PterygiumNCT07858045
Video-Assisted Patient Education and Eye Fixation Training in Pterygium Surgery
A study testing Video-Assisted Patient Education in people with Pterygium and Preoperative Anxiety, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pterygium, Preoperative Anxiety, Postoperative Pain
- What is being tested?
- Video-Assisted Patient Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Oct 2026to 15 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital
Erzincan, Merkez, 24000
Mehmet Günay Uyar, +905543488391, mehmet.uyar@erzincan.edu.tr
About this study
Official title: 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
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.
- Conditions
- Pterygium, Preoperative Anxiety, Postoperative Pain
- Being tested
- Video-Assisted Patient Education
- Keywords
- Pterygium surgery, Video-assisted patient education, Eye position fixation training, Enhanced Recovery After Surgery, Physiological parameters
- Medical subject headings
- Pterygium, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Assisted Patient EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Video-Assisted Education | Experimental | Participants 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). Receives: Behavioral: Video-Assisted Patient Education |
| Routine Preoperative Care Group | No intervention | Participants 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperatively (baseline, in the waiting area before surgery) and postoperatively (10 minutes after transfer to the ward following surgery)
Secondary outcomes (7)
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.
Measured: Postoperatively (10 minutes after transfer to the ward following surgery)
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.
Measured: Immediately at the end of surgery (before the patient leaves the operating table)
Total Operation Duration
Total surgical procedure duration measured objectively in minutes, recorded from the initial incision to the completion of the final surgical suture.
Measured: At the completion of the surgical procedure (recorded immediately post-surgery)
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.
Measured: Baseline (preoperative waiting area), intraoperatively (during surgery), and postoperatively (10 minutes after transfer to the ward)
Heart Rate
Heart rate measured in beats per minute (bpm) via continuous clinical monitoring to evaluate autonomic response.
Measured: Baseline (preoperative waiting area), intraoperatively (during surgery), and postoperatively (10 minutes after transfer to the ward)
Respiratory Rate
Respiratory rate measured in breaths per minute via clinical observation/monitoring.
Measured: Baseline (preoperative waiting area), intraoperatively (during surgery), and postoperatively (10 minutes after transfer to the ward)
Peripheral Oxygen Saturation (SpO2)
Peripheral oxygen saturation measured as a percentage (%) using a pulse oximeter.
Measured: Baseline (preoperative waiting area), intraoperatively (during surgery), and postoperatively (10 minutes after transfer to the ward)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start12 Oct 2026 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to two parallel groups: the Video-Assisted Education and Eye Fixation Training Group (n = 76) and the Routine Care Control Group (n = 76).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Gunay Uyar, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858045
- Sponsor's protocol ID
- 07/10
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07858045
- Acronym / sponsor ID
- 07/10
- Conditions
- Pterygium, Preoperative Anxiety, Postoperative Pain
- Keywords
- Pterygium surgery, Video-assisted patient education, Eye position fixation training, Enhanced Recovery After Surgery, Physiological parameters
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 12 Oct 2026 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to two parallel groups: the Video-Assisted Education and Eye Fixation Training Group (n = 76) and the Routine Care Control Group (n = 76).
| Arm | Type | Receives |
|---|---|---|
| Video-Assisted Education | Experimental | Behavioral: 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 Group | No intervention | –Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-Assisted Patient EducationAn 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. | Behavioural | Video-Assisted Education |
Primary outcome
State Anxiety
Time frame: 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.
7 secondary outcomes
Postoperative Pain
Time frame: Postoperatively (10 minutes after transfer to the ward following surgery)
Intraoperative Patient Compliance and Surgeon Evaluation Score
Time frame: Immediately at the end of surgery (before the patient leaves the operating table)
Total Operation Duration
Time frame: At the completion of the surgical procedure (recorded immediately post-surgery)
Systolic and Diastolic Blood Pressure
Time frame: Baseline (preoperative waiting area), intraoperatively (during surgery), and postoperatively (10 minutes after transfer to the ward)
Heart Rate
Time frame: Baseline (preoperative waiting area), intraoperatively (during surgery), and postoperatively (10 minutes after transfer to the ward)
Respiratory Rate
Time frame: Baseline (preoperative waiting area), intraoperatively (during surgery), and postoperatively (10 minutes after transfer to the ward)
Peripheral Oxygen Saturation (SpO2)
Time frame: Baseline (preoperative waiting area), intraoperatively (during surgery), and postoperatively (10 minutes after transfer to the ward)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-Assisted Patient Education in people with Pterygium and Preoperative Anxiety, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Günay Uyar, PhD (+905543488391, mehmet.uyar@erzincan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety (time frame: Preoperatively (baseline, in the waiting area before surgery) and postoperatively (10 minutes after transfer to the ward following surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.