scholarly journals A RANDOMIZED CONTROLLED TRIAL ON THE ISLAMIC-BASED PROGRAM USING FAMILY APPROACHES IN PREVENTING ADOLESCENTS’ SMOKING BEHAVIOR IN INDONESIA: A STUDY PROTOCOL

2020 ◽  
Vol 6 (4) ◽  
pp. 136-140
Author(s):  
Fithria Fithria ◽  
Muhammad Adlim ◽  
Syarifah Rauzatul Jannah ◽  
Teuku Tahlil
Keyword(s):  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Intervention Program ◽  
Controlled Trial ◽  
Smoking Behavior ◽  
Smoking Prevention ◽  
Control Group ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Family Approach

Background: Smoking is a significant problem especially among Indonesian adolescents. A number of smoking prevention programs have been developed and implemented, but most of them do not work significantly for the Indonesian adolescents who are mostly Muslim.Objective: The aim of this article is to outline a study protocol for measuring the effects of Islamic-based program using family approaches on the prevention of adolescents’ smoking behavior.Methods: The study will use a cluster randomized controlled trial conducted in three junior high schools, in Aceh Province, Indonesia. A total of 150 students will be involved in this study, where each school will be represented by 50 students. Each school group will be given the respective treatments. The first group will receive health-based intervention program, the second group will receive Islamic-based intervention program, and the last group will act as a control group receiving no intervention. The outcomes include the knowledge about smoking, attitudes toward smoking, smoking intention and smoking behavior of the adolescents. All outcomes will be measured using validated questionnaires.Discussion: If the Islamic-based intervention using family approach is effective, then this approach could be implemented not only in Indonesia but also in other countries with the same social characteristics.Trial registration: Australian New Zealand Clinical Trial Registry, ACTRN 12620000465954

scholarly journals Early intervention for children at risk of visual processing dysfunctions from 1 year of age: a randomized controlled trial protocol

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Marlou J. G. Kooiker ◽  
Yoni van der Linden ◽  
Jenneke van Dijk ◽  
Ymie J. van der Zee ◽  
Renate M. C. Swarte ◽  
...  
Keyword(s):  
At Risk ◽  
Randomized Controlled Trial ◽  
Visual Processing ◽  
Intervention Program ◽  
Controlled Trial ◽  
Clinical Care ◽  
Control Group ◽  
Randomized Controlled ◽  
Extremely Preterm ◽  
Intervention Protocol

Abstract Background An increasing number of children are suffering from brain damage-related visual processing dysfunctions (VPD). There is currently a lack of evidence-based intervention methods that can be used early in development. We developed a visual intervention protocol suitable from 1 year of age. The protocol is structured, comprehensive and individually adaptive, and is paired with quantitative outcome assessments. Our aim is to investigate the effectiveness of this first visual intervention program for young children with (a risk of) VPD. Methods This is a single-blind, placebo-controlled trial that is embedded within standard clinical care. The study population consists of 100 children born very or extremely preterm (< 30 weeks) at 1 year of corrected age (CA), of whom 50% are expected to have VPD. First, children undergo a visual screening at 1 year CA. If they are classified as being at risk of VPD, they are referred to standard care, which involves an ophthalmic and visual function assessment and a (newly developed) visual intervention program. This program consists of a general protocol (standardized and similar for all children) and a supplement protocol (adapted to the specific needs of the child). Children are randomly allocated to an intervention group (starting upon inclusion at 1 year CA) or a control group (postponed: starting at 2 years CA). The control group will receive a placebo treatment. The effectiveness of early visual intervention will be examined with follow-up visual and neurocognitive assessments after 1 year (upon completion of the direct intervention) and after 2 years (upon completion of the postponed intervention). Discussion Through this randomized controlled trial we will establish the effectiveness of a new and early visual intervention program. Combining a general and supplement protocol enables both structured comparisons between participants and groups, and custom habilitation that is tailored to a child’s specific needs. The design ensures that all included children will benefit from participation by advancing the age at which they start receiving an intervention. We expect results to be applicable to the overall population of children with (a risk of) VPD early in life. Trial registration Netherlands Trial Register: NTR6952. Registered 19 January 2018.

scholarly journals A Non-Randomized Controlled Trial for the Effectiveness of the ‘Aibo’ Intervention Program for Distraction in Childhood Vaccination

2021 ◽  
Author(s):  
Kyoko Tanaka ◽  
Maoko Hayakawa ◽  
Chihiro Noda ◽  
Moemi Nakamura ◽  
Akio Nakamura ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intervention Program ◽  
Controlled Trial ◽  
Intervention Group ◽  
Behavioral Observation ◽  
Childhood Vaccination ◽  
Control Group ◽  
Randomized Controlled ◽  
Study Results ◽  
Face Scale

