LO52: Distraction in the ED using Virtual reality for Intravenous Needs in Children to Improve comfort- DEVINCI - a pilot RCT

Introduction: Venipuncture is a frequent cause of pain and distress in the pediatric emergency department (ED). Distraction, which can improve patient experience, remains the most studied psychological intervention. Virtual reality (VR) is a method of immersive distraction that can contribute to the multi-modal management of procedural pain and distress. Methods: The main objectives of this study were to determine the feasibility and acceptability of Virtual Reality (VR) distraction for pain management associated with venipunctures and to examine its preliminary effects on pain and distress in the pediatric ED. Children 7-17 years requiring a venipuncture in the pediatric ED were recruited. Participants were randomized to either a control group (standard care) or intervention group (standard of care + VR). Principal clinical outcome was the mean level of procedural pain, measured by the verbal numerical rating scale (VNRS). Distress was also measured using the Child Fear Scale (CFS) and the Procedure Behavior Check List (PBCL) and memory of pain using the VNRS. Side effects were documented. Results: A total of 63 patients were recruited. Results showed feasibility and acceptability of VR in the PED and overall high satisfaction levels (79% recruitment rate of eligible families, 90% rate of VR game completion, and overall high mean satisfaction levels). There was a significantly higher level of satisfaction among healthcare providers in the intervention group, and 93% of those were willing to use this technology again for the same procedure. Regarding clinical outcomes, no significant difference was observed between groups on procedural pain. Distress evaluated by proxy (10/40 vs 13.2/40, p = 0.007) and memory of pain at 24 hours (2.4 vs 4.2, p = 0.027) were significantly lower in the VR group. Venipuncture was successful on first attempt in 23/31 patients (74%) in the VR group and 15/30 (50%) patients in the control group (p = 0.039). Five of the 31 patients (16%) in the VR group reported side effects Conclusion: The addition of VR to standard care is feasible and acceptable for pain and distress management during venipunctures in the pediatric ED. There was no difference in self-reported procedural pain between groups. Levels of procedural distress and memory of pain at 24 hours were lower in the VR group.

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80 Distraction in the ED using Virtual reality for Intravenous Needs in Children to Improve comfort -the DEVINCI project: A Pilot RCT

Paediatrics & Child Health ◽

10.1093/pch/pxaa068.079 ◽

2020 ◽

Vol 25 (Supplement_2) ◽

pp. e33-e33

Author(s):

Evelyne D Trottier ◽

Esli Osmanlliu ◽

Benoit Bailey ◽

Maryse Lagacé ◽

Marisol Sanchez ◽

...

Keyword(s):

