Effect of a Nursing Intervention Based on Stress Adaptation Theory on Stress Status in Patients Undergoing Diabetic Retinal Laser Surgery: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Procedural pain intensity during ambulatory retinal laser photocoagulation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •unable to cooperate with peri-procedural assessment
- •incomplete peri-procedural outcome data
- •any condition judged by investigators to make participation inappropriate
研究组 & 干预措施
Intervention Group
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.
干预措施: Nursing Intervention Based on Stress Adaptation Theory (Behavioral)
Control Group
Participants received routine peri-procedural nursing care according to standard clinical practice.
干预措施: Routine Peri-Procedural Care (Other)
结局指标
主要结局
Procedural pain intensity during ambulatory retinal laser photocoagulation
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)
- Procedural cooperation at completion of retinal laser photocoagulation(Immediately after completion of the procedure)
- Procedure-related adverse events during or immediately after retinal laser photocoagulation(During the procedure and immediately after completion of the procedure)
研究者
Laiwen Lv
Principal Investigator
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong