NCT07106905

Brief Summary

This is a cross-sectional study that aims to determine the prevalence of low back pain in mothers of children with disabilities following the COVID-19 pandemic and to describe its relationship with exposure to the virus, handgrip strength, physical workload, and depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
179

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2022

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

July 30, 2025

Last Update Submit

July 30, 2025

Conditions

Keywords

Low back painMothers of children with disabilities.Handgrip strengthPhysical workloadDepression

Outcome Measures

Primary Outcomes (3)

  • . Beck Depression Inventory

    It is a scale consisting of 21 items that measures depressive symptoms. A maximum of 63 points can be obtained, with higher scores indicating an increase in depression.

    Baseline

  • Physical Workload Questionnaire

    A 19-item Likert scale with scores ranging from 0 to 4, developed to identify the load on the lumbar region during work activities. Higher scores indicate increased work load.

    Baseline

  • Handgrip strength measurement

    This measurement was performed on the dominant hand while the participant was seated in a chair in the standard position defined by the American Hand Therapy Association. They were asked to squeeze the dynamometer as hard as possible. The average of three measurements taken at 30-second intervals was recorded in pounds.

    Baseline

Secondary Outcomes (1)

  • 1-10 Numerical Pain Rating Scale (NPRS)

    Baseline

Study Arms (1)

Mothers of children with disabilities

Other: Measurements

Interventions

These measurements are used in other clinical applications. However, the effectiveness of these measurements in discriminating the presence of low back pain in mothers of children with disabilities over the past year has been identified.

Mothers of children with disabilities

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMothers of Children with Disabilities
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Mothers of Children with Disabilities

You may qualify if:

  • Volunteering to participate in the study
  • Having a disabled child
  • Being responsible for the care of a disabled child
  • Having provided care for a disabled child for at least one year

You may not qualify if:

  • Having more than one disabled child and being responsible for their care
  • Having previously undergone surgery on the lower back
  • Having a previous upper extremity disorder
  • Receiving psychological treatment or medication
  • Being pregnant or having recently given birth
  • Having a recent history of trauma to the musculoskeletal system
  • Having a defined chronic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Sivas Cumhuriyet University

Sivas, 58140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back PainDepression

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Ph.D.

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 6, 2025

Study Start

November 10, 2021

Primary Completion

September 1, 2022

Study Completion

September 8, 2022

Last Updated

August 6, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations