Reducing Children’s Preoperative Fear with an Educational Pop-up Book: A Randomized Controlled Trial

2021 ◽  
pp. 019459982110531
Author(s):  
Holly Cordray ◽  
Chhaya Patel ◽  
Kara K. Prickett
Keyword(s):  
Randomized Controlled Trial ◽  
Coping Strategies ◽  
Outpatient Surgery ◽  
Controlled Trial ◽  
Intervention Group ◽  
Anesthesia Induction ◽  
Patients Âgés ◽  
Randomized Controlled ◽  
Positive Coping ◽  
And Coping

Objective Preoperative education empowers children to approach surgery with positive expectations, and providers need efficient, child-focused resources. This study aimed to evaluate an interactive pop-up book as a tool for explaining surgery, managing preoperative anxiety, and strengthening coping strategies. Study Design Prospective randomized controlled trial. Setting Pediatric outpatient surgery center. Methods Patients ages 5 to 12 undergoing outpatient surgery read a pop-up book about anesthesia (intervention) or received standard care (control). Patients self-reported their preoperative fear, pain expectations, views of the procedure and preoperative explanations, and coping strategies. Outcomes also included observer-rated behavioral anxiety and caregiver satisfaction. Results In total, 148 patients completed the study. The pop-up book had a significant, large effect in reducing patients’ fear of anesthesia induction (Cohen’s d effect size = 0.94; P < .001). Intervention patients also expected less pain than control patients from the anesthesia mask and during surgery ( d = 0.60-0.80; P < .001). The book encouraged more positive views of the procedure and preoperative explanations ( P < .005). Furthermore, the book prepared patients to cope adaptively: intervention patients were significantly more likely to generate positive active coping strategies, distraction strategies, and support-seeking strategies ( P < .001). Observer-rated behavioral anxiety at anesthesia induction did not differ between groups ( P = .75). Caregivers in the intervention group were significantly more satisfied with each aspect of the surgical experience ( P≤ .02). Conclusion The educational pop-up book offers a child-focused resource that helps alleviate children’s preoperative fears, encourages positive coping, and improves caregivers’ perceptions of the experience. This study was registered at ClinicalTrials.gov (NCT04796077).

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.

scholarly journals Adherence to a Lifestyle Exercise and Nutrition Intervention in University Employees during the COVID-19 Pandemic: A Randomized Controlled Trial

2021 ◽  
Vol 18 (14) ◽  
pp. 7510
Author(s):  
Guillermo García Pérez de Sevilla ◽  
Olga Barceló Guido ◽  
María de la Paz De la Cruz ◽  
Ascensión Blanco Fernández ◽  
Lidia B. Alejo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Effect Size ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Nutrition Intervention ◽  
Sitting Time ◽  
Post Intervention ◽  
University Employees ◽  
Randomized Controlled

Healthy lifestyles should be encouraged in the workplace through the occupational health teams of the companies. The objective of the present study was to evaluate the adherence to a lifestyle intervention carried out in university employees during the COVID-19 pandemic and its impact on health-related quality of life (HrQoL). A randomized controlled trial following the CONSORT guidelines was performed, consisting of three supervised interventions lasting for 18 weeks: an educational intervention on healthy habits, a nutritional intervention, and a telematic aerobic and strength exercise intervention. Lifestyle and HrQoL were analyzed six months post-intervention to assess adherence. Twenty-three middle-aged participants completed the study. The intervention group significantly improved their lifestyle according to the Health Promoting Lifestyle Profile II questionnaire, especially in the categories of Health Responsibility, Physical Activity, and Nutrition, with a large effect size. Sitting time was reduced by 2.5 h per day, with a moderate effect size. Regarding HrQoL, the intervention group showed a clinically significant improvement in the Physical Component Summary. Despite the lockdown and the mobility restrictions caused by the COVID-19 pandemic, this intervention performed on university employees achieved adherence to a healthier lifestyle and improved their HrQoL, which is of great clinical relevance.

