Single-centre study on the use of virtual reality in the reduction of pain after the administration of vaccines in children aged 3 to 6 years in primary care centres in Central Catalonia: randomized clinical trial (Preprint)

2021 ◽  
Author(s):  
Mercedes de la Cruz Herrera ◽  
Aïna Fuster Casanovas ◽  
Queralt Miró Catalina ◽  
Mireia Cigarrán Mensa ◽  
Pablo Alcántara Pinillos ◽  
...  
Keyword(s):  
Primary Care ◽  
Clinical Trial ◽  
Virtual Reality ◽  
Intervention Group ◽  
Third Party ◽  
Primary Care Centre ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Care Centre ◽  
Reduction Of Pain

BACKGROUND Pain and anxiety caused by vaccination and other medical procedures in childhood can cause discomfort for both the patient and their parents. Virtual reality (VR) is a technology capable of entertaining and distracting the user. Among its many applications, we find the improvement of pain management and the reduction of anxiety in patients undergoing medical interventions. OBJECTIVE Reduction of pain and anxiety after the administration of two vaccines in children aged 3 to 6 years. METHODS Randomized, parallel, controlled clinical trial with two assigned groups. The intervention group will wear virtual reality goggles during the administration of two vaccines, while the control group will receive standard primary care centre care for the procedure. Randomization will be carried out using the "RandomizedR" computer system, a randomization tool of the R Studio program. This is an open or unblinded trial, both the subject and the investigator will know the assigned treatment group. Due to the nature of the VR intervention, it is impossible to blind patients, caregivers or observers. However, a blind third party assessment will be carried out. The study population focuses on children aged 3 to 6 years, included in the patient registry and cared for in the primary care centre of the region of Central Catalonia, who will receive the following vaccines during the well child check-up: triple viral + varicella at 3 years of age and hepatitis A + Diphtheria-Tetanus-Pertussis at 6 years of age. RESULTS The study is scheduled to begin in January 2022 and is scheduled to end in January 2023 when the statistical analysis will begin. CONCLUSIONS Virtual reality can be a useful tool in paediatric procedures that generate pain and anxiety. CLINICALTRIAL The clinical trial has been approved by the IDIAP Jordi Gol i Guirna ethics committee with code 4R21/061.

scholarly journals The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zahra Barati ◽  
Mina Iravani ◽  
Majid Karandish ◽  
Mohammad Hosein Haghighizadeh ◽  
Sara Masihi
Keyword(s):  
Clinical Trial ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Standard Diet ◽  
Oat Bran ◽  
Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

scholarly journals Effectiveness of a home care teaching program for prostatectomized patients: a randomized controlled clinical trial

2019 ◽  
Vol 53 ◽  
Author(s):  
Luciana Regina Ferreira da Mata ◽  
Cissa Azevedo ◽  
Mariana Ferreira Vaz Gontijo Bernardes ◽  
Tânia Couto Machado Chianca ◽  
Maria da Graça Pereira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Home Care ◽  
Self Efficacy ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Teaching Program ◽  
Significant Difference ◽  
The Times

ABSTRACT Objective: To evaluate the effectiveness of a teaching program for hospital discharge of patients submitted to radical prostatectomy based on the self-efficacy construct of the Cognitive Social Theory. Method: A controlled clinical trial carried out on a 2-month follow-up of 68 prostatectomized men randomized into intervention group (n = 34) and control (n = 34). The intervention group received routine guidance from the service plus the teaching program. The control group only received routine guidance from the service. The data collection instruments were: sociodemographic and clinical questionnaire, self-efficacy scale, hospital depression and anxiety scale, household care knowledge questionnaire, and an item on satisfaction with a score of 1 to 5. Results: There was a significant difference between the intragroups for satisfaction (p<0.001) and knowledge (p<0.001) of the pre-test to the post-test. In the intervention group, there were significant changes between the times for anxiety (p=0.011) and knowledge (p<0.001). Conclusion: The teaching program with a combination of oral guidance, written instruction and telephone follow-up was effective in improving knowledge about home care and personal satisfaction. Brazilian Registry of Clinical Trials: RBR-5n95rm.

