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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202506832481901 Date of Registration: 27/06/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of a single music listening session on physical and cognitive performance in adolescents with visual impairment
Official scientific title The effect of a single music listening session on physical and cognitive performance in adolescents with visual impairment
Brief summary describing the background and objectives of the trial Adolescents with visual impairment often experience challenges in physical and cognitive functioning due to reduced sensory input and limited access to stimulating environments. Both acute and chronic music-based interventions have shown promise in enhancing both physical and cognitive performance across various populations, including those with visual impairment. However, the effect of a music listening session on adolescents with visual impairment remains understudied. This study aims to investigate the acute effects of a single music listening session on physical and cognitive performance in adolescents with visual impairment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied visual impairment
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/01/2024
Actual trial start date 01/01/2024
Anticipated date of last follow up 01/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 29
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group music listening session 30 minutes During the music listening session, each participant sat on a comfortable chair wearing a standardized headphone in front of a white wall to eliminate attention distraction. Each participant listened during 30 minutes to his playlist containing a guided preferred music; the music selection was based on the study’s purpose; a stimulating music with a fast tempo (> 120-140 beat per minute) to enhance energy and motivation. 15
Control Group control group 30 minutes During the control session, participants were invited to spend the 30-minute session without listening to any music, following the same procedures as the music listening session 14 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Adolescents: age between12-19years old -Severe visual impairment (Visual acuity between 6/60 and 3/60 in the better eye -Participants with neurological, vestibular, orthopedic or musculoskeletal problems, hearing impairment and those who have undergone orthopedic surgery within the past 12 months. Adolescent: 13 Year(s)-17 Year(s),Child: 6 Year-12 Year 12 Year(s) 19 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 25/01/2022 the Southern Committee Protection of Persons
Ethics Committee Address
Street address City Postal code Country
Road Manzel Cheker Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome consisted on the evaluation of the physical and the cognitive performance. According to the physical performance evaluation - The static postural balance was evaluated using the stabilometric platform (postureWin©, Techno Concept ®,Cereste, France; 40 Hz frequency,12-bits A/D conversion) and the single leg stance clinical test and the mobility performance using the Timed Up and Go Test TUGT. - The lower limb muscle strength was evaluated using the Sit to Stand clinical test. - Indeed, the lower limb endurance was evaluated by the killy test and the risk of falls by the functional reach test. The cognitive performance was evaluated by the auditory reaction time using the Inquisit 6 Millisecond Software (version 6.6.1) and by the letter fluency test and the Serial subtraction test. All measurements for both the experimental group and the control group were taken before and immediately after the control session and the music listening session
Secondary Outcome Anthropometric data, including age, sex, weight, and height, and participants preferred music were collected in the familiarization session 48 hours before the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The high school of students with visual impairment Bir Chebbak 4000 Sousse, Sousse sousse Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Hana maatoug Avenue de l environnement, Sousse Sousse Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Laboratory EM2S road el Matar Sfax Tunisia laboratory
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hana maatoug hana06@yahoo.com 26282023 Avenue de lenvironnement, Sousse
City Postal code Country Position/Affiliation
Sousse Tunisia LR19JS01
Role Name Email Phone Street address
Public Enquiries Hana maatoug hana06@yahoo.com 26282023 Avenue de l environnement, Sousse
City Postal code Country Position/Affiliation
Sousse Tunisia LR19JS01
Role Name Email Phone Street address
Scientific Enquiries Hana maatoug hana06@yahoo.com 26282023 Avenue de l environnement, Sousse
City Postal code Country Position/Affiliation
Sousse Tunisia LR19JS01
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 identification (text, tables, figures, and appendices) Informed Consent Form 12 months following article's publication Researchers who provide a methodologically sound proposal
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 27/06/2025 PACTR Admin 01 Jan 2024
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 27/06/2025 PACTR Admin Adolescent: 13 Year-18 Year Child: 6 Year-12 Year, Adolescent: 13 Year-18 Year