Video-Assisted Patient Education and Eye Fixation Training in Pterygium Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAtaturk University
About this trial
This randomized controlled trial aims to investigate the effects of preoperative video-assisted patient education combined with eye position fixation training on anxiety, pain, intraoperative compliance, operation duration, and physiological parameters in adult patients undergoing primary pterygium surgery under local anesthesia. A total of 152 patients aged 18 to 75 years scheduled for primary pterygium excision with conjunctival autograft will be randomly assigned to either the intervention group (n = 76) or the control group (n = 76). Patients in the intervention group will receive an 8-to-10-minute tablet-based audiovisual surgical preparation module prior to surgery. This module consists of two stages: (1) cognitive preparation based on Enhanced Recovery After Surgery (ERAS) principles, including 2D animations of the procedure, desensitization to operating room sights and sounds, and postoperative care instructions; and (2) interactive eye position fixation and motor compliance training. Patients in the control group will receive standard routine verbal preoperative information. Anxiety levels, pain intensity, and physiological parameters (blood pressure, heart rate, respiratory rate, and oxygen saturation) will be assessed preoperatively and postoperatively. Intraoperative patient compliance and surgical comfort will be evaluated immediately after surgery by a blinded surgeon, along with total operation duration and intraoperative physiological parameters.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged between 18 and over
Diagnosed with primary pterygium scheduled for surgical excision with conjunctival autograft under local anesthesia
American Society of Anesthesiologists (ASA) physical status class I or II
Ability to read, understand, and communicate in Turkish
Disqualifiers
Requirement for general anesthesia
History of psychiatric illness or regular use of anxiolytic/psychotropic medications
Severe visual impairment in the contralateral eye or severe hearing impairment interfering with communication
History of prior major ocular surgery in the study eye or contralateral eye
Trial design
Design model
Parallel
Treatments tested in this trial
Video-Assisted Patient Education
BehavioralAn 8-to-10-minute two-stage audiovisual preparation module administered on a standard tablet prior to pterygium surgery. Stage 1 involves ERAS-based cognitive preparation, including 2D animations of pterygium surgery and local anesthesia, audiovisual desensitization to operating room lights and monitor beeps, and postoperative eye care instructions. Stage 2 consists of interactive eye fixation and motor compliance training, where participants follow voice prompts to track a moving red target without moving their heads, followed by static gaze fixation exercises held for 1 to 3 minutes to improve intraoperative surgical compliance.
Treatment groups
152 Participants
are divided into 2 treatment groupsGroup A: Video-Assisted EducationExperimental treatment 1 intervention
Group B: Routine Preoperative Care GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
State Anxiety
State anxiety is assessed using the State Anxiety Inventory (STAI Form TX-1), developed by Spielberger et al. The scale consists of 20 items designed to measure situational/transient anxiety. Each item is rated on a 4-point Likert scale ranging from 1 ("not at all") to 4 ("very much so"). Total scores range from 20 to 80, with higher scores indicating greater levels of acute anxiety.
Time frame
Preoperatively (baseline, in the waiting area before surgery) and postoperatively (10 minutes after transfer to the ward following surgery)Secondary outcomes
1
Postoperative Pain
Pain intensity is assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants select the number that best represents their current pain level. Higher scores indicate greater pain severity.
Time frame
Postoperatively (10 minutes after transfer to the ward following surgery)2
Intraoperative Patient Compliance and Surgeon Evaluation Score
Evaluated immediately post-surgery by the operating surgeon, who is blinded to participant group allocation, using a 4-item questionnaire on a 5-point Likert scale (1 = most negative to 5 = most positive). The scale assesses speed and accuracy of response to commands, eye fixation quality, involuntary head/eye movements, and overall surgical facilitation/comfort. Total scores range from 4 to 20, with higher scores indicating superior intraoperative compliance and surgical ease.
Time frame
Immediately at the end of surgery (before the patient leaves the operating table)3
Total Operation Duration
Total surgical procedure duration measured objectively in minutes, recorded from the initial incision to the completion of the final surgical suture.
Time frame
At the completion of the surgical procedure (recorded immediately post-surgery)4
Systolic and Diastolic Blood Pressure
Systolic and diastolic blood pressure measured in millimeters of mercury (mmHg) using a calibrated clinical monitor to evaluate hemodynamic stability.
Time frame
Baseline (preoperative waiting area), intraoperatively (during surgery), and postoperatively (10 minutes after transfer to the ward)Sponsors and contacts
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Source ClinicalTrials.gov
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