Virtual Reality ◽

Side Effects ◽

Adverse Events ◽

Standard Care ◽

Healthcare Providers ◽

Intervention Group ◽

Procedural Pain ◽

Control Group ◽

Memory Of Pain ◽

Pilot Rct

Abstract Background Venipuncture is a frequent cause of pain and distress in the pediatric emergency department (ED). Healthcare professionals must optimize patient comfort during such procedures, given the associated short- and long-term adverse events. Distraction, which can improve patient experience, remains the most studied psychological intervention. Virtual reality (VR) is a method of immersive distraction that can contribute to the multi-modal management of procedural pain and distress. Its use in the healthcare setting has become more accessible due to the development of more portable and affordable systems. Objectives The primary outcome of this study was to determine the feasibility and acceptability of a VR distraction device in the pediatric ED. The secondary outcomes were to examine the preliminary effects of the addition of VR to standard practice on children’s pain, distress, and memory of pain associated with venipunctures in the pediatric ED. Design/Methods This pilot RCT was performed at a tertiary pediatric centre. Children 7-17 years old requiring a venipuncture in the ED were recruited. Participants were randomized to either a control group (standard care) or intervention group (standard care+VR). A priori feasibility and acceptability criteria were established following expert consensus (nurses/physicians working in the ED): - 80% of families approached for recruitment consent to participate; - 80% of recruited patients finish the game as planned (intervention group); - Mean >7 on the 0-10 satisfaction scale (patients/parents/healthcare providers); - No serious adverse events. The principal clinical outcome was the mean level of procedural pain as measured by the verbal numerical rating scale (VNRS). Auto-evaluation of procedural-related distress was performed using the Child Fear Scale (CFS). The level of distress related to the procedure was also evaluated by proxy using the Procedure Behavior Check List (PBCL). Memory of pain was measured at 24h using the VNRS. Side effects were documented. Results A total of 63 patients were recruited between December 2018 and April 2019 (one was excluded as the venipuncture was later cancelled). The results showed feasibility and acceptability of VR in the pediatric ED with: -79% recruitment rate of eligible families -90% rate of VR game completion as per protocol (reason for not completing the game: prior headache, wanting to see, VR not working well) and -overall high mean satisfaction levels. In addition, there was a significantly higher level of satisfaction among healthcare providers in the intervention group, and 93% of those were willing to use this technology again for the same procedure. Regarding clinical outcomes, there was no significant difference between groups in self-reported procedural pain, but evaluation of distress by proxy (10/40 vs 13.2/40, p = 0.007) and memory of pain at 24 hours (2.4 vs 4.2, p = 0.027) were significantly lower in the intervention group. Venipuncture was successful on first attempt in 23/31 patients (74%) in the VR group and 15/30 (50%) patients in the control group (p = 0.039). Five of the 31 patients (16%) in the VR group reported side effects, which were mild and self-resolving. Conclusion The addition of VR to standard of care for pain and distress management related to venipunctures in the pediatric ED is a feasible and acceptable intervention. Side effects related to VR were few and self-resolving. Both experimental groups were similar with respect to self-reported procedural pain. A lower level of procedural distress, lower memory of pain at 24 hours, and higher venipuncture first attempt success rate were observed in the VR group.

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The Efficacy and Mechanism of Positive Psychological Intervention on Well-Being for Colostomy Patients: A Randomized Controlled Trial

10.21203/rs.3.rs-1137918/v1 ◽

2021 ◽

Author(s):

Yanfei Jin ◽

Yuqing Wang ◽

Hongwen Ma ◽

Xu Tian ◽

Wang Honghong

Keyword(s):

Life Satisfaction ◽

Psychological Distress ◽

Standard Care ◽

Psychological Capital ◽

Psychological Intervention ◽

Well Being ◽

Control Group ◽

Significant Difference ◽

Experimental Group ◽

Positive Psychological Intervention

Abstract Aims To evaluate the efficacy and mechanism of positive psychological intervention (PPI) on the psychological capital, psychological distress, and life satisfaction among colostomy patients. Methods Patients (n=120) with permanent stomas were recruited and randomly assigned into two groups. Patients in the experimental group (n=60) received standard care and PPI, whereas patients in the control group (n=60) only received standard care. The psychological capital, psychological distress, and life satisfaction were measured and compared between two groups before the intervention, the immediate post-intervention, and follow-up. Results All 120 patients completed the study. The hope, optimism, resilience, psychological distress, and life satisfaction score of the experimental group were significantly higher than those of the control group at T1 and T2 (P<0.05). Self-efficacy score of the experimental group had no significant difference at the two-time points after the intervention than the control group (P>0.05). Changes in hope and resilience which belong to psychological capital mediated the intervention’s efficacy on changes in PPI on life satisfaction (β = 0.265, P=0.005; β = 0.686, P=0.002). Conclusions PPI could effectively improve psychological capital, psychological distress, and life satisfaction among patients with stomas. Besides, our findings add novel support that increased hope and resilience are the active ingredients that promote intervention change.

