Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06102317
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-10-08
Brief Title:
the Use of Smart Mobile Application in Mothers With Cerebral Palsy Children
Sponsor:
Dr Behcet Uz Childrens Hospital
Organization:
Dr Behcet Uz Childrens Hospital
Study Overview
Official Title:
The Effects of Smartphone-assisted Nursing Care Used for Mothers of Children With Cerebral Palsy Who Receive Home Healthcare Services on the Care Burden Coping With Stress and Quality of Life of Mothers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There are studies in the literature aimed at supporting parents who care for children who have Cerebral Palsy Among these the study conducted on the use of mobile applications in supporting parents has attracted attention in recent years When the studies on supporting parents were examined it was found in one study that a mobile application designed for caregivers enabled parents to support their childrens nutrition bathing toileting playing carrying and movement training As a result of this study it was reported that the knowledge and skills of caregivers regarding the care of their children increased It was emphasized in another study that mobile medicine applications that are developed for children who have disabilities such as Cerebral Palsy must have a drug list drug name drug reminder module drug registration section and additional characteristics In a randomized controlled study it was reported that a web-based daycare program designed for the children of mothers who had children with CP increased the quality of life of the mothers In another study it was explained to caregivers of children who had Cerebral Palsy that the application facilitated the daily care of children anytime and anywhere in a training module consisting of a mobile application with information about CP nutrition toilet bath transportation games and medication reminder modules Studies conducted on the use of technology-based telehealth mobile applications web-based education healthcare service delivery education and consultancy services in supporting families in Turkey are limited The present study aimed to reduce the care burden and stress of parents of children who had Cerebral Palsy and improve their quality of life with the mobile application developed with the support of nurses
The purpose of the present study is to examine the effects of smartphone-supported nursing consultancy applied to mothers of children who have Cerebral Palsy receiving home healthcare services on their care burden coping with stress and quality of life
The purpose of the present study is to examine the effects of smartphone-supported nursing consultancy applied to mothers of children who have Cerebral Palsy receiving home healthcare services on their care burden coping with stress and quality of life
Detailed Description:
Study Question In the present study an answer will be sought to the question Does the smartphone-supported nursing consultancy used by the mothers of children with Cerebral Palsy who receive home healthcare and are registered at SBU Dr Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital Home Healthcare Services Unit located in Konak district of Izmir affect the mothers care burden coping with stress and quality of life
Hypotheses Hypothesis 1 H1 There is a difference between the care burden scale scores of the Intervention and Control Group according to time pre-test 1st month after the intervention 3rd month 6th month
Hypothesis 2 H1 There is a difference between the quality of life scale scores of the Intervention and Control Group according to time pre-test 1st month after the intervention 3rd month 6th month
Hypothesis 3 H1 There is a difference between the stress scale scores of the Intervention and Control Group according to time pre-test 1st month after the intervention 3rd month 6th month
Original value of the study Coordination between parents and healthcare professionals in pediatric home health services will be improved with the mobile application that will be developed as a result of the study and effective use of healthcare services will be ensured contributing to the protection development and maintenance of healthcare
There are many studies in the literature on the caregivers of children with Cerebral Palsy However no randomized controlled study was detected on the effects of mobile applications on care burden stress and quality of life For this reason it is expected to be an original study in this field and to contribute to the literature in planning future studies
It is envisaged that nurses will reflect innovative and easy-to-access technological developments in nursing care and the mobile application will form the basis for supportive studies based on mobile applications in the nursing care of parents
Studies in the literature report that the quality of life of parents who had children with Cerebral Palsy decreased during the COVID-19 pandemic because of social distance and curfews stress their care burden increased and they could not benefit from qualified healthcare services For this reason it is recommended to use telehealth services effectively during Covid-19 and in future epidemicspandemics For this reason it is expected that parents active participation and compliance with the treatment process will be easier because a smartphone-supported program will be used in the study and time will be saved in transportation to healthcare professionals
It is expected that rapid insight into the existing evidence base will be provided at the intersection between policymakers public healthcare staff and other professionals who work in this field
