Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized controlled study evaluated whether a nursing intervention based on stress adaptation theory could improve pain trajectory and procedural tolerance in patients undergoing ambulatory retinal laser photocoagulation for diabetic retinal disease. Patients were randomized to receive either routine peri-procedural care or routine care plus a structured nursing intervention including a brief treatment pause, guided slow breathing, anticipatory communication, real-time reassurance, and post-procedure observation. Outcomes included pain intensity, physiologic responses, procedural cooperation, and adverse events.
Retinal laser photocoagulation remains an important treatment for diabetic retinal disease, but the procedure may cause pain, physiologic stress, and adverse reactions that reduce treatment tolerance and cooperation. This study was designed to evaluate a nursing intervention based on stress adaptation theory in patients undergoing diabetic retinal laser surgery. Participants were randomized to an intervention group or a control group. The intervention group received structured peri-procedural nursing support aimed at reducing stress and improving adaptation during the most painful phases of treatment. The control group received routine care. The primary outcome was pain intensity measured at four peri-procedural time points. Secondary outcomes included peripheral oxygen saturation, heart rate, respiratory rate, blood pressure, procedural cooperation, and adverse events.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Participants received routine peri-procedural care plus a nursing intervention based on stress adaptation theory, including a brief treatment pause, guided slow breathing, anticipatory communication before the most painful phase of treatment, real-time symptom inquiry and reassurance, and immediate post-procedure observation. |
|
| Control Group | Other | Participants received routine peri-procedural nursing care according to standard clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nursing Intervention Based on Stress Adaptation Theory | Behavioral | A structured peri-procedural nursing intervention delivered during ambulatory retinal laser photocoagulation to reduce stress and improve procedural tolerance. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural pain intensity during ambulatory retinal laser photocoagulation | Pain intensity measured using a 10-point visual analog scale (VAS; range 0 to 10, with higher scores indicating greater pain). Pain was assessed at four predefined peri-procedural time points: immediately before laser treatment, after the first 50 laser shots, after temporal posterior pole photocoagulation, and immediately after completion of the procedure. | Immediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral oxygen saturation during ambulatory retinal laser photocoagulation | Peripheral oxygen saturation (SpO2, %) measured by bedside physiologic monitoring at four predefined peri-procedural time points: immediately before laser treatment, after the first 50 laser shots, after temporal posterior pole photocoagulation, and immediately after completion of the procedure. | Immediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong | Shantou | Guangdong | 515041 | China |
De-identified individual participant data will not be made publicly available at this time. Because this was a single-center study with a relatively limited sample size and detailed peri-procedural clinical variables, the study team judged that participant-level data sharing may carry a risk of re-identification. No plan has therefore been established for public sharing of individual participant data.
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were randomized to either routine peri-procedural care or routine care plus a theory-informed nursing intervention delivered during retinal laser photocoagulation.
Not provided
Not provided
Not provided
Not provided
| Routine Peri-Procedural Care | Other | Standard peri-procedural nursing care delivered during ambulatory retinal laser photocoagulation. |
|
| Heart rate during ambulatory retinal laser photocoagulation | Heart rate (beats per minute) measured by bedside physiologic monitoring at four predefined peri-procedural time points: immediately before laser treatment, after the first 50 laser shots, after temporal posterior pole photocoagulation, and immediately after completion of the procedure. | Immediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedure |
| Respiratory rate during ambulatory retinal laser photocoagulation | Respiratory rate (breaths per minute) measured by bedside physiologic monitoring at four predefined peri-procedural time points: immediately before laser treatment, after the first 50 laser shots, after temporal posterior pole photocoagulation, and immediately after completion of the procedure. | Immediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedure |
| Systolic blood pressure during ambulatory retinal laser photocoagulation | Systolic blood pressure (mmHg) measured by bedside physiologic monitoring at four predefined peri-procedural time points: immediately before laser treatment, after the first 50 laser shots, after temporal posterior pole photocoagulation, and immediately after completion of the procedure. | Immediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedure |
| Diastolic blood pressure during ambulatory retinal laser photocoagulation | Diastolic blood pressure (mmHg) measured by bedside physiologic monitoring at four predefined peri-procedural time points: immediately before laser treatment, after the first 50 laser shots, after temporal posterior pole photocoagulation, and immediately after completion of the procedure. | Immediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedure |
| Procedural cooperation at completion of retinal laser photocoagulation | Procedural cooperation assessed by the treating ophthalmologist at the end of the procedure using a 5-point satisfaction-based cooperation scale: 0 = extremely dissatisfied, 1 = dissatisfied, 2 = neutral, 3 = satisfied, and 4 = very satisfied. Higher scores indicate better cooperation during treatment. | Immediately after completion of the procedure |
| Procedure-related adverse events during or immediately after retinal laser photocoagulation | Occurrence of clinically relevant discomfort or symptoms during or shortly after laser treatment, including dizziness, headache, fatigue, diaphoresis, palpitations, nausea, or intolerance requiring a pause, observation, or supportive management. This outcome is recorded as the presence or absence of at least one procedure-related adverse event for each participant. | During the procedure and immediately after completion of the procedure |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided