Clinical trial NCT05731505: The Effect Of Supportive Approach According To Kolcaba Comfort Theory Applied To Parents Of Children With Cerebral Palsy
Official title: The Effect Of Supportive Approach Structured According To Kolcaba Comfort Theory Applied To Parents Of Children With Cerebral Palsy On Child's Comfort, Quality Of Life, And Parent's Self-Efficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
comfort theory
nursing care
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 73
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: experimental, randomized controlled, single-blind study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: This study was conducted to evaluate the effect of the structured supportive approach given to the parents of children with cerebral palsy according to Kolcaba Comfort Theory on the child's comfort, quality of life and parent's self-efficacy._

H01: According to Kolcaba's Comfort Theory, there is no difference between the comfort scores of the children of parents (study group) to whom the structured supportive approach was applied and the children of the parents who did not apply this approach (control group).

H02: According to Kolcaba's Comfort Theory, there is no difference between the quality of life scores of the children of parents (study group) to whom the structured supportive approach was applied and the children of parents who did not apply this approach (control group).

H03: According to Kolcaba's Comfort Theory, there is no difference between the self-efficacy scores of the parents (study group) who applied the structured supportive approach and the parents who did not apply this approach (control group)_

Detailed description: This is an experimental, randomized controlled, single-blind study. The study was conducted with the parents of children with CP aged 8-16 years, who went to the rehabilitation centers in a randomized controlled manner between 11 October 2021 and 11 November 2022 to receive education and treatment. The sample consisted of 73 parents, the study group (n=35), and the control group (n=38). Parents in the study groups were given education-support in accordance with their needs in the educational topics specified in the Parent Education-Support Booklet for a Child with Cerebral Palsy. The control group was not trained. Research data were collected using the Child and Parent Information Form, the Needs Determination Form, the Comfort Behaviors Checklist (KDKL), the Parent Form of the Quality of Life Scale for Children (PIDQ) and the Self-Efficacy Scale. The comfort and quality of life of the children in the study group and the self-efficacy of the parents were evaluated before, 1 month and 3 months after the education. The control group's data were collected at the same time as the other groups. Descriptive statistics, Pearson chi-square, Fisher exact chi-square, Student-t, and ANOVA were used in the analysis of the data.

Eligibility criteria: The criteria for inclusion of children in the study are:

* Having been diagnosed with cerebral palsy,
* Being between the ages of 8-16,
* Being at the level of 1/2/3/4/5 according to the Gross Motor Function Classification System (KMFSS)

The criteria for inclusion of parents in the study are:

* Being at least literate,
* Being able to speak and understand Turkish,
* Having a smart phone and/or internet connection.

The criteria for exclusion of children from the study are:

• Having drug-resistant epilepsy.

The criteria for exclusion of parents from the study are:

* Caring for other dependent people (elderly, disabled, etc.),
* Being pregnant,
* Having a chronic physical illness (heart disease, diabetes mellitus, hypertension, etc.)
* Having a mental illness (major depression, psychosis, etc.),
* Being hearing, seeing or speaking impaired,
* Having a mental disability.

Primary outcomes:
measure: Comfort Behaviors Checklist
timeFrame: on completion of the study, an average of 3 months
measure: Quality of Life Scale for Children Parent Form
timeFrame: on completion of the study, an average of 3 months
measure: Self-Efficiency Scale
timeFrame: on completion of the study, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Adnan Menderes Univercity
state: Efeler
Study officials:
affiliation: Aydın Adnan Menderes Univercity
name: Hüsniye Çalışır, Prof. Dr.
role: STUDY_DIRECTOR
References: