The Effects of Music on Perioperative Outcomes in Cataract Surgery
1 other identifier
interventional
139
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2014
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 12, 2014
CompletedFirst Posted
Study publicly available on registry
March 13, 2019
CompletedMarch 13, 2019
March 1, 2019
2 months
August 12, 2014
March 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (3)
Experimental Group
ACTIVE COMPARATORThe experimental group listened to music and wore Sennheiser non-occlusive headphones
Control 1 with no music
OTHERThis cohort wore non-occlusive earphones but did not listen to music
Control 2 with no music
OTHERThe control 2 patients did not listen to music nor wore earphones.
Interventions
Patients listened to music of their choice using non-occlusive headphones
Patients wore non-occlusive headphones but had no music playing
Patients did not wear non-occlusive headphones and did not listen to music
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Severe/profound hearing impairments, patients with intellectual disabilities, patients on psychotropic medications or drugs affecting mood or hemodynamic status, ASA grade 4 and parturients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National University Hospital
Singapore, 119074, Singapore
Singapore National Eye Centre
Singapore, 168751, Singapore
Study Officials
- PRINCIPAL INVESTIGATOR
A/Prof Lian Kah Ti, MBBS, MMED
National University Hospital, Singapore
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 12, 2014
First Posted
March 13, 2019
Study Start
May 1, 2014
Primary Completion
July 1, 2014
Study Completion
August 1, 2014
Last Updated
March 13, 2019
Record last verified: 2019-03