Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05233345 |
| Other study ID # |
2020/213 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 13, 2020 |
| Est. completion date |
March 30, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Hacettepe University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
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.
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.