Study Design The study will have a randomized controlled follow-up design with a pretest-posttest control group The population of the study will consist of the mothers of 58 children diagnosed primarily with Cerebral Palsy among the 170 patients who receive home healthcare and are registered at SBU Dr Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital Home Healthcare Services Unit located in the Konak district of Izmir The study will be conducted in the home healthcare services of the hospital The size of the study population was determined by the researcher from the results of the study titled Retrospective evaluation of applications made to the home care services unit of a public hospital with the decision of protocol 591 and 202112_09 to SBU Dr Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital on 080721
A power analysis was performed to determine the sample size in the study by using the GPower 3197 program The final tests of the total scores on the quality of life scale of study which was previously conducted on a similar subject were taken as a reference in determining the sample size of the study
In the present study it was envisaged to conduct a t-test Experiment-Control to determine whether the smartphone-supported nursing consultancy applied to mothers of children with Cerebral Palsy receiving home healthcare had an effect on the mothers care burden coping with stress and quality of life As a result of the analysis the standardized effect size was found to be 093 at α005 level based on previous studies and the minimum number of samples was determined to be 40 20 in the first group and 20 in the second group with a theoretical power of 095 It was emphasized in the literature that it must be taken into consideration that there will be a 20 case loss in randomized controlled studies for this reason the number of samples was determined as 48 24 experimental 24 control
The Stratified Randomization Method will be used according to the gender and age of the children diagnosed with CP whom the mothers care for The way randomization will be implemented based on the literature data with the simple random sampling method because there of the lists of parents in the study previously conducted by the researcher to determine the population the population was less than 1000 N1000 registered in the same unit to ensure the homogeneity of the sample in the study in this study it was decided to use the Program R 421 to strongly randomize and evenly distribute it to the intervention-control group at once
Inclusion Criteria
1 Having a child with CP registered in the Home Healthcare Services Unit at SBU Dr Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital
2 Residing in the province of Izmir and at home
3 Having a primary diagnosis of Cerebral Palsy in the home health care file
4 The primary caregiver of the child is the mother
5 The mother does not have any communication or mental problems
6 The mothers ability to read and write in Turkish
7 Having an Android or IOS-based smartphone
8 Voluntary participation in the study
Exclusion Criteria
1 Children who were residing in the Ministry of Family and Social Policies Services
Study Variables
The independent variable of the study Status of receiving smartphone-supported nursing consultancy
The dependent variable of the study Zarit Care Burden Scale score Parental Stress Index score and Quality of Life Scale score
Place and Time of Study The study will be conducted at SBU Dr Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital Home Healthcare Services Unit located in the Konak district of Izmir The study is planned to be conducted between 01 February 2024 and 31 July 2024 The pilot application of the smartphone application is planned between 01 february 2024 and 31 January 2024
Data Collection A telephone conversation will be made with the mothers registered to the Home Healthcare Services Unit and meet the inclusion criteria and the necessary information will be given about the study during the data collection The forms to be used in the pre-test will be collected from the mothers in the intervention and control groups with the face-to-face interview method by going to the homes of the mothers who agree to participate in the study taking into account the necessary COVID-19 pandemic measures A mobile application will be installed on the phones of the mothers in the intervention group and individual information will be given to the patients about how to use the smartphone application during these meetings and participants will be informed about follow-ups After the application is started to be used Intervention Group mothers will be notified of the applications developed for smart mobiles for the disease management process every two weeks for six months Also the Intervention Group will continue to receive standard care practices such as examination analysis treatment medical care and rehabilitation offered by the Home Health Services Unit
No intervention will be made to the Control Group which will continue to receive standard care practices provided by the Home Healthcare Services Unit
