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.: PACTR202001512959209 Date of Approval: 21/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Development of Smart Phone Application for Preventing Musculoskeletal Conditions among Undergraduates with Smart Phone Addiction
Official scientific title Development of Smart Phone Application: Effects on Pain, Disability and Craniovertebral Angle of Undergraduates with Smart Phone Addiction
Brief summary describing the background and objectives of the trial Smartphone addiction is said to be on the rise amongst young adult. Smart phone was introduced and embraced in Nigeria, because of the vital role it plays in communication but not with its detrimental effect on the individuals in return. Smartphone addiction has been reported to cause forward head posture (FHP) which increases musculoskeletal disorders of the spine resulting into many physiological problems including depression, cervicogenic headache, respiratory insufficiency and neck pain.This study is aimed at developing a smart phone application for the prevention of musculoskeletal pain and disability of neck, shoulder, low back and its impact on craniovertebral angle of undergraduates addicted to smart phone.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 31/12/2019
Actual trial start date 15/01/2020
Anticipated date of last follow up 15/03/2020
Actual Last follow-up date 31/03/2020
Anticipated target sample size (number of participants) 210
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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 Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group subjects with smart phone addiction that have the smart phone application installed on their phones. Subjects in this group will have the newly developed smart phone application downloaded and installed on their android phones. They will be instructed to use the smart phone application for a period of 12 weeks. This will be monitored by a web portal through a profile that will be created for the users. 12 weeks A system to monitor the smart phone users’ neck angles in real time. An application utilizing the embedded sensors and functions in the smart phone is proposed. These sensors are the 3 axis accelerometer. The system calculates the neck angle based on the relative position of the face and the phone using the accelerometer (roll, pitch and yaw angles). Custom calibration of the accelerometer output values are used to calculate the neck angle as explained by Junhyuk et al (2015). The system monitors this neck angle average over time and sends response in form of push notifications to the user. The system provides exercises for registered users. The users can set daily/weekly goals to monitor their progress. 70
Experimental Group Smartphone application combined with educational leaflet Subjects in this group will have the newly developed smart phone application downloaded and installed on their android phones in addition to advice on proper posture while using their smart phones with the aid of an ergonomic educational leaflet. 12 weeks Subjects in this group will have the newly developed smart phone application downloaded and installed on their android phones in addition to advice on proper posture while using their smart phones with the aid of an ergonomic educational leaflet. They will be instructed to use it for a period of 12 weeks. The usage and activity of the subjects on the smart phone will be monitored by a web portal through a profile that will be created for the users. 70
Control Group ergonomic educational leaflet. Subjects in this group will be advised on proper posture while using their smart phones with the aid of an ergonomic educational leaflet. They will be instructed to use it for a period of 12 weeks. The usage of the ergonomic educational leaflet and activities of the subjects on the smart phone will be monitored with the aid of phone calls and short messaging services every week to ensure adherence and retention. 12 weeks Content of the educational leaflet a. Hold or position the device at eye level. b. Adjust the device settings. c. Use the devices’ digital assistants. e. Remove the Distractions from your Phone f. Voice to text. g. Sit on a chair with arm rest and back support. h. Use a headset microphone to avoid awkward postures i. To prevent muscle strain – avoid holding the phone with your head. j. When you do hold the phone raise it to your chest to minimize extreme neck bending – avoid holding the phone between your face and shoulders. k. Alternate between finger and thumb use – don’t always use your thumbs. l. Keep your wrists straight while holding and looking at the screen. m. Take breaks – every 15 minutes for 2-3 minutes 70 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Sex matched undergraduates that have been using smart phone for a period of 1 year. Sex matched undergraduates that score above 30 on smart phone addiction questionnaire. Sex matched undergraduates using smart phones with android operating system. Undergraduates that do not use smart phone. Undergraduates using smart phones with iOS operating system. Undergraduates with history of specific spinal pathology such as neck, shoulder and low back pain as a result of cancer, tuberculosis and trauma of the spine. Undergraduates with previous back surgeries, confirmed through their past medical history. Undergraduates with history of depression. Undergraduates with history of cervicogenic headache. Undergraduates with history of respiratory distress. Adult: 19 Year-44 Year 18 Year(s) 30 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 17/06/2019 College of Medicine University of Lagos Health research and ethics committee
Ethics Committee Address
Street address City Postal code Country
Idi-araba, Lagos Lagos 2341 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Smart phone addiction, Pain, shoulder pain related diasbiity, functional disability of the low back, neck disability, depression using Short Version Smartphone addiction scale, Numerical pain rating scale, The Shoulder Pain and Disability Index (SPADI), Oswestry Disability Questionnaire (ODQ), Neck disability index, Beck Depression Inventory Baseline
Secondary Outcome Craniovertebral angle , Mobile App rating scale Baseline, 6 weeks and 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
College of Medicine University of Lagos Idi-araba Lagos 2341 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
BRAINS LAGOS LAGOS Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor BUILDING RESEARCH AND INNOVATION IN NIGERIANS SCIENCE LAGOS Lagos Nigeria Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Akodu Ashiyat Kehinde Idi-araba Lagos 2341 Nigeria
IPINNIMO OLUFEMI Akoka Lagos 2341 Nigeria
OSUNTOKI Akinniyi Adediran Idi-araba Lagos 2341 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ashiyat Akodu akoduashiyat@gmail.com 08034269053 Department of Physiotherapy, College of Medicine, University of Lagos
City Postal code Country Position/Affiliation
Lagos 2341 Nigeria Senior lecturer
Role Name Email Phone Street address
Public Enquiries Ashiyat Akodu akoduashiyat@gmail.com +2348034269053 Idi-araba
City Postal code Country Position/Affiliation
Lagos Nigeria Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Ashiyat Akodu akoduashiyat@gmail.com +2348034269053 Idi-araba
City Postal code Country Position/Affiliation
Lagos 2341 Nigeria Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I will share if there is a request Informed Consent Form,Statistical Analysis Plan Within a year of completion Smart phone application, Musculoskeletal, Smart phone addiction, Undergraduates, Smartphone addiction
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