Cataract, Music Therapy
Conditions
Keywords
Cataract, Music therapy, Preoperative anxiety
Brief summary
The researchers designed this study to investigate whether implementing preoperative music intervention in cataract surgery can reduce perioperative anxiety, alleviate postoperative pain, and enhance patient satisfaction with the surgical procedure.
Detailed description
This is a single-center, randomized controlled single-blind trial. Computer-generated randomization will be used to allocate patients into two groups: a control group (without music therapy) and music therapy group A (listening to music preoperatively). Patient anxiety levels, pain intensity, satisfaction with the surgical procedure, and degree of cooperation during surgery will be assessed through preoperative and postoperative questionnaires and salivary cortisol measurements. Blood pressure and heart rate will be monitored both preoperatively and intraoperatively.
Interventions
BEHAVIORALNo music intervention
Patients wore headphones 15 minutes before the operation, but no music was played.
BEHAVIORALMusic intervention
Patients listen to the selected music through headphones fifteen minutes before the operation.
Sponsors
Guangzhou First People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 90 Years
Healthy volunteers
No
Inclusion criteria
* Meets the diagnostic criteria for cataract * Age ≤ 90 years * Scheduled for phacoemulsification with IOL implantation under topical anesthesia at the Ophthalmology Department of Guangzhou First People's Hospital * Voluntarily participates and provides signed informed consent
Exclusion criteria
* Requires complex and prolonged surgery, such as: 1. Shallow anterior chamber with risk of glaucoma 2. Advanced cataracts with hard nuclei 3. Small pupils * Has hearing impairment or communication difficulties * Shows significant anxiety/depression tendencies or has a history of mental illness with prior/current use of sedatives * Refuses to participate, or has difficulty understanding/answering questionnaires, or has cognitive impairments * Uses medications that may affect cortisol and cardiovascular reactivity, including: 1. Oral contraceptives 2. Thyroid drugs 3. Steroids 4. Psychotropic drugs * Diagnosed with autoimmune diseases (e.g., Sjögren's syndrome) or oral diseases with inflammation/active lesions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Cortisol Levels | Operational day | Saliva samples were collected at admission and 15 minutes postoperatively using Salivette tubes, centrifuged, and stored at -80°C. Cortisol concentrations were measured via ELISA using the R&D Systems Cortisol Assay Kit (Cat. No. KGE008B) |
| SATI simplified questionnaire | Operational day | Anxiety was assessed using the SATI simplified questionnaire (6 items, Likert scale 1-4, 1 = none, 4 = severe) |
| Visual Analog Scale | Operational day | Visual Analog Scale (VAS, 0-10, 0 = no anxiety, 10 = extreme anxiety) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate | Operational day | Respiratory rate is continuously monitored and recorded in breaths per minute in the operating room |
| Blood pressure | Operational day | Blood pressure is continuously monitored and recorded in mmHg in the operating room |
| The patient's cooperation | Operational day | The patient's cooperation was assessed by the operating surgeon on a 4-point scale (4=Very Cooperative, 1=Poorly Cooperative). |
| Intraoperative Pain | Operational day | Pain intensity was quantified using a VAS (0-10, 0 = no pain, 10 = worst pain) |
| Heart rate | Operational day | Heart rate is continuously monitored and recorded in beats per minute in the operating room |
Countries
China
Outcome results
None listed