AnxietyNCT06230029
Music's Impact on Preoperative Anxiety: Heart Rate Variability Study During Cataract Surgery
A study testing Music listening in people with Anxiety and Cataract Surgery, run by Azienda Ospedaliera Universitaria Mater Domini, Catanzaro at 3 sites in 2 countries.
Trial summary
The goal of this Randomized Controlled Trial is to evaluate heart rate variability (HRV)before and after listening to music in patients scheduled for cataract surgery under topical anesthesia, compared to patients who do not listen to music. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Cataract Surgery, Heart Rate Variability
- What is being tested?
- Music listening
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Dec 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- information and consent of the patient,
- age greater than or equal to 18 years,
- affiliation to a social security system,
- benefiting from non-emergency ambulatory cataract surgery under topical anesthesia
- not being under legal protection.
Who cannot join
- Refusal to participate,
- language barriers that are incompatible with a reliable assessment
- use of beta-blockers, including eye drops
- use of adrenergic, antiadrenergic, cholinergic and anticholinergic drugs
- use of psychotropic drugs, anxiolytics.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Italy2 sites
Eye Clinic, Department of Surgical Sciences, University of Cagliari
Cagliari
University of Catanzaro
Catanzaro, 88100
About this study
Official title: Impact of Music on Preoperative Anxiety Level Measured by Heart Rate Variability During Cataract Surgery
The goal of this Randomized Controlled Trial is to evaluate heart rate variability (HRV)before and after listening to music in patients scheduled for cataract surgery under topical anesthesia, compared to patients who do not listen to music. Our hypothesis is that the anxious population with a low HRV benefits from an anxiolytic effect of music to increase HRV levels.
- Conditions
- Anxiety, Cataract Surgery, Heart Rate Variability
- Being tested
- Music listening
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music listeningOther
Music will be played through individual headphones (BOSE AE2®). The headphones give the impression of personalized music that only the patient can hear. Patients will have a mask over their eyes to limit visual aggression. The songs will be pre-recorded on a digital tablet (Samsung Galaxy®) allowing the broadcasting of music programs. Patients will have the choice to listen to a song according to their musical preferences among 16 different musical styles. The volume will be adapted to the level that suits the patient.
| Study group | Role | What they receive |
|---|---|---|
| Music Listening | Experimental | The presentation of the music listening session will be standardized and will be as follows: "Make yourself comfortable; we will first choose the musical style; then adjust the volume; put on the headphones; then the mask; let us know if something is wrong; we can take off the headphones or the mask at any time if you wish; we will stay by your side".
The following data will be collected just before the headset is put on and just after its removal:
* heart rate using a previously disinfected chest belt (PolarH10®)
* blood pressure
* level of anxiety (according to the validated SFQ and VAS scales)
Music listening session will last 15 minutes, at the end of which the headphones will be removed before the patient is transferred to the operating room. Receives: Other: Music listening |
| No Music | No intervention | Heart rate variability monitoring while NOT listening to music. The presentation for the patients included in the group without music will be as follows: "Make yourself comfortable; we will first put on the headphones but there will be no music; let us know if anything is wrong; we can remove the headphones or mask at any time if you wish; we will stay by your side". The following data will be collected just before the headset is put on and just after its removal: * heart rate using a previously disinfected chest belt (PolarH10®) * blood pressure * level of anxiety (according to the validated SFQ and VAS scales) The session will last 15 minutes, at the end of which the headphones will be removed before the patient is transferred to the operating room. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of heart rate variability before vs after listening to music in patients scheduled for cataract surgery under topical anesthesia.
Use of a non-invasive sensor: recording chest belt
Measured: Baseline vs pre-surgery
Secondary outcomes (3)
Evaluation of the impact of music on the incidence of surgical complications
Incidence of posterior capsular rupture
Measured: Immediately after the surgery
Measurement of subjective anxiety level
Surgical Fear Questionnaire (SFQ): The questionnaire consists of 8 questions (items). The Items 1-4 refer to the subscale 'fear of short term consequences of surgery', the items 5-8 refer to the subscale 'fear of long term consequences of surgery'. All items are scored on an eleven point numeric rating scale (NRS) ranging from 0 (not at all afraid) to 10 (very afraid). This results in a total score of 0 to 80, calculated by summing item 1-8.
Measured: Before surgery
Measurement of subjective anxiety level
Visual Analogue scale (VAS).
