Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06221085 |
| Other study ID # |
HAPO-10-Z-003 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 18, 2024 |
| Est. completion date |
April 29, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
University of Jazan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
An observational cross-sectional study will be conducted on 90 female students (right
dominant) aged 19-26 years at Jazan University, they will have 40 points or more on
Smartphone Addiction Proneness Scale (SAPS) and will be divided into three groups (30
students for each): Group I (BMI<25kg/m2), Group II (BMI 25-30kg/m2), and Group III (BMI >30
kg/m2). Pain pressure thresholds were measured using a pressure gauge algometer (PGA) over
trigger points in the neck muscles.
Description:
Materials and Methods
Study design:
This is an observational cross-sectional design will be conducted on female subjects from
Applied Medical College, Jazan University, Kingdome of Saudi Arabia.
Participants:
A study will be conducted on 90 female students from Jazan University based on the following:
The study will be conducted according to the tenets of the Declaration of Helsinki, and
registered in the clinical registry after getting the ethical approval from the Standing
Committee for Scientific Research at Jazan University. The sample size is determined using
G-Power software (Universities, Düsseldorf, Germany) with a power of 80%, a p-value of 0.05,
and an effect size of 0.5. A sample size of 75 (25 individuals in each group) individuals
will be included in the study, and to compensate for the dropout rate, the sample size will
be increased by 20% in each group to be 30 individuals in each group. The Participants will
be divided according to the BMI into three groups: Group I: 30 female students who have
normal BMI <25kg/m2. Group II: 30 female students who are overweight and their BMI 25 - 30
kg/m2. Group III: 30 female students who are obese and their BMI > 30 kg/m2.
Measurements:
Body mass index assessment and calculation:
Investigators will measure the height of the participants using a stadiometer with a
calibrated analog scale and the weight using a Breuer electronic scale with an accuracy of
0.01 kg.
Pain Pressure Threshold (PPT):
The examiner identifies a trigger point by palpating and applying vertical pressure to the
skin. Once identified, the clinician guides the tip of Pressure gauge algometer (PGA) between
the finger and thumb to avoid slipping along rounded contours. The clinician applies it
perpendicular to the long axis of the structure on which it is placed. The examiner increases
the pressure at a rate of 1 kg/s until the subject feels pain or discomfort, and then the PPT
values are measured three times for each muscle. Participants verbally report the first
sensation of pain or discomfort, at which point the examiner stops the pressure.
PPT of upper fiber of trapezius muscle: The upper trapezius trigger point is located in the
more horizontal fibers of the upper trapezius at the back of the shoulder, about halfway
between the spine and the acromion.
Sternocleidomastoid (SCM) PPT:
TrPs are in the upper part of the sternal division of the muscle, near its insertion into the
mastoid process. TrPs are in the middle part of this division. TrPs are at the lower end of
this division, near its attachment to the sternum.