scholarly journals Efficacy of a Chinese Herbal Medicine Compound Zhangpi Ointment against Hydroxyurea-Induced Leg Ulcers: A Prospective, Randomized, Open-Label, Controlled Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
Yu-yang Pang ◽  
Yan Li ◽  
Gang Kui ◽  
Yong Tang ◽  
Ming-juan Liao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Myeloproliferative Neoplasms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Complete Healing ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Leg Ulcers ◽  
Open Label ◽  
Chinese Herbal

Objective.The randomized controlled trial was to evaluate the efficacy of topical Chinese herbal Zhangpi Ointment for hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms.Patients and Methods.This single-center, prospective, randomized, open-label, controlled clinical trial conducted at Shanghai Ninth People’s Hospital enrolled 54 patients with hydroxyurea-induced leg ulcers. Patients were randomly assigned to the control group (n = 27) treated with chlorhexidine dressing or the intervention group (n = 27) treated with the Zhangpi Ointment. Finally, 26 patients in the control group and 23 patients in the intervention group completed 8 weeks of observation.Results.The rate of complete healing was 100% for the intervention group, which was significantly higher than that of the control group (96.15%) (P<0.05). Furthermore, the intervention group achieved a significantly higher rate of wound healing (95.56%) than the control group (69.02%) at week 4 (P<0.01). The intervention group took 34 ± 5 days to achieve complete healing while the control group took 41 ± 7 days (P< 0.01). Moreover, grade 3/4 side effects were observed in neither group.Conclusion.The Zhangpi Ointment is effective in promoting the healing of hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms, providing a therapeutic option for a condition that is recalcitrant to conventional therapy.

Effect of an early mobilisation programme on pain intensity after laparoscopic surgery: a randomised clinical trial

2020 ◽  
pp. bmjspcare-2020-002618
Author(s):  
Azam Dehghani ◽  
Ali Hajibagheri ◽  
Ismail Azizi-Fini ◽  
Fatemeh Atoof ◽  
Noushin Mousavi
Keyword(s):  
Clinical Trial ◽  
Laparoscopic Surgery ◽  
Pain Intensity ◽  
Repeated Measures ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Early Mobilisation ◽  
Repeated Measures Analysis ◽  
The Mean

BackgroundPain is a common complication after laparoscopic surgery. This study aimed to examine the effect of an early mobilisation programme on postoperative pain intensity after laparoscopic surgery.MethodsA randomised controlled clinical trial was conducted on 80 patients who underwent laparoscopic surgery in Shahid Beheshti Hospital in Kashan, Iran. The patients were randomly allocated to intervention (n=40) and a control (n=40) group. In the intervention group, an early mobilisation programme was implemented in two rounds. The patient’s perceived pain was assessed using a Visual Analogue Scale 15 min before and 30 min after each round of early mobilisation. Data were analysed through the independent samples t, χ2 and Fisher’s exact tests and the repeated measures analysis.ResultsThe repeated measures analysis showed that the mean pain scores have been decreased over time (F=98.88, p<0.001). Considering the observed interaction between time and the intervention, the t test was used for pairwise comparisons and showed that the mean pain score was not significantly different between the two groups in 15 min before the first round of early mobilisation (p=0.95). However, the mean pain in the intervention group was significantly less than the control group in all subsequent measurements (p<0.05).ConclusionEarly mobilisation programmes such as the one implemented in the current study are easy and inexpensive and can be implemented safely for the reduction of pain after laparoscopic surgeries.

scholarly journals Yoga Effects on Anthropometric Indices and Polycystic Ovary Syndrome Symptoms in Women Undergoing Infertility Treatment: A Randomized Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Maryam Mohseni ◽  
Mohammad Eghbali ◽  
Homa Bahrami ◽  
Farzaneh Dastaran ◽  
Leila Amini
Keyword(s):  
Clinical Trial ◽  
Polycystic Ovary ◽  
Intervention Group ◽  
Clinical Signs ◽  
Infertility Treatment ◽  
Abdominal Circumference ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Hip Circumference ◽  
Anthropometric Parameter

