CholelithiasisNCT07512024
Effects of Postoperative Video-assisted Early Mobilization on Recovery Outcomes
A study testing Video-Assisted Early Mobilization Training in people with Cholelithiasis, run by Muş Alparslan University.
Trial summary
This randomized controlled trial aims to evaluate the effects of video-assisted early mobilization education on postoperative recovery in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Video-Assisted Early Mobilization Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Video-assisted Early Mobilization Training on Patient Outcomes in Individuals Undergoing Laparoscopic Cholecystectomy: a Randomized Controlled 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.
Read the detailed description
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.
- Conditions
- Cholelithiasis
- Being tested
- Video-Assisted Early Mobilization Training
- Keywords
- Postoperative Recovery, Enhanced Recovery After Surgery (ERAS), Early Mobilization, Surgical Stress Response, Postoperative Pain
- Medical subject headings
- Cholelithiasis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Assisted Early Mobilization TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Capillary glucose measurements will be compared between groups across four time points to assess metabolic stress response.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline (preoperative), and at 3 hours (time point 1), 6 hours (time point 2), and 24 hours (time point 3) after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BARIŞ ÖZDERE, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512024
- Sponsor's protocol ID
- 228425
- Status last verified
- Oct 2026
- First submitted
- 18 Mar 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.