scholarly journals A pilot study to determine the feasibility of a cluster randomised controlled trial of an intervention to change peer attitudes towards children who stutter

Author(s):  
Rizwana B. Mallick ◽  
Lehana Thabane ◽  
A.S.M. Borhan ◽  
Harsha Kathard

Background: While randomised controlled trials (RCTs) are considered the gold standard of research, prior study is needed to determine the feasibility of a future large-scale RCT study. Objectives: This pilot study, therefore, aimed to determine feasibility of an RCT by exploring: (1) procedural issues and (2) treatment effect of the Classroom Communication Resource (CCR), an intervention for changing peer attitudes towards children who stutter. Method: A pilot cluster stratified RCT design was employed whereby the recruitment took place first at school-level and then at individual level. The dropout rate was reported at baseline, 1 and 6 months post-intervention. For treatment effect, schools were the unit of randomisation and were randomised to receive either the CCR intervention administered by teachers or usual practice, using a 1:1 allocation ratio. The stuttering resource outcomes measure (SROM) measured treatment effect at baseline, 1 and 6 months post-intervention overall and within the constructs (positive social distance, social pressure and verbal interaction). Results: For school recruitment, 11 schools were invited to participate and 82% (n = 9) were recruited. Based on the school recruitment, N = 610 participants were eligible for this study while only n = 449 were recruited, where there was n = 183 in the intervention group and n = 266 in the control group. The dropout rate from recruitment to baseline was as follows: intervention, 23% (n = 34), and control, 6% (n = 15). At 1 month a dropout rate of 7% (n = 10) was noted in the intervention and 6% (n = 15) in the control group, whereas at 6 months, dropout rates of 7% (n = 10) and 17% (n = 44) were found in the intervention and control groups, respectively. For treatment effect on the SROM, the estimated mean differences between intervention and control groups were (95% Confidence Interval (CI): -1.07, 5.11) at 1 month and 3.01 (95% CI: -0.69, 6.69) at 6 months. A statistically significant difference was observed at 6 months on the VI subscale of the SROM, with 1.35 (95% CI: 0.58, 2.13). Conclusion: A high recruitment rate of schools and participants was observed with a high dropout rate of participants. Significant differences were only noted at 6 months post-intervention within one of the constructs of the SROM. These findings suggest that a future RCT study is warranted and feasible.

2019 ◽  
Vol 7 (17) ◽  
pp. 2917-2923
Author(s):  
Khalid T. Aboalshamat ◽  
Assim M. Banjar ◽  
Mahmoud I. Al-Jaber ◽  
Noor M. Turkistani ◽  
Mohammed T. Al-Amoudi

AIM: This study aimed to assess the effectiveness of a recognised antimicrobial resistance (AMR) online module on knowledge and perception among dental students, using a randomised controlled trial study design. METHODS: Dental students (n = 64, aged 21-25 years) in clinical years agreed to participate in this triple-blinded, parallel, randomised controlled trial. There were 34 students in the study group and 30 students in the control group. The study group participated in an online course covering information about AMR, while students in the control group received another online course about microorganisms in dentistry. Both groups were assessed three times using online questionnaires: before the intervention (T1), after the intervention (T2), and two months later (T3). Each one of T1, T2 and T3 had 22 questions. The questions were repeated each time in T1, T2, and T3 asking about AMR but with different question format, to avoid the possibility of students to memorise the answers. RESULTS: The mean (m) of correct answers for all students on T1 was 12.56, with standard deviation (SD) of 3.2. On T2, m = 14.03 and SD = 3.85, and on T3, m = 14.36 and SD = 3.71. Scores ranged from 0 to 22. The participants in the study and control groups showed significant score improvements from T1 to T2, immediately after the intervention, but there was no significant difference between T2 and T3. The study group students’ scores did not improve significantly from T1 to T3, in contrast to the control group students’ scores. More importantly, there was no significant difference in improvement from T1 to T2 when comparing the study and control groups. CONCLUSION: Online courses might not be reliable learning methods for ensuring the optimal levels of AMR knowledge that are needed by dental practitioners.