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THE EFFECT OF THE POP-UP BOOK AKU DAN GIGIKU ON PULSE RATE IN CHILDREN AGED 4–6 YEARS

International Journal of Applied Pharmaceutics ◽

10.22159/ijap.2017.v9s2.36 ◽

2018 ◽

Vol 9 ◽

pp. 135

Author(s):

Meutia D Citrawuni ◽

Margaretha Suharsini ◽

Eva Fauziah ◽

Kusuma P Adriani

Keyword(s):

Health Education ◽

Clinical Research ◽

Pulse Rate ◽

Dental Treatment ◽

Psychological Intervention ◽

Dental Health ◽

Physiological Responses ◽

Intervention Group ◽

Control Group ◽

Significant Difference

Objective: Anxiety is regarded as a major problem in children undergoing dental treatment. One of the physiological responses to anxiety is an increased pulse rate. Young children respond aggressively to anxiety and are in need of psychological intervention. Pop-up books can be used as an instrument to improve their interest and to help them understand the substance of dental health education.The objective of this study was to utilize pulse rate measurements to investigate the intervention of a pop-up book in reducing anxiety. A total of 78 children aged 4–6 years were divided into two groups: An intervention group with the pop-up book Aku dan Gigiku and a control group without intervention. The pulse rates of both groups were measured. This study comprised an experimental clinical research design. The independent t-test was used to measure comparisons of decreased pulse rate between the two groups.Result: The result showed that there was a statistically significant difference in decreased pulse rate with and without the intervention of the pop-up book Aku dan Gigiku. Pop-up books are often used as an educational medium for children because they present interesting illustrations and are easy to understand.Conclusion: As a medium of dental health education, pop-up books can contribute significantly to reducing anxiety in children.

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Virtual reality to improve patient information and reduce anxiety towards atrial fibrillation ablation in times of remote patient care (and after)

EP Europace ◽

10.1093/europace/euab116.520 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

ANL Hermans ◽

P Van Duijnhoven ◽

DVM Verhaert ◽

S Philippens ◽

M Lahaije ◽

...

Keyword(s):

Atrial Fibrillation ◽

Virtual Reality ◽

Patient Care ◽

Patient Information ◽

Intervention Group ◽

Control Group ◽

Af Ablation ◽

Significant Difference ◽

Remote Patient ◽

Preoperative Patient

Abstract Funding Acknowledgements Type of funding sources: None. Background. Nowadays frequently deployed invasive catheter ablation therapy in patients with symptomatic atrial fibrillation (AF) is unfortunately associated with distress such as preoperative anxiety. Improving preoperative patient information may lower anxiety towards AF ablation procedures. Purpose. To evaluate whether a lifelike 360˚ virtual reality (VR) patient information video decreases anxiety levels and improves patient preparation towards AF ablation as compared to standard preoperative patient information. Methods. Consecutive patients planned for AF ablation were recruited from the outpatient AF clinic and were randomized into two groups: the control group and the intervention group (VR group). The control group received standard preoperative information through oral counselling and information leaflets, the VR group received the standard information as well as a short dedicated 360˚ VR video (via in-hospital VR headset and disposable cardboard VR glasses for home use). Online questionnaires (aimed at information provision, anxiety and procedural experience) were administered both pre- and post-ablation. Results. A total of 103 patients (39.8% female, age 64 [58-71] years) were included in the analysis. The VR group (n = 58) reported to be clearly better informed about catheterization laboratory environment (78% vs. 73%) and the course of the procedure (82% vs. 78%), indicated fewer concerns about the procedure (47% vs. 55%) and were eager to learn even more (82% vs. 74%) as compared to controls (n = 45). However, there was no significant difference in the anxiety scores between the VR group and controls (10 [8-12] vs. 10 [8-14], p = 0.548). Home use of the video was satisfactory and resulted in discussion with relatives. Patient overall satisfaction was higher in VR group as compared to controls (84% vs. 81%). Conclusions. This study shows that a dedicated 360˚ VR video reduces concerns but does not reduce anxiety scores. Though, it easily improves procedural knowledge, patient information and patient satisfaction. Especially in times of remote patient care, this new way of informing patients may be of added value.

