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

NCT05731505 | Completed

• 1 other identifier: Adnan Menderes Universıty
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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)\_

Conditions

Cerebral Palsy

Keywords

cerebral palsy; comfort theory; nursing care

Outcome Measures

Primary Outcomes (3)

• 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.

  on completion of the study, an average of 3 months

• 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.

  on completion of the study, an average of 3 months

• 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.

  on completion of the study, an average of 3 months

Study Arms (2)

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

EXPERIMENTAL

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

Behavioral: theory-based education-consulting

KOLCABA COMFORT THEORY APPLİED TO PARENTS OF CHİLDREN WİTH CEREBRAL PALSY

EXPERIMENTAL

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.

Behavioral: theory-based education-consulting

Interventions

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.

KOLCABA COMFORT THEORY APPLİED TO PARENTS OF CHİLDREN WİTH CEREBRAL PALSY; THE EFFECT OF A SUPPORTIVE APPROACH STRUCTURED ACCORDING TO KOLCABA'S COMFORT THEORY

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes Univercity

Aydin, Efeler, 09000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Hüsniye Çalışır, Prof. Dr.

  Aydın Adnan Menderes Univercity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research asistant

Model Details: experimental, randomized controlled, single-blind study

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: February 16, 2023
• Study Start: November 2, 2021
• Primary Completion: November 11, 2022
• Study Completion: February 27, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)