scholarly journals Virtual reality environment using a dome screen for procedural pain in young children during intravenous placement: A pilot randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (8) ◽  
pp. e0256489
Author(s):  
Ha Ni Lee ◽  
Woori Bae ◽  
Joong Wan Park ◽  
Jae Yun Jung ◽  
Soyun Hwang ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Young Children ◽  
Controlled Trial ◽  
Intervention Group ◽  
Pediatric Emergency ◽  
Control Group ◽  
Blood Collection ◽  
Randomized Controlled ◽  
The Difference ◽  
Study Process

We assessed the feasibility and potential efficacy of a virtual reality (VR) environment using a dome screen as a distraction method in young children during intravenous (IV) placement in the pediatric emergency department. This randomized controlled pilot study enrolled children aged 2 to 6 years who underwent IV placement into either the intervention group or the control group. Children in the intervention group experienced VR using a dome screen during IV placement. The child’s pain intensity was measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale at four time points of IV placement: immediately after arrival to the blood collection room (base); immediately after the child laid down on the bed (preparation); when the tourniquet was applied (tourniquet); and the moment at which the needle penetrated the skin (venipuncture). The guardian’s satisfaction and rating of the child’s distress were assessed using a 5-point Likert-type questionnaire. We recruited 19 children (9 in the intervention group and 10 in the control group). Five children in the control group were excluded from the analysis because of missing video recordings (n = 3), failed first attempt at IV placement (n = 1), and the child’s refusal to lie on the bed during the procedure (n = 1). No side effects of VR were reported during the study period. Although the average FLACC scale score at each time point (preparation, tourniquet, venipuncture) was lower in the intervention group than the control group, the difference was not statistically significant (2.3, interquartile range [IQR]: 2.0–3.0; vs. 3.3, IQR: 2.7–6.7, P = 0.255). There were no statistically significant differences between the groups in the guardian’s satisfaction and anxiety or his/her rating of the child’s pain and anxiety. The guardians and emergency medical technicians reported satisfaction with the use of VR with a dome screen and considered it a useful distraction during the procedure. VR using a dome screen is a feasible distraction method for young children during IV placement. A larger clinical trial with further development of the VR environment and study process is required to adequately evaluate the efficacy of VR using a dome screen.

scholarly journals The Effect of Providing Eggs Early in Complementary Feeding on Energy Intake and Dietary Diversity: The Mazira Project Randomized Controlled Trial

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 863-863
Author(s):  
Chessa Lutter ◽  
Bess Caswell ◽  
Charles Arnold ◽  
Lora Iannotti ◽  
Elizabeth Prado ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Young Children ◽  
Energy Intake ◽  
Complementary Feeding ◽  
Dietary Diversity ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Minimum Dietary Diversity

Abstract Objectives Complementary feeding diets in low- and middle-income countries are usually inadequate to meet requirements for healthy growth and development. Food-based interventions may prevent nutrient inadequacies provided they do not replace other nutrient-rich foods. They may also be more sustainable than manufactured food supplements. We describe the contribution of daily egg supplementation to usual energy intake, usual energy intake by food group, and minimum dietary diversity of rural Malawian infants and young children. Methods We conducted a randomized controlled trial in rural Malawi in which 660 children aged 6 to 9 months were randomly allocated to receive an egg a day for 6 months or to a control group. Dietary intake of foods and drinks was assessed at baseline, 3-month midline, and 6-month endline visits using a tablet-based mulitpass 24-hour recall. Up to two repeat recalls were collected at each timepoint in a subsample of 100 children per intervention group. Results The intervention resulted in an increased usual energy intake in the intervention group of 30 kcal at midline (P = 0.128) and 36 kcal at endline (P = 0.087). It also resulted in a 7 kcal displacement of legumes and nuts in children at endline (P = 0.059). At midline and endline, usual energy intake from eggs was about 30 kcal higher in the egg group compared to controls (P < 0.0001). Compared to controls, children in the egg group were over 9 times more likely to consume eggs at midline and endline. At midline and endline more than 80% of children in the egg group consumed a minimally diverse diet compared to 53% at midline and 60% at endline in the control group. Conclusions Mothers in the egg group fed eggs to young children on a regular basis without substantial displacement of other nutrient-rich complementary foods. The intervention resulted in higher energy intake from eggs, greater dietary diversity, and an increased percentage of children meeting a minimum dietary diversity cutoff. Funding Sources Bill & Melinda Gates Foundation.

