scholarly journals Mobile Phone Virtual Reality Game for Pediatric Home Burn Dressing Pain Management, a Randomized Clinical Trial

2022 ◽  
Author(s):  
Megan Armstrong ◽  
Jonathan Lun ◽  
Jonathan I Groner ◽  
Rajan K Thakkar ◽  
Renata Fabia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Virtual Reality ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Ease Of Use ◽  
Control Group ◽  
Perceived Pain ◽  
English Speaking ◽  
Dressing Change ◽  
At Home

Importance: Virtual Reality (VR) gaming is considered a safe and effective alternative to standard pain alleviation in the hospital, we advocate for its use during repeated redressing at home. Objective: This study will address the effectiveness and feasibility of the Virtual Reality Pain Alleviation Tool (VR-PAT) that was developed by the research team for repeated at-home burn dressing changes. Design, Setting and Participants: Randomized clinical trial among patients recruited at the Nationwide Childrens Hospital (NCH) outpatient burn clinic between September 2019 and June 2021. We included English-speaking burn patients 5-17 years old requiring daily dressing changes for at least one week after first outpatient dressing change. Interventions: One group played an interactive VR-PAT game during dressing changes, while the other utilized standard distraction techniques available in the home for a week. Both child and caretaker were later asked to assess perceived pain. Those in the intervention group were asked to evaluate convenience and enjoyment of the VR-PAT game. Outcomes: Patients were asked to rate perceived pain on a scale of 1-10, and caregivers were asked to rate observed pain on a scale of 1-10. For the VR-PAT group, patients were also asked to rate various aspects of the VR game on a scale of 1-10 and caregivers were asked questions assessing ease of use. Conclusions: Subjects found the VR-PAT to be a useful distraction during home dressing changes and reported it be easy to implement. In the VR-PAT group, child and caregiver reported pain decreased as the week of dressing changes progressed and was lower than those in the control group after the fourth dressing change. Children playing the VR-PAT reported consistent happiness and fun as the week went on and increased realism and engagement, which means our results were not just due to the novel experience of VR-PAT.

scholarly journals Dietary habits and metabolic response improve in obese children whose mothers received an intervention to promote healthy eating: Randomized clinical trial

2020 ◽  
Author(s):  
Iris Nallely López-Contreras ◽  
Jenny Vilchis-Gil ◽  
Miguel Klünder-Klünder ◽  
Salvador Villalpando-Carrión ◽  
Samuel Flores-Huerta
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Healthy Eating ◽  
Dietary Habits ◽  
Metabolic Response ◽  
Intervention Group ◽  
Control Group ◽  
Obese Children ◽  
Mixed Effect ◽  
At Home

Abstract Background: Lifestyles habits such as eating unhealthy foodscommence at home and are associated with the development of obesity and comorbidities such as insulin resistance, metabolic syndrome, and chronic degenerative diseases, which are the main causes of death in adults.The present study compared changes in dietary habits, behaviors and metabolic profiles of obese children whose mothers attended at the hospital to group sessions, with those who received the usual nutritional consultation. Methods: Randomized clinical trial, 177 mother/obese child pairs participated, 90 in the intervention group and 87 in the control group. The intervention group attended six group education sessions to promote healthy eating, being this an alternative of change of habits in children with obesity. The control group received the usual nutritional consultation; both groups were followed up for three months. Frequency of food consumption, behaviors during feeding in the house and metabolic profile was evaluated. Mixed effect linear regression models were used to evaluate the effect of the intervention on the variables of interest, especially in HOMA-IR. Results: The intervention group reduced the filling of their dishes (p = 0.009), forcing the children to finish meals (p = 0.003) and food substitution (p < 0.001), moreover increased the consumption of roasted foods (p = 0.046), fruits (p = 0.002) and vegetables (p < 0.001). The children in the control group slightly increased HOMA-IR levels (0.51; 95% CI -0.48 to 1.50), while the children in the intervention group significantly decreased (-1.22; 95% CI -2.28 to -1.16). The difference in HOMA-IR between the control and intervention group at the end of the follow-up was -1.67; 95% CI: -3.11 to -0.24. Conclusions: The educational intervention improved some eating habits at home, as well as HOMA-IR levels; why we consider that it can be an extra resource in the management of childhood obesity. Trial registration: Clinicaltrials.gov, NCT04374292 (Date assigned: May 5, 2020). Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04374292

Effects of a diuretic adjustment algorithm protocol on heart failure admissions: A randomized clinical trial

