Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05233345
Study type Interventional
Source Hacettepe University
Contact
Status Completed
Phase N/A
Start date December 13, 2020
Completion date March 30, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT06238557 - Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT05472935 - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers N/A
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04281953 - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting NCT05546931 - Mobile Health Program for Rural Hypertension N/A
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Recruiting NCT04142827 - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX) N/A
Active, not recruiting NCT05903638 - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT03813420 - Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level N/A
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Recruiting NCT05233020 - Robotic Versus Hybrid Assisted Ventral Hernia Repair N/A
Terminated NCT03304184 - The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life Phase 3
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Recruiting NCT05380856 - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction N/A