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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental:Music therapy | Active Comparator | The patient listened to the selected music through headphones fifteen minutes before the operation. |
|
| Control group (without music therapy) | Placebo Comparator | Patients wore headphones 15 minutes before the operation, but no music was played. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music intervention | Behavioral | Patients listen to the selected music through headphones fifteen minutes before the operation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Salivary Cortisol Levels | 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) | Operational day |
| SATI simplified questionnaire | Anxiety was assessed using the SATI simplified questionnaire (6 items, Likert scale 1-4, 1 = none, 4 = severe) | Operational day |
| Visual Analog Scale | Visual Analog Scale (VAS, 0-10, 0 = no anxiety, 10 = extreme anxiety) | Operational day |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Blood pressure is continuously monitored and recorded in mmHg in the operating room | Operational day |
| Intraoperative Pain | Pain intensity was quantified using a VAS (0-10, 0 = no pain, 10 = worst pain) |
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Inclusion Criteria:
Exclusion Criteria:
Requires complex and prolonged surgery, such as:
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:
Diagnosed with autoimmune diseases (e.g., Sjögren's syndrome) or oral diseases with inflammation/active lesions
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| Name | Affiliation | Role |
|---|---|---|
| Yuehong Zhang | Guangzhou First People's Hosipital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou First People's Hospital | Guangzhou | Guangzhou | 510180 | China |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| No music intervention | Behavioral | Patients wore headphones 15 minutes before the operation, but no music was played. |
|
| Operational day |
| Heart rate | Heart rate is continuously monitored and recorded in beats per minute in the operating room | Operational day |
| Respiratory rate | Respiratory rate is continuously monitored and recorded in breaths per minute in the operating room | Operational day |
| The patient's cooperation | The patient's cooperation was assessed by the operating surgeon on a 4-point scale (4=Very Cooperative, 1=Poorly Cooperative). | Operational day |