跳至主要内容
临床试验/NCT05233345
NCT05233345已完成不适用

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

Hacettepe University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2020年12月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Occupational Balance Questionnaire (revised version, OBQ11)

研究概览

简要总结

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.

详细描述

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 individual's 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 score=Arithmetic 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

Single (Investigator)

入排标准

年龄范围
13 Years 至 15 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •aged between 13-15 years
  • •having experienced war at home country
  • •being a current resident in Fatih province of Istanbul
  • •being able to read and write (literate) in Turkish
  • •living at home during the lockdown
  • •attending online classes through the Ministry of National Education Online Education Platform (EBA)
  • •willingness to participate in the study by both the child and their families.

排除标准

  • •the presence of a known neurologic or developmental disorder or learning difficulty
  • •already participating in an additional education or activity program apart from the EBA

研究组 & 干预措施

Experimental group: web based occupational therapy program

Experimental

Web-based occupational therapy 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. 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. 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.

Also, all study participants continued taking classes from the EBA program as part of their routine education plan while taking occupational therapy program. EBA program is online classes given by government on local television.

干预措施: Occupational Therapy (Behavioral)

Control Group

No Intervention

There are no interventions except EBA which all study participants are already taking classes from as part of their routine education plan. EBA program is online classes given by government on local television. This program is out of our study.

结局指标

主要结局

Occupational Balance Questionnaire (revised version, OBQ11)

时间窗: 3 weeks

The total score is between 0-33. Minimum score is 0. Maximum score is 33. 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.

次要结局

  • The Well-Star Scale(3 weeks)
  • Pediatric Quality of Life Inventory (PedsQL)(3 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sümeyye Belhan Çelik

Principal Investigator

Hacettepe University

研究点 (1)

Loading locations...

相似试验