Abstract Procedures and actions such as injections and immobilization cause pain and distress to children. In the pediatric field, there is a need for interventions and support to alleviate the pain and distress caused by such medical procedures. In recent years, the introduction of robots as a means of distraction has begun to be attempted. In this study, we conducted a non-randomized controlled trial to examine the effect of intervention using ‘aibo’, a dog-like robot which has artificial intelligence (AI), to promote distraction in children after vaccination. As a result, 57 children (32 in the intervention group) participated in the study. Results of a t-test with the control group showed that the intervention group using aibo had significantly less pain following the post-vaccination intervention than the control group using stuffed dog (Face Scale, t(55) = 2.582, p = .0125; Behavioral Observation Scale, t(55) = 2.772, p = .00759). The results support the hypothesis that the aibo intervention group will be less distressed and able to calm down more quickly after vaccination than the control group. Conclusion : AI-powered aibo interventions that allow for interactive interaction can be an effective distraction method during painful procedures such as vaccinations.

scholarly journals The novel effectiveness of Tai Chi on cardiopulmonary fitness among stroke patients in the recovery phase: a study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Tianyang Tan ◽  
Xinyu Li ◽  
Ruina Bai ◽  
Chengchao Wang ◽  
Jiaxuan Lv ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Tai Chi ◽  
Controlled Trial ◽  
Developed Countries ◽  
Recovery Phase ◽  
Control Group ◽  
Stroke Patients ◽  
Clinical Trial Registry ◽  
Cardiopulmonary Fitness ◽  
Randomized Controlled

Abstract Background: Stroke is the leading cause of death worldwide. China faces a similar risk of stroke as developed countries because of considerable changes in lifestyle, such as overeating and smoking. Tai Chi is a traditional form of mind-body exercise that has been widely practiced in China for thousands of years. However, there are few studies on the effect of Tai Chi on the cardiopulmonary function of stroke patients in the recovery phase. Therefore, it is necessary to observe the effect of Tai Chi on the cardiorespiratory fitness of patients after stroke.Methods: This is a parallel-design, two-arm, analyst assessor-blinded, randomized controlled trial. A total of 226 stroke patients in the recovery phase will be recruited and assigned randomly to a control group or Tai Chi group at a 1:1 ratio. The patients in the Tai Chi group will perform the Tai Chi exercise. The patients in the control group will perform walking exercises. Patients in both groups will receive conventional treatments and healthy education. The primary outcomes will be VO2peak and scores on the MOS item short from health survey (SF-36) scale. Secondary outcomes will include vital capacity (VC), ejection fractions (EF), and cardiac output (CO). The assessments of the tests will be performed at three time points (before exercise, at the end of exercise, and 6 weeks after exercise). Adverse events will be recorded faithfully during the study.Discussion: If the results are positive, this study will contribute to the establishment of further guided Tai Chi rehabilitation programs.Trial registration: Chinese Clinical Trial Registry ChiCTR2000034719, Registered on 16 July 2020

scholarly journals The efficacy of the novel zinc-containing desensitizer CAREDYNE Shield on dentin hypersensitivity: a study protocol for a pilot randomized controlled trial

2020 ◽  
Author(s):  
Takashi Matsuura ◽  
Megumi Mae ◽  
Masayuki Ohira ◽  
Yasunori Yamashita ◽  
Ayako Nakazono ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Dentin Hypersensitivity ◽  
Root Caries ◽  
The Novel ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background: Dentin hypersensitivity (DH) is a condition characterized by short and sharp pain which will arise in response to tactile, chemical, thermal, evaporative or osmotic stimuli. The painful symptoms cause discomfort in patients and reduce their quality of life. Recently, the novel zinc-containing desensitizer CAREDYNE Shield has been developed as a new type of desensitizer that acts by inducing chemical occlusion of dentinal tubules, and releasing zinc ion for root caries prevention. However, the clinical effectiveness of CAREDYNE Shield on DH remains unclear. Therefore, the aim of this study is to evaluate the effectiveness of CAREDYNE Shield on DH by comparing with that of another desensitizer Nanoseal commonly used in Japan.Methods/Design: This study protocol is a two-arm parallel pilot randomized controlled trial. Forty DH patients will be randomly allocated to two groups. Participants in the intervention group will be treated with CAREDYNE Shield, while those in the control group will be treated with Nanoseal. The primary outcome is the reduction of pain intensity in response to air stimuli measured with a five-points verbal response scale from baseline to four weeks after the intervention, and Fisher's exact test will be used for analyses.Discussion: CAREDYNE Shield can be casually applied to subgingival areas and proximal surfaces because it reacts with only tooth substance. Furthermore, zinc has been reported to reduce the demineralization of enamel and dentin and inhibit biofilm formation, plaque growth and dentin collagen degradation. Therefore, CAREDYNE Shield may be expected to be a useful novel desensitizer that acts not only as a desensitizer but also as a root caries inhibitor.Trial registration:UMIN Clinical Trials Registry (UMIN-CTR), UMIN000038072. Registered on 21st September 2019.Trial statusThis study (protocol version number: version 1.4.0; approved on 22 October 2019) is ongoing. The recruitment of participants began in December 2019 and will be continued until November 2020 (1).