2021 ◽  
pp. 1357633X2110096
Author(s):  
Maria KEF Feijó ◽  
Karen Brasil Ruschel ◽  
Daniela Bernardes ◽  
Eduarda B Ferro ◽  
Luis E Rohde ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Heart Association ◽  
Functional Class ◽  
Emergency Department Visits ◽  
Control Group ◽  
Point Change ◽  
Clinical Instability

Introduction The aim of this study was to evaluate the effectiveness of a diuretic adjustment algorithm (DAA) in maintaining clinical stability and reducing HF readmissions using telemonitoring Technologies. Methods Randomized clinical trial of patients with an indication for furosemide dose adjustment during routine outpatient visits. In the intervention group (IG), the diuretic dose was adjusted according to the DAA and the patients received telephone calls for 30 days. In the control group (CG), the diuretic dose was adjusted by a physician at baseline only. Co-primary outcomes were hospital readmission and/or emergency department visits due to decompensated HF within 90 days, and a 2-point change in the Clinical Congestion Score and/or a deterioration in New York Heart Association functional class within 30 days. Results A total of 206 patients were included. Most patients were male ( n=119; 58%), with a mean age of 62 (SD 13) years. Four patients (2%) in the IG and 14 (7%) in the CG were hospitalized for HF (odds ratio (OR) 0.31 (0.10–0.91); p=0.04). Multivariate analysis showed a reduction of 67% in readmissions and/or emergency department visits due to decompensated HF in the IG compared with the CG (95% CI 0.13–0.88; p=0.027). Regarding the combined outcome of HF readmission and/or emergency department visits or clinical instability, the IG had 20% fewer events than the CG within 30 days (IG: n=48 (23%), CG: n=70 (34%); OR 0.80 (0.63–0.93); p=0.03). Discussion Using DAA improved the combined outcome in these outpatients, with favorable and significant results that included a reduction in HF admissions and in clinical instability. (NCT02068937)

Effect of prenatal recommendations of Traditional Persian Medicine on obstetric outcomes: a randomized clinical trial

2018 ◽  
Vol 15 (3) ◽  
Author(s):  
Mansoor Keshavarz ◽  
Maryam Kashanian ◽  
Soodabeh Bioos ◽  
Yasaman Vazani
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Active Phase ◽  
Obstetric Outcomes ◽  
Control Group ◽  
Control Groups ◽  
Persian Medicine ◽  
Traditional Persian Medicine ◽  
And Control

Abstract Background Traditional Persian Medicine (TPM) is an ancient medical system that provides suggestions to improve the health of mothers and children during pregnancy and labor. Persian physicians believed that these instructions made labor easier, safer, and less painful. Methods The present randomized clinical trial was conducted among women at 33–38 weeks of pregnancy in Tehran, Iran. TPM instructions consisted of diet, bathing, and application of oil from the 38th week of pregnancy to the onset of labor. The primary outcome was the duration of the active phase of labor. Results The mean duration of the active phase was 331.60 ± 151.48 min for the intervention group and 344.40 ± 271.46 min for the control groups, but it was not statistically significant. The active phase was significantly shorter in women who had better compliance (p=0.03). The need for oxytocin augmentation was 53.3% in the control group and 38.5% in the intervention group (p=0.17). The rate of perineal infection was 13% in the control group and 0% in the intervention group (p=0.11). Conclusions The active phase was not different in the intervention and control groups, but it was shorter in compliant women. It is possible that prolonged use of these recommendations in combination with a sitz baths and a larger sample size could result in more significant outcomes.

scholarly journals The Effect of Support Surfaces on the Incidence of Pressure Injuries in Critically Ill Patients: A Randomized Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Wesley Henrique Bueno de Camargo ◽  
Rita de Cassia Pereira ◽  
Marcos T. Tanita ◽  
Lidiane Heko ◽  
Isadora C Grion ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Intervention Group ◽  
Control Group ◽  
Support Surface ◽  
Intention To Treat ◽  
Support Surfaces ◽  
Effect Of Support

Purpose. To analyze whether a viscoelastic mattress support surface can reduce the incidence of stage 2 pressure injuries compared to a standard hospital mattress with pyramidal overlay in critically ill patients. Method. A randomized clinical trial with intention-to-treat analysis was carried out recruiting patients with Braden scale ≤14 on intensive care unit admission from April 2016 to April 2017. Patients were allocated into two groups: intervention group (viscoelastic mattress) and control group (standard mattress with pyramidal overlay). The level of significance adopted was 5%. Results. A total of 62 patients were included in the study. There was a predominance of males (53%) and the mean age was 67.9 (SD 18.8) years. There were no differences in clinical or severity characteristics between the patients in the control group and the intervention group. Pressure injuries occurred in 35 patients, with a median time of 7 days (ITQ 4–10) from admission. The frequency of pressure injuries was higher in the control group (80.6%) compared to the intervention group (32.2%; p<0.001). Conclusions. Viscoelastic support surfaces reduced the incidence of pressure injuries in moderate or higher risk critically ill patients when compared to pyramidal support surfaces.

scholarly journals Effect of Mindfulness Sessions on Chronic Fatigue Syndrome and Job Satisfaction of Nurses: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Nasrin Bonakdari ◽  
Nadereh Mohammadi ◽  
Mohammad Reza Taghvizadeh Yazdi ◽  
Reza Norouzadeh ◽  
Mohammad Abbasinia ◽  
...  
Keyword(s):  
Job Satisfaction ◽  
Clinical Trial ◽  
Chronic Fatigue Syndrome ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Clinical Trial Design ◽  
Well Being ◽  
Chronic Fatigue ◽  
Control Group ◽  
Fatigue Syndrome

Abstract Background: Nursing is considered a stressful profession, so nurses are at higher risk of physical and mental illness. Mindfulness is an important concept for nursing with practical implications for nurse well-being, development, and quality nursing care sustainability.Objectives: This study identified mindfulness sessions' effect on nurses' chronic fatigue syndrome(CFS) and job satisfaction )JS.(Methods: A randomized clinical trial design was conducted on 80 nurses to intervention and control groups. The intervention in the intervention group was eight mindfulness sessions training, and the control group had no intervention. Nurses' CFS and JS were assessed using the Minnesota Satisfaction Questionnaire and The Multidimensional Fatigue Inventory.Results: After implementing a mindfulness-based stress reduction program, the intervention group nurses reported lower CFS and higher JS than the control group(p<0.005). Conclusion: The findings of this study indicate the effectiveness of mindfulness programs on improving nurses' chronic fatigue and JS. Since CFS and job dissatisfaction are two disturbing elements for nurses' optimal performance in professional and personal life, this study can recommend the implementation of mindfulness exercises as a routine, operational and uncomplicated program in nurses.

scholarly journals The impact of social network-based nursing care training on oncology nurses’ occupational stress and self-efficacy: Non-randomized clinical trial

2020 ◽  
Author(s):  
Mehri Bozorgnejad ◽  
Tahereh Najafi Ghezeljeh ◽  
Hamid Haghani ◽  
Amin Iri
Keyword(s):  
Clinical Trial ◽  
Social Network ◽  
Randomized Clinical Trial ◽  
Occupational Stress ◽  
Nursing Care ◽  
Self Efficacy ◽  
Intervention Group ◽  
Oncology Nurses ◽  
Control Group ◽  
Care Training

Background & Aim: Inadequate clinical knowledge is one of the leading causes of stress and low occupational self-efficacy among nurses. Nursing training can enhance self-efficacy and reduce stress. Therefore, this study aimed to determine the effect of social network-based nursing care training, using mobile phones, occupational stress, and self-efficacy among oncology nurses. Methods & Materials: This non-randomized clinical trial study was conducted on 78 nurses working in oncology wards of two selected educational hospitals in Tehran in 2018. The nurses entered the study through available sampling. They were randomly assigned to two groups of control and intervention. Nursing care training in chemotherapy was provided to the nurses in the intervention group through a mobile phone social network for four weeks. On the other hand, the nurses in the control group were provided with the routine training pamphlets and brochures in the oncology ward. The nurses’ stress level was examined using an expanded nursing stress scale and their occupational stress was measured using a job self-efficacy questionnaire once before the intervention and then one month after the intervention. The data analysis was then performed according to independent t-test, paired t-test, and chi-square using SPSS software version 16. Results: The two groups were homogeneous in terms of age, gender, work experience, and education. There was no significant difference in terms of occupational stress and self-efficacy between the two groups before the intervention (P<0.05). The changes in the occupational stress score were statistically significant (P<0.05) among the nurses in the intervention group. Moreover, the changes in the occupational self-efficacy score were statistically significant among nurses in the intervention group compared to the control group (P<0.05). Conclusion: Educational intervention through social networking can lead to a reduction of occupational stress and an increase in self-efficacy among oncology nurses. Reducing stress and increasing nurses’ occupational self-efficacy will improve their performance at the bedside. This is an easy, inexpensive, and effective training method that can be used by health managers and educators to enhance employee’s performance.

scholarly journals The Effect of Simultaneous Sand-Ice Bag Application on Hemorrhage and Hematoma after Percutaneous Coronary Intervention: A Randomized Clinical Trial

2020 ◽  
Vol 9 (4) ◽  
pp. 188-194
Author(s):  
Maryam Valikhani ◽  
Seyyed Mousa Mahdizadeh ◽  
Ali Eshraghi ◽  
Seyyed Reza Mazloum ◽  
Javad Dehghani
Keyword(s):  
Clinical Trial ◽  
Percutaneous Coronary Intervention ◽  
Randomized Clinical Trial ◽  
Hospital Costs ◽  
Intervention Group ◽  
Coronary Intervention ◽  
Control Group ◽  
Selective Treatment ◽  
Percutaneous Coronary ◽  
Coronary Syndromes

Introduction: Angioplasty is widely used as a selective treatment for acute coronary syndromes. The complications of this procedure often lead to an increase in the length of the patients’ stay and hospital costs. Therefore, this study aimed to determine the effect of using sand and ice bags on hematoma and hemorrhage after percutaneous coronary intervention (PCI). Methods: In this randomized clinical trial, study was completed with participation of 60 patients with femoral angioplasty candidate, referring to Imam Reza hospital in Mashhad, were randomly divided into control and intervention groups. In the control group, a sand bag was placed on the location for up to 4 hours. In the intervention group, the ice bag and the sand bag were used simultaneously for 15 minutes, and then for 45 minutes, with the pressure of the sand bag only. This cycle was repeated four times. Hemorrhage (volume and weight) and hematoma (area and lump) were checked four times. The data were analyzed using SPSS software version 22. Results: The rate of hemorrhage after intervention was significantly reduced in the intervention group compared to the control group. Although the incidence of hematoma in the intervention group decreased from control to 20% to 6.7%, but the statistical test was not significant. Conclusion: According to the results of the present study, the simultaneous sand-ice bag application can reduce post-PCI’ hemorrhage (and hematoma rate, though insignificantly) through compression and vasoconstriction.

scholarly journals Evaluation of the Effect of Atorvastatin Administration on the Outcomes of Patients with Traumatic Brain Injury: A Double-Blinded Randomized Clinical Trial

2021 ◽  
Vol 11 (4) ◽  
Author(s):  
Farhad Soltani ◽  
Farahzad Janatmakan ◽  
Sara Jorairahmadi ◽  
Fatemeh Javaherforooshzadeh ◽  
Pooyan Alizadeh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Randomized Clinical Trial ◽  
Rating Scale ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
Disability Rating Scale ◽  
Double Blinded

Background: Traumatic brain injury (TBI) is one of the common causes of long-term disabilities and mortality. This study aimed to evaluate the effect of atorvastatin administration on the Glasgow Coma Scale (GCS), Glasgow Outcome Scale (GOS), and Disability Rating Scale (DRS) in patients with TBI. Methods: This double-blinded randomized clinical trial included 60 patients with TBI in Golestan Hospital of Ahvaz, Iran. After obtaining an informed consent from all patients, the patients were randomly assigned into two groups. For the intervention group, atorvastatin with a daily dose of 20 mg was used. The control group was administered the same amount of placebo for 10 days. Changes in the level of consciousness were measured using the GCS, and functional recovery rate in patients was measured by GOS and DRS in the third follow-up month. Results: According to the obtained results, compared with the control group, the atorvastatin administration significantly increased the level of GCS and DRS within 2 - 3 months post-intervention and improved GOS since the tenth day after the study (P < 0.05). Conclusions: The results revealed the positive effect of atorvastatin on the improvement of outcomes measurements such as GCS, DRS, and GOS in patients after moderate and severe TBI.

scholarly journals Effectiveness of a Group Educational Intervention – Prolact - In Primary Care to Promote Exclusive Breastfeeding. A Cluster Randomized Clinical Trial.

