Cerebral PalsyNCT05731505
The Effect Of Supportive Approach According To Kolcaba Comfort Theory Applied To Parents Of Children With Cerebral Palsy
A study testing theory-based education-consulting in people with Cerebral Palsy, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- theory-based education-consulting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2021to 27 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adnan Menderes Univercity
Aydin, Efeler, 09000
About this study
Official 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
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).
Read more
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)_
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- theory-based education-consulting
- Keywords
- cerebral palsy, comfort theory, nursing care
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
theory-based education-consultingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: theory-based education-consulting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: on completion of the study, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start2 Nov 2021
- Primary completion11 Nov 2022
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- experimental, randomized controlled, single-blind study
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bircan Kahraman Berberoglu, Aydin Adnan Menderes University
- Investigators
- Hüsniye Çalışır, Prof. Dr., Study director, Aydın Adnan Menderes Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731505
- Sponsor's protocol ID
- Adnan Menderes Universıty
- Status last verified
- Feb 2023
- First submitted
- 10 Dec 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05731505
- Acronym / sponsor ID
- Adnan Menderes Universıty
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, comfort theory, nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- experimental, randomized controlled, single-blind study
| Arm | Type | Receives |
|---|---|---|
| THE EFFECT OF A SUPPORTIVE APPROACH STRUCTURED ACCORDING TO KOLCABA'S COMFORT THEORY | Experimental | Behavioral: theory-based education-consultingThe study group consisted of parents who were given a supportive approach structured according to Kolcaba's Comfort Theory by the researcher. |
| KOLCABA COMFORT THEORY APPLİED TO PARENTS OF CHİLDREN WİTH CEREBRAL PALSY | Experimental | Behavioral: theory-based education-consultingDuring 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. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| theory-based education-consultingParents 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. | Behavioural | KOLCABA COMFORT THEORY APPLİED TO PARENTS OF CHİLDREN WİTH CEREBRAL PALSY, THE EFFECT OF A SUPPORTIVE APPROACH STRUCTURED ACCORDING TO KOLCABA'S COMFORT THEORY |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hüsniye Çalışır, Prof. Dr. study director
Aydın Adnan Menderes Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing theory-based education-consulting in people with Cerebral Palsy, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort Behaviors Checklist (time frame: on completion of the study, an average of 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.