scholarly journals Development and Assessment of a Gastroscopy Electronic Learning System for Primary Learners: Randomized Controlled Trial

10.2196/16233 ◽  
2020 ◽  
Vol 22 (3) ◽  
pp. e16233 ◽  
Author(s):  
Shuang Li ◽  
Guoqing Li ◽  
Ying Liu ◽  
Wanying Xu ◽  
Ningning Yang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
User Satisfaction ◽  
Teaching And Learning ◽  
Controlled Trial ◽  
Learning System ◽  
Control Group ◽  
Clinical Trial Registry ◽  
Electronic Learning ◽  
Randomized Controlled ◽  
E Learning

Background Endoscopic examination is a popular and routine procedure for the diagnosis and treatment of gastrointestinal (GI) diseases. Skilled endoscopists are in great demand in clinical practice, but the training process for beginners to become endoscopy specialists is fairly long. Convenience and a self-paced, learner-centered approach make electronic learning (e-learning) an excellent instructional prospect. Objective This study aimed to develop and apply an e-learning system in gastroscopy teaching and learning and to evaluate its effectiveness and user satisfaction. Methods The e-learning software Gastroscope Roaming System was developed for primary learners. The system simulates the real structure of the upper gastrointestinal (UGI) tract to teach the main characteristics of gastroscopy under both normal conditions and conditions of common UGI tract diseases. A randomized controlled trial was conducted. Participants were randomly allocated to an e-learning group (EG)or a non–e-learning control group after a pretest. On completing the training, participants undertook a posttest and gastroscopy examination. In addition, the EG completed a satisfaction questionnaire. Results Of the 44 volunteers, 41 (93%) completed the gastroscopy learning and testing components. No significant pretest differences were found between the intervention and control groups (mean 50.86, SD 6.12 vs mean 50.76, SD 6.88; P=.96). After 1 month of learning, the EG’s posttest scores were higher (mean 83.70, SD 5.99 vs mean 78.76, SD 7.58; P=.03) and improved more (P=.01) than those of the control group, with better performance in the gastroscopy examination (mean 91.05, SD 4.58 vs mean 84.38, SD 5.19; P<.001). Overall, 85% (17/20) of the participants were satisfied with the e-learning system, and 95% (19/20) of the participants considered it successful. Conclusions E-learning is an effective educational strategy for primary learners to acquire skills in gastroscopy examination and endoscopic imaging of the GI tract. Trial Registration Chinese Clinical Trial Registry ChiCTR-IOR-17013091; http://www.chictr.org.cn/showproj.aspx?proj=22142

scholarly journals Effect of a parent-provided early intervention program on infant health and development: a randomized controlled trial

2018 ◽  
Vol 5 (3) ◽  
pp. 695
Author(s):  
Basavaraj K. ◽  
Sireesha S. ◽  
Suresh J.
Keyword(s):  
Randomized Controlled Trial ◽  
Early Intervention ◽  
Problem Solving ◽  
Intervention Program ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Early Intervention Program ◽  
Problem Solving Skills ◽  
Randomized Controlled

Background: Early Intervention Program (EIP) is a unique way of providing ideal stimulation, education and care for children. EIP are designed to provide detection, treatment, prevention of handicaps, developmental delays, and environmental deprivation as early in a child's life as possible. Objective of present study were to assess the effect of parent-provided EIP on infant cognitive, psychomotor and socio- emotional behaviors at the completion of age 12 months and to evaluate whether these effects were moderated by the infant feeding practices, general health status and socio-demographic characters.Methods: The present study was randomized controlled trial conducted at villages under Vantamuri PHC area attached to J.N Medical College, Belgaum during the period May 2012 to August 2013, with a sample size of 64, full term, normal babies and weighing ≥2.5 kg. At the end of 12 months, babies were assessed by an independent evaluator using BSID-II and ASQ/SE questionnaire.Results: In the present study the mental index (MDI) scores were higher in intervention group than control group (106.63 Vs 94.45, P=0.0001). Problem solving skills were higher in intervention group compared to control group (21.33 Vs 11.56, P=0.000). Person social skills were higher for intervention compared to control (27.66 Vs 22.34, P=0.001). Children with fewer episodes of diarrhea and acute respiratory infections showed better performance.Conclusions: Early Intervention Program effectively increases the cognitive, person social, problem solving and socio-emotional skills at 12 months of age.

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