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The Effects of Music on Perioperative Outcomes in Cataract Surgery

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Sennheiser non-occlusive headphones
Sennheiser non-occlusive headphones without music
No Sennheiser non-occlusive headphones
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cataract Surgery focused on measuring cataract surgery, music, salivary cortisol

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National University Hospital
  • Singapore National Eye Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

Other

Arm Label

Experimental Group

Control 1 with no music

Control 2 with no music

Arm Description

The experimental group listened to music and wore Sennheiser non-occlusive headphones

This cohort wore non-occlusive earphones but did not listen to music

The control 2 patients did not listen to music nor wore earphones.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 12, 2014
Last Updated
March 11, 2019
Sponsor
National University Hospital, Singapore
Collaborators
Singapore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03873454
Brief Title
The Effects of Music on Perioperative Outcomes in Cataract Surgery
Official Title
The Effects of Music on Perioperative Outcomes in Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Hospital, Singapore
Collaborators
Singapore General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery, Stress Levels, Music Improving Outcomes in Cataract Surgery
Keywords
cataract surgery, music, salivary cortisol

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Active Comparator
Arm Description
The experimental group listened to music and wore Sennheiser non-occlusive headphones
Arm Title
Control 1 with no music
Arm Type
Other
Arm Description
This cohort wore non-occlusive earphones but did not listen to music
Arm Title
Control 2 with no music
Arm Type
Other
Arm Description
The control 2 patients did not listen to music nor wore earphones.
Intervention Type
Device
Intervention Name(s)
Sennheiser non-occlusive headphones
Intervention Description
Patients listened to music of their choice using non-occlusive headphones
Intervention Type
Device
Intervention Name(s)
Sennheiser non-occlusive headphones without music
Intervention Description
Patients wore non-occlusive headphones but had no music playing
Intervention Type
Other
Intervention Name(s)
No Sennheiser non-occlusive headphones
Intervention Description
Patients did not wear non-occlusive headphones and did not listen to music
Primary Outcome Measure Information:
Title
Salivary Cortisol
Description
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.
Time Frame
Pre-operatively
Title
Salivary Cortisol
Description
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.
Time Frame
10 minutes post-operatively

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A/Prof Lian Kah Ti, MBBS, MMED
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore National Eye Centre
City
Singapore
ZIP/Postal Code
168751
Country
Singapore

12. IPD Sharing Statement

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The Effects of Music on Perioperative Outcomes in Cataract Surgery

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