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The Effect Of Supportive Approach According To Kolcaba Comfort Theory Applied To Parents Of Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
theory-based education-consulting
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cerebral Palsy focused on measuring cerebral palsy, comfort theory, nursing care

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Adnan Menderes Univercity

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

THE EFFECT OF A SUPPORTIVE APPROACH STRUCTURED ACCORDING TO KOLCABA'S COMFORT THEORY

KOLCABA COMFORT THEORY APPLİED TO PARENTS OF CHİLDREN WİTH CEREBRAL PALSY

Arm Description

The study group consisted of parents who were given a supportive approach structured according to Kolcaba's Comfort Theory by the researcher.

During the training given by the researcher, the children continued their routine education in the rehabilitation center. Although the education to be done is for the child and their parents, the education was given directly to the parents, since the mental perception levels of the children may not be sufficient and mostly children with CP live dependent on their parents. The parent who will be involved in the research is the primary caregiver who is most interested in the child.

Outcomes

Primary Outcome Measures

Comfort Behaviors Checklist
This form is used to evaluate the comfort of patients who are unable to fill out a questionnaire or who have cognitive limitations. It consists of 30 items. High scores indicate a high level of comfort. If all questions are answered, the lowest score that can be obtained from the scale is 25, and the highest score is 100.High scores indicate increased comfort and low scores indicate decreased comfort.
Quality of Life Scale for Children Parent Form
The scale is a self-report scale and questions the status of children and adolescents regarding quality of life in the last month. The scale consists of four subsections, 23 items in total, in which physical, emotional, social and school-related functionality are questioned. The scale has a five-choice Likert-type response scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=always). The scores obtained from the items are translated linearly as 0=100, 1=75, 2=50, 3=25, 4=0. If all questions are answered, the lowest score that can be obtained from the scale is 25, and the highest score is 100.High scores indicate an increase in quality of life, and low scores indicate a decrease.
Self-Efficiency Scale
There are 19 items, seven of which are fillers, and are of a five-point Likert type. Respondents were presented with response categories ranging from "strongly disagree" to "strongly agree". In scoring the items, "strongly disagree" gets 1 point and "strongly agree" gets 5 points; High scores indicate high self-efficacy. If all questions are answered, the lowest score that can be obtained from the scale is 19, and the highest score is 95. High scores indicate an increase in self-efficiency, and low scores indicate a decrease.

Secondary Outcome Measures

Full Information

First Posted
December 10, 2022
Last Updated
February 27, 2023
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT05731505
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
November 11, 2022 (Actual)
Study Completion Date
February 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, comfort theory, nursing care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
experimental, randomized controlled, single-blind study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
THE EFFECT OF A SUPPORTIVE APPROACH STRUCTURED ACCORDING TO KOLCABA'S COMFORT THEORY
Arm Type
Experimental
Arm Description
The study group consisted of parents who were given a supportive approach structured according to Kolcaba's Comfort Theory by the researcher.
Arm Title
KOLCABA COMFORT THEORY APPLİED TO PARENTS OF CHİLDREN WİTH CEREBRAL PALSY
Arm Type
Experimental
Arm Description
During the training given by the researcher, the children continued their routine education in the rehabilitation center. Although the education to be done is for the child and their parents, the education was given directly to the parents, since the mental perception levels of the children may not be sufficient and mostly children with CP live dependent on their parents. The parent who will be involved in the research is the primary caregiver who is most interested in the child.
Intervention Type
Behavioral
Intervention Name(s)
theory-based education-consulting
Intervention Description
Parents in the study groups were provided with training and support in line with their needs in the educational issues specified in the Family 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, Needs Determination Form, Relaxed Behavior Checklist (KDKL), Quality of Life for Children Parent Form (PIDQ) and 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 the education, 1 month and 3 months after the education.
Primary Outcome Measure Information:
Title
Comfort Behaviors Checklist
Description
This form is used to evaluate the comfort of patients who are unable to fill out a questionnaire or who have cognitive limitations. It consists of 30 items. High scores indicate a high level of comfort. If all questions are answered, the lowest score that can be obtained from the scale is 25, and the highest score is 100.High scores indicate increased comfort and low scores indicate decreased comfort.
Time Frame
on completion of the study, an average of 3 months
Title
Quality of Life Scale for Children Parent Form
Description
The scale is a self-report scale and questions the status of children and adolescents regarding quality of life in the last month. The scale consists of four subsections, 23 items in total, in which physical, emotional, social and school-related functionality are questioned. The scale has a five-choice Likert-type response scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=always). The scores obtained from the items are translated linearly as 0=100, 1=75, 2=50, 3=25, 4=0. If all questions are answered, the lowest score that can be obtained from the scale is 25, and the highest score is 100.High scores indicate an increase in quality of life, and low scores indicate a decrease.
Time Frame
on completion of the study, an average of 3 months
Title
Self-Efficiency Scale
Description
There are 19 items, seven of which are fillers, and are of a five-point Likert type. Respondents were presented with response categories ranging from "strongly disagree" to "strongly agree". In scoring the items, "strongly disagree" gets 1 point and "strongly agree" gets 5 points; High scores indicate high self-efficacy. If all questions are answered, the lowest score that can be obtained from the scale is 19, and the highest score is 95. High scores indicate an increase in self-efficiency, and low scores indicate a decrease.
Time Frame
on completion of the study, an average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hüsniye Çalışır, Prof. Dr.
Organizational Affiliation
Aydın Adnan Menderes Univercity
Official's Role
Study Director
Facility Information:
Facility Name
Adnan Menderes Univercity
City
Aydın
State/Province
Efeler
ZIP/Postal Code
09000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect Of Supportive Approach According To Kolcaba Comfort Theory Applied To Parents Of Children With Cerebral Palsy

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