scholarly journals One-year effects of bifocal and unifocal glasses on executive functions in children with Down syndrome in a randomized controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Christine de Weger ◽  
F. Nienke Boonstra ◽  
Jeroen Goossens
Keyword(s):  
Randomized Controlled Trial ◽  
Executive Functions ◽  
Controlled Trial ◽  
Intergroup Difference ◽  
Post Intervention ◽  
Near Vision ◽  
Children With Down Syndrome ◽  
Randomized Controlled ◽  
Cohen’S D ◽  
Cohen's D

AbstractAppropriate glasses can improve visual functioning of children with Down syndrome (DS), but it is unknown if such interventions influence their cognitive impairments. In a randomized controlled trial with 1-year follow-up. Children with DS (2–16 years) were provided either bifocal glasses (add +2.5 Dioptres; n = 50) or unifocal glasses (n = 52). Executive functions were assessed pre- and post-intervention with the task-based Minnesota Executive Function Scale (MEFS) and with questionnaires, BRIEF-P and BRIEF, parents’ and teachers’ version. Intervention effects and associations between executive functions, (near) vision and ocular alignment were analysed. Intervention improved MEFS-Total-scores in the bifocal group (p = 0.002; Cohen’s d = 0.60) but not in the unifocal group (p = 0.191; Cohen’s d = 0.24). Post-intervention, there was no intergroup difference (p = 0.120; Cohen’s d = 0.34). Post-intervention, higher MEFS-scores were associated with better visual acuities (crowded near p = 0.025; uncrowded near p = 0.019; distant p = 0.045). Pre-post changes in MEFS-scores correlated significantly with improved ocular alignment (p = 0.040). Exploratory analysis of the questionnaires showed improved teacher-rated BRIEF-scores in both groups (bifocals: p = 0.014, Cohen’s d = 1.91; unifocals: p = 0.022, Cohen’s d = 1.46), with no intergroup difference (p = 0.594; Cohen’s d = 0.23). These results demonstrate positive effects of wearing better-correcting glasses on executive functioning in children with DS, suggesting a link between their visual and executive functioning. However, the relative contributions of distant and near vision need further study.

Evaluation of a Decision Aid for Women with Epilepsy Who Are Considering Pregnancy: A Randomized Controlled Trial

2017 ◽  
Vol 37 (5) ◽  
pp. 589-599 ◽  
Author(s):  
Amanda McGrath ◽  
Louise Sharpe ◽  
Suncica Lah ◽  
Kaitlyn Parratt
Keyword(s):  
Randomized Controlled Trial ◽  
Decision Aid ◽  
Controlled Trial ◽  
Future Research ◽  
Control Group ◽  
Childbearing Age ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Cohen’S D ◽  
Cohen's D

Background. For many women with epilepsy (WWE), decision making about pregnancy is complicated by considerations such as the potential teratogenicity of antiepileptic drugs, offspring risk of epilepsy, seizure occurrence during pregnancy, and the challenges of parenting amidst poorly controlled seizures. Objective. This proof-of-concept, randomized controlled trial aimed to evaluate a decision aid (DA) developed to help WWE decide if they should start or enlarge their families. Methods. Seventy-nine WWE of childbearing age were recruited from Epilepsy Action Australia between October and November 2013 and randomized to receive the intervention (the DA) or not, and to complete a set of questionnaires pre- and post- intervention. The DA, delivered as a PDF booklet, provided balanced evidence-based information about options, risks and benefits, including probabilities; as well as steps for clarifying values and considering options within one’s personal situation. Results. Compared with the control group, the DA group had statistically significant improvements in knowledge about pregnancy and epilepsy (Cohen’s d = 1.24; 95%CI = 0.77 to 1.83) and reduced decisional conflict (Cohen’s d = 0.59; 95%CI = 0.21 to 0.99). Changes in decision self-efficacy, certainty of choice, patient-practitioner communication abilities and value congruence with choice were comparable between the DA and control group. Importantly, women’s decisions about motherhood were not biased towards either direction, and there were no adverse effects on depression or anxiety. All women who received the DA indicated they would recommend it to other WWE. Conclusions. The DA has the potential to serve as a useful support tool for WWE who are considering motherhood. Future research is needed to test the DA in clinical settings with guidance from a health professional. The trial was registered with the Australian New Zealand Clinical Trials Registry (ID ACTRN12613001082796).

