NCT06221085

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

January 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2024

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

January 13, 2024

Last Update Submit

June 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    two minutes

Secondary Outcomes (3)

  • PPT of Upper Part of Sternocleidomastoid (SCM)

    two minutes

  • PPT of middle Part of Sternocleidomastoid (SCM)

    two minutes

  • PPT of lower Part of Sternocleidomastoid (SCM)

    two minutes

Study Arms (3)

normal BMI

30 female students who have normal BMI \<25kg/m2.

Diagnostic Test: Pain Pressure Threshold (PPT)

overweight

30 female students who are overweight and their BMI 25 - 30 kg/m2

Diagnostic Test: Pain Pressure Threshold (PPT)

obese

30 female students who are obese and their BMI \> 30 kg/m2.

Diagnostic Test: Pain Pressure Threshold (PPT)

Interventions

Researchers measure pain pressure thresholds (PPTs) by applying a Pressure gauge algometer (PGA) over the myofascial trigger points (TrPs) on the body. PPT is defined as the lowest stimulus intensity at which a subject perceives pain. 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.

Also known as: PPTs
normal BMIobeseoverweight

Eligibility Criteria

Age19 Years - 26 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

A study will be conducted on 90 female students from Jazan University

You may qualify if:

  • Age between 19 and 26 years.
  • Participants who send at least 25 text messages or emails per day.
  • Use their smartphone to browse the Internet, and/or play games for more than one hour per day.
  • If participants score on the Smartphone Addiction Scale (SAPS) \> 40 points.
  • Right dominant hand.

You may not qualify if:

  • Any subject will be excluded from the study if they meet one or more of the following criteria:
  • Neck musculoskeletal trauma.
  • Congenital deformities.
  • Surgical or neurological disease.
  • History of neck injury, and pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jazan University

Riyadh, Jazan Region, 45142, Saudi Arabia

Location

MeSH Terms

Conditions

Internet Addiction DisorderBody WeightObesity

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Mohamed M. Ahmed, PHD

    University of Jazan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 13, 2024

First Posted

January 24, 2024

Study Start

January 18, 2024

Primary Completion

April 15, 2024

Study Completion

April 29, 2024

Last Updated

June 21, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Data is available upon official request.

Locations