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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

Tracking Information
First Submitted Date  ICMJE August 12, 2014
First Posted Date  ICMJE March 13, 2019
Last Update Posted Date March 13, 2019
Study Start Date  ICMJE May 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Music on Perioperative Outcomes in Cataract Surgery
Official Title  ICMJE The Effects of Music on Perioperative Outcomes in Cataract Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Cataract Surgery
  • Stress Levels
  • Music Improving Outcomes in Cataract Surgery
Intervention  ICMJE
  • Device: Sennheiser non-occlusive headphones
    Patients listened to music of their choice using non-occlusive headphones
  • Device: 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
Study Arms  ICMJE
  • Active Comparator: Experimental Group
    The experimental group listened to music and wore Sennheiser non-occlusive headphones
    Intervention: Device: Sennheiser non-occlusive headphones
  • Control 1 with no music
    This cohort wore non-occlusive earphones but did not listen to music
    Intervention: Device: Sennheiser non-occlusive headphones without music
  • Control 2 with no music
    The control 2 patients did not listen to music nor wore earphones.
    Intervention: Other: No Sennheiser non-occlusive headphones
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2019)
139
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03873454
Other Study ID Numbers  ICMJE CIRB 2014/378/D
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anaesthesia, National University Hospital, Singapore
Study Sponsor  ICMJE National University Hospital, Singapore
Collaborators  ICMJE Singapore General Hospital
Investigators  ICMJE
Principal Investigator: A/Prof Lian Kah Ti, MBBS, MMED National University Hospital, Singapore
PRS Account National University Hospital, Singapore
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP