- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05731505
The Effect Of Supportive Approach According To Kolcaba Comfort Theory Applied To Parents Of Children With Cerebral Palsy
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
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)_
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bircan Kahraman Berberoğlu
- Phone Number: 05535844047
- Email: biircan5@gmail.com
Study Contact Backup
- Name: Hüsniye Çalışır
- Phone Number: 05056807219
- Email: calisirh@hotmail.com
Study Locations
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-
Efeler
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Aydın, Efeler, Turkey, 09000
- Adnan Menderes Univercity
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: THE EFFECT OF A SUPPORTIVE APPROACH STRUCTURED ACCORDING TO KOLCABA'S COMFORT THEORY
The study group consisted of parents who were given a supportive approach structured according to Kolcaba's Comfort Theory by the researcher.
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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.
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Experimental: KOLCABA COMFORT THEORY APPLİED TO PARENTS OF CHİLDREN WİTH CEREBRAL PALSY
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comfort Behaviors Checklist
Time Frame: on completion of the study, an average of 3 months
|
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.
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on completion of the study, an average of 3 months
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Quality of Life Scale for Children Parent Form
Time Frame: on completion of the study, an average of 3 months
|
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.
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on completion of the study, an average of 3 months
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Self-Efficiency Scale
Time Frame: on completion of the study, an average of 3 months
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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.
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on completion of the study, an average of 3 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hüsniye Çalışır, Prof. Dr., Aydın Adnan Menderes Univercity
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Adnan Menderes Universıty
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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