2021 ◽  
Author(s):  
Wey Guan Lem ◽  
Ayako Kohyama-Koganeya ◽  
Toki Saito ◽  
Hiroshi Oyama

BACKGROUND Public stigma against depression contributes to low employment rates among individuals with depression and self-stigmatization of people with depression. Contact-based educational (CBE) interventions, either using in-person contact or video-based contact, have been shown to reduce stigma against mental illness effectively. In-person contacts can stimulate empathy in participants but are challenging to arrange, while video-based contact is cost-effective but encounters difficulty stimulating empathy towards the patient. In this paper, we examined the usefulness of the virtual-reality anti-stigma (VRAS) application to reduce public stigma. OBJECTIVE To develop and evaluate a VRAS application that could provide CBE intervention without using real patients. METHODS Sixteen medical students were recruited and randomized 1:1 to intervention and control groups. Participants in the intervention group (VRAS group) used the VRAS application, while those in the control group watched video material on depression. Participants' depression stigma score was assessed using the Depression Stigma Scale (DSS) and Attitudinal Social Distance (ASD), both pre-and post-intervention. The feasibility of both the VRAS application and video, and the utility of the VRAS application was also evaluated post-intervention. RESULTS Feasibility score was significantly higher in the intervention group (mean 5.63, SD 0.74) than in the control group (mean 3.88, SD 1.73; P=.03). This result indicates that the VRAS application promoted an understanding of stigma in participants. However, no significant differences were apparent between the intervention and control groups for DSS (intervention: mean 35.13, SD 5.30; control: mean 35.38, SD 4.50; P=.92) or ASD (intervention: mean 12.25, SD 3.33; control: mean 11.25, SD 1.91; P=.92). Stigma scores tended to decrease, but the stigma-reducing effects of the VRAS application were not statistically significant for either DSS (pre: mean 33.00, SD 4.44; post: mean 35.13, SD 5.30; P=.12) or ASD (pre: mean 13.25, SD 3.92; post: mean 12.25, SD 3.33; P=.12). CONCLUSIONS No significant differences in mean DSS or ASD were seen between VRAS and control groups. However, one item in the feasibility score showed a significant difference, and feedback comments suggested that VRAS was effective in educating about the stigma of depression. CLINICALTRIAL University hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000043020; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049109


2016 ◽  
Vol 1 (1) ◽  
pp. 22
Author(s):  
Nazli Zainuddin ◽  
Nurul Azira Mohd Shah ◽  
Rosdan Salim

Introduction: The role of virgin coconut oil in the treatment of allergic rhinitis is controversial. Thus, the aim of the present study is to determine the effects of virgin coconut oil ingestion, in addition to standard medications, on allergic rhinitis. We also studied the side effects of consumption of virgin coconut oil. Methods: Fifty two subjects were equally divided into test and control groups. All subjects received a daily dose of 10mg of loratadine for 28 days. The test group was given 10ml of virgin coconut oil three times a day in addition to loratadine. The symptoms of allergic rhinitis were scored at the beginning and end of the study. Results:, the symptom score were divided into nasal and non-nasal symptom scores. Sneezing score showed a significant difference, however the score was more in control group than test group, indicating that improvement in symptom was more in control group. The rest of the nasal symptom and non-nasal symptom score showed no significant difference between test and control groups. Approximately 58% of the test subjects developed side effects from consumption of virgin coconut oil, mainly gastrointestinal side effects. Conclusion: In the present study, ingestion of virgin coconut oil does not improve the overall and individual symptoms of allergic rhinitis, furthermore it has side effects.


2021 ◽  
pp. 1-9
Author(s):  
Hiroki Ushirozako ◽  
Tomohiko Hasegawa ◽  
Yu Yamato ◽  
Go Yoshida ◽  
Tatsuya Yasuda ◽  
...  