scholarly journals Improving surgical patient’s knowledge about safe use of opioids: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Helen R Doherty ◽  
Enoch Lam ◽  
Maria Garstka ◽  
Junior Chuang ◽  
David Tai Wong ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Knowledge Score ◽  
Controlled Study ◽  
Control Group ◽  
Routine Practice ◽  
Opioid Use ◽  
Randomized Controlled ◽  
The Difference ◽  
The Impact

Abstract Background Currently, it is not routine practice to provide standardized patient education for safe postoperative opioid use. The objective of our study was to evaluate the impact of an educational pamphlet for surgical patients on knowledge about safe use, proper storage, and disposal of opioids.Methods This multi-center randomized controlled study recruited 100 patients in the pre-operative clinic. Inclusion criteria were English-speaking, ≥ 18 years, able to give informed consent, and not on opioids for chronic pain or within the past 30 days. All patients completed a baseline knowledge questionnaire (maximum score 38) on opioid safety. Patients were randomized to intervention: educational pamphlet, or control: standard care (no pamphlet) group. Questionnaires were repeated immediately post-education in the intervention group, and at 15, and 30 days after surgery in both groups. The primary outcome was change in knowledge score post-education in the intervention compared to control group. Secondary outcomes were immediate post-education, 15, and 30-day score, and answering safe storage, and disposal questions correctly.Results Between groups, the post-education score immediately after the intervention was higher in the intervention vs. control group baseline 34.2 [95% CI 33.1–35.3] vs 28.3 [95% CI 26.6–29.9]; P < 0.0001). In the intervention vs control group, mean scores were higher 31.6 (95% CI 30.5–32.7) vs 29.1 (95% CI 27.9–30.2; P = .002) at 15 days, and 32.4 (95%CI 31.4–33.5) vs 30.5 (95% CI 29.2–31.7; P = .017) at 30 days. Within the intervention group, the mean score immediately post-education (34.2 [95% confidence interval (CI) 33.1–35.3]) was higher than baseline (27.8 [95% CI 26.3–29.3]); P < 0.0001. Within the intervention group, the difference in mean score versus baseline was 3.8 (95% CI 2.1–5.5) at 15 days, and 4.6 (95% CI 2.9–6.3) at 30 days, (P < 0.05 for all timepoints). For safe disposal, a correct answer was given (intervention vs control group) by 100% vs 89.7% at 30 days (P = 0.04).Conclusions Within the intervention group, there was a significant improvement in knowledge on safe opioid use immediately post-education, and retention of knowledge at 15 and 30 days postoperatively. The intervention group had better knowledge scores compared to the baseline control group, and 15 and 30 days after surgery.Trial Registration: This study was registered in clinicaltrials.gov: NCT03959787 on May 22, 2019.

scholarly journals Reducing “Screen-Time” and Promoting Self Care Activities among Overweight and Obese Pre-Adolescents: A Randomized Controlled Trial

2021 ◽  
Vol 5 (4) ◽  
pp. OR1-OR4
Author(s):  
Sahil Bansal ◽  
Meera Pradhan ◽  
Ishan Nagar ◽  
Praveen Kumar N.G.
Keyword(s):  
Randomized Controlled Trial ◽  
Screen Time ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Study Data ◽  
Control Group ◽  
Randomized Controlled ◽  
Public Health Challenges ◽  
The Difference

