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Completed

NCT Number: NCT05731505

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

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)_

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adnan Menderes Univercity

Aydin, Efeler, 09000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

theory-based education-consulting

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 16, 2023
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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