The Smartphone Application for Parents of Children who have Primary Cerebral Palsy For the Intervention Group the healthcare service needs of families who have children with Cerebral Palsy will be determined by examining them in line with the literature data These nursing needs will be designed by a consulting company that specializes in the application The content evaluation of the designed smartphone application will be made with the DISCERN Measurement Tool Specialists in the field will be asked to fill out the DISCERN Measurement Tool and their opinions will be evaluated with the Kendall Coefficient of Concordance which is an analysis method used to evaluate inter-rater concordance Kendall is shown with W Kendall W can range from 0 no concordance to 1 full concordance As this value approaches 1 it indicates a good level of concordance among specialists Then a pilot study will be conducted to evaluate the effectiveness of the smartphone application and to identify the deficiencies by taking institutional permission from 10 of the sample and testing it on mothers of children who are diagnosed with Cerebral Palsy in one of the private rehabilitation centers The smartphone application will be finalized in line with the feedback that will be obtained from the pilot application The content of the smartphone application will be created according to the literature data under the following headings
1 Information on Cerebral Palsy
2 Medication reminder
3 Parental self-care plan
4 Exercise module
5 Fever management
6 Communication panel to ask questions to the specialist
7 Parent-Peer interaction
Data analysis The SPSS 220 Package program will be used to analyze the study data The data will be evaluated statistically at a 95 Confidence Interval and a significance level of p005 Numbers and percentage distributions will be used in the analysis of the data for sociodemographic characteristics Parametric and nonparametric tests will be used after analyzing the suitability of the quantitative data for normal distribution
Hypotheses Hypothesis 1 H1 There is a difference between the care burden scale scores of the Intervention and Control Group according to time pre-test 1st month after the intervention 3rd month 6th month
Hypothesis 2 H1 There is a difference between the quality of life scale scores of the Intervention and Control Group according to time pre-test 1st month after the intervention 3rd month 6th month
Hypothesis 3 H1 There is a difference between the stress scale scores of the Intervention and Control Group according to time pre-test 1st month after the intervention 3rd month 6th month
Original value of the study Coordination between parents and healthcare professionals in pediatric home health services will be improved with the mobile application that will be developed as a result of the study and effective use of healthcare services will be ensured contributing to the protection development and maintenance of healthcare
There are many studies in the literature on the caregivers of children with Cerebral Palsy However no randomized controlled study was detected on the effects of mobile applications on care burden stress and quality of life For this reason it is expected to be an original study in this field and to contribute to the literature in planning future studies
It is envisaged that nurses will reflect innovative and easy-to-access technological developments in nursing care and the mobile application will form the basis for supportive studies based on mobile applications in the nursing care of parents
Studies in the literature report that the quality of life of parents who had children with Cerebral Palsy decreased during the COVID-19 pandemic because of social distance and curfews stress their care burden increased and they could not benefit from qualified healthcare services For this reason it is recommended to use telehealth services effectively during Covid-19 and in future epidemicspandemics For this reason it is expected that parents active participation and compliance with the treatment process will be easier because a smartphone-supported program will be used in the study and time will be saved in transportation to healthcare professionals
It is expected that rapid insight into the existing evidence base will be provided at the intersection between policymakers public healthcare staff and other professionals who work in this field
Study Design The study will have a randomized controlled follow-up design with a pretest-posttest control group The population of the study will consist of the mothers of 58 children diagnosed primarily with Cerebral Palsy among the 170 patients who receive home healthcare and are registered at SBU Dr Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital Home Healthcare Services Unit located in the Konak district of Izmir The study will be conducted in the home healthcare services of the hospital The size of the study population was determined by the researcher from the results of the study titled Retrospective evaluation of applications made to the home care services unit of a public hospital with the decision of protocol 591 and 202112_09 to SBU Dr Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital on 080721
A power analysis was performed to determine the sample size in the study by using the GPower 3197 program The final tests of the total scores on the quality of life scale of study which was previously conducted on a similar subject were taken as a reference in determining the sample size of the study
In the present study it was envisaged to conduct a t-test Experiment-Control to determine whether the smartphone-supported nursing consultancy applied to mothers of children with Cerebral Palsy receiving home healthcare had an effect on the mothers care burden coping with stress and quality of life As a result of the analysis the standardized effect size was found to be 093 at α005 level based on previous studies and the minimum number of samples was determined to be 40 20 in the first group and 20 in the second group with a theoretical power of 095 It was emphasized in the literature that it must be taken into consideration that there will be a 20 case loss in randomized controlled studies for this reason the number of samples was determined as 48 24 experimental 24 control