2021 ◽  
Author(s):  
María Jesús Santamaría-Martín ◽  
Susana Martín Iglesias ◽  
Christine Schwarz ◽  
Milagros Rico-Blázquez ◽  
Julián Alexander Portocarrero-Nuñez ◽  
...  
Keyword(s):  
Primary Care ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Educational Intervention ◽  
Exclusive Breastfeeding ◽  
Intervention Group ◽  
Control Group ◽  
Usual Practice ◽  
Factors Associated ◽  
Cluster Randomized

Abstract Background: The rates of exclusive breastfeeding at 6 months in Spain are far from the target recommended by the World Health Organization, which is 50% by 2025. Evidence of the effectiveness of group interventions in late postpartum is limited. The objective of this study was to evaluate the effectiveness of the PROLACT group educational intervention for increasing the proportion of mother-child dyads with exclusive breastfeeding at 6 months compared to the usual practice in primary care.Method: Multicentre cluster randomized clinical trial. A total of 434 mother-child dyads (215 in the control group and 219 in the intervention group) who breastfed exclusively in the first 4 weeks of the infant's life and agreed to participate were included. The main outcome variable was exclusive breastfeeding at 6 months. Secondary variables were the type of breastfeeding, reasons for abandonment, degree of adherence and satisfaction with the intervention. To study the effectiveness, the difference in the proportions of dyads with exclusive breastfeeding at 6 months was calculated, and the relative risk (RR) and number needed to treat (NNT) were calculated with their 95% CIs. To study the factors associated with the maintenance of exclusive breastfeeding at 6 months, a multilevel logistic regression model was fitted. All analyses were performed according to intention to treat.Results: The percentage of dyads with exclusive breastfeeding at 6 months was 22.4% in the intervention group and 8.8% in the control group. The PROLACT intervention obtained an RR of 2.53 (95% CI 1.54-4.15) and an NNT of 7 (95% CI 5-14). The factors associated with exclusive breastfeeding at 6 months were the PROLACT intervention, OR 3.51 (95% CI 1.55-7.93); age > 39 years, OR 2.79 (95% CI 1.02-7.6); previous breastfeeding experience, OR 2.61 (95% CI 1.29-5.29); monthly income/person > 833.33 €, OR 2.15 (95% CI: 0.996-4.65); planning to start work before the infant was 6 months old, OR 0.35 (0.19-0.63); and use of a pacifier, OR 0.58 (95% CI 0.30-1.11).Conclusions: The PROLACT group educational intervention in primary care is more effective than the usual practice for maintaining exclusive breastfeeding at 6 months.Trial registration: The trial was registered with ClinicalTrials.gov under code number NCT01869920 (03/06/2013).

The Effect of Olive Oil and Honey Combination on Episiotomy Wound Healing and Pain Relief: A Randomized Clinical Trial

2020 ◽  
Vol 16 (2) ◽  
pp. 145-151
Author(s):  
Arezoo Shayan ◽  
Hadis Sourinezhad ◽  
Fariba Barzegar ◽  
Hassan Ahmadinia ◽  
Zahra Masoumi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Wound Healing ◽  
Pain Relief ◽  
Pain Intensity ◽  
Olive Oil ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Perineal Pain ◽  
Control Group ◽  
Primiparous Women

Background: Episiotomy is one of the most common surgical procedures in the world that is associated with perineal pain and can be exposed to infection, or might be healed with delay. Objective: The aim of this study was to investigate the effects of honey-olive oil combination on episiotomy wound healing and pain relief in primiparous women. Methods: This single-blind, parallel randomized clinical trial (IRCT20120215009014N208) was conducted on 80 primiparous women. They were allocated randomly to each of the groups through random allocation rule: 40 in honey-olive oil group and 40 in the control group. Every 12 hours and for 14 days, the treatment group used about 1 inch of the cream on the wound area. Pain intensity and wound healing were measured by REEDA Scale and Visual Analogue Scale on days 7, 10, and 14 in both groups. The statistical analyst was not informed about the allocation of the groups. A significant level of 0.05 was considered. Results: There was a significant difference between healing score and pain intensity between the two groups on 7th, 10th and 14th postpartum days (p <0.05). Wound healing occurred much faster (Scores on days 7,10, and 14 were 11.25±2.13, 7.47±1.96 and 4.95±1.53 in the control group and 4.45±1.25, 2.32±.69 and 10±.30 in the intervention group, p <0.05). Moreover, pain intensity was significantly relieved in those who used Honey and olive oil cream (the scores were 5.6750±1.43, 3.3500±1.52, 2.2250±1.34 in the control group and 1.9750±1.52, .2250±.57, .0250±.15 in the intervention group, p<0.05). Conclusion: Using honey and olive oil combination improves episiotomy wound healing and also relieves its’ associated pain.

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