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Effect of Behavioral Intervention (Baduanjin Alone or Laughter Exercise Plus Artificial Tears) Versus Artificial Tear on Dry Eye Disease: a Randomised Controlled Trial

NCT07524725 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2026-04-13

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the effect of behavioral intervention (Baduanjin alone or laughter exercise plus artificial tears) versus artificial tears in patients with dry eye disease.

The main questions it aims to answer are:

* Does the Baduanjin improve the Ocular Surface Disease Index score of patients with dry eye disease?
* Does the laughter exercise plus artificial tears improve the Ocular Surface Disease Index score of patients with dry eye disease?

Researchers will compare behavioral intervention (Baduanjin alone or laughter exercise plus artificial tears) versus artificial tears to see if behavioral intervention works to treat dry eye disease.

Participants will：

* Do the Baduanjin 5 times per week, or do laughter exercise plus artifical tears 4 times per day, or use artificial tears alone 4 times per day for 12 weeks
* Visit the clinic once right before the intervention and the 4, 8, 12, 16, 24, 36, and 48 weeks after starting the intervention for checkups and tests
* Use the app developed by our study to record the behavioral intervention and/or use of eye drops.

Conditions

  • Dry Eye Disease (DED)

Interventions

BEHAVIORAL

Baduanjin

Participants perform Baduanjin 5 times per week for 12 weeks. The standardized version, endorsed by the General Administration of Sport of China, includes 8 movements performed for 10 to 15 minutes.

BEHAVIORAL

Laughter exercise

Launch the "smile face recognition" APP on smart phone, after user guidance and pretest, a smile exercise will display on the phone, while facing the front camera on the phone, participant will do an exercise emphasizing facial movements, as exaggerated as possible. The exercise last for 12 weeks and 4 times a day

DRUG

Artificial tears

Participants use 0.1% sodium hyaluronate eye drops 4 times per day in both eyes.

Sponsors & Collaborators

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2032-12-31
Completion
2033-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07524725 on ClinicalTrials.gov