| CTRI Number |
CTRI/2024/02/063191 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of smartphone users forward head position in related to the quality of their sleep |
|
Scientific Title of Study
|
assessment of forward head posture among smartphone users in relation to their sleep quality |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kartik shirasangi |
| Designation |
post graduate student |
| Affiliation |
SDM PHYSIOTHERAPY |
| Address |
OPD no 5
SDM college of physiotherapy sattur Dharwad
OPD no 5
SDM college of physiotherapy sattur Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9148173035 |
| Fax |
|
| Email |
kartikshirasangi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Kulkarni |
| Designation |
Professor & PG Guide |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Physiotherapy |
| Address |
OPD no.5
SDM college of physiotherapy sattur Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9886276543 |
| Fax |
|
| Email |
dr.shweta07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kartik shirasangi |
| Designation |
post graduate student |
| Affiliation |
SDM PHYSIOTHERAPY |
| Address |
OPD no 5
SDM college of physiotherapy sattur Dharwad
OPD no 5
SDM college of physiotherapy sattur Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9148173035 |
| Fax |
|
| Email |
kartikshirasangi@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM UNIVERSITY
Sattur Dharwad |
|
|
Primary Sponsor
|
| Name |
kartik shirasangi |
| Address |
OPD NO:5
SDM college of physiotherapy |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kartik Shirasangi |
SDM UNIVERSITY |
OPD NO 5
SDM college of physiotherapy
sattur dharwad
Dharwad
KARNATAKA |
9148173035
kartikshirasangi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
forward neck posture |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals.
Individuals who have been using smartphones for more than a year.
Subjects of either gender
|
|
| ExclusionCriteria |
| Details |
Individuals diagnosed with neck pain and known causes of radicular pain
Serious and progressive neurological deficits.
structural deformities of the spine, ankylosing spondylosis. Subjects already diagnosed with psychosomatic disorders
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) smartphone addiction scale short version
2) Pittsburgh sleep quality index
|
1)To assess the smartphone addiction smartphone addiction scale short version (SAS-SV) is used.
2)Measurement of Craniovertebral angle.
3)To assess the sleep quality Pittsburgh sleep quality index is used. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="450"
Sample Size from India="450"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The twenty-first century is referred to as the
era of information technology. Internet connectivity and wireless communication
are amazing innovations that have transformed the communication industry. For instance, there were around 2.1 billion
smartphone users globally in 2017 and it was anticipated that number will
approach 2.8 billion by 2020. India is the second-largest Internet
market after China, with more than 460 million users. India Had roughly 635.8
million internet users by 2021. The Internet serves as the foundation for
smartphones, which offer many features such as social networking, gaming,
surfing, blogs etc. Smartphone usage is growing due to their ease and vast
range of features. Text neck, scholar’s neck, reading neck, and
wearies neck are other names for Forward Head Posture (FHP). FHP is characterized
by Increased extension of the upper cervical spine and decreased flexion of the
lower cervical spine and upper thoracic area. Standing or sitting while using a phone in one hand and
touching the screen with the other are the two most popular smartphone user
positions. Standing or sitting while using a phone in one
hand and touching the screen with the other are the two most popular smartphone
user positions. When using
a smartphone, people usually flex their neck downwards to stare at the lowered
object and maintain the head in a forward position for long periods of time, which may cause
musculoskeletal disorders, such as “upper crossed syndrome. Sleep is a mechanism
for restoring the body and its functions and maintaining energy and health, and
has renewing and replenishing effects both physically and emotionally. The
night time sleeping posture is strongly related to the quality of sleep. The
sleeping posture is related to musculoskeletal disorders of the shoulder or
neck, as well as to headaches. Specifically, poor cervical posture during
sleep, which is believed to increase biomechanical stresses on the structure of
the cervical spine, can produce cervical pain and stiffness, headache, and
scapular or arm pain, resulting in low-quality sleep. In the present Era, addiction towards gadget has
been growing enormously and it has become field of concern specially in the
younger population, the tendency to use various gadgets has become a craze, The
addiction towards these gadgets has led to various behavioral issues, decreased
interpersonal communication. When a person adapts Forward head posture, upper
trapezius, sternocleidomastoid, and cervical
extensor muscles goes for shortening. A study states that 4.5kgs extra load is
taken by cervical spine even with a 1inch anterior positioning of head. Studies
done on student population reveals that the Prevalence of Forward head posture
in students who use smartphone is more (73%) and they further experience neck
pain. Smartphone Addiction Scale short version
(SAS-SV) is well validated questionnaire consisting of 10 questions. The SAS-SV
validity was confirmed using SAS, SAPS & KS- Scale. PITTSBURGH SLEEP
QUALITY INDEX PSQI had internal consistency, internal homogeneity, and diagnostic
characteristics that compared well with PSG among a sample of young adult male
students in India. This supports the applicability and certain aspects of the
validity of the PSQI in the population. The craniovertebral angle will be measured by
instructing the participants to stand in an anatomical position with the head
erect. The tripod and smartphone camera will be set 1m away from the
participants. The landmarks (the tragus of the participants’ ear and the 7th
cervical vertebrae) will marked clearly with adhesive markers; this will be
done by instructing the participants to flex and extend their neck. The
participants’ photographs will be taken laterally with a smartphone camera. (Sony IMX 766 sensor). The photographs will import into
KINOVEA software by using a laptop. To measure the cranio-vertebral angle, then
a diagonal line will draw through the tragus of the ear to the spinous process
of the 7th cervical vertebrae. |