• Title/Summary/Keyword: random clinical trial

Search Result 44, Processing Time 0.021 seconds

A comparative evaluation of peppermint oil and lignocaine spray as topical anesthetic agents prior to local anesthesia in children: a randomized clinical trial

  • Harika Petluru;SVSG Nirmala;Sivakumar Nuvvula
    • Journal of Dental Anesthesia and Pain Medicine
    • /
    • v.24 no.2
    • /
    • pp.119-128
    • /
    • 2024
  • Background: In pediatric dentistry, fear and anxiety are common among children. Local anesthetics (LA) are widely used to control pain and reduce discomfort in children during dental treatment. Topical anesthetics play a vital role in reducing pain and the unpleasant sensation of a needle puncture in children. Peppermint oil has been extensively used for various diseases. However, its anesthetic properties remain unknown. Peppermint oil, used in mouthwashes, toothpastes, and other topical preparations has analgesic, anesthetic, and antiseptic properties. This study aimed to compare and evaluate pain perception following the topical application of peppermint oil versus lignocaine spray before an intraoral injection in children, aged 8-13 years. Method: Fifty-two children, aged between 8-13 years, who required local anesthesia for dental treatment were divided into two groups of 26 each by simple random sampling (Group 1: 0.2% peppermint oil and Group 2: lignocaine spray). In both groups, physiological measurements (e.g., heart rate) were recorded using pulse oximetry before, during, and after the procedure. Objective pain measurement (Sound Eye Motor (SEM) scale) during administration and subjective measuremeant (Wong-Baker Faces Pain Rating Scale (WBFPRS)) after LA administration were recorded. This was followed by the required treatment of the child. Physiological parameters were compared between the two groups using an independent t-test for intergroup assessment and a paired t-test and repeated-measures ANOVA for intragroup comparisons. The Mann-Whitney U test was used to analyze the pain scores. Results: Intragroup mean heart rates, before, during, and after treatment were statistically significantly different (P < 0.05). However, the intergroup mean pulse rates did not differ significantly between the two groups. The mean WBFPS score in the lignocaine spray group was 4.133 ± 2.06 was statistically different from that of the peppermint oil group (0.933 ± 1.03; P < 0.001*). The mean SEM score was significantly lower in the peppermint oil group than that in the lignocaine spray group (P = 0.006). No negative effects were observed in this study. Conclusion: 0.2% peppermint oil was effective in reducing pain perception.

Effect of Cognitive Behavioral Therapy (CBT) for Perinatal Depression: A Systematic Review and Meta-Analysis (산전우울 임부를 위한 인지행동치료 프로그램의 효과: 체계적 문헌고찰 및 메타분석)

  • Shin, Hyeon-Hee;Shin, Yeong-Hee;Kim, Ga-Eun
    • Journal of the Korea Academia-Industrial cooperation Society
    • /
    • v.17 no.11
    • /
    • pp.271-284
    • /
    • 2016
  • This study was carried out to evaluate the efficacy of CBT for perinatal depression through systematic literature review and meta-analysis. The following databases were used to search the literature: CINAHL, PubMed, EMBASE, Koreamed, Library of Korean Congress, KISS, and Korean Academic Publication Database. Keywords included 'perinatal depression,' 'pregnant women,' and 'cognitive behavioral therapy,' and the evaluated articles were published up to May 2016. Using the R program, the effect size of perinatal depression and anxiety were calculated by random-effects model. The heterogeneity of the effect size was analyzed by data moderator analysis using the meta-ANOVA. Furthermore, the funnel plot, Egger's regression test, fail-safe N, trim-and-fill test, and publication bias analysis were conducted and used to verify the results. Out of the 180 selected articles, 16 clinical trial studies were meta-analyzed. Each articles were evaluated for the risk of bias by the checklist of SIGN; the overall risk of bias was low. The effect size of CBT for perinatal depression was Hedges' g=-0.55 (95% CI: -0.76~-0.33), which was a moderate level, while for anxiety reduction, Hedges' g=-0.20 (95% CI: -0.48~-0.08) and it was not statistically significant. Heterogeneity or risk of publication bias were low. This meta-analytic study found that CBT is moderately effective in reducing perinatal depression in pregnant women.

Indigo Naturalis in Inflammatory Bowel Disease: mechanisms of action and insights from clinical trials

  • Hyeonjin Kim;Soohyun Jeong;Sung Wook Kim;Hyung-Jin Kim;Dae Yong Kim;Tae Han Yook;Gabsik Yang
    • Journal of Pharmacopuncture
    • /
    • v.27 no.2
    • /
    • pp.59-69
    • /
    • 2024
  • This study investigates the therapeutic potential of Indigo Naturalis (IN) in treating a Inflammatory Bowel Disease (IBD). The objective is to comprehensively examine the effects and pharmacological mechanisms of IN on IBD, assessing its potential as an novel treatment for IBD. Analysis of 11 selected papers is conducted to understand the effects of IN, focusing on compounds like indirubin, isatin, indigo, and tryptanthrin. This study evaluates their impact on Disease Activity Index (DAI) score, colon length, mucosal damage, and macrophage infiltration in Dextran Sulfate Sodium (DSS)-induced colitis mice. Additionally, It investigate into the anti-inflammatory mechanisms, including Aryl hydrocarbon Receptor (AhR) pathway activation, Nuclