The Effects of Music on Perioperative Outcomes in Cataract Surgery

Cataract Surgery Clinical Trial

Official title:

The Effects of Music on Perioperative Outcomes in Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03873454
• Other study ID #: CIRB 2014/378/D
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: August 2014

Study information

• Verified date: March 2019
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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. Exclusion criteria for anaesthetists was anaesthetists using moderate sedation, or who used non-standard drugs including Droperidol.

Related Conditions & MeSH terms

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

Intervention

Device:
• Sennheiser non-occlusive headphones
Patients listened to music of their choice using non-occlusive headphones
• Sennheiser non-occlusive headphones without music
Patients wore non-occlusive headphones but had no music playing

Other:
• No Sennheiser non-occlusive headphones
Patients did not wear non-occlusive headphones and did not listen to music

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore
Singapore	Singapore National Eye Centre	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-operatively
Primary	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.	10 minutes post-operatively