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

NCT ID: NCT05731505

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-02

Study Completion Date

2023-02-27

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

experimental, randomized controlled, single-blind study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

theory-based education-consulting

Intervention Type 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.

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.

Group Type EXPERIMENTAL

theory-based education-consulting

Intervention Type 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.

Interventions

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theory-based education-consulting

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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Bircan Kahraman Berberoglu

research asistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hüsniye Çalışır, Prof. Dr.

Role: STUDY_DIRECTOR

Aydın Adnan Menderes Univercity

Locations

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Adnan Menderes Univercity

Aydin, Efeler, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Adnan Menderes Universıty

Identifier Type: -

Identifier Source: org_study_id

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