Effects of Postoperative Video-assisted Early Mobilization on Recovery Outcomes

NCT07512024 | Not Yet Recruiting DMC

• 1 other identifier: 228425
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cholelithiasis

Keywords

Postoperative Recovery; Enhanced Recovery After Surgery (ERAS); Early Mobilization; Surgical Stress Response; Postoperative Pain

Outcome Measures

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.

  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 (11)

• Change in Blood Glucose Levels Over Time

  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

  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)

  From the completion of surgery through the first 24 hours postoperative.

• Step count

  From the completion of surgery through the first 24 hours postoperative.

• Ambulation duration

  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

  From hospital discharge through 30 days postoperative.

Study Arms (2)

Intervention Group (Video-Assisted Early Mobilization Training)

EXPERIMENTAL

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

Control Group (Standard Postoperative Care)

NO INTERVENTION

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.

Interventions

Video-Assisted Early Mobilization Training BEHAVIORAL

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.

Intervention Group (Video-Assisted Early Mobilization Training)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Adequate cognitive capacity to understand video education and operate the wearable activity tracker.
• Willingness to participate and signing the informed consent form

You may not qualify if:

• 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).
• Diagnosed severe psychiatric or cognitive disorders (e.g., dementia, major depression).
• Skin allergies or medical device contraindications preventing use of the activity tracker.
• Conversion to open surgery or major intraoperative complications.

Sponsors & Collaborators

• Muş Alparslan University: lead

MeSH Terms

Conditions

Cholelithiasis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Barış ÖZDERE, PhD (Candidate)

CONTACT

+90 539 7675964; b.ozdere6565@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is conducted as an open-label trial because participants and care providers cannot be blinded to the video-based intervention. However, the data analyst/biostatistician will be blinded to group allocation during statistical analysis. Group labels will be coded, and the statistician will not have access to the allocation key until all primary analyses are completed. This approach reduces assessment bias, while physiological and functional outcomes (cortisol, glucose, step count) further support objectivity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study uses a prospective, two-arm, parallel-group randomized controlled design in which participants are assigned in a 1:1 ratio to either the intervention group (video-assisted early mobilization training) or the control group (standard postoperative care). Block randomization is performed using a computer-generated sequence, and both groups are followed concurrently. Although the trial is open-label due to the nature of the video intervention, outcome assessments rely on objective physiological and functional measures to minimize bias.

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share