AzTrials
AzTrials

Cataract SurgeryNCT03873454

The Effects of Music on Perioperative Outcomes in Cataract Surgery

A study testing Sennheiser non-occlusive headphones, Sennheiser non-occlusive headphones without music and No Sennheiser non-occlusive headphones in people with Cataract Surgery and Stress Levels, run by National University Hospital, Singapore at 2 sites in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The hypothesis of this trial is that listening to music will decrease the stress levels that patients face as evidenced by their STAI scores, salivary cortisol levels and intra-operative autonomic parameters. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Sennheiser non-occlusive headphones, Sennheiser non-occlusive headphones without music and No Sennheiser non-occlusive headphones
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
2 sitesSingapore
Study dates
May 2014to Aug 2014
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Cataract surgery patients aged 50 years and above, with an acceptable hearing level based on CALFRAST hearing and the ability to wear clip-on on-ear headphones without discomfort. They were required to be mentally and physically capable of informed consent. Patients were also required to be ASA Grade 3 or lower.
  • Surgeons doing phacoemulsification cataract surgeries, and for anaesthetists, the inclusion criteria was anaesthetists using only minimal sedation for the procedure.

Who cannot join

  • Severe/profound hearing impairments, patients with intellectual disabilities, patients on psychotropic medications or drugs affecting mood or hemodynamic status, ASA grade 4 and parturients
  • Exclusion criterion for surgeons included ECCE procedures. Exclusion criteria for anaesthetists was anaesthetists using moderate sedation, or who used non-standard drugs including Droperidol.

Trial locations and contacts

2 sites in 1 country.

Singapore2 sites
  • National University Hospital

    Singapore, 119074

  • Singapore National Eye Centre

    Singapore, 168751

Other trials in Singapore

About this study

The hypothesis of this trial is that listening to music will decrease the stress levels that patients face as evidenced by their STAI scores, salivary cortisol levels and intra-operative autonomic parameters.

Read the detailed description

This randomized control trial was conducted from May- July 2014 across National University Hospital and Singapore National Eye Centre. All the patients of 10 consultants and senior consults and X medical officers were included in the study. A total of 148 participants were surveyed, and a total of X saliva samples were collected.

The inclusion criterion for patients was cataract surgery patients aged 50 years and above, with an acceptable hearing level based on CALFRAST hearing and the ability to wear clip-on on-ear headphones without discomfort. They were required to be mentally and physically capable of informed consent. Patients were also required to be ASA Grade 3 or lower.

Inclusion criterion for surgeons was surgeons doing phacoemulsification cataract surgeries, and for anaesthetists, the inclusion criteria was anaesthetists using only minimal sedation for the procedure.

Exclusion criteria was severe/profound hearing impairments, patients with intellectual disabilities, patients on psychotropic medications or drugs affecting mood or hemodynamic status, ASA grade 4 and parturients

Exclusion criterion for surgeons included ECCE procedures. Exclusion criteria for anaesthetists was anaesthetists using moderate sedation, or who used non-standard drugs including Droperidol.

Both the NHG Domain-Specific Institutional Review Board and the Singhealth Institutional Review Board approved the study in May 2014, and all ethical consideration complied with. Written informed consent was sought prior to the questionnaire administration, and participants were allowed to withdraw from the study at any time during data collection.

The study had 3 arms- an experimental group of patients who listened to music via headphones, a first control group of patients who wore earphones but did not listen to music, and a second control group of patients who neither listened to music nor wore headphones. All patients were assigned a study number and no patient identifiers were noted.

1 hour before the procedure, study participants were approached to do an anonymous survey. Patients were then asked to produce a saliva sample by pooling saliva under the tongue for 5 minutes.

Finally, patients in the experimental group choose one of 30 playlists; if a patient did not find a playlist to their satisfaction, Spotifiy® was used to generate a new playlist. Patients were also allowed to listen to their preferred local radio station. Music was played using wireless headphones synced with a Jabra® Bluetooth device which was clipped onto the patients OT gown.

Intra-operatively, both the surgeon and anaesthetist were blinded to what arm of the study the patient was undergoing. Autonomic parameters (blood pressure, Mean Arterial Pressure, Respiratory Rate and Heart Rate) as well as dosages of drugs administered (anxiolytics, sedatives, anaesthetics, any other drugs used). The total time for the procedure was noted. Post-operatively, the surgeon was surveyed for complexity of the case and ease of communication with the patient, whilst the anaesthetist was surveyed for depth of anaesthesia and ease of communication with the patient.

10 minutes post-procedurally, the patient was surveyed again and saliva samples were collected.

Being tested
Sennheiser non-occlusive headphones, Sennheiser non-occlusive headphones without music, No Sennheiser non-occlusive headphones
Keywords
cataract surgery, music, salivary cortisol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sennheiser non-occlusive headphonesDevice

    Patients listened to music of their choice using non-occlusive headphones

  • Sennheiser non-occlusive headphones without musicDevice

    Patients wore non-occlusive headphones but had no music playing

  • No Sennheiser non-occlusive headphonesOther

    Patients did not wear non-occlusive headphones and did not listen to music

Study groups in NCT03873454
Study groupRoleWhat they receive
Experimental GroupActive comparatorThe experimental group listened to music and wore Sennheiser non-occlusive headphones
Receives: Device: Sennheiser non-occlusive headphones
Control 1 with no musicOtherThis cohort wore non-occlusive earphones but did not listen to music
Receives: Device: Sennheiser non-occlusive headphones without music
Control 2 with no musicOtherThe control 2 patients did not listen to music nor wore earphones.
Receives: Other: No Sennheiser non-occlusive headphones

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Salivary Cortisol

    1 hour before the surgery a saliva sample was collected from the patient in order to test for salivary cortisol as a measure of stress.

    Measured: Pre-operatively

  2. Salivary Cortisol

    10 minutes after the surgery, a saliva sample was collected from the patient in order to test for salivary cortisol as a measure of stress.

    Measured: 10 minutes post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2019
  2. Study startMay 2014
  3. Primary completionJul 2014
  4. Study completionAug 2014

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03873454
Sponsor's protocol ID
CIRB 2014/378/D
Status last verified
Mar 2019
First submitted
12 Aug 2014
Last updated
13 Mar 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Sennheiser non-occlusive headphones, Sennheiser non-occlusive headphones without music and No Sennheiser non-occlusive headphones in people with Cataract Surgery and Stress Levels, run by National University Hospital, Singapore at 2 sites in Singapore.

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 2 inclusion and 2 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 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. 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?

Salivary Cortisol (time frame: Pre-operatively). The study lists 2 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 13 Mar 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in