NCT06287359

Brief Summary

Parents of disabled children suffer from back pain more frequently than the general population. At present, the literature does not identify any specific factors responsible for this suffering. For patients suffering from chronic back pain, there are specific treatment programmes in the Physical Medicine and Rehabilitation Department, with a focus on pain management. The investigators would like to develop specific programmes for parents/carers of children/adolescents with severe motor disabilities. To achieve this, it is important to gain a better understanding of the factors that contribute to the onset of pain. With this in mind, the investigators are conducting a qualitative study to gain a better understanding of the day-to-day lives of these parents.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

February 23, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 1, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

February 23, 2024

Last Update Submit

October 31, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Individual interviews

    To understand the lived experience of parents/carers during the daily care of their child by means of a phenomenological analysis of the interviews

    baseline

Study Arms (1)

Parents/carers

Parents or carers of children with severe motor disabilities complaining of spinal pain

Other: individual interviews

Interventions

Qualitative research with individual interviews

Parents/carers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Parents or carers of children with severe motor disabilities complaining of spinal pain

You may qualify if:

  • Parents or carers of children with severe motor disabilities complaining of spinal pain

You may not qualify if:

  • Parent/carer refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anissa MEGZARI

    Centre Hospitalier Universitaire de Nīmes

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2024

First Posted

March 1, 2024

Study Start

December 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 1, 2024

Record last verified: 2024-04