Neuromuscular DiseasesNCT05771727
Impact of Covid-19 Pandemic on Children With Neuromuscular Disease and Their Parents in Turkey: Parent Perspective
An observational study of Neuromuscular Diseases, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Parents of children with neuromuscular disease have been already at risk of depression, anxiety and burden. Additionally, the daily lives of children with neuromuscular disease and their parents have been significantly affected by the COVID-19 pandemic. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- survey
- How many people
- 134 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Parents of children with pediatric neuromuscular diseases
Who may be able to join
- taking care for a child with NMD whose age was between 0-18 years,
- having the ability to read and write Turkish language,
- having access to phone or e-mail,
- being volunteer.
Who cannot join
- having a child who have an additional diagnosis besides NMD and taking care of any other person in the family.
Trial locations and contacts
1 site in 1 country.
About this study
Parents of children with neuromuscular disease have been already at risk of depression, anxiety and burden. Additionally, the daily lives of children with neuromuscular disease and their parents have been significantly affected by the COVID-19 pandemic. Therefore, this study investigated parents' perspective on the effect of the COVID-19 pandemic on children with neuromuscular diseases and themselves.
Read the detailed description
The 55-item survey created by the researchers was applied online to determine the psychological and physical effects of COVID-19 on neuromuscular patients and their families. This survey also included the Content of the 9-Item Caregiver COVID-19 Limitations Scale (CCLS-9).
- Conditions
- Neuromuscular Diseases
- Being tested
- survey
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
The 55-item survey created by the researchers was applied online to determine the psychological and physical effects of COVID-19 on neuromuscular patients and their families. This survey also included the Content of the 9-Item Caregiver COVID-19 Limitations Scale (CCLS-9).
| Study group | Role | What they receive |
|---|---|---|
| Parents of children with pediatric neuromuscular diseases | Parents of a total of 169 children with pediatric neuromuscular diseases, including 63 Duchnenne Muscular Dystrophy, 53 Spinal Muscular Atrophy and 18 other pediatric neuromuscular diseases (Congenital Muscular Dystrophy, Hereditary Motor and Sensory Neuropathy, Becker Muscular Dystrophy, Limb-Girdle Muscular Dystrophy, etc.) were included in the study Receives: Other: survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
The questionnaire which created by the researchers
The 55-item survey created by the researchers was applied online to determine the psychological and physical effects of COVID-19 on neuromuscular patients and their families.
Measured: 30 minutes
Secondary outcomes (1)
Content of the 9-Item Caregiver COVID-19 Limitations Scale (CCLS-9)
This scale consists of 9 items and has a scoring system between 1-10 for each item which is chosen by the caregiver. According to the CCLS-9 scale, the lowest anxiety, stress or burden of the caregiver scored as 1 while the highest level was 10.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Jul 2021
- Primary completion1 Aug 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Bora, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771727
- Sponsor's protocol ID
- GO 21/722
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Covid-19 Pandemic on Children With Neuromuscular Disease and Their Parents in Turkey: Parent Perspective
- ClinicalTrials.gov ID
- NCT05771727
- Acronym / sponsor ID
- GO 21/722
- Conditions
- Neuromuscular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parents of children with neuromuscular disease have been already at risk of depression, anxiety and burden. Additionally, the daily lives of children with neuromuscular disease and their parents have been significantly affected by the COVID-19 pandemic. Therefore, this study investigated parents' perspective on the effect of the COVID-19 pandemic on children with neuromuscular diseases and themselves.
Detailed description
The 55-item survey created by the researchers was applied online to determine the psychological and physical effects of COVID-19 on neuromuscular patients and their families. This survey also included the Content of the 9-Item Caregiver COVID-19 Limitations Scale (CCLS-9).
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents of children with pediatric neuromuscular diseases | – | Other: surveyParents of a total of 169 children with pediatric neuromuscular diseases, including 63 Duchnenne Muscular Dystrophy, 53 Spinal Muscular Atrophy and 18 other pediatric neuromuscular diseases (Congenital Muscular Dystrophy, Hereditary Motor and Sensory Neuropathy, Becker Muscular Dystrophy, Limb-Girdle Muscular Dystrophy, etc.) were included in the study |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Parents of children with pediatric neuromuscular diseases
Key inclusion criteria (4 listed)
- taking care for a child with NMD whose age was between 0-18 years,
- having the ability to read and write Turkish language,
- having access to phone or e-mail,
- being volunteer.
Key exclusion criteria (1 listed)
- having a child who have an additional diagnosis besides NMD and taking care of any other person in the family.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surveyThe 55-item survey created by the researchers was applied online to determine the psychological and physical effects of COVID-19 on neuromuscular patients and their families. This survey also included the Content of the 9-Item Caregiver COVID-19 Limitations Scale (CCLS-9). | Other | Parents of children with pediatric neuromuscular diseases |
Primary outcome
The questionnaire which created by the researchers
Time frame: 30 minutes
The 55-item survey created by the researchers was applied online to determine the psychological and physical effects of COVID-19 on neuromuscular patients and their families.
1 secondary outcome
Content of the 9-Item Caregiver COVID-19 Limitations Scale (CCLS-9)
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The questionnaire which created by the researchers (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.