Ignite Creation Date:
2024-05-06 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05233345
Status:
COMPLETED
Last Update Posted:
2022-02-10
First Post:
2022-01-30
Brief Title:
Online Occupational Therapy on Occupational Balance Well-being and Quality of Life in Syrian Refugee Children
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
Effects of Online Occupational Therapy on Occupational Balance Well-being and Quality of Life in Syrian Refugee Children in COVID 19 Lockdown A Randomized-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-02
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:
Cognitive and learning difficulties created by traumatic events related to difficulties and trauma experienced during the Syrian civil war and resettlement period in Turkey might have been complicated by the limitations of the COVID19 pandemic Thus it is of utmost importance to find out and implement effective and feasible ways of intervention to ameliorate adverse effects of the refugee experience and COVID19 pandemic on cognitive functions well-being quality of life and occupational balance in these children Thus this research was designed a randomized controlled trial in which examining the effects of a customized online occupational training program encompassing various activities on the aforementioned aspects of refugee children resettled in Turkey
The present study was designed as a randomized controlled study including pre-post testing Occupational balance well-being and health-related quality of life were evaluated via the Occupational Balance Questionnaire OBQ11 Well Star Scale WSS and the Pediatric Quality of Life Inventory PedsQL The intervention group attended online occupational therapy classes Online classes were carried out as 5 sessions per week each session lasting 1 hour for 3 weeks Questionnaires performed at the outset of the study and following the training program Overall 52 refugee children were randomized into intervention and control groups each including 26 children The mean WSS PedsQL and OBQ11 scores significantly improved in the intervention group than in the control group This was the first study investigating the effects of a customized online training course on well-being occupational balance and quality of life in Syrian refugee children also affected unfavorably by COVID19 lockdown The results showed significant improvements in all study scales that we used to quantify the alterations in the aforementioned traits
The present study was designed as a randomized controlled study including pre-post testing Occupational balance well-being and health-related quality of life were evaluated via the Occupational Balance Questionnaire OBQ11 Well Star Scale WSS and the Pediatric Quality of Life Inventory PedsQL The intervention group attended online occupational therapy classes Online classes were carried out as 5 sessions per week each session lasting 1 hour for 3 weeks Questionnaires performed at the outset of the study and following the training program Overall 52 refugee children were randomized into intervention and control groups each including 26 children The mean WSS PedsQL and OBQ11 scores significantly improved in the intervention group than in the control group This was the first study investigating the effects of a customized online training course on well-being occupational balance and quality of life in Syrian refugee children also affected unfavorably by COVID19 lockdown The results showed significant improvements in all study scales that we used to quantify the alterations in the aforementioned traits
Detailed Description:
Occupational Balance Questionnaire OBQ11 Well Star Scale WSS and the Pediatric Quality of Life Inventory PedsQL were administered to the children before and after the intervention and the results were compared
Occupational Balance Questionnaire revised version OBQ11 This questionnaire is used to assess the activity-role balance according to the level of contention and to define the variety of the activities and occupational balance based on the results of obtained data A reliability and validity study of the Turkish version was conducted by Gunal et al Each item in the OBQ is scored between zero strongly disagree and 3 strongly agree The total score varies between 0 and 33 points Higher scores indicate better occupational balance
The Well-Star Scale The Well Star Scale developed by Korkut-Owen et al consists of 24 items and 5 dimensions In its broadest meaning well-being is a concept that means to be well in a number of dimensions of life and is explained by a series of models This scale evaluates an individuals well-being state making sense of life and being target-oriented in the context of cognitive emotional physical and social dimensions The scores that can be obtained from the scale ranges between 24 and 120 Higher scores indicate that an individual view their well-being favorably Subscores of this scale can be calculated in various dimensions as well
Pediatric Quality of Life Inventory PedsQL The Pediatric Quality of Life Inventory is used to assess the health-related quality of life of the subjects The reliability and validity study of the Turkish version was performed by Memik el al Physical emotional social and school functioning are among the key scales included in this survey This inventory is a useful tool for assessing the health-related quality of life of healthy children and adolescents as well as those with acute and chronic illnesses in big groups such as schools and hospitals The PedsQL inventory consists of 23 items that are scored between 0 and 100 When a question is answered as never 100 points are given Almost never sometimes often and almost always answers are given 75 50 25 and 0 points respectively The items of the PedsQL cover school functioning and core dimensions of health described by the WHO including consists of physical health emotional functioning and social functioning Three summary scales are scored based on the answers given to inventory questions total scale score TSS physical health summary score PHSS and psychosocial health summary score PsHSS Psychosocial health summary score is composed of scores obtained from the scales of emotional EFS social SFS and school functioning ScFS Higher PedsQL scores indicate the better health-related quality of life Brevity easy applicability and scoring by the investigator and the short time needed to complete are important advantages of the inventory Total PedsQL scoreArithmetic averages of PHSS and PHSS PHSS averages of EFS SFS and ScFS
52 refugee children were randomized into intervention and control groups each including 26 children All study participants 52 refugee children continued taking classes from the EBA program as part of their routine education plan Only children in the intervention group attended web-based occupational therapy classes Online classes were carried out as 5 sessions per week each session lasting 1 hour for 3 weeks In total 15 sessions were performed during the study period Group activities were performed through the Zoom application by means of a video camera Online group activities included painting and cake making together sports activities to be performed simultaneously with the movements shown by the researcher memory games and games that can be played with the group such as the categories game