scholarly journals Effect of Continues Midwifery Support in Labor on the Childbirth Experience and Self-Esteem of Primipara Women: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Nasrin Soleimani ◽  
Mansoureh Refaei ◽  
Farideh Kazemi
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Esteem ◽  
Control Group ◽  
Randomized Controlled ◽  
Childbirth Experience ◽  
Cohen’S D ◽  
The Mean ◽  
Cohen's D

Abstract Background: The World Health Organization states that mothers during labor and delivery should be supported by people with whom they feel comfortable, because one of the non-pharmacological methods of relieving labor pain is the continued support of midwives in labor. The primary objectives of this study were to determine the effect of continuous midwifery support in labor on delivery experience and self-esteem of nulliparous women 6 weeks after delivery.Methods: This randomized controlled trial was performed in 2021 on 70 pregnant women admitted to the delivery ward who met the inclusion criteria. Participants were randomly allocated to two groups through balanced block randomization with a block size of 4. Participants completed a demographic and midwifery information questionnaire before entering the study. In the intervention group, in addition to routine labor care, the researcher was present at the mother's bedside and was present with the mother continuously throughout the labor and up to 2 hours after delivery and provided the necessary support. The control group received only routine labor and postpartum care. Six weeks after delivery, participants in both groups were contacted to complete the CEQ and Rosenberg self-esteem questionnaires. Finally, data were collected and analyzed. Significance level was considered 0.05.Results: By controlling the effect of duration of the first and second stages of labor as potential confounders, the mean (sd) of childbirth experience 6 weeks after delivery was 70.92 (7.07) in the intervention group and 59.69 (7.08) in the control group, and this difference was statistically significant (p <0.001). The amount of effect size indicates a very strong effect of the intervention on improving the childbirth experience (Cohen’s d = 1.69; 95% CI: 1.12, 2.26). Comparison of the mean of maternal self-esteem showed that this rate in the intervention group was 2 scores higher than the control group and this difference was statistically significant (p = 0.05). Cohen's d indicates the average effect of intervention on mothers' self-esteem score (Cohen's d = 0.56; 95% CI: 0.06, 1.05).Conclusions: Continuous support of the midwife in labor and up to 2 hours after delivery can lead to a better childbirth experience and increase the mother's self-esteem up to 6 weeks after delivery.Trial registration: IRCT ID: IRCT20201102049233N1, First Registration date: 2021-06-04

scholarly journals Boxing vs Sensory Exercise for Parkinson’s Disease: A Double-Blinded Randomized Controlled Trial

2021 ◽  
pp. 154596832110231
Author(s):  
Kishoree Sangarapillai ◽  
Benjamin M. Norman ◽  
Quincy J. Almeida
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Randomized Controlled Trial ◽  
Repeated Measures ◽  
Rating Scale ◽  
Controlled Trial ◽  
Motor Symptoms ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Double Blinded

Background. Exercise is increasingly becoming recognized as an important adjunct to medications in the clinical management of Parkinson’s disease (PD). Boxing and sensory exercise have shown immediate benefits, but whether they continue beyond program completion is unknown. This study aimed to investigate the effects of boxing and sensory training on motor symptoms of PD, and whether these benefits remain upon completion of the intervention. Methods. In this 20-week double-blinded randomized controlled trial, 40 participants with idiopathic PD were randomized into 2 treatment groups, (n = 20) boxing or (n = 20) sensory exercise. Participants completed 10 weeks of intervention. Motor symptoms were assessed at (week 0, 10, and 20) using the Unified Parkinson’s Disease Rating Scale (UPDRS-III). Data were analyzed using SPSS, and repeated-measures ANOVA was conducted. Results. A significant interaction effect between groups and time were observed F(1, 39) = 4.566, P = .036, where the sensory group improved in comparison to the boxing group. Post hoc analysis revealed that in comparison to boxing, the effects of exercise did not wear off at washout (week 20) P < .006. Conclusion. Future rehabilitation research should incorporate similar measures to explore whether effects of exercise wear off post intervention.