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Investigation the Effects of Adding Intravenous Transoxalic Acid and Its Complications in the Prevention of Postpartum Hemorrhage after Vaginal Delivery in Patients Admitted to Ali-ibn-Abitaleb Hospital in Zahedan

Journal of Zabol Medical School ◽

10.18502/jzms.v4i1.6759 ◽

2021 ◽

Author(s):

Tahereh Hajian ◽

Maryam Razavi ◽

Ali Dashipour

Keyword(s):

Side Effects ◽

Postpartum Hemorrhage ◽

Intervention Group ◽

Vital Signs ◽

Control Group ◽

Drug Side Effects ◽

Blood Samples ◽

Significant Difference ◽

The Mean ◽

Uterine Fundus

Background: This study was designed to investigate the effect of tranexamic acid and its side effects in preventing postpartum hemorrhage in patients referred to Ali ibn Abitaleb Hospital in Zahedan during 2020-2021. Methods: Patients were divided into two groups of 85 patients. Vital signs as well as drug side effects related to tranexamicity are monitored and recorded every15 minutes in the first hour and every 30 minutes in the second hour. Also, blood samples are taken from patients to measure hemoglobin and hematocrit within6 hours after delivery. The number and weight difference of droschitis used during 2 hours after delivery are also measured. In addition, PPH (Postpartum hemorrhage) cases in both groups were checked by repeated examination of the uterine fundus during the first 2 hours and after 6 weeks. Results: There was no statistically significant difference between the two groups in terms of the number of deliveries and further decrease in hemoglobin levels in the control group compared to the intervention group. Nausea, vomiting, and dizziness were observed in the intervention group and thrombosis was not observed in any group. According to the independent samples t-test, there was a statistically significant difference between the mean blood volume lost between the two groups. The mean hematocrit drop was statistically significant between the two groups. No blood transfusion was observed in any of the patients. Conclusion: Tranxamic acid injections can effectively reduce postpartum hemorrhage and reduce maternal hemoglobin and hematocrit following this complication.

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Efficacy of Levamisole with Standard Care Treatment vs Standard Care in Clinical Presentations of Non-Hospitalized Patients with COVID-19: A Randomized Clinical Trial

10.21203/rs.3.rs-964097/v1 ◽

2021 ◽

Author(s):

Mohammad Hossein Asgardoon ◽

Hamid Emadi koochak ◽

Mohammad Hassan Kazemi-Galougahi ◽

Ali Zare Dehnavi ◽

Behzad Khodaei ◽

...

Keyword(s):

Clinical Benefit ◽

General Health ◽

Standard Care ◽

Intervention Group ◽

Health Condition ◽

Hospitalized Patients ◽

Care Group ◽

Control Group ◽

Significant Difference ◽

General Health Condition

Abstract Introduction: Levamisole (LVM) demonstrated clinical benefit in a trial in patients with mild to moderate coronavirus disease 2019 (COVID-19), but its effect in a larger sample size needs to be confirmed. Methods In this randomized open-label trial, we enrolled non-hospitalized patients with mild to moderate COVID-19 at nine health centers in Tehran province, Iran, in 2021. Patients were randomly assigned to receive a 10-day course of LVM with standard care (n = 185), or standard care (n = 180) in a 1:1 ratio. On days 1 to 10, LVM was administered orally at a dosage of 50 mg. The participants were called and followed on days 1, 3, 5, 7, 9, and 14. The outcomes were general health condition, hospitalization rate, sign and symptoms, and adverse events (AEs). Generalized Estimating Equations model was used for analysis. Results Among 507 randomized patients, 473 started the experiment and received LVM in addition to standard care or received only the standard care (median age, 40 [IQR, 32-50.75] years; 164 [44.9%] women; 9.4% had diabetes, 8.8% hypertension, 1.6% cardiovascular disease), and 346 (98%) completed the trial. Compared to control group, LVM decreased the general health condition of the patients (B=-0.635; CI= -0.041, -0.329; P= 0.000). Patients in the LVM with standard care group had significantly lower odds of developing fever (OR= 0.260; 95% CI= ‎0.11‎‎3‎-0.59‎‎9‎; P = .002), chills (OR= 0.223; 95% CI= ‎‎0.07‎‎6‎-‎0.64‎‎8‎; P = 0.006), fatigue (OR= 0.576; 95% CI= ‎0.34‎‎6‎-‎0.96‎‎0‎‎; P = ‎0.034), and myalgia (OR= 0.54‎‎4‎; 95% CI= ‎0.31‎‎7‎-‎0.93‎‎2‎‎; P =0.027). During the therapy, there was no significant difference in the parameters of dyspnea, cough, diarrhea, nausea, vomiting, sore throat, hyposmia, dysgeusia, and anorexia (P > 0.05). No significant difference was observed in the rate of hospitalization. Although the intervention group had greater AEs than the control group, yet, the difference was not statistically significant. Conclusions LVM has clinical benefit in improving health condition of patients with mild to moderate COVID-19. Further studies are needed to confirm our findings. Trial Registration: Iranian Registry of Clinical Trials: IRCT20201124049480N1; Registration date: 28/03/2021.

