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The Effects of Music on Perioperative Outcomes in Cataract Surgery

The Effects of Music on Perioperative Outcomes in Cataract Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03873454
Enrollment
139
Registered
2019-03-13
Start date
2014-05-31
Completion date
2014-08-31
Last updated
2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Surgery, Music Improving Outcomes in Cataract Surgery, Stress Levels

Keywords

cataract surgery, music, salivary cortisol

Brief 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.

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.

Interventions

DEVICESennheiser non-occlusive headphones

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

DEVICESennheiser non-occlusive headphones without music

Patients wore non-occlusive headphones but had no music playing

OTHERNo Sennheiser non-occlusive headphones

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

Sponsors

Singapore General Hospital
CollaboratorOTHER
National University Hospital, Singapore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Salivary CortisolPre-operatively1 hour before the surgery a saliva sample was collected from the patient in order to test for salivary cortisol as a measure of stress.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026