Educational intervention to adopt selective laser trabeculoplasty as first-line glaucoma treatment: Randomized controlled trial: Educational intervention on selective laser trabeculoplasty

2021 ◽  
pp. 112067212110183
Author(s):  
Evelyn Tran ◽  
Carina Sanvicente ◽  
Lisa A Hark ◽  
Jonathan S Myers ◽  
Qiang Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Educational Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Selective Laser Trabeculoplasty ◽  
First Line ◽  
Randomized Controlled ◽  
Laser Trabeculoplasty ◽  
Glaucoma Treatment

Purpose: To determine the efficacy of an educational intervention on patient adoption and attitudes toward selective laser trabeculoplasty (SLT) as first-line treatment for glaucoma. Methods: This study is a randomized controlled trial. Subjects include 33 patients within 1-year diagnosis of either primary open-angle glaucoma, ocular hypertension, or pseudoexfoliation syndrome. After informed consent, subjects were randomly assigned to a Usual Care or Educational Intervention group. All subjects completed a pre-intervention questionnaire. The Educational Intervention group was shown a slideshow presentation and a 3-min video and given a post-intervention questionnaire. Follow-up examinations were reviewed for 6 months to determine subject completion of SLT, the primary outcome. Secondary outcomes include assessment of attitude toward SLT before and after intervention. Results: Age, gender, and baseline characteristics between the groups did not differ. The Usual Care group had a higher proportion of African Americans (77% vs 31%, p = 0.04). At 6 months following the intervention, 63% of subjects underwent SLT compared to 35% of Usual Care subjects ( p = 0.12). Older age was associated with decreased SLT uptake (OR 0.90, 95% CI 0.82–0.99, p = 0.03). Prior to the intervention, there were no differences in attitudes of both groups regarding SLT therapy. Nineteen percent of Educational Intervention subjects changed positively toward SLT ( p = 0.08) and 50% scheduled an SLT appointment after intervention ( p = 0.005). Conclusions: A slideshow and video-based educational intervention may positively enhance patient adoption of SLT. Clinical trial registration name, number, URL: Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment, NCT03365778, https://clinicaltrials.gov/ct2/show/NCT03365778

scholarly journals OP0010 EFFECTIVENESS OF THE MAKING IT WORK™ PROGRAM AT IMPROVING PRESENTEEISM AND WORK CESSATION IN WORKERS WITH INFLAMMATORY ARTHRITIS – RESULTS OF A RANDOMIZED CONTROLLED TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 7.1-8
Author(s):  
A. Luquini ◽  
Y. Zheng ◽  
H. Xie ◽  
C. Backman ◽  
P. Rogers ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Work Disability ◽  
Inflammatory Arthritis ◽  
Missing Values ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Mixed Effect ◽  
Randomized Controlled ◽  
Baseline Characteristics

Background:Arthritis often leads to presenteeism (decreased at-work productivity), missed days from work and permanent work disability, leading to reduced quality of life and high costs to individuals and society. Yet, health services addressing the employment needs of people with arthritis are lacking.Objectives:We evaluated the effectiveness of the Making-it-WorkTM(MiW) program, an online self-management program developed to help people with inflammatory arthritis (IA) deal with employment issues.Methods:A multi-center RCT evaluated the effectiveness of MiW at improving presenteeism and preventing work cessation (WC) over two years. Participants were recruited from rheumatologist practices, consumer organizations and arthritis programs, in three Canadian provinces. Eligibility criteria: diagnosis of IA, employed, age 18-59, and concerned about ability to work. Participants were randomized 1:1 to MiW or usual care plus printed material on workplace tips. MiW consists of five online self-learning modules and group meetings, and individual vocational counselling and ergonomic consultations. Questionnaires were administered every 6 months. Outcomes were presenteeism [Rheumatoid Arthritis Work Instability Scale (RA-WIS)], time to WC ≥ 6 months, and time to WC ≥ 2 months (secondary outcome). Baseline characteristics (age, gender, ethnicity, occupation, education, disease duration and self-employment) were collected. Intention-to-treat (ITT) longitudinal analysis of RA-WIS using linear mixed effect regression models with 2-year comparison as primary endpoint and survival analysis for time to WC using Kaplan-Meier and Cox Proportional Hazard models were performed. Robustness analyses were conducted by using various missing values imputation methods like last observation carried forward, imputation using worse possible outcomes and model-based multiple imputations; using square root transformation of RA-WIS outcome; and adjusting for baseline covariates. SAS version 9.4 was used.Results:A total of 564 participants were recruited, with 478 (84.75%) completing 2-year follow-up. Baseline characteristics were similar between groups. Mean RA-WIS scores were significantly lower in the intervention group from 6 months onwards, with the greatest difference observed at 2 years (-1.78, 95%CI: -2.7, -0.9, p < .0001), yielding a standardized effect size of 32%. Satisfactory robustness was observed. Work cessation occurred less often in intervention than control groups, but only reached statistical significance for WC ≥ 2 months (WC ≥ 6 months: 31 versus 44 events, aHR 0.70, 95%CI: 0.44, 1.11, p = 0.13; WC ≥ 2 months: 39 versus 61 events, aHR: 0.65, 95%CI: 0.43, 0.98, p = 0.04).Conclusion:Results of the RCT reveal the program was effective at improving presenteeism and preventing short-term WC. Effectiveness at preventing long-term work disability will be assessed at 5 years. This program fills one of the most important and costly unmet needs for people with inflammatory arthritis.References:[1]Carruthers EC, Rogers P, Backman CL, et al. “Employment and arthritis: making it work” a randomized controlled trial evaluating an online program to help people with inflammatory arthritis maintain employment (study protocol).BMC Med Inform Decis Mak. 2014;14:59. Published 2014 Jul 21. doi:10.1186/1472-6947-14-59Disclosure of Interests:Andre Luquini: None declared, Yufei Zheng: None declared, Hui Xie: None declared, Catherine Backman: None declared, Pamela Rogers: None declared, Alex Kwok: None declared, Astrid Knight: None declared, Monique Gignac: None declared, Dianne Mosher: None declared, Linda Li: None declared, John Esdaile: None declared, Carter Thorne Consultant of: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Diane Lacaille: None declared