In this 5-score system, we employ illustrative facial expressions to represent varying degrees of anxiety. Each segment is paired with a distinct face, visually conveying the corresponding level of anxiety:
- No Anxiety: The initial segment features a face showing calmness, symbolizing absence of anxiety.
- Mild Anxiety: The second segment depicts a face with a slightly concerned expression, indicative of mild anxiety.
- Moderate Anxiety: In the third segment, the face exhibits clear signs of worry, corresponding to moderate anxiety.
- Severe Anxiety: The fourth segment portrays a face with a deeply troubled expression, denoting severe anxiety.
- Extreme Anxiety: The final segment illustrates a face overwhelmed with distress, representing extreme or unbearable anxiety.
Patients are invited to select the face that best aligns with their current perceived level of anxiety, enabling a more relatable and empathetic approach to self-assessment.
Measured: Before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Dec 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Giannaccare, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230029
- Sponsor's protocol ID
- Musictop2
- Status last verified
- Sep 2024
- First submitted
- 10 Jan 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Music on Preoperative Anxiety Level Measured by Heart Rate Variability During Cataract Surgery
- ClinicalTrials.gov ID
- NCT06230029
- Acronym / sponsor ID
- Musictop2
- Conditions
- Anxiety, Cataract Surgery, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Mater Domini, CatanzaroUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 29 Jan 2024 (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 goal of this Randomized Controlled Trial is to evaluate heart rate variability (HRV)before and after listening to music in patients scheduled for cataract surgery under topical anesthesia, compared to patients who do not listen to music. Our hypothesis is that the anxious population with a low HRV benefits from an anxiolytic effect of music to increase HRV levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Listening | Experimental | Other: Music listeningThe presentation of the music listening session will be standardized and will be as follows: "Make yourself comfortable; we will first choose the musical style; then adjust the volume; put on the headphones; then the mask; let us know if something is wrong; we can take off the headphones or the mask at any time if you wish; we will stay by your side". The following data will be collected just before the headset is put on and just after its removal: * heart rate using a previously disinfected chest belt (PolarH10®) * blood pressure * level of anxiety (according to the validated SFQ and VAS scales) Music listening session will last 15 minutes, at the end of which the headphones will be removed before the patient is transferred to the operating room. |
| No Music | No intervention | –Heart rate variability monitoring while NOT listening to music. The presentation for the patients included in the group without music will be as follows: "Make yourself comfortable; we will first put on the headphones but there will be no music; let us know if anything is wrong; we can remove the headphones or mask at any time if you wish; we will stay by your side". The following data will be collected just before the headset is put on and just after its removal: * heart rate using a previously disinfected chest belt (PolarH10®) * blood pressure * level of anxiety (according to the validated SFQ and VAS scales) The session will last 15 minutes, at the end of which the headphones will be removed before the patient is transferred to the operating room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- information and consent of the patient,
- age greater than or equal to 18 years,
- affiliation to a social security system,
- benefiting from non-emergency ambulatory cataract surgery under topical anesthesia
- not being under legal protection.
Key exclusion criteria (5 listed)
- Refusal to participate,
- language barriers that are incompatible with a reliable assessment
- use of beta-blockers, including eye drops
- use of adrenergic, antiadrenergic, cholinergic and anticholinergic drugs
- use of psychotropic drugs, anxiolytics.
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 listeningMusic will be played through individual headphones (BOSE AE2®). The headphones give the impression of personalized music that only the patient can hear. Patients will have a mask over their eyes to limit visual aggression. The songs will be pre-recorded on a digital tablet (Samsung Galaxy®) allowing the broadcasting of music programs. Patients will have the choice to listen to a song according to their musical preferences among 16 different musical styles. The volume will be adapted to the level that suits the patient. | Other | Music Listening |
Primary outcome
Comparison of heart rate variability before vs after listening to music in patients scheduled for cataract surgery under topical anesthesia.
Time frame: Baseline vs pre-surgery
Use of a non-invasive sensor: recording chest belt
3 secondary outcomes
Evaluation of the impact of music on the incidence of surgical complications
Time frame: Immediately after the surgery
Measurement of subjective anxiety level
Time frame: Before surgery
Measurement of subjective anxiety level
Time frame: Before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music listening in people with Anxiety and Cataract Surgery, run by Azienda Ospedaliera Universitaria Mater Domini, Catanzaro at 3 sites in 2 countries.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, France. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of heart rate variability before vs after listening to music in patients scheduled for cataract surgery under topical anesthesia. (time frame: Baseline vs pre-surgery). 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 1 Oct 2024.