[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633287":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":40,"locations":31,"responsibleParty":46,"collaborators":31,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":31,"eligibilityCriteria":54,"healthyVolunteers":51,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":31,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":31,"overallStatus":67,"whyStopped":31,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":31},{"fullName":5,"class":6},"Zhongshan Ophthalmic Center, Sun Yat-sen University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Baduanjin alone","EXPERIMENTAL","Perform Baduanjin 5 times per week for 12 weeks. During the first 4 weeks, participants will practice with a coach in person once per week. The remaining sessions will be done by following a video or live online class. Each session lasts 24 minutes.",[13],"Behavioral: Baduanjin",{"label":15,"type":10,"description":16,"interventionNames":17},"Laughter exercise plus artificial tears","Perform laughter exercise 4 times per day and use 0.1% sodium hyaluronate eye drops in both eyes 4 times per day.",[18,19],"Behavioral: Laughter exercise","Drug: Artificial tears",{"label":21,"type":22,"description":23,"interventionNames":24},"Artificial tears","ACTIVE_COMPARATOR","Use 0.1% sodium hyaluronate eye drops in both eyes 4 times per day for 12 weeks.",[19],[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"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.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"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",[15],{"type":37,"name":21,"description":38,"armGroupLabels":39,"otherNames":31},"DRUG","Participants use 0.1% sodium hyaluronate eye drops 4 times per day in both eyes.",[21,15],[41],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Lingyi Liang","CONTACT","13829738319","lianglingyi@gzzoc.com",{"type":47,"investigatorFullName":42,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Professor; Vice President of Zhongshan Ophthalmic Center, Head of the Preventive Ophthalmology Department","100633287","effect-of-behavioral-intervention-baduanjin-alone-or-laughter-exercise-plus-artificial-tears-versus-artificial-tear-on-dry-eye-disease-a-randomised-controlled-trial-100633287",false,"NCT07524725","Effect of Behavioral Intervention (Baduanjin Alone or Laughter Exercise Plus Artificial Tears) Versus Artificial Tear on Dry Eye Disease: a Randomised Controlled Trial","Inclusion Criteria:\n\n* ≥18 TO ≤45 years of age, any sex.\n* Meet the dry eye diagnostic criteria of the DEWS international consensus, and show both of the following two conditions: OSDI score between 18 and 80; NIBUT (Non-invasive tear break-up time) \\\u003C 8 seconds\n* Best corrected visual acuity ≥ 0.5(10\u002F20) (in each eye).\n* Intraocular pressure between 5 and 21 mmHg (in each eye).\n* Women of childbearing potential must agree to use safe contraception during the study.\n* Willingness\u002Fability to return for all study visits and to follow instructions from the study investigator and their staff.\n* Voluntary participation and signing of the informed consent form approved by the Ethics Committee.\n\nExclusion Criteria:\n\n* NEI corneal fluorescein staining score \\> 5 (in either eye).\n* Wore contact lenses within the past 14 days and cannot commit to not wearing them during the study period (3 months) (in either eye).\n* Received refractive surgery (LASIK, SMILE) or other ocular surgery, or had ocular trauma within the past 12 months (in either eye).\n* Had acute allergic conjunctivitis, infection, or ocular surface inflammation within the past 3 months (in either eye).\n* Eyelid abnormalities that affect eyelid function, such as nystagmus, blepharospasm, ectropion, entropion, or severe trichiasis (in either eye).\n* Previously diagnosed with glaucoma and received medical or surgical treatment (in either eye).\n* Currently receiving other ophthalmic or systemic treatments that may affect the tear film.\n* Allergy to fluorescein sodium.\n* Have a serious health condition that may limit their ability to participate.\n* Pregnant, breastfeeding, or planning to become pregnant.\n* Diagnosed with neurological or psychiatric disorders (e.g., severe anxiety, depression, or severe sleep disorder).\n* Have difficulty with physical movement.\n* Previous experience with traditional exercise such as Baduanjin.\n* Previous experience with laughter exercise.","ALL","18 Years","65 Years",{"count":59,"type":60},540,"ESTIMATED","INTERVENTIONAL",[63],"NA","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.\n\nThe main questions it aims to answer are:\n\n* Does the Baduanjin improve the Ocular Surface Disease Index score of patients with dry eye disease?\n* Does the laughter exercise plus artificial tears improve the Ocular Surface Disease Index score of patients with dry eye disease?\n\nResearchers 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.\n\nParticipants will：\n\n* 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\n* 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\n* Use the app developed by our study to record the behavioral intervention and\u002For use of eye drops.",[66],"Dry Eye Disease (DED)","NOT_YET_RECRUITING","2026-04-05",{"date":70,"type":71},"2026-04-13","ACTUAL",{"date":73,"type":60},"2027-01-01",{"date":75,"type":60},"2033-12-31",{"name":5,"class":6}]