scores are classified as follows: 1-4 mild pain, 5-6 moderate pain, and 7-10 severe pain.
Time frame
Preoperative baseline (time point 0), and at 3 hours (time point 1), 6 hours (time point 2), and 24 hours (time point 3) after surgery.3
Postoperative Nausea and Vomiting (PONV)
Nausea: Evaluated using the Visual Analogue Scale (VAS), where patients mark their nausea level on a scale of 0 to 10. Scores range from 0 to 10, where 0 indicates no nausea and 10 indicates unbearable nausea. A higher score indicates a worse outcome. Severity is classified as: 1-3 mild, 4-6 moderate, 7-9 severe, and 10 very severe nausea. Vomiting: Severity will be determined using the Korttila scale. Scores are based on frequency, where 0 indicates no vomiting, less than 3 episodes indicate mild, 3-5 episodes indicate moderate, and more than 5 episodes indicate severe vomiting. A higher frequency/score indicates a worse outcome.
Time frame
From the completion of surgery through the first 24 hours postoperative.4
Step count
The total number of steps taken by the patient will be recorded using a passive wearable activity tracker. Unit of Measure: Steps
Time frame
From the completion of surgery through the first 24 hours postoperative.Other outcomes
1
Number of participants with emergency department visits, unplanned hospital readmissions, and postoperative complications readmissions, and postoperative complications
This exploratory outcome includes emergency department visits, unplanned hospital readmissions, and postoperative complications occurring within 30 days after discharge. These outcomes are pre-specified to evaluate broader system-level recovery patterns and potential differences between the intervention and control groups.
Time frame
From hospital discharge through 30 days postoperative.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: