An interventional study of Video-Assisted Early Mobilization Training in Cholelithiasis, sponsored by Muş Alparslan University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Muş Alparslan University · Not applicable, Interventional, and Treatment
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.
Laparoscopic cholecystectomy is among the most frequently performed surgical procedures worldwide and is associated with shorter recovery times and lower postoperative complication rates compared with open surgery. However, despite the advantages of minimally invasive techniques, postoperative physiological stress responses-characterized by elevations in cortisol and glucose levels-together with pain, nausea, delayed mobilization, and prolonged gastrointestinal recovery remain significant challenges to achieving optimal patient outcomes. Early mobilization is a key component of Enhanced Recovery After Surgery (ERAS) protocols and has been shown to reduce postoperative complications, accelerate functional recovery, and shorten hospital length of stay. Nevertheless, limited patient awareness and insufficient education continue to represent major barriers to effective adherence to mobilization recommendations.
This randomized controlled trial investigates whether video-assisted early mobilization education, combined with objective monitoring using wearable activity tracking systems, can improve postoperative outcomes in patients undergoing laparoscopic cholecystectomy. The intervention consists of two professionally produced educational videos developed in a university television studio: Part 1 of the video; a preoperative theoretical module that explains the physiological benefits of early mobilization using clear language supported by animations, and Part 2 of the video; a postoperative practical module recorded in an actual patient room, demonstrating safe and stepwise mobilization techniques based on evidence-based ERAS practices. The video content has been culturally adapted and will be pilot-tested to ensure comprehensibility across different levels of health literacy.
Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group using a computer-generated block randomization method. Both groups will receive standard postoperative care; however, only the intervention group will receive the video-based mobilization education. To maintain objectivity, patients in both groups will wear passive pedometer devices during the first 24 hours after surgery. These devices will record step count, time to first mobilization, and total ambulation duration, while motivational feedback features will be disabled to ensure that any observed effects can be attributed solely to the video intervention.
Physiological stress responses will be assessed using salivary cortisol and capillary glucose measurements collected at four standardized time points: preoperative baseline (T0), postoperative hour 3 (T1), hour 6 (T2), and hour 24 (T3). These time points were selected based on the circadian rhythm of cortisol secretion and the temporal dynamics of the surgical stress response. Postoperative symptoms, including pain, nausea, and vomiting, will be evaluated using validated Visual Analogue Scales. Functional outcomes will include step count, walking duration, and time to first mobilization. Clinical outcomes, such as length of hospital stay, time to first flatus, oral intake, and defecation, as well as stability of vital signs (heart rate, blood pressure, respiratory rate, body temperature, and peripheral oxygen saturation [SpO₂]), will also be monitored. In addition, postoperative follow-up at 30 days will be conducted to assess emergency department visits, hospital readmissions, and complications.
This study aims to generate robust evidence regarding the effectiveness of digital, video-based patient education integrated with wearable technology in optimizing postoperative recovery. It is anticipated that video-assisted early mobilization education may reduce physiological stress markers, enhance mobilization performance, improve adherence to ERAS protocols, shorten recovery timelines, and increase patient satisfaction. Given that the intervention is easily scalable and adaptable to different surgical populations, the findings of this trial may contribute to clinical practice improvement, inform national health policy development, and support cost-effective, technology-assisted perioperative care strategies.
189 studies on the registry are indexed under Cholelithiasis; 42 are open to participants now.
This study's planned enrollment of 44 is below the median of 90 across 135 interventional studies indexed under Cholelithiasis.
Browse Cholelithiasis studies →Muş Alparslan University is the lead sponsor of 62 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the experimental arm will receive a structured video-assisted early mobilization training program in addition to standard postoperative care. The intervention includes two professionally produced educational videos. The first is a preoperative theoretical video explaining the physiological benefits of early mobilization in clear, patient-friendly language. The second is a postoperative demonstrative video recorded in an actual patient room, showing ERAS-based step-by-step mobilization techniques. After the patient awakens from anesthesia, the demonstrative video will be shown again, and mobilization will begin as demonstrated. To objectively monitor activity, a passive pedometer will be worn to record step count, ambulation duration, and time to first mobilization. The device does not provide feedback, reminders, or alerts, ensuring that behavioral influence derives only from the video-based intervention
Behavioral: Video-Assisted Early Mobilization Training
Participants in the control arm will receive standard postoperative care routinely provided in the surgical unit. They will not receive the video-assisted early mobilization training. To ensure objective comparison with the experimental group, participants in the control group will also wear a passive pedometer that records step count, ambulation duration, and time to first mobilization. The device will not provide feedback, reminders, alerts, or motivational messages. This ensures that any behavioral influence on mobilization originates exclusively from the intervention applied to the experimental group.
A 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.
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.
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.
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.
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.
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.
Ambulation duration
The total duration of walking or active movement will be measured using a passive wearable activity tracker. Unit of Measure: Minutes
Time frame: From the completion of surgery through the first 24 hours postoperative.
Time to first mobilization
The time elapsed from the completion of surgery until the patient's first out-of-bed mobilization will be recorded. Unit of Measure: hours
Time frame: From the completion of surgery until the first mobilization event (within 24 hours postoperative).
Time to first oral intake
The time from the completion of surgery until the patient successfully tolerates their first oral intake (e.g., clear liquids or solid food) will be recorded in hours. Oral intake will only be initiated after the effects of anesthesia have subsided, the patient has regained full consciousness, and the risk of aspiration is clinically ruled out. A shorter time to first oral intake indicates a better outcome (faster return of gastrointestinal function and post-anesthesia recovery).
Time frame: From the completion of surgery until the first oral intake occurs (up to study completion, an average of 3 days).
Time to first flatus
The time from the completion of surgery until the patient first passes gas (flatus) will be recorded in hours to evaluate the return of gastrointestinal function. A shorter time to first flatus indicates a better outcome (faster recovery of gastrointestinal function).
Time frame: From the completion of surgery until the first flatus occurs (up to study completion, an average of 3 days).
Time to first defecation
The time elapsed from the completion of surgery until the patient's first bowel movement (defecation) will be recorded in hours as a marker of the return of gastrointestinal function. A shorter time to first defecation indicates a better outcome (faster recovery of gastrointestinal motility).
Time frame: From the completion of surgery until the first defecation occurs (up to study completion, an average of 3 days).
Length of Hospital Stay
The total duration of hospitalization from the completion of surgery until the patient is clinically stable and meets the criteria for hospital discharge. The duration will be recorded in hours. A shorter length of stay indicates a better outcome (faster postoperative recovery and lower healthcare resource utilization).
Time frame: From the completion of surgery until hospital discharge, up to 72 hours.
Number of participants with stable vital signs
Participants whose vital signs (heart rate, blood pressure, respiratory rate, body temperature, and SpO₂) remained within predefined normal ranges during the postoperative period.
Time frame: Baseline (preoperative), and at 3 hours (time point 1), 6 hours (time point 2), and 24 hours (time point 3) after surgery.
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.
No study locations are listed for this record.
Plan to share: No — No, individual participant data (IPD) will not be shared. Due to ethical considerations, privacy requirements, and the sensitive nature of physiological and clinical data collected in this study, individual-level data cannot be made publicly available.
No publications or documents are linked to this record.
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Muş Alparslan University