Does Nursery-Based Intensified Anticipatory Guidance Reduce Emergency Department Use for Nonurgent Conditions in the First Month of Life? A Randomized Controlled Trial

Objective.We aimed to evaluate the impact of an intensified anticipatory guidance program in the nursery on Emergency Department (ED) use for nonurgent conditions (NUCs) in the neonatal period.Methods. Parturient mothers of healthy newborns were randomized to an intervention group or control group. Baseline and 1-month follow-up knowledge surveys regarding newborn care were conducted. The primary outcome was the proportion of neonates who used the ED for a NUC. Secondary outcome was change in caregivers’ knowledge on NUC.Results. Of a total of 594 mothers, 323 (54%) agreed to participate and were randomized to intervention (n=170) or control (n=153) group. Most were Hispanic (68%), single (61%), primiparous (39%), and without high school diploma (44%). 35 (21%) neonates in the intervention group and 41 (27%) in the control group were brought at least once for a NUC to the ED (p=0.12). There was no statistically significant difference in within subject change on knowledge scores between the two study arms.Conclusions. Neonatal ED visits for NUCs occur frequently. This nursery-based intensified anticipatory guidance program had no statistically significant impact on neonatal ED use for NUC, nor on neonatal care-relevant knowledge among parturient mothers. Alternative modalities and timing of parental educational intervention may need to be considered. This trial is registered with Clinical Trials NumberNCT01859065(Clinicaltrials.gov).

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Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-036799 ◽

2020 ◽

Vol 10 (5) ◽

pp. e036799 ◽

Cited By ~ 1

Author(s):

David Blanco ◽

Sara Schroter ◽

Adrian Aldcroft ◽

David Moher ◽

Isabelle Boutron ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Peer Review ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Randomised Trials ◽

Randomised Controlled ◽

The Impact ◽

Completeness Of Reporting

ObjectiveTo evaluate the impact of an editorial intervention to improve completeness of reporting of reports of randomised trials.DesignRandomised controlled trial (RCT).SettingBMJ Open’s quality improvement programme.Participants24 manuscripts describing RCTs.InterventionsWe used an R Shiny application to randomise manuscripts (1:1 allocation ratio, blocks of 4) to the intervention (n=12) or control (n=12) group. The intervention was performed by a researcher with expertise in the content of the Consolidated Standards of Reporting Trials (CONSORT) and consisted of an evaluation of completeness of reporting of eight core CONSORT items using the submitted checklist to locate information, and the production of a report containing specific requests for authors based on the reporting issues found, provided alongside the peer review reports. The control group underwent the usual peer review.OutcomesThe primary outcome is the number of adequately reported items (0–8 scale) in the revised manuscript after the first round of peer review. The main analysis was intention-to-treat (n=24), and we imputed the scores of lost to follow-up manuscripts (rejected after peer review and not resubmitted). The secondary outcome is the proportion of manuscripts where each item was adequately reported. Two blinded reviewers assessed the outcomes independently and in duplicate and solved disagreements by consensus. We also recorded the amount of time to perform the intervention.ResultsManuscripts in the intervention group (mean: 7.01; SD: 1.47) were more completely reported than those in the control group (mean: 5.68; SD: 1.43) (mean difference 1.43, 95% CI 0.31 to 2.58). We observed the main differences in items 6a (outcomes), 9 (allocation concealment mechanism), 11a (blinding) and 17a (outcomes and estimation). The mean time to perform the intervention was 87 (SD 42) min.ConclusionsWe demonstrated the benefit of involving a reporting guideline expert in the editorial process. Improving the completeness of RCTs is essential to enhance their usability.Trial registration numberNCT03751878.

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"The effect of Exercise during hemodialysis on serum levels of Albumin, calcium, phosphorus and parathyroid hormone: a randomized clinical trial"

10.21203/rs.3.rs-446114/v1 ◽

2021 ◽

Author(s):

Alireza Dashtidehkordi ◽

Nahid Shahgholian ◽

Jaleh Sadeghian

Keyword(s):

Parathyroid Hormone ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Program ◽

