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The Effects of Music on Perioperative Outcomes in Cataract Surgery

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ClinicalTrials.gov Identifier: NCT03873454
Recruitment Status : Completed
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Singapore General Hospital
Information provided by (Responsible Party):
Anaesthesia, National University Hospital, Singapore

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.

Condition or disease Intervention/treatment Phase
Cataract Surgery Stress Levels Music Improving Outcomes in Cataract Surgery Device: Sennheiser non-occlusive headphones Device: Sennheiser non-occlusive headphones without music Other: No Sennheiser non-occlusive headphones Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effects of Music on Perioperative Outcomes in Cataract Surgery
Study Start Date : May 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: Experimental Group
The experimental group listened to music and wore Sennheiser non-occlusive headphones
Device: Sennheiser non-occlusive headphones
Patients listened to music of their choice using non-occlusive headphones

Control 1 with no music
This cohort wore non-occlusive earphones but did not listen to music
Device: Sennheiser non-occlusive headphones without music
Patients wore non-occlusive headphones but had no music playing

Control 2 with no music
The control 2 patients did not listen to music nor wore earphones.
Other: No Sennheiser non-occlusive headphones
Patients did not wear non-occlusive headphones and did not listen to music




Primary Outcome Measures :
  1. Salivary Cortisol [ Time Frame: Pre-operatively ]
    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.

  2. Salivary Cortisol [ Time Frame: 10 minutes post-operatively ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873454


Locations
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Singapore
National University Hospital
Singapore, Singapore, 119074
Singapore National Eye Centre
Singapore, Singapore, 168751
Sponsors and Collaborators
National University Hospital, Singapore
Singapore General Hospital
Investigators
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Principal Investigator: A/Prof Lian Kah Ti, MBBS, MMED National University Hospital, Singapore

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Responsible Party: Anaesthesia, Principal Investigator, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT03873454     History of Changes
Other Study ID Numbers: CIRB 2014/378/D
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

Keywords provided by Anaesthesia, National University Hospital, Singapore:
cataract surgery
music
salivary cortisol

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases