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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06022172
Other study ID # Gulcin1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 10, 2023
Est. completion date December 30, 2023

Study information

Verified date September 2023
Source Igdir University
Contact Gülçin ASUT, Doctorate
Phone 0546 841 96 48
Email g.asut@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cerebral palsy (CP) is a non-progressive problem that occurs as a result of damage or lesion in the brain tissue in the prenatal, perinatal or postnatal periods for any reason, causing permanent impairment in the development of posture and movement. In addition to the impairments in the motor area in CP; It can be seen in problems such as perception, cognitive, sensory, communication, social, behavioral, musculoskeletal, epilepsy .Parents who are primary caregivers of the child with CP; They have a very important caregiver role in meeting the processes such as the treatment of the child, daily life needs and rehabilitation.Parental self-efficacy has been defined as the judgments and beliefs held by the parents to cope with the difficulties they experience in raising and caring for children with developmental disabilities and to reach the goal.The long process of caring for the child with cerebral palsy and the dependence of the child on the parent increase the stress of the caregivers. The Calgary Family Intervention Model (CAMM), one of the nursing models, is the first family intervention model in the field of nursing. The model focuses on improving, developing and maintaining the family's functionality in three areas. These three areas are cognitive, emotional and behavioral.


Description:

Cerebral palsy is a problem that causes permanent impairment in the development of non-progressive posture and movement, which occurs as a result of damage or lesion in the brain tissue for any reason in prenatal, perinatal or postnatal periods. In addition to the disorders in the motor area in SP; It can be seen in problems such as perception, cognitive, sensory, communication, social, behavioral, musculoskeletal, epilepsy . Parents who are primary caregivers of the child with CP; They have a very important caregiver role in meeting the processes such as the treatment of the child, daily life needs and rehabilitation . Meeting all these special needs of the child with CP creates the burden of care for the parents . Parental self-efficacy has been defined as the judgments and beliefs held by the parents to cope with the difficulties they experience in raising and caring for children with developmental disabilities and to reach the goal . People with high parental self-efficacy; It has been stated that they are more self-confident in taking and fulfilling their parenting duties, they make more effort, and they focus more on a solution in the face of any problem. The long process of caring for the child with cerebral palsy and the dependence of the child on the parent increase the stress of the caregivers. Caregiving stress affects the physiological, psychological, economic and social behaviors of parents. The Calgary Family Intervention Model, one of the nursing models, is the first family intervention model in the field of nursing. The model focuses on improving, developing and maintaining the family's functionality in three areas. These three areas are cognitive, emotional and behavioral. The Calgary Family Intervention Model is an important model in increasing family functionality and providing change in pediatric nursing practice . In the literature review, no other study has been found yet, examining the effect of motivational interviewing based on the Calgary Family Intervention model on the burden of care, self-efficacy and coping with stress in parents of children with cerebral palsy. It is believed that the motivational interview technique to be applied to the parents can be more beneficial for the children they care for and themselves, by revealing the effects of the disease, the responsibilities brought by the disease, the care burden arising from these responsibilities, parent self-efficacy and coping with stress. Materials and Methods This study is a randomized controlled study. The research will be carried out in the interview rooms of the rehabilitation centers with the parents of children with cerebral palsy whose children attend a special rehabilitation center in the province of Iğdır. The universe of the research will be the parents of 120 children with cerebral palsy between the ages of 6-18 who attend private rehabilitation centers in the province of Iğdır. Without using any sample selection method in the research, parents who meet the inclusion criteria and participate voluntarily in the research will be considered as the sample of the research. The number of samples was calculated in G*Power program. There is no similar research in the related literature. As a result of the power analysis performed before the study, the number of people to be included in the study group for percentage 80 power was calculated as 26. At least 30 parents will be included in both groups for possible sample loss during the implementation phase of the research. A list will be created by assigning a code number to each parent. Personal information form, caregiving burden scale, Parental Self-Efficacy Scale, and Ways of Coping with Stress Scale developed by the researchers will be used to collect research data.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 30, 2023
Est. primary completion date October 10, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: - Having a child with cerebral palsy between the ages of 6-18, - Able to read and write Turkish, accessible and able to communicate, - Orientation and cooperation - Hearing, comprehension and vision problems, - Parents who agreed to participate in the study were determined as . Exclusion Criteria: - Having difficulty in communication - Not being literate

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
MOTIVATIONAL INTERVIEW BASED ON THE CALGARY FAMILY INTERVENTION MODEL IN PARENTS WITH A CHILD WITH CEREBRAL PALS.
Motivational interview based on Calgary family intervention model in parents of children with cerebral palsy. Introductory information form, caregiving burden, parent self-efficacy and stress coping styles scale will be used.

Locations

Country Name City State
Turkey Igdir university Igdir

Sponsors (2)

Lead Sponsor Collaborator
Igdir University Kafkas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pre-test data collection The research pre-test data will be carried out by the researcher between September 2023 and October 2023 in the interview rooms of rehabilitation centers, with the parents of children with cerebral palsy attending a private rehabilitation center in Igdir. Introductory information form The burden of care for individuals in the experimental and control groups in data collection, parent self-efficacy scale and coping styles scale will be applied. In the care burden scale, a minimum score of 0 and a maximum of 88 points can be obtained from the scale. The lowest score in the self-efficacy scale is 17 and the highest score is 119. In the scale of coping with stress, the total score is calculated is not done. Time frame 1 or 2 months.
Primary Collection of post-test data The motivational interview based on the Calgary family intervention model for each parent in the experimental group will consist of 6 sessions lasting 45 minutes, one week apart. After the interviews, the final test will be held after the last session and 15 days later. Parents of children with cerebral palsy whose children attend a special rehabilitation center in Istanbul will meet in the meeting rooms of the rehabilitation centers. Introductory information form, caregiver burden scale, parent self-efficacy scale and coping styles scale will be used to collect data.
A score of 88 can be obtained. The lowest score in the self-efficacy scale is 17, and the highest score is 119. The total score is not calculated in the scale of coping with stress.
Time frame one or two months.
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