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.

scholarly journals Equol effects on AGE skin products, visceral fat and climacteric symptoms in post-menopausal women: A randomized controlled trial

2021 ◽  
Author(s):  
Remi Yoshikata ◽  
Khin Zay Yar Myint ◽  
Hiroaki Ohta ◽  
Yoko Ishigaki
Keyword(s):  
Randomized Controlled Trial ◽  
Visceral Fat ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Climacteric Symptoms ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Menopausal Women ◽  
Post Menopausal

Abstract Introduction: Equol, an isoflavone derivative whose chemical structure is similar to estrogen, is considered as a potentially effective agent for relieving climacteric symptoms, for the prevention of the lifestyle-related diseases, and for aging care in post-menopausal women. We investigated the effect of an equol-containing supplement on metabolism and aging, and climacteric symptoms, with respect to internally-produced equol in post-menopausal women.Methods: A single center, randomized controlled trial (registration number: UMIN000030975) on 57 post-menopausal Japanese women (mean age: 56±5.37 years), was conducted. Twenty-seven women received the equol supplement, while the remaining received Control. Metabolic and aging-related biomarkers were compared before and after the 3-month intervention. Climacteric symptoms were assessed every month using a validated self-administered questionnaire in Japanese post-menopausal women. Results: Three months post intervention, the treatment group showed significant improvement in climacteric symptoms, when compared to the Control group (81% vs. 53% respectively, p=0.045). We did not observe any beneficial effect on metabolic and aging-related biomarkers in the intervention group. However, in certain populations significant improvement in skin auto-fluorescence, which is a measurement of AGE skin products, and visceral fat area was observed, especially among equol producers. Conclusion: Women receiving equol supplement showed improved climacteric symptoms. This study offered a new hypothesis that there may be a synergy between supplemented equol and endogenously-produced equol to improve skin aging and visceral fat in certain populations.

scholarly journals Brain Training Game Boosts Executive Functions, Working Memory and Processing Speed in the Young Adults: A Randomized Controlled Trial

PLoS ONE ◽  
2013 ◽  
Vol 8 (2) ◽  
pp. e55518 ◽  
Author(s):  
Rui Nouchi ◽  
Yasuyuki Taki ◽  
Hikaru Takeuchi ◽  
Hiroshi Hashizume ◽  
Takayuki Nozawa ◽  
...  
Keyword(s):  
Working Memory ◽  
Randomized Controlled Trial ◽  
Young Adults ◽  
Executive Functions ◽  
Processing Speed ◽  
Controlled Trial ◽  
Brain Training ◽  
Randomized Controlled

Effects of Guitar Accompaniment Patterns on Hospitalized Infants: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Kory Antonacci ◽  
Nicole Steele ◽  
Jacob Wheatley ◽  
Donna M Weyant ◽  
Beverly Brozanski ◽  
...  
Keyword(s):  
Heart Rate ◽  
Randomized Controlled Trial ◽  
Music Therapy ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Pain Scale ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Stressful Environment ◽  
The Difference