OBJECTIVESurgical site infection (SSI) after posterior spinal surgery is one of the severe complications that may occur despite administration of prophylactic antibiotics and the use of intraoperative aseptic precautions. The use of intrawound vancomycin powder for SSI prevention is still controversial, with a lack of high-quality and large-scale studies. The purpose of this retrospective study using a propensity score–matched analysis was to clarify whether intrawound vancomycin powder prevents SSI occurrence after spinal surgery.METHODSThe authors analyzed 1261 adult patients who underwent posterior spinal surgery between 2010 and 2018 (mean age 62.3 years; 506 men, 755 women; follow-up period at least 1 year). Baseline and surgical data were assessed. After a preliminary analysis, a propensity score model was established with adjustments for age, sex, type of disease, and previously reported risk factors for SSI. The SSI rates were compared between patients with intrawound vancomycin powder treatment (vancomycin group) and those without (control group).RESULTSIn a preliminary analysis of 1261 unmatched patients (623 patients in the vancomycin group and 638 patients in the control group), there were significant differences between the groups in age (p = 0.041), body mass index (p = 0.013), American Society of Anesthesiologists classification (p < 0.001), malnutrition (p = 0.001), revision status (p < 0.001), use of steroids (p = 0.019), use of anticoagulation (p = 0.033), length of surgery (p = 0.003), estimated blood loss (p < 0.001), and use of instrumentation (p < 0.001). There was no significant difference in SSI rates between the vancomycin and control groups (21 SSIs [3.4%] vs 33 SSIs [5.2%]; OR 0.640, 95% CI 0.368–1.111; p = 0.114). Using a one-to-one propensity score–matched analysis, 444 pairs of patients from the vancomycin and control groups were selected. There was no significant difference in the baseline and surgical data, except for height (p = 0.046), between both groups. The C-statistic for the propensity score model was 0.702. In the score-matched analysis, 12 (2.7%) and 24 (5.4%) patients in the vancomycin and control groups, respectively, developed SSIs (OR 0.486, 95% CI 0.243–0.972; p = 0.041). There were no systemic complications related to the use of vancomycin.CONCLUSIONSThe current study showed that intrawound vancomycin powder was useful in reducing the risk of SSI after posterior spinal surgery by half, without adverse events. Intrawound vancomycin powder use is a safe and effective procedure for SSI prevention.


2021 ◽  
pp. 1-8
Author(s):  
Sevde Aksu ◽  
Pelin Palas Karaca

<b><i>Aim:</i></b> The research was conducted as a randomized controlled pilot study to evaluate the effects of reflexology on lactation in mothers who delivered by cesarean section (CS). <b><i>Methods:</i></b> A single-blind randomized controlled experimental study was conducted with a total of 60 postpartum women in the reflexology application (<i>n</i> = 30) and control groups (<i>n</i> = 30). After the CS, the mothers in the control group were given approximately 3-h routine nursing care after recovering from the effects of anesthesia; the introductory information form was applied, and the Breastfeeding Charting System and Documentation Tool (LATCH) and visual analog scale (VAS) for the signs of the onset of lactation were implemented on the first and second days. Reflexology was applied to the women in the intervention group after an average of 3 h following the mother’s condition had become stable and she had recovered from the effects of anesthesia. Reflexology was applied a total of 20 min – 10 min for the right foot, 10 min for the left foot – twice a day with 8-h intervals on the first and second days after CS. After the last reflexology application, the LATCH and VAS for the signs of the onset of lactation were applied. <b><i>Results:</i></b> Of the women, 70% breastfed their babies within 60 min after delivery; 46.7% of the mothers received breastfeeding training and 81.7% needed support for breastfeeding after the CS. The LATCH breastfeeding scores of the women in the intervention group on both days were significantly higher compared to those of the women in the control group (<i>p</i> &#x3c; 0.001). On the first day after the CS, apart from breast pain, there was no significant difference between the two groups in terms of breast heat and breast tension (<i>p</i> &#x3e; 0.05). On the second day after the CS, apart from breast tension, there was no significant difference between the groups in terms of breast heat and breast pain (<i>p</i> &#x3c; 0.05). In the study, women in the intervention group were found to have higher scores in terms of all three symptoms compared to the control group (<i>p</i> &#x3c; 0.05). <b><i>Conclusions:</i></b> In the study, it was determined that LATCH scores and signs of the onset of breastfeeding increased in the mothers who received reflexology after CS.