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Pengaruh Relaksasi Aromaterapi Jasmine terhadap Kualitas Tidur pada Lansia di Karang Werdha

Pustaka Kesehatan ◽

10.19184/pk.v6i3.11745 ◽

2018 ◽

Vol 6 (3) ◽

pp. 461

Author(s):

Mahda Febriyanti Eka Pertiwi Putri ◽

Murtaqib Murtaqib ◽

Mulia Hakam

Keyword(s):

Side Effects ◽

Intervention Group ◽

The Elderly ◽

Average Score ◽

Control Group ◽

P Value ◽

Control Group Design ◽

Sleeping Pills ◽

Significant Difference ◽

Negative Side Effects

During the quality of sleep the elderly is good, some changes that will occur to the elderly arenormal as well, but if not, it will cause health problems. This research aims to analyze theeffect of jasmine aromatherapy relaxation on sleeping quality to the elderly at elderlyassociation in Jenggawah Jember. This research used quasy experimental design methodwith pre-post test and control group design. Sleeping quality was measured using a PSQIquestionnaire and interventions which were given for 28 days. The result of dependent t testshowed no significant difference on the average score of control group (p value = 1,000).While in the intervention group there was a decrease in the mean score of PSQI after beinggiven jasmine aromatherapy relaxation, so that there was a significant difference in sleepingquality of the intervention group (p value = 0,001). Independent t tests showed significantdifferences between the control group and the intervention group after jasmine aromatherapyrelaxation (p value = 0,001). Overall, jasmine aromatherapy relaxation can improve sleepingquality in the elderly, so that jasmine aromatherapy relaxation may be used as an alternativenon-pharmacological treatment which has no adverse side effects compared to the use oflong-term sleeping pills that would give negative side effects to its users. Keywords: aromatherapy, sleeping quality, elderly.

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Evaluating lubiprostone for effective bowel preparation before colonoscopy

Egyptian Liver Journal ◽

10.1186/s43066-021-00087-7 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Yasser Hamada ◽

Ibrahim Emam ◽

Rabab Maher ◽

Hassan El-Garem

Keyword(s):

Single Dose ◽

Side Effects ◽

Bowel Preparation ◽

Intervention Group ◽

The Other ◽

Current Evidence ◽

Control Group ◽

Significant Difference ◽

Colon Preparation ◽

Scale 8

Abstract Background Colon preparation is a fundamental step for performing a successful colonoscopy. We aimed to evaluate the effectiveness of administering lubiprostone (LB) added to a single dose of oral polyethylene glycol (PEG) solution in achieving satisfactory colon cleanliness and decreasing the side effects. Results One-hundred percent of the control group patients reported that the experienced taste was worse than expected, while in the intervention group half of the patients (50%) said that the taste was natural and 48% experienced taste worse than expected (p<0.0001). Regarding Boston bowel preparation scale (BBPS), there was a significant difference in the overall Boston scale (p=0.02) with more efficacy in the intervention group as 66% of patients in the intervention group had good bowel preparation (5–7) and 24% excellent preparation (8–9). On the other hand, the overall Boston scale in the control group showed that 54% of patients were between 5 and 7, and only 16% of patients had overall Boston scale 8–9. In terms of the side effects of the preparation in both arms, the majority of cases in the intervention arm did not complain of any side effects (78%), while the majority of the complaints were vomiting in 16% of the intervention cases. Conclusion The current evidence suggested that adding LB to the colon preparation significantly improved the tolerability and efficacy.