Abstract A neonatal intensive care unit (NICU) can be an extremely stressful environment for infants receiving complex medical care at a pediatric facility. Music therapy can help address the stressful environment by increasing comfort and relaxation as well as decreasing a patient’s physiological response of heart rate and respiratory rate. A randomized controlled trial was completed, examining the effects of 2 guitar accompaniment patterns on infants (an arpeggiated pattern and a bass/chord pattern) in a NICU. There were 180 infants enrolled with mean chronological ages of 7.4 ± 6.1 weeks and postmenstrual ages (gestational age at birth + their chronological age) of 39.8 ± 7.9 weeks. All subject enrollees participated in a 12-minute initial music therapy session. Outcome measures included heart rate, respirations, and comfort responses. The results of the research study demonstrated that the arpeggiated guitar pattern had a lower mean heart rate and respiratory across all 3 data points (pre, during, and post intervention); however, the difference in means between the 2 accompaniment pattern groups was not statistically significant. Using the Neonatal Infant Pain Scale (NIPS) to measure comfort response, the results demonstrated no difference between the 2 group accompaniment patterns. Although the results show no significant differences among accompaniment pattern groups, the researchers describe the clinical significance that supports the use of both accompaniment patterns as suitable interventions for infants in the NICU receiving music therapy intervention.

scholarly journals The Role of Executive Functions in Socioeconomic Attainment Gaps: Results From a Randomized Controlled Trial

2020 ◽  
Vol 91 (5) ◽  
pp. 1594-1614
Author(s):  
Emma Blakey ◽  
Danielle Matthews ◽  
Lucy Cragg ◽  
Jessica Buck ◽  
David Cameron ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Executive Functions ◽  
Controlled Trial ◽  
Socioeconomic Attainment ◽  
Randomized Controlled ◽  
Attainment Gaps

scholarly journals Effectiveness of using a meditation app in reducing anxiety and improving well-being during the COVID-19 pandemic: A structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Katherine T. O’Donnell ◽  
Melanie Dunbar ◽  
Diana L. Speelman
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Intervention Period ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Survey Questions ◽  
Full Protocol ◽  
Allocation Ratio ◽  
Survey Responses

Abstract Objectives This interventional study will investigate the effect of daily use of a mindfulness app on measures of participant anxiety, well-being, and perceived outlook during the COVID-19 pandemic, by comparing pre-intervention survey responses to post-intervention survey responses. Trial design Randomized, controlled trial with parallel assignment. Adults will be assigned either to daily use of a meditation app for 30 days or to a control group (no usage of meditation app) with a 1:1 equivalence allocation ratio. Participants Inclusion Criteria: Participants must be 18 or older, have a smartphone, able to download apps to their smartphone, must be fluent in the English language, able to complete surveys on their own, and must be in the United States for the duration of the study. Exclusion Criteria: Current regular use of a mindfulness or meditation app, regular practice of mindfulness or meditation, regular therapy sessions, inability to complete surveys independently, or any mental health restrictions that would prevent participation. All data will be collected through the Insight Timer Meditation App and Google Forms. This trial is being conducted through the Lake Erie College of Osteopathic Medicine in Erie, PA, with all data collected digitally. Intervention and comparator Intervention: Participants will be sent a link to a pre-intervention survey prior to first use of the mindfulness app. Participants will be instructed to use the Insight Timer app for 10 minutes daily for 30 days. At the end of the 30-day intervention period, participants will be sent a link for the post-intervention survey. Two months after the conclusion of the 30-day intervention period, participants will be sent a link for another post-intervention survey. Comparator: Participants will receive the same surveys, but will not use any mindfulness app for the 30-day intervention period. After this 30-day period, participants are invited to use the Insight Timer app if they so choose. Main outcomes The main outcomes are (1) anxiety as assessed by survey questions adapted from the GAD7, comparing pre-intervention to post-30-days of app usage and (2) well-being as assessed by survey questions adapted from the WHO-5, comparing pre-intervention and post-30-days of app usage. Randomization Participants will be allocated to interventions via a block random sequence generator with a 1:1 allocation ratio in blocks of 8. Blinding (masking) No masking is being used in this study (open label). Numbers to be randomized (sample size) Approximately 75 participants will be randomized to each group, with an estimated enrollment of 150 participants. Trial status This study is protocol version number 27-126 and was approved on May 10, 2020. Recruitment began on August 19, 2020 and will end February 28, 2021. The study is estimated to complete on April 30, 2021. Trial registration This trial was registered to ClinicalTrials.gov on 30 April 2020. The ClinicalTrials.gov Identifier is NCT04369378. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional File 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

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