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Clinical Trials/NCT05731505
NCT05731505
Completed
Not Applicable

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

Aydin Adnan Menderes University1 site in 1 country73 target enrollmentNovember 2, 2021
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Aydin Adnan Menderes University
Enrollment
73
Locations
1
Primary Endpoint
Comfort Behaviors Checklist
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2, 2021
End Date
February 27, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aydin Adnan Menderes University
Responsible Party
Principal Investigator
Principal Investigator

Bircan Kahraman Berberoglu

research asistant

Aydin Adnan Menderes University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Self-Efficiency Scale

Time Frame: on completion of the study, an average of 3 months

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.

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.

Study Sites (1)

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