Author(s):  
Elif Karatoprak ◽  
Samet Paksoy

AbstractThe aim of this study was to investigate the thyroid functions in children receiving levetiracetam or valproate monotherapy. We retrospectively reviewed the records of children with controlled epilepsy receiving valproic acid (VPA group) or levetiracetam monotherapy (LEV group) for at least 6 months. Free thyroxine 4 levels (fT4) and thyroid stimulating hormone (TSH) levels were compared between VPA group, LEV group, and age- and gender-matched healthy children (control group). A total of 190 children were included in the study: 63 were in the VPA, 60 in the LEV, and 67 in the control group. Although there was no significant difference regarding average fT4 levels, higher TSH levels were found in the VPA group when compared with the LEV and control groups (p < 0.001 and p < 0.001, respectively). There was no significant difference in terms of fT4 and TSH values in the LEV group when compared with the control group (p = 0.56 and p = 0.61, respectively). Subclinical hypothyroidism (defined as a TSH level above 5 uIU/mL with a normal fT4 level was detected in 16% of patients in the VPA group, none in the LEV and control groups. Our study found that VPA therapy is associated with an increased risk of subclinical hypothyroidism while LEV had no effect on thyroid function tests.


Nutrients ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 2604
Author(s):  
Jin-Young Park ◽  
Kyung-A Ko ◽  
Ji-Yeong Lee ◽  
Jae-Woon Oh ◽  
Hyun-Chang Lim ◽  
...  

Background: Mangosteen and propolis extracts (MAEC) have been potential therapeutic agents known to exhibit powerful antioxidant and anti-inflammatory properties. The aim of the current study was to evaluate the clinical and immunological efficacy of MAEC as well as safety and patient-reported outcomes (PROMs) on gingivitis and incipient periodontitis. Methods: This study was performed on 104 patients diagnosed with gingivitis or incipient periodontitis. At baseline, the participants were randomly allocated to either the test group, with daily intake of a single capsule containing 194 mg of MAEC for eight weeks, or control group, with placebo. Clinical periodontal evaluation and immunological parameters from saliva and gingival sulcular fluid were assessed at baseline, four, and eight weeks. Individual PROMs were assessed by OHIP-14 questionnaires. Results: There was a significant difference of modified gingival index at four and eight weeks between the test and control groups. In the test group, crevicular interleukin (IL)-6 was reduced, and the salivary matrix metalloproteinase (MMP)-9 was increased after eight weeks. PROMs were improved up to four weeks compared to placebo. Conclusion: Oral administration of MAEC would have a potential to reduce gingival inflammation clinically and immunologically in the patients with gingivitis and incipient periodontitis.


2020 ◽  
pp. bmjstel-2020-000657
Author(s):  
Rebecca Singer ◽  
Grace Leo ◽  
Tessa Davis ◽  
Ben Lawton ◽  
Henry Goldstein ◽  
...  

Previous research has examined the utilisation of musical cues to improve the performance of cardiopulmonary resuscitation (CPR) delivered in training environments. We postulated a musical cue that is both contemporary and transcends cultures may improve CPR performance. Our aim was to establish whether chest compressions are performed with improved rate and depth if a song of a fixed beat (PinkFong’s ‘Baby Shark’ with a tempo of 115 beats per minute (bpm) and 15 beats in each verse) is played to a healthcare professional immediately before undertaking CPR compared to whale noises (a non-metronomic rhythm). 58 Participants of a paediatric conference (majority doctors) were randomly assigned to listen to a minute of Baby Shark (28) or whale song (30) and then undertake a minute of CPR. There was no significant difference in the mean compression rate between the Baby Shark and control groups, with the groups achieving 121 and 125 bpm, respectively (p=0.18). In relation to compression depth within the target zone, the Baby Shark group had more compressions completed within the target zone (55%) than the control group (39%) although this difference was not significant (p=0.08). Listening to Baby Shark prior to undertaking simulated CPR does not improve overall performance, but there is a potential tendency to improve adequate compression depth which may be beneficial in training exercises.