At the same time children were asked to interpret idioms and proverbs and to express what they understood from the book they needed to read daily by choosing a different person in the group every day Sports activities comprised the movements demonstrated by researcher through online Zoom meeting performed simultaneously with all group members These sports activities were performed in the last 15 minutes of group activities 5 days a week in order to increase the physical activity level of children whose physical activities decreased during the lockdown period at home
Apart from the web-based training to be held with the group an occupational balance program chart was created for individuals and applied through a single-person online session to organize daily routines and occupations and to perform activities in a balanced way This chart comprised what children did hour by hour from waking up to bedtime The children were asked to apply this chart 6 days a week while Sunday was considered as a resting day The routine daily chart included test solving 50 questions a day reading a book learning an idiom and a proverb and playing 10 games from the Mental Up application The child played 10 games from this application for 3 weeks 6 days a week and sent the score they got to the researcher via the WhatsApp application on a daily basis The winner of the day was announced in the WhatsApp group in which all the children were involved to create a competitive environment and to ensure their motivation
Occupational Balance Questionnaire revised version OBQ11 This questionnaire is used to assess the activity-role balance according to the level of contention and to define the variety of the activities and occupational balance based on the results of obtained data A reliability and validity study of the Turkish version was conducted by Gunal et al Each item in the OBQ is scored between zero strongly disagree and 3 strongly agree The total score varies between 0 and 33 points Higher scores indicate better occupational balance
The Well-Star Scale The Well Star Scale developed by Korkut-Owen et al consists of 24 items and 5 dimensions In its broadest meaning well-being is a concept that means to be well in a number of dimensions of life and is explained by a series of models This scale evaluates an individuals well-being state making sense of life and being target-oriented in the context of cognitive emotional physical and social dimensions The scores that can be obtained from the scale ranges between 24 and 120 Higher scores indicate that an individual view their well-being favorably Subscores of this scale can be calculated in various dimensions as well
Pediatric Quality of Life Inventory PedsQL The Pediatric Quality of Life Inventory is used to assess the health-related quality of life of the subjects The reliability and validity study of the Turkish version was performed by Memik el al Physical emotional social and school functioning are among the key scales included in this survey This inventory is a useful tool for assessing the health-related quality of life of healthy children and adolescents as well as those with acute and chronic illnesses in big groups such as schools and hospitals The PedsQL inventory consists of 23 items that are scored between 0 and 100 When a question is answered as never 100 points are given Almost never sometimes often and almost always answers are given 75 50 25 and 0 points respectively The items of the PedsQL cover school functioning and core dimensions of health described by the WHO including consists of physical health emotional functioning and social functioning Three summary scales are scored based on the answers given to inventory questions total scale score TSS physical health summary score PHSS and psychosocial health summary score PsHSS Psychosocial health summary score is composed of scores obtained from the scales of emotional EFS social SFS and school functioning ScFS Higher PedsQL scores indicate the better health-related quality of life Brevity easy applicability and scoring by the investigator and the short time needed to complete are important advantages of the inventory Total PedsQL scoreArithmetic averages of PHSS and PHSS PHSS averages of EFS SFS and ScFS
52 refugee children were randomized into intervention and control groups each including 26 children All study participants 52 refugee children continued taking classes from the EBA program as part of their routine education plan Only children in the intervention group attended web-based occupational therapy classes Online classes were carried out as 5 sessions per week each session lasting 1 hour for 3 weeks In total 15 sessions were performed during the study period Group activities were performed through the Zoom application by means of a video camera Online group activities included painting and cake making together sports activities to be performed simultaneously with the movements shown by the researcher memory games and games that can be played with the group such as the categories game
At the same time children were asked to interpret idioms and proverbs and to express what they understood from the book they needed to read daily by choosing a different person in the group every day Sports activities comprised the movements demonstrated by researcher through online Zoom meeting performed simultaneously with all group members These sports activities were performed in the last 15 minutes of group activities 5 days a week in order to increase the physical activity level of children whose physical activities decreased during the lockdown period at home
Apart from the web-based training to be held with the group an occupational balance program chart was created for individuals and applied through a single-person online session to organize daily routines and occupations and to perform activities in a balanced way This chart comprised what children did hour by hour from waking up to bedtime The children were asked to apply this chart 6 days a week while Sunday was considered as a resting day The routine daily chart included test solving 50 questions a day reading a book learning an idiom and a proverb and playing 10 games from the Mental Up application The child played 10 games from this application for 3 weeks 6 days a week and sent the score they got to the researcher via the WhatsApp application on a daily basis The winner of the day was announced in the WhatsApp group in which all the children were involved to create a competitive environment and to ensure their motivation
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