- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07279974
Preoperative Video-Based Education in Total Hip Arthroplasty
The Effect of Preoperative Video-Based Education on Fear of Mobilization in Patients Undergoing Total Hip Arthroplasty: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Total hip arthroplasty (THA) is a common orthopedic procedure in which early postoperative mobilization plays a key role in preventing complications, reducing pain, and accelerating functional recovery. However, fear of movement (kinesiophobia), insufficient preoperative preparation, and uncertainty regarding mobility expectations may negatively affect patients' early rehabilitation performance. Providing structured, standardized education before surgery has been shown to improve postoperative participation and enhance patient confidence, yet the most effective format of such education remains unclear.
This randomized controlled trial was designed to evaluate the impact of a preoperative video-based mobilization education program on postoperative kinesiophobia, pain during the first mobilization, and early mobilization characteristics among patients undergoing primary THA. A total of 96 participants were randomly assigned to an intervention group or a control group using a simple randomization method. Both groups received routine preoperative verbal education, while the intervention group additionally viewed a structured mobilization training video developed by a multidisciplinary team of orthopedic surgeons, physiatrists, physiotherapists, and orthopedic nurses.
The educational video included demonstrations of bed exercises, safe ambulation techniques with assistive devices, chair transfer mechanics, toilet use, stair negotiation, and postoperative precautions. All postoperative outcomes were measured on the first postoperative day following each patient's initial mobilization session. Kinesiophobia was assessed using the Tampa Scale of Kinesiophobia (TSK); pain intensity was measured using the Numerical Pain Rating Scale (NPRS) immediately before and after the first mobilization; and mobilization characteristics (duration, number of steps, activity level, and level of assistance required) were recorded using a standardized observation form.
The aim of the study was to determine whether video-based preoperative education provides measurable benefits compared with routine verbal instruction alone. By focusing on both psychological (kinesiophobia) and physical (pain and mobilization performance) outcomes, this trial seeks to contribute new evidence to the field of musculoskeletal rehabilitation and to support more effective perioperative education strategies in THA care. No adverse events related to the intervention were reported.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye), 34752
- Acibadem Healthcare Group Hospital - Orthopedic Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age 18 years or older
Able to communicate verbally
Scheduled for primary total hip arthroplasty
No major neurological disease
No major psychiatric disease
Able to participate in postoperative mobilization
Provided written informed consent
Exclusion Criteria:
Scheduled for revision total hip arthroplasty
Comorbidities that prevent safe mobilization (e.g., severe cardiopulmonary limitations, severe balance disorders)
Severe cognitive impairment affecting comprehension or cooperation
Any condition preventing participation in the mobilization protocol
Declining to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Participants in this arm receive routine preoperative verbal education plus a structured video-based mobilization training.
The video includes demonstrations of bed exercises, mobilization with assistive devices, chair transfer techniques, toilet use, stair negotiation, and postoperative precautions.
|
A structured preoperative video-based mobilization training including demonstrations of bed exercises, mobilization with assistive devices, chair transfer, toilet use, stair negotiation, and postoperative precautions.
|
|
Active Comparator: Control Group
Participants in this arm receive only routine preoperative verbal education provided by ward nurses.
No video-based training is given.
|
Routine preoperative verbal instruction provided by ward nurses.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinesiophobia (TSK Score)
Time Frame: First postoperative day, after first mobilization
|
Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia (TSK), a 17-item scale scored on a 4-point Likert system (1-4).
Total scores range from 17 to 68, with higher scores indicating greater fear of movement.
The Turkish validated version will be used.
|
First postoperative day, after first mobilization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity Before First Mobilization
Time Frame: Immediately before first mobilization
|
Pain intensity will be assessed using the Numerical Pain Rating Scale (NPRS), in which patients rate their pain on a scale from 1 to 10. Higher scores represent greater pain intensity.
|
Immediately before first mobilization
|
|
Pain Intensity After First Mobilization
Time Frame: Immediately after first mobilization
|
Pain intensity will be assessed using the Numerical Pain Rating Scale (NPRS), recorded on a scale from 1 to 10, where higher scores indicate more severe pain.
|
Immediately after first mobilization
|
|
Mobilization Duration
Time Frame: First postoperative day
|
The total duration (in minutes) of the patient's first mobilization session will be recorded by the researcher using a standardized observation form.
|
First postoperative day
|
|
Number of Steps During First Mobilization
Time Frame: First postoperative day
|
The number of steps taken during the first mobilization session will be counted using the standardized mobilization observation form.
|
First postoperative day
|
|
Activity Level During First Mobilization
Time Frame: First postoperative day
|
Activity level will be evaluated using the standardized mobilization observation form, which records walking distance, device use, and functional quality of ambulation.
|
First postoperative day
|
|
Level of Assistance Required During First Mobilization
Time Frame: First postoperative day
|
The required level of assistance (independent, minimal assistance, moderate assistance, or full assistance) will be assessed during the first mobilization session using a standardized observation form.
|
First postoperative day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nermin Ocaktan, Acıbadem Mehmet Ali Aydınlar University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Mental Disorders
- Postoperative Complications
- Pathologic Processes
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Osteoarthritis
- Phobic Disorders
- Anxiety Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Kinesiophobia
- Pain, Postoperative
- Osteoarthritis, Hip
Other Study ID Numbers
- 2022-17-46
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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