scholarly journals Scale development and an educational program to reduce the stigma of schizophrenia among community pharmacists: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Tomoo Fujii ◽  
Manako Hanya ◽  
Kenta Murotani ◽  
Hiroyuki Kamei
Keyword(s):  
Randomized Controlled Trial ◽  
Factor Analysis ◽  
Social Distance ◽  
Educational Program ◽  
Controlled Trial ◽  
Intervention Group ◽  
Community Pharmacists ◽  
Factor I ◽  
Randomized Controlled ◽  
Factor Ii

Abstract Background Stigma associated with mental disorders is rooted among many pharmacists, and represents a major barrier to patient support in community-based psychiatry. We developed an assessment scale that is specifically designed to assess the level of stigma that pharmacists may have toward schizophrenia, and then examined the effects of reducing stigma with an educational program that focuses on communication with patients diagnosed with schizophrenia (PDS) using the newly developed Stigma Scale towards Schizophrenia for Community Pharmacists (SSCP). Methods SSCP was developed by exploratory factor analysis with promax rotation based on responses from 822 randomly selected community pharmacists. Furthermore, a randomized controlled trial was conducted for 115 community pharmacists to clarify the effects of reducing the stigma of schizophrenia using an educational program for them with a focus on communication with PDS. Participants were individually allocated to two groups: educational lecture group (56; only attending a lecture on schizophrenia) or contact-based intervention group (59; communicating with PDS and attending the lecture). The stigma assessment using SSCP was conducted immediately before and after the educational intervention. Results A total of 4 factors and 27 items were extracted from the exploratory factor analysis to comprise the SSCP. Cronbach’s α of SSCP, social distance at professional pharmacy service (factor I), attitudes towards PDS (factor II), self-disclosure (factor III), and social distance in personal (factor IV) were 0.89, 0.88, 0.76, 0.62, and 0.62, respectively. Educational program-related changes of the median (interquartile range) total SSCP score from baseline were − 9.0 (− 16.0 – − 5.0) in the contact-based intervention group and − 3.0 (− 7.0–1.0) in the educational lecture group, reflecting a significant reduction of stigma levels in the contact-based intervention group. On examining the SSCP subscales, scores for factor I and factor II significantly improved. The educational program was more effective for pharmacists aged 20–39 years or with negligible experience of communicating with PDS at work and/or in private life. Conclusions SSCP and the educational program for community pharmacists that focuses on communication with PDS were useful for assessing and reducing, respectively, the stigma attached by these pharmacists to schizophrenia. Trial registration UMIN Clinical Trials Registry (UMIN000043189, registered on January 30, 2021), Retrospectively registered.

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