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Diabetic RetinopathyNCT07544381

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

A study testing Nursing Intervention Based on Stress Adaptation Theory and Routine Peri-Procedural Care in people with Diabetic Retinopathy and Diabetic Retinal Disease, run by Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nursing Intervention Based on Stress Adaptation Theory and Routine Peri-Procedural Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteChina
Study dates
1 Oct 2022to 13 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Shantou, Guangdong, 515041

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Nursing Intervention Based on Stress Adaptation Theory, Routine Peri-Procedural Care
Keywords
retinal laser photocoagulation, nursing intervention, stress adaptation theory, procedural pain, diabetic retinopathy
Medical subject headings
Diabetic Retinopathy, Pain, Procedural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nursing Intervention Based on Stress Adaptation TheoryBehavioural

    A structured peri-procedural nursing intervention delivered during ambulatory retinal laser photocoagulation to reduce stress and improve procedural tolerance.

  • Routine Peri-Procedural CareOther

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

Study groups in NCT07544381
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants 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.
Receives: Behavioral: Nursing Intervention Based on Stress Adaptation Theory
Control GroupOtherParticipants received routine peri-procedural nursing care according to standard clinical practice.
Receives: Other: Routine Peri-Procedural Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

    Measured: Immediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedure

  2. 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.

    Measured: Immediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedure

  3. 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.

    Measured: Immediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedure

  4. 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.

    Measured: Immediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedure

  5. 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.

    Measured: Immediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedure

  6. 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.

    Measured: Immediately after completion of the procedure

  7. 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.

    Measured: During the procedure and immediately after completion of the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2026
  2. Study start1 Oct 2022
  3. Primary completion13 Jan 2024
  4. Study completion13 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07544381
Sponsor's protocol ID
EC 20220505(4)-P25
Status last verified
Apr 2026
First submitted
15 Apr 2026
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Nursing Intervention Based on Stress Adaptation Theory and Routine Peri-Procedural Care in people with Diabetic Retinopathy and Diabetic Retinal Disease, run by Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural pain intensity during ambulatory retinal laser photocoagulation (time frame: Immediately before laser treatment; after the first 50 laser shots; after temporal posterior pole photocoagulation; and immediately after completion of the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07544381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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