NCT07524725

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2027-01-01
• Primary completion: 2032-12-31
• Completion: 2033-12-31
• First posted: 2026-04-13
• Last updated: 2026-04-13