The aim of this study was to investigate the effects of yoga exercises on anthropometric parameter and clinical sign of PCOS among women undergoing infertility treatment. This clinical trial study was performed on 61 women with PCOS who have undergone infertility treatment at Sarem Hospital in Tehran, Iran. The patients were first selecting based on purposeful and then randomly assigning to the intervention and control groups. In the intervention group, yoga exercises were performed for 6 weeks and the patients in the control group only received routine care. Anthropometric parameters and clinical signs were performed and recorded. After the intervention, here was a significant reduction in hirsutism, abdominal circumference, and hip circumference scores in the intervention group compared to the control group ( P < 0.05 ). Given the effects of yoga exercises on the improvement of hirsutism, abdominal circumference, and hip circumference, it is suggested to use yoga as a treatment strategy in women with PCOS.

scholarly journals The Effect of Combined Herbal Capsule on Glycemic Indices and Lipid Profile in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Clinical Trial

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Rezvan Ghafarzadegan ◽  
Javad Javaheri ◽  
Mina Asgari ◽  
Mohammad Golitaleb ◽  
Fatemeh Maraki ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Type 2 Diabetes Mellitus ◽  
Lipid Profile ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Glycemic Indices

Objectives: The present study aimed to investigate the potential effects of the combined herbal capsule (CHC), as a nutritional supplement, on glycemic indices (GIs) and lipid profile (LP) of patients with type 2 diabetes mellitus (T2DM). Methods: Following a randomized, single-blind, placebo-controlled clinical trial, the current study was conducted on 80 cases with T2DM who were randomly assigned into two groups of treatment (CHCs; n = 40) and control (placebo; n = 40). Both groups received the intervention (500 mg capsules) twice a day for three months, without changes in the previous dose of oral anti-hyperglycemic drugs. The GI and LP levels were measured before the intervention and three months later to investigate the potential efficacy of the interventions. Results: For those in the intervention group, the mean GI [i.e., fasting blood sugar, two hours postprandial (2hpp), and HbA1c] was significantly different after 3 months (P < 0.05). The GI- and LP-related outcomes (TG, LDL-C except for TC) were improved after 3-month of receiving the intervention compared to the control group; however, the observed improvement was no statistically significant (P > 0.05). The HDL-C level was also significantly improved in the intervention group compared to the control group (P < 0.05). Conclusions: This study demonstrated that receiving CHCs could improve GI and LP levels (TG, LDL-C, and HDL-C, except for TC), which indicates its potential to control T2DM. Moreover, no significant side effect was observed in the intervention group. It can be argued that the use of CHCs, as adjuvant therapy, in combination with conventional hypoglycemic and lipid-lowering drugs, as well as following a modified lifestyle, not only can significantly enhance glycemic control but also may prevent T2DM complications.

scholarly journals Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Perceived Disability ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

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).

scholarly journals Telephone intervention to promote maternal breastfeeding self-efficacy: randomized clinical trial

2021 ◽  
Vol 55 ◽  
Author(s):  
Hilana Dayana Dodou ◽  
Raylla Araújo Bezerra ◽  
Anne Fayma Lopes Chaves ◽  
Camila Teixeira Moreira Vasconcelos ◽  
Lorena Pinheiro Barbosa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Educational Intervention ◽  
Self Efficacy ◽  
Short Form ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Care Hospital ◽  
Telephone Intervention ◽  
Clinical Trial Registry

ABSTRACT Objective: To analyze the effects of an educational intervention via telephone on maternal breastfeeding self-efficacy. Method: Randomized controlled clinical trial including 240 puerperae from a secondary care hospital randomized into two groups: control and intervention. The educational intervention took place at seven, 30, 90, and 150 days postpartum and centered on self-efficacy and motivational interviewing principles. Self-efficacy was measured by the Breastfeeding Self-Efficacy Scale – Short Form. The data followed the abnormal distribution, so non-parametric tests were used. Results: The intervention group obtained higher median breastfeeding self-efficacy scores across the three outcome measures when compared to the control group (p < 0,001). Furthermore, the intervention group showed increased self-efficacy scores at all monitoring moments, which shows that the educational intervention was able to raise and maintain women’s confidence in breastfeeding their child over time. Conclusion: The use of a telephone-based intervention focused on self-efficacy principles and delivered by trained nurses effectively promoted maternal confidence in breastfeeding. Brazilian Clinical Trial Registry: RBR-7m7vc8.

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