Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202110788409818 Date of Approval: 20/10/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Listening to Patient Preferred Music for Perioperative Anxiolysis During Cataract Surgery in Ibadan, Nigeria. A Randomized Controlled Trial
Official scientific title Listening to Patient Preferred Music for Perioperative Anxiolysis During Cataract Surgery in Ibadan, Nigeria. A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Background: Cataract surgery is the most common surgical procedure performed by Ophthalmologists and it is mostly performed under local anaesthesia. Anecdotally there seems to be high surgical anxiety in patients scheduled for routine cataract surgery despite the short duration of the procedure and good visual prognosis of uncomplicated cases. Drugs, patient education and preoperative counselling are some measures employed to mitigate excessive perioperative anxiety. Music has been proposed as adjunctive means of reducing surgical anxiety, especially where local anaesthesia is employed thereby providing another non-pharmacologic option for perioperative anxiolysis. Aim: To investigate the effect of listening to patient’s preferred music on perioperative anxiety among patients scheduled for elective cataract surgery. Methodology: This was a hospital-based randomised controlled trial where the effect of patient’s choice of music on anxiety levels of patients for elective cataract surgery was investigated. Eligible participants were randomised into 2 groups. The test group received music intervention in addition to routine preoperative counselling while the control group only received standard preoperative counselling with no music intervention. Perioperative anxiety was assessed using the Spielberger State-Trait Anxiety questionnaire (STAI-S) pre and postoperatively. Anxiety influenced physiological parameters such as heart rate, respiratory rate, systolic and diastolic blood pressures were compared between the two groups for a mean change pre and postoperatively.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 20/12/2020
Actual trial start date 19/03/2021
Anticipated date of last follow up 19/03/2021
Actual Last follow-up date 09/04/2021
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 101
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Music intervention patients randomized into the intervention group listened to music of their choice as long as they were in the operating room. As long as the cataract surgery lasted. Music intervention involved playing the patient’s selected music/playlist via the fitted wireless earbuds throughout the period of surgery. 50
Control Group No music intervention not applicable not applicable The control group, though also fitted with similar earbuds as those in the intervention group, they did not have any music played through them. 51 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients aged 18 years and above, scheduled for routine cataract surgery. • Patients scheduled to have manual small incision cataract surgery with posterior capsular intraocular lens implantation (SICS + PC-IOL) to be done by the principal investigator and the unit supervising consultants under local anaesthesia (peribulbar block + facial block). • Patients having cataracts with poor visual prognosis e.g., traumatic cataract, cataract complicated with uveitis or retinal detachment, ectopia lentis, zonular dialysis. • Patients undergoing multiple procedures at the same time such as cataract surgery with pterygium excision, trabeculectomy, etc. • Patients with hearing impairment, tinnitus, internal or external ear infections. • patients with co-morbidities like uncontrolled hypertension, heart disease, renal failure, patients on β-blockers, inotropic agents like adrenaline, digoxin, dopamine. • Patients who had previously been diagnosed and had been on treatment for anxiety or depressive disorders in the last 6 months. • Patients routinely on sedatives and hypnotics, narcotics or patients who for any reason had to be given sedatives on the morning of surgery. • Patients who neither can read nor understand English language or Yoruba language. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/08/2020 University of Ibadan Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Institute for Advanced Medical Research and Training, College of Medicine, University of Ibadan. Ibadan 200284 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean change in STAI-S scores between intervention and control group pre and post surgery before surgery and after surgery
Secondary Outcome mean change in anxiety influenced physiologic parameters such as pulse rate, systolic blood pressure, diastolic blood pressure and respiratory rate between the two groups pre and post-surgery. before surgery and after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Eye Clinic of the University College Hospital Ibadan Nigeria. Queen Elizabeth II Road, Agodi Ibadan 200285 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof Charles Bekibele Head, Department of Ophthalmology, University of Ibadan College of Medicine Ibadan 200284 Nigeria Hospital
Primary Sponsor Dr Bibilola Oladeji Department of Psychiatry, University College Hospital Ibadan 200284 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator OKOLI EMMANUEL e.chineduokoli@gmail.com +2348039472032 Department of Ophthalmology, University College Hospital
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Okoli Chinedu e.chineduokoli@gmail.com +2348039472032 Department of Ophthalmology, University College Hospital
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries OKOLI CHINEDU e.chineduokoli@gmail.com +2348039472032 Department of Ophthalmology, University College Hospital
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification, will be available. Informed Consent Form 1 year of posting results summaries open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information