2018 ◽  
Vol 2018 ◽  
pp. 1-11
Author(s):  
Qiang Chen ◽  
Manman Wang ◽  
Shuai Shao ◽  
Hongze Liu ◽  
Xiaodong Xia ◽  
...  

Objectives. Percutaneous coronary intervention (PCI) is the mainstay treatment for coronary artery disease but complications such as in-stent restenosis and thrombosis remain problematic. Radiofrequency balloon angioplasty (RBA) can improve lumen dimension, fusing intimal tears, and artery dissection but is associated with higher restenosis rate. Methods. After establishing an atherosclerosis model based on endothelial abrasion and high cholesterol diet, forty-five rabbits were randomly divided into three groups: RBA (n=20), percutaneous transluminal angioplasty (PTA) (n=20), and control groups (n=5). The RBA and PTA groups were subdivided according to harvested time posttreatment, respectively (1 hour, 7 days, 14 days, and 28 days). Aorta segments were then isolated for hematoxylin and eosin staining, Masson trichrome staining, immunohistochemistry, and Western blot for TLR-4, NF-κB, MCP-1, and VCAM-1expression. Results. At 28 days, intimal area was significantly lower in the RBA group compared to the PTA and control groups, whilst luminal and medial area were comparable in the RBA and PTA group but higher and lower than the control group, respectively. Expression of TLR-4, NF-κB, MCP-1, and VCAM-1 showed no significant difference between RBA and PTA groups. Conclusions. RBA can depress the intimal hyperplasia and promote dilatation of the artery to greater extents than PTA at 28 days. However, this did not involve TLR-4 signaling pathway, which likely plays a negligible role in mediating restenosis. Reduction of intimal hyperplasia may be due to injury of ablation to the tunica media and inhibition of VSMC proliferation and migration.


2021 ◽  
pp. 112067212110087
Author(s):  
Ersin Muhafiz ◽  
Erdinç Bozkurt ◽  
Remzi Erten

Purpose: To evaluate the tear parameters, meibomian glands and lid margin and tarsal conjunctival impression cytology in patients with conjunctivochalasis (CCH). Methods: The study included 57 patients diagnosed with CCH and 35 healthy volunteers. Tear break-up time (TBUT) was measured and Schirmer test was performed. Meibomian gland morphologies, dropout rates, and meiboscores were evaluated using meibography. Finally, impression cytology samples were taken by pressing the impression filters on the lower lid margin and lower tarsal conjunctiva. The samples were evaluated according to the Nelson grading system. Results: Schirmer test was longer and TBUT was shorter in the study group ( p = 0.035 and p < 0.001, respectively). The median of meibomian gland dropout rate was 33.45% (Interquartile range [IQR]; 23.17%–49.75%) and 18.80% (IQR; 12.35%–26.50%) in the study and control groups, respectively ( p < 0.001). There was no significant difference in terms of lid-margin cytology between the two groups ( p = 0.481). In tarsal conjunctiva cytology, the median value of Nelson grade of the study group was 2 (IQR; 1–2) and that of the control group was 1 (IQR; 1–2) ( p = 0.040). When Nelson grade-2 and above was accepted as the pathological limit, it was found that 27.5% of the study group and 15.2% of the control group showed pathological findings ( p = 0.204). Conclusions: In patients with CCH, damage occurs in the tarsal conjunctiva with the effects of redundant conjunctival folds. In these patients, atrophy occurs in the meibomian glands and tear stability is impaired. Therefore, CCH should not be overlooked in clinical practice.


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