INTRODUCTION: Pediatric obesity has been considered as one of the most serious public health challenges in the world. AIM: To reduce “Screen-time” and promoting self care activities among overweight and obese pre-adolescents (aged 10-12 years) in India through proper intervention measures. MATERIALS AND METHOD: Designed as a two-armed randomized controlled trial, 537 pre-adolescents aged 10-12 years were enrolled in this online study. Data was collected through a questionnaire (containing close-ended 26 questions). Pre- adolescents, whose BMI was classified as “overweight” and “obese” were enrolled and randomly assigned (flip of coin) to the intervention group and control group. The intervention group were then given monthly online one-on-one sessions (to maintain confidentiality) by five standardized instructors. The study lasted for four months and a total of four individual sessions were provided to each child in the intervention group. Data was transferred into Excel for descriptive statistics, and analysed using SPSS version 22.0 using the paired t-test and multi variate logistic regression was applied keeping the significance value of p as  0.05. RESULTS: A total of 537 pre- adolescents met the inclusion criteria. Among them, 270(50.3%) belonged to the intervention group and 267 (49.7%) belonged to the control group. Majority of the pre- adolescents were males (59.4%). In the intervention group, there were 61.8% overweight pre-adolescents, which reduced to 42.9%, while in the control group, there were 89.5% overweight pre-adolescents, which reduced 9.8% and the difference between both the groups was observed to be significant (p=0.02). CONCLUSION: Techniques used in the intervention group led to positive outcomes like weight loss and reduced screen time among the pre-adolescents which in turn, helped reduce the global burden of disease.

scholarly journals The VRIMM study: Virtual Reality for IMMunisation pain in young children—protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e038354
Author(s):  
Kirrily Ellerton ◽  
Harishan Tharmarajah ◽  
Rimma Medres ◽  
Lona Brown ◽  
David Ringelblum ◽  
...  
Keyword(s):  
General Practice ◽  
Virtual Reality ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Pain Scale ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
The Difference ◽  
Randomised Controlled

IntroductionPain caused by routine immunisations is distressing to children, their parents and those administering injections. If poorly managed, it can lead to anxiety about future medical procedures, needle phobia and avoidance of future vaccinations and other medical treatment. Several strategies, such as distraction, are used to manage the distress associated with routine immunisations. Virtual reality (VR), a technology which transports users into an immersive ‘virtual world’, has been used to manage pain and distress in various settings such as burns dressing changes and dental treatments. In this study, we aim to compare the effectiveness of VR to standard care in a general practice setting as a distraction technique to reduce pain and distress in 4-year-old children receiving routine immunisations.Methods and analysisThe study is a randomised controlled clinical trial comparing VR with standard care in 100 children receiving routine 4-year-old vaccination. Children attending a single general practice in metropolitan Melbourne, Australia will be allocated using blocked randomisation to either VR or standard care. Children in the intervention group will receive VR intervention prior to vaccination in addition to standard care; the control group will receive standard care. The primary outcome is the difference in the child’s self-rated pain scores between the VR intervention and control groups measured using The Faces Pain Scale-Revised. Secondary outcomes include another measure of self-rated pain (the Poker Chip Tool), parent/guardian and healthcare provider ratings of pain (standard 100 mm visual analogue scales) and adverse effects.Ethics and disseminationEthics approval has been obtained in Australia from the Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee (NREEC 18-010). Recruitment commenced in July 2019. We plan to submit study findings for publication in a peer-reviewed journal and presentation at relevant conferences.Trial registration numberACTRN12618001363279.

scholarly journals PENGARUH PEMBERIAN MIXED JUICE TERHADAP ASUPAN ENERGI IBU BERSALIN

2018 ◽  
Vol 7 (2) ◽  
pp. 114
Author(s):  
Sri Maharani
Keyword(s):  
Energy Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Second Stage ◽  
Randomized Controlled ◽  
Uterine Muscle ◽  
Significant Difference ◽  
The Difference ◽  
Lactate Levels

The process of labor, especially the second stage of increased contraction in the uterine muscle that causes decreased blood supply and oxygen needed by muscles to convert glucose into energy. Anaerobic metabolism usually occurs in activities that require large energy and briefly.This study to analyze differences in energy intake in mothers giving birth between those who were given mixed juice and those who were given the freedom to consume food and beverages during labor. This study uses randomized controlled trial design, single blinded. There was a significant difference in control group energy intake and intervention group (p <0.05). Giving mixed juice during delivery in maternal mothers affects maternal satisfaction and the difference of maternal energy intake, but there is no difference in lactate levels of infants born.

Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Musheer Abdulwahid Al-Jaberi ◽  
Muhamad Hanafiah Juni ◽  
Hayati Kadir Shahar ◽  
Siti Irma Fadhilah Ismail ◽  
Murad Abdu Saeed ◽  
...  
Keyword(s):  
International Students ◽  
Acculturative Stress ◽  
Educational Program ◽  
Public Universities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Policy Makers ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i>&lt;.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;amp;EncHid=&amp;amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

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