Effect of a Nursing Intervention Based on Stress Adaptation Theory on Stress Status in Patients Undergoing Diabetic Retinal Laser Surgery: A Randomized Controlled Study
| Registry | NCT07544381 |
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 136 (Actual) |
| Sponsor | Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong (Other) |
| Conditions | Diabetic Retinopathy, Diabetic Retinal Disease |
| Interventions | Nursing Intervention Based on Stress Adaptation Theory, Routine Peri-Procedural Care (Behavioral, other) |
| Dates | start 2022-10-01, primary completion 2024-01-13, completion 2026-01-13, first posted 2026-04-22, last updated 2026-04-24 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Diabetic Retinopathy All trials for Diabetic Retinal Disease All trials of Nursing Intervention Based on Stress Adaptation Theory All trials of Routine Peri-Procedural Care
-Summary
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.
Expand all sections · Collapse all
+Detailed description
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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Intervention Group | Experimental | Behavioral: Nursing Intervention Based on Stress Adaptation Theory | 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 | Other: Routine Peri-Procedural Care | Participants received routine peri-procedural nursing care according to standard clinical practice. |
- 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.
- Routine Peri-Procedural Care (Other): Standard peri-procedural nursing care delivered during ambulatory retinal laser photocoagulation.
+Outcome measures
Primary outcomes
- Procedural pain intensity during ambulatory retinal laser photocoagulation [Immediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedure]: 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.
Secondary outcomes
- Peripheral oxygen saturation during ambulatory retinal laser photocoagulation [Immediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedure]: 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.
- Heart rate during ambulatory retinal laser photocoagulation [Immediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedure]: 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.
- Respiratory rate during ambulatory retinal laser photocoagulation [Immediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedure]: 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.
- Systolic blood pressure during ambulatory retinal laser photocoagulation [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 (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.
- Diastolic blood pressure during ambulatory retinal laser photocoagulation [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 (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.
- Procedural cooperation at completion of retinal laser photocoagulation [Immediately after completion of the procedure]: 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.
- Procedure-related adverse events during or immediately after retinal laser photocoagulation [During the procedure and immediately after completion of the procedure]: 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.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* adults undergoing ambulatory retinal laser photocoagulation for diabetic retinal disease
* able to understand the study procedures and provide informed consent
* able to complete pain assessment during the procedure
Exclusion Criteria:
* unable to cooperate with peri-procedural assessment
* incomplete peri-procedural outcome data
* any condition judged by investigators to make participation inappropriate
+Locations (1)
| Facility | City | Country | Status |
|---|
| Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong | Shantou, Guangdong | China | |