Video-Assisted Patient Education and Eye Fixation Training in Pterygium Surgery

NCT07858045 — Not applicable, Not yet recruiting, 152 participants, Ataturk University

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The Effect of Video-Assisted Eye Position Fixation and Patient Education on Anxiety, Pain, Intraoperative Compliance, and Physiological Parameters in Pterygium Surgery: A Randomized Controlled Trial

RegistryNCT07858045
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, supportive care
Enrollment152 (Estimated)
SponsorAtaturk University (Other)
ConditionsPterygium, Preoperative Anxiety, Postoperative Pain
InterventionsVideo-Assisted Patient Education (Behavioral)
Datesstart 2026-10-12 (estimated), primary completion 2027-10-15 (estimated), completion 2027-10-15 (estimated), first posted 2026-10-05, last updated 2026-10-05
Locations1 site in Turkey (Türkiye)

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All trials for Pterygium All trials for Preoperative Anxiety All trials of Video-Assisted Patient Education

-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
Video-Assisted EducationExperimentalBehavioral: Video-Assisted Patient EducationParticipants in this group (n = 76) will receive an 8-to-10-minute two-stage audiovisual surgical preparation module on a tablet prior to pterygium surgery, in addition to routine clinical care. Stage 1 provides ERAS-based cognitive preparation (2D animation of pterygium and local anesthesia, audiovisual desensitization to operating room lights and monitor sounds, and postoperative care rules). Stage 2 provides interactive eye position fixation and motor compliance training (dynamic gaze tracking of a moving red target followed by static gaze fixation exercises lasting 1 to 3 minutes).
Routine Preoperative Care GroupNo interventionParticipants in this group (n = 76) will receive standard routine verbal preoperative information provided by the ward nurse (surgery time, fasting status, and general process) without any video-assisted education or eye fixation training.
  • Video-Assisted Patient Education (Behavioral): An 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.

+Outcome measures

Primary outcomes

  • State Anxiety [Preoperatively (baseline, in the waiting area before surgery) and postoperatively (10 minutes after transfer to the ward following surgery)]: 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.

Secondary outcomes

  • Postoperative Pain [Postoperatively (10 minutes after transfer to the ward following surgery)]: 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.
  • Intraoperative Patient Compliance and Surgeon Evaluation Score [Immediately at the end of surgery (before the patient leaves the operating table)]: 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.
  • Total Operation Duration [At the completion of the surgical procedure (recorded immediately post-surgery)]: Total surgical procedure duration measured objectively in minutes, recorded from the initial incision to the completion of the final surgical suture.
  • Systolic and Diastolic Blood Pressure [Baseline (preoperative waiting area), intraoperatively (during surgery), and postoperatively (10 minutes after transfer to the ward)]: Systolic and diastolic blood pressure measured in millimeters of mercury (mmHg) using a calibrated clinical monitor to evaluate hemodynamic stability.
  • Heart Rate [Baseline (preoperative waiting area), intraoperatively (during surgery), and postoperatively (10 minutes after transfer to the ward)]: Heart rate measured in beats per minute (bpm) via continuous clinical monitoring to evaluate autonomic response.
  • Respiratory Rate [Baseline (preoperative waiting area), intraoperatively (during surgery), and postoperatively (10 minutes after transfer to the ward)]: Respiratory rate measured in breaths per minute via clinical observation/monitoring.
  • Peripheral Oxygen Saturation (SpO2) [Baseline (preoperative waiting area), intraoperatively (during surgery), and postoperatively (10 minutes after transfer to the ward)]: Peripheral oxygen saturation measured as a percentage (%) using a pulse oximeter.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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
* Voluntary agreement to participate in the study with written informed consent

Exclusion Criteria:

* 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
* Presence of systemic comorbidities including diabetes mellitus, severe respiratory diseases, or significant cardiovascular diseases
* Cancellation of surgery due to technical or medical reasons
* Withdrawal of consent or request to leave the study at any stage

+Locations (1)

FacilityCityCountryStatus
Erzincan Binali Yildirim University Mengucek Gazi Training and Research HospitalErzincan, MerkezTurkey (Türkiye)