The Stratified Randomization Method will be used according to the gender and age of the children diagnosed with CP whom the mothers care for The way randomization will be implemented based on the literature data with the simple random sampling method because there of the lists of parents in the study previously conducted by the researcher to determine the population the population was less than 1000 N1000 registered in the same unit to ensure the homogeneity of the sample in the study in this study it was decided to use the Program R 421 to strongly randomize and evenly distribute it to the intervention-control group at once
Inclusion Criteria
1 Having a child with CP registered in the Home Healthcare Services Unit at SBU Dr Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital
2 Residing in the province of Izmir and at home
3 Having a primary diagnosis of Cerebral Palsy in the home health care file
4 The primary caregiver of the child is the mother
5 The mother does not have any communication or mental problems
6 The mothers ability to read and write in Turkish
7 Having an Android or IOS-based smartphone
8 Voluntary participation in the study
Exclusion Criteria
1 Children who were residing in the Ministry of Family and Social Policies Services
Study Variables
The independent variable of the study Status of receiving smartphone-supported nursing consultancy
The dependent variable of the study Zarit Care Burden Scale score Parental Stress Index score and Quality of Life Scale score
Place and Time of Study The study will be conducted at SBU Dr Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital Home Healthcare Services Unit located in the Konak district of Izmir The study is planned to be conducted between 01 February 2024 and 31 July 2024 The pilot application of the smartphone application is planned between 01 february 2024 and 31 January 2024
Data Collection A telephone conversation will be made with the mothers registered to the Home Healthcare Services Unit and meet the inclusion criteria and the necessary information will be given about the study during the data collection The forms to be used in the pre-test will be collected from the mothers in the intervention and control groups with the face-to-face interview method by going to the homes of the mothers who agree to participate in the study taking into account the necessary COVID-19 pandemic measures A mobile application will be installed on the phones of the mothers in the intervention group and individual information will be given to the patients about how to use the smartphone application during these meetings and participants will be informed about follow-ups After the application is started to be used Intervention Group mothers will be notified of the applications developed for smart mobiles for the disease management process every two weeks for six months Also the Intervention Group will continue to receive standard care practices such as examination analysis treatment medical care and rehabilitation offered by the Home Health Services Unit
No intervention will be made to the Control Group which will continue to receive standard care practices provided by the Home Healthcare Services Unit
The Smartphone Application for Parents of Children who have Primary Cerebral Palsy For the Intervention Group the healthcare service needs of families who have children with Cerebral Palsy will be determined by examining them in line with the literature data These nursing needs will be designed by a consulting company that specializes in the application The content evaluation of the designed smartphone application will be made with the DISCERN Measurement Tool Specialists in the field will be asked to fill out the DISCERN Measurement Tool and their opinions will be evaluated with the Kendall Coefficient of Concordance which is an analysis method used to evaluate inter-rater concordance Kendall is shown with W Kendall W can range from 0 no concordance to 1 full concordance As this value approaches 1 it indicates a good level of concordance among specialists Then a pilot study will be conducted to evaluate the effectiveness of the smartphone application and to identify the deficiencies by taking institutional permission from 10 of the sample and testing it on mothers of children who are diagnosed with Cerebral Palsy in one of the private rehabilitation centers The smartphone application will be finalized in line with the feedback that will be obtained from the pilot application The content of the smartphone application will be created according to the literature data under the following headings
1 Information on Cerebral Palsy
2 Medication reminder
3 Parental self-care plan
4 Exercise module
5 Fever management
6 Communication panel to ask questions to the specialist
7 Parent-Peer interaction
Data analysis The SPSS 220 Package program will be used to analyze the study data The data will be evaluated statistically at a 95 Confidence Interval and a significance level of p005 Numbers and percentage distributions will be used in the analysis of the data for sociodemographic characteristics Parametric and nonparametric tests will be used after analyzing the suitability of the quantitative data for normal distribution
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None