Rehabilitation Status of Children With Cerebral Palsy and Anxiety of Their Caregivers During the Covid19 Pandemic

Anxiety Clinical Trial

— CP  

Official title:

Rehabilitation Status of Children With Cerebral Palsy and Anxiety of Their Caregivers During the Covid19 Pandemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04916873
• Other study ID #: FSMEAH-KAEK 2020/56
• Status: Completed
• Start date: May 28, 2020
• Est. completion date: July 30, 2020

Study information

• Verified date: June 2021
• Source: Fatih Sultan Mehmet Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Rehabilitation status of children with cerebral palsy (CP) and anxiety of their caregivers during the covid19 pandemic were explored. 206 caregivers who voluntarily accepted to participate were administered the State-Trait Anxiety Inventory and evaluated about the rehabilitation status of their children.The anxiety levels of all caregivers were found high and the rehabilitation programmes of the children were interrupted.

Description:

Investigators aimed to explore the rehabilitation status of children with CP and anxiety of their caregivers during the covid19 pandemic. Caregivers of children with CP who were under follow up in the outpatient CP clinic were called up during pandemic period. 206 caregivers who voluntarily accepted to participate were administered the State-Trait Anxiety Inventory and evaluated about the rehabilitation status of their children. Demographic data, associated problems of children, Gross Motor Function Classification System (GMFCS) and Manual Ability Classification System (MACS) levels were recorded from their files. For the statistical analysis, IBM SPSS Statistics 22 (SPSS IBM, Turkey) programs were used. While evaluating the study data, the suitability of the parameters to the normal distribution was evaluated with the Shapiro Wilks test. Significance was evaluated at the p <0.05 level.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: July 30, 2020
• Est. primary completion date: June 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• Caregivers of children with CP who were under follow up in the outpatient CP clinic who voluntarily accepted to participate

Exclusion Criteria:

• Caregivers of children with CP who were under follow up in the outpatient CP clinic who didn't accept to participate

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cerebral Palsy
• Covid19
• Paralysis

Locations

Country	Name	City	State
Turkey	Pinar Akpinar	Istanbul	Atasehir

Sponsors (1)

Lead Sponsor	Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Cacioppo M, Bouvier S, Bailly R, Houx L, Lempereur M, Mensah-Gourmel J, Kandalaft C, Varengue R, Chatelin A, Vagnoni J, Vuillerot C, Gautheron V, Dinomais M, Dheilly E, Brochard S, Pons C; ECHO Group. Emerging health challenges for children with physical — View Citation

Dhiman S, Sahu PK, Reed WR, Ganesh GS, Goyal RK, Jain S. Impact of COVID-19 outbreak on mental health and perceived strain among caregivers tending children with special needs. Res Dev Disabil. 2020 Dec;107:103790. doi: 10.1016/j.ridd.2020.103790. Epub 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety of the caregivers of the children with cerebral palsy	State-Trait Anxiety levels of caregivers of the children with cerebral palsy during the covid19 pandemic.The total score of the State-Trait Anxiety scale varies between 20 and 80. Those who score below 36 are classified as "no anxiety", those between 37-42 points as "mild anxiety" and those with 42 points and above as "high anxiety".	1 month
Primary	Rehabilitation process of the children with cerebral palsy	Rehabilitation status of the children with cerebral palsy during the covid19 pandemic. Rehabilitation frequency of children and home exercise status are evaluated	1 month