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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07544381
Enrollment
136
Registered
2026-04-22
Start date
2022-10-01
Completion date
2026-01-13
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinal Disease, Diabetic Retinopathy

Keywords

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

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.

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.

Interventions

BEHAVIORALNursing 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.

OTHERRoutine Peri-Procedural Care

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

Sponsors

Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Procedural pain intensity during ambulatory retinal laser photocoagulationImmediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedurePain 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

MeasureTime frameDescription
Peripheral oxygen saturation during ambulatory retinal laser photocoagulationImmediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedurePeripheral 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 photocoagulationImmediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedureHeart 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 photocoagulationImmediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedureRespiratory 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 photocoagulationImmediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedureSystolic 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 photocoagulationImmediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedureDiastolic 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 photocoagulationImmediately after completion of the procedureProcedural 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 photocoagulationDuring the procedure and immediately after completion of the procedureOccurrence 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026