CataractNCT07296731
Anxiety in Cataract Patients Using Preoperative Music Therapy
A study testing Music intervention and No music intervention in people with Cataract and Music Therapy, run by Guangzhou First People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Cataract, Music Therapy
- What is being tested?
- Music intervention and No music intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Requires complex and prolonged surgery, such as:
- Shallow anterior chamber with risk of glaucoma
- Advanced cataracts with hard nuclei
- 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
Show all 13Show fewer
- Refuses to participate, or has difficulty understanding/answering questionnaires, or has cognitive impairments
- Uses medications that may affect cortisol and cardiovascular reactivity, including:
- Oral contraceptives
- Thyroid drugs
- Steroids
- Psychotropic drugs
- Diagnosed with autoimmune diseases (e.g., Sjögren's syndrome) or oral diseases with inflammation/active lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research on Interventions for Anxiety in Cataract Patients Using Preoperative Music Therapy
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.
Read the 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.
- Conditions
- Cataract, Music Therapy
- Being tested
- Music intervention, No music intervention
- Keywords
- Cataract, Music therapy, Preoperative anxiety
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionBehavioural
Patients listen to the selected music through headphones fifteen minutes before the operation.
No music interventionBehavioural
Patients wore headphones 15 minutes before the operation, but no music was played.
| Study group | Role | What they receive |
|---|---|---|
| Experimental:Music therapy | Active comparator | The patient listened to the selected music through headphones fifteen minutes before the operation. Receives: Behavioral: Music intervention |
| Control group (without music therapy) | Placebo comparator | Patients wore headphones 15 minutes before the operation, but no music was played. Receives: Behavioral: No music intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Operational day
SATI simplified questionnaire
Anxiety was assessed using the SATI simplified questionnaire (6 items, Likert scale 1-4, 1 = none, 4 = severe)
Measured: Operational day
Visual Analog Scale
Visual Analog Scale (VAS, 0-10, 0 = no anxiety, 10 = extreme anxiety)
Measured: Operational day
Secondary outcomes (5)
Blood pressure
Blood pressure is continuously monitored and recorded in mmHg in the operating room
Measured: Operational day
Intraoperative Pain
Pain intensity was quantified using a VAS (0-10, 0 = no pain, 10 = worst pain)
Measured: Operational day
Heart rate
Heart rate is continuously monitored and recorded in beats per minute in the operating room
Measured: Operational day
Respiratory rate
Respiratory rate is continuously monitored and recorded in breaths per minute in the operating room
Measured: 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).
Measured: Operational day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start31 Mar 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou First People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuehong Zhang, Principal investigator, Guangzhou First People's Hosipital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296731
- Sponsor's protocol ID
- k-2025-073-01
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Interventions for Anxiety in Cataract Patients Using Preoperative Music Therapy
- ClinicalTrials.gov ID
- NCT07296731
- Acronym / sponsor ID
- k-2025-073-01
- Conditions
- Cataract, Music Therapy
- Keywords
- Cataract, Music therapy, Preoperative anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangzhou First People's HospitalUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental:Music therapy | Active comparator | Behavioral: Music interventionThe patient listened to the selected music through headphones fifteen minutes before the operation. |
| Control group (without music therapy) | Placebo comparator | Behavioral: No music interventionPatients wore headphones 15 minutes before the operation, but no music was played. |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionPatients listen to the selected music through headphones fifteen minutes before the operation. | Behavioural | Experimental:Music therapy |
| No music interventionPatients wore headphones 15 minutes before the operation, but no music was played. | Behavioural | Control group (without music therapy) |
Primary outcome
Salivary Cortisol Levels
Time frame: 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
Time frame: Operational day
Anxiety was assessed using the SATI simplified questionnaire (6 items, Likert scale 1-4, 1 = none, 4 = severe)
Visual Analog Scale
Time frame: Operational day
Visual Analog Scale (VAS, 0-10, 0 = no anxiety, 10 = extreme anxiety)
5 secondary outcomes
Blood pressure
Time frame: Operational day
Intraoperative Pain
Time frame: Operational day
Heart rate
Time frame: Operational day
Respiratory rate
Time frame: Operational day
The patient's cooperation
Time frame: Operational day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuehong Zhang principal investigator
Guangzhou First People's Hosipital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention and No music intervention in people with Cataract and Music Therapy, run by Guangzhou First People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Cortisol Levels (time frame: Operational day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.