Serum Levels ◽

Electrolyte Imbalance ◽

Control Group ◽

Significant Difference ◽

Calcium Phosphorus ◽

The Impact

Abstract Background: Chronic kidney disease is often accompanied by disturbances in the levels of serum electrolytes. Because of electrolyte imbalance and other factors, the patients experience some of the systemic symptoms and physical and mental dysfunction. We aimed determine the impact of exercise during hemodialysis on serum levels of Albumin, calcium, phosphorus and parathyroid hormone. Methods: In a randomized controlled trial in hemodialysis units of Iran’s two hospital, 60 patients undergoing hemodialysis having required criteria were included and assigned into the exercise group (n = 30) and the control group (n = 30). An exercise program using stationary bicycles were done in the intervention group, 60 minutes/ every session, three times a week, for 8 weeks. The main outcome measures were the serum levels of Albumin, Calcium, Phosphate, and Parathyroid hormone. Results: The independent t-test results showed no significant difference between the mean serum levels of Albumin, Calcium, Phosphorus and Parathyroid hormone before the intervention (P > 0.05). However, after an eight-week intervention, significant improvements were seen in serum phosphate levels and Parathyroid hormone (P=0.04), while the serum levels of Albumin (P=0.3) and calcium (P = 0. 5) did not change significantly in the intervention group. Conclusions: An exercise program by stationary bicycles is a safe, effective and complementary clinical intervention in patients with ESRD on hemodialysis.

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The Impact of Umbilical Cord Clamping Time on the Infant Anemia: A Randomized Controlled Trial

Iranian Journal of Public Health ◽

10.18502/ijph.v50i5.6116 ◽

2021 ◽

Author(s):

Sevil Güner ◽

Birsen Karaca Saydam

Keyword(s):

Randomized Controlled Trial ◽

Umbilical Cord ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Cord Clamping ◽

Significant Difference ◽

Umbilical Cord Clamping ◽

The Impact

Background: Anemia during infancy causes irreversible physical, cognitive, motor, and behavioral development disorders. This study aimed to determine the effect of delaying umbilical cord clamping time on certain parameters regarding anemia during the infancy. Methods: This randomized controlled trial was conducted at a university hospital in west of Turkey (Dec 2017- Dec 2018). Overall, 110 participants were evaluated for the research, 65 participants were randomized after excluding those who did not meet the inclusion criteria (intervention=32, control=33). Randomly assigned to delayed clamping (1 min after delivery) or early clamping (in 15 sec after delivery), and followed up until 4 months postpartum. 48th-hour hematocrit, bilirubin values, need for phototherapy and hematocrit, hemoglobin values, diagnosis of anemia at the postnatal fourth month were compared between two groups. The data showing normal distribution were assessed using the parametric tests. The level of statistical significance was determined as P<0.05. Results: The 48th-hour hematocrit and bilirubin levels of the intervention group were significantly higher than the control (P<0.01 and P<0.05, respectively). No significant difference regarding the need for phototherapy due to postnatal hyperbilirubinemia was observed between the two groups (P>0.05). Means of the intervention group hematocrit and hemoglobin levels measured during anemia screening performed at the fourth month were found to be higher than those of the infants in the control group (P<0.05 and P<0.05, respectively). Conclusion: Delaying umbilical cord clamping had a positive impact on the haematological parameters of infants. Clamping the cord at least one minute in birth can be performed to prevent the iron deficit anemia that could be seen during the first years of infants’ lives.

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Reducing the Social Stigma Associated with Obsessive Compulsive Disorder: A Controlled Trial of an Intervention Program in a Turkish Community Sample

Journal of Evidence-Based Psychotherapies ◽

10.24193/jebp.2020.2.14 ◽

2020 ◽

Vol 20 (2) ◽

pp. 101-120

Author(s):

Ayça Aktaç Gürbüz ◽

Orçun YORULMAZ ◽

Gülşah DURNA

Keyword(s):

Obsessive Compulsive Disorder ◽

Intervention Program ◽

Controlled Trial ◽

Community Sample ◽

Case Vignette ◽

Control Group ◽

Obsessive Compulsive ◽

Compulsive Disorder ◽

Significant Difference ◽

The Impact

Scientific research into the reduction of stigmatization, particularly related to specific problems such as Obsessive-Compulsive Disorder (OCD), is scarce. In the present study, we examine the impact of a video-based antistigma intervention program for OCD in a pretest-posttest control group research. After being randomly assigned to either an intervention (n= 101) or control group (n= 96), the participants reported their attitudes on a hypothetical case vignette before and after OCD vs. Multiple Sclerosis (MS) videos, and again six months later as a follow up assessment. The mixed design analyses for the group comparisons indicated that although there was no significant difference in the measures of the control group, the participants watching the anti-stigma OCD video, in which the focus was psychoeducation and interaction strategies, reported significantly lower scores on social distances and negative beliefs for the case vignettes they read, and this difference was maintained six months later. Then, the present results indicate the effectiveness of our anti-stigma intervention program for OCD. Interventions to reduce stigmatization can also be viewed as effective tools for changing the attitudes of people toward OCD, although further research and applications are needed related to specific disorders if a longlasting impact is to be achieved.