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The efficacy and safety of silymarin in the treatment of chemotherapy-induced peripheral neuropathy, a randomized double-blinded clinical trial

10.22541/au.162837649.93180154/v1 ◽

2021 ◽

Author(s):

Ramin Shekarriz ◽

Hojjat Ghorbani ◽

Mahmoud Mousazadeh ◽

Khatereh Vahedi ◽

Ebrahim Salehifar

Keyword(s):

Quality Of Life ◽

Side Effects ◽

Intervention Group ◽

Gastrointestinal Symptoms ◽

Treated Group ◽

Control Group ◽

Significant Difference ◽

Eortc Qlq ◽

Double Blinded

Aim: The aim of this study was to evaluate the efficacy and side effects of silymarin in the treatment of CIPN. Methods: Patients who referred to outpatient oncology department of a referral educational hospital affiliated to Mazandaran University of Medical Sciences and experienced CIPN were randomized to receive silymarin or placebo. Intervention group received 140 mg of the Silymarin twice daily accompanied and 300 mg/day Gabapentin, whereas control group received 300 mg/day of Gabapentin and placebo twice daily for 3 months. The grade of neuropathy was determined according to the CTCAE criterion. The improvement of neuropathy was defined as the reduction of at least one neuropathic score. The visual analogue scale (VAS) was used to assess the severity of patients’ pain and the EORTC-QLQ-C30 criterion was used to assess the quality of life. Patients were evaluated initially and at the follow up visit 3 months after the enrollment. Results: A total of 80 patients were enrolled in the study. There was no significant difference between the groups in terms of severity of neuropathy at baseline. At the end of the study, the number of people with improved neuropathy in the silymarin group was 82.8% patients, which was significantly higher than 48.4% observed in the patients received placebo (P= 0.005). The silymarin-treated group showed a significant reduction in pain compared with those receiving placebo. Despite the improvement in quality of life in the intervention group compared to the comparison group, this difference was not statistically significant. Gastrointestinal symptoms were the only reported side effects with a similar incidence in two groups. Conclusion: The present data demonstrate the potential clinical use of silymarin as an adjuvant therapy to reduce CIPN symptoms.

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Effect of Progressive Muscle Relaxation on Sleep Quality and Side Effects of Chemotherapy in Children with Cancer: Randomized Clinical Trial

Open Access Macedonian Journal of Medical Sciences ◽

10.3889/oamjms.2021.5774 ◽

2021 ◽

Vol 9 (T4) ◽

pp. 300-308

Author(s):

Erna Sulistyawati ◽

Allenidekania Allenidekania ◽

Dewi Gayatri

Keyword(s):

Clinical Trial ◽

Side Effects ◽

Sleep Quality ◽

Randomized Clinical Trial ◽

Muscle Relaxation ◽

Intervention Group ◽

Progressive Muscle Relaxation ◽

Control Group ◽

Children With Cancer ◽

Significant Difference

BACKGROUND: Sleep disturbance affects quality of life in children receiving chemotherapy. AIM: The aim of this study was to identify the effect of progressive muscle relaxation on the sleep quality and side effects of chemotherapy in children with cancer. METHODS: This study used randomized clinical trial with single blind method, where 30 children were allocated randomly to the control group and intervention group. The intervention group received progressive muscle relaxation twice a day, in the morning and evening, 15 minutes each session for 7 days. Control group received routine nursing care. RESULTS: The study concluded there was no significant difference in the two groups on fatigue and pain. However, progressive muscle relaxation had significant relation to decreased sleep quality score. CONCLUSION: Relaxation therapy, particularly progressive muscle relaxation, may be one of the nursing cares to improve sleep quality and reduce the side effects of chemotherapy in children with cancer.

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