Nursing Intervention Based on Stress Adaptation Theory for Patients Undergoing Diabetic Retinal Laser Surgery

Effect of a Nursing Intervention Based on Stress Adaptation Theory on Stress Status in Patients Undergoing Diabetic Retinal Laser Surgery: A Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy; Diabetic Retinal Disease
• Intervention / Treatment: Behavioral: Nursing Intervention Based on Stress Adaptation Theory; Other: Routine Peri-Procedural Care

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.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shantou, Guangdong, China, 515041
      • Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Nursing Intervention Based on Stress Adaptation Theory; A structured peri-procedural nursing intervention delivered during ambulatory retinal laser photocoagulation to reduce stress and improve procedural tolerance.
Other: Control Group; Participants received routine peri-procedural nursing care according to standard clinical practice.	Other: Routine Peri-Procedural Care; Standard peri-procedural nursing care delivered during ambulatory retinal laser photocoagulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): January 13, 2024
• Study Completion (Actual): January 13, 2026

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: diabetic retinopathy; procedural pain; nursing intervention; retinal laser photocoagulation; stress adaptation theory
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Eye Diseases; Diabetic Angiopathies; Diabetes Complications; Retinal Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Procedural; Diabetic Retinopathy
• Other Study ID Numbers: EC 20220505(4)-P25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No