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Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

Africa Journal of Nursing and Midwifery ◽

10.25159/2520-5293/6232 ◽

2020 ◽

Vol 22 (1) ◽

Author(s):

Farokh Saljughi ◽

Mitra Savabi-Esfahani ◽

Shahnaz Kohan ◽

Soheila Ehsanpour

Keyword(s):

Pregnant Women ◽

Maternal Employment ◽

Controlled Trial ◽

Role Play ◽

Intervention Group ◽

Control Group ◽

Maternal Behaviour ◽

Infant Attachment ◽

Significant Difference ◽

History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

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The Effect of Reflexology on Labor Pain and Length Among Primiparous Women: A Randomized Controlled Trial

International Electronic Journal of Medicine ◽

10.31661/iejm805 ◽

2018 ◽

Vol 7 ◽

Author(s):

Azita Kamjoo

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Active Phase ◽

Labor Pain ◽

Control Group ◽

Singleton Pregnancy ◽

Group Data ◽

Significant Difference ◽

Labor Length ◽

Primiparous Women

Background: Pain control is considered as the key issue in modern midwifery. Along with medical painkillers, reflexology is viewed as a non-medical and noninvasive method. Hence, we aimed to investigate the effect of reflexology on the intensity of pain and length of labor. Materials and Methods: In this clinical trial, participants included 240 Iranian primiparous women with term and singleton pregnancy. Having a 3-4 cm cervical dilatation once they visited the hospital. Through a convenient sampling method, they were selected and then randomly divided into two groups. In the intervention group, reflexology was performed, and the intensity of pain during the active phase of labor along with the length of labor in the active phase was measured by visual analog scale (VAS) and compared with the control group. Data were analyzed using descriptive statistics, t-test, and Mann-Whitney U-test. Result: Data analysis showed a statistically significant difference between the intensity of pain in the 5-7 and 8-10 cm dilatation in the two groups (P=0.01). Moreover, the labor length in the active phase was found to be significantly shorter in the intervention group (P<0.001). Conclusion: It appears that reflexology can lead to a reduction in the pain and length of labor. Therefore, through instructing this technique, a goal of midwifery, which is reducing labor pain and its length can be achieved. Keywords: Reflexology, Labor Pain, Labor Length, Primiparous Women

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Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

Journal of Nursing Education and Practice ◽

10.5430/jnep.v10n2p70 ◽

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.

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Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

Otolaryngology ◽

10.1177/0194599821994742 ◽

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.

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Peer-led exercise program for ageing adults to improve physical functions - a randomized trial

European Review of Aging and Physical Activity ◽

10.1186/s11556-021-00257-x ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

D. R. Bouchard ◽

J. V. Olthuis ◽

V. Bouffard-Levasseur ◽

C. Shannon ◽

T. McDonald ◽

...

Keyword(s):

Physical Function ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Program ◽

Control Group ◽

Walk Test ◽

Blood Draw ◽

Chair Stand ◽

Significant Difference ◽

Physical Functions

Abstract Background A peer-led exercise program is one way to empower people sharing similar characteristics to encourage others to be active, but there is a lack of evidence that these programs have physical function and other benefits when delivered to ageing adults. Methods This randomized controlled trial lasting 12 weeks proposed an exercise peer-led program offered to 31 adults aged 50 and above, twice a week, by a trained leader of the same age from March to May 2019. The program was offered for free with limited space and equipment. Valid tests of physical function (e.g., 30-s chair stand, 6-min walk test) were used to assess the functional benefits. Psychosocial outcomes were assessed using self-reported questionnaires and metabolic outcomes via a fasted blood draw. Results A significant difference was found between pre-and post-values in most physical function tests in the intervention group (all p < 0.05). When adjusted for potential confounders, the intervention group was significantly associated with a more significant improvement on the chair stand test (ß = .26; p < 0.001; r2 = 0.26), the arm curl (ß = .29; p < 0.001; r2 = 0.49), as well as the 6-min walk test (ß = -.14; p < 0.001; r2 = 0.62) compared with the control group. Using repetitive measures generalized linear model, the interaction between the changes and the group was significant for all three tests. Benefits were also observed for participants’ stress level and perceived health in the intervention group compared to the control. Finally, no significant difference was observed between groups for metabolic health. Conclusions The current work suggests that a 12-week peer-led exercise program can improve physical function for adults age 50 and above. Trial registration NCT03799952(ClinicalTrials.gov) 12/20/2018.

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Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18063097 ◽

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.

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