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

NCT07544381 | Completed

• 1 other identifier: EC 20220505(4)-P25
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Retinopathy; Diabetic Retinal Disease

Keywords

retinal laser photocoagulation; nursing intervention; stress adaptation theory; procedural pain; diabetic retinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

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.

Behavioral: Nursing Intervention Based on Stress Adaptation Theory

Control Group

OTHER

Participants received routine peri-procedural nursing care according to standard clinical practice.

Other: Routine Peri-Procedural Care

Interventions

Routine Peri-Procedural Care OTHER

Standard peri-procedural nursing care delivered during ambulatory retinal laser photocoagulation.

Control Group

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• unable to cooperate with peri-procedural assessment
• incomplete peri-procedural outcome data
• any condition judged by investigators to make participation inappropriate

Sponsors & Collaborators

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

Study Sites (1)

Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong

Shantou, Guangdong, 515041, China

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Pain, Procedural

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomized to either routine peri-procedural care or routine care plus a theory-informed nursing intervention delivered during retinal laser photocoagulation.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: October 1, 2022
• Primary Completion: January 13, 2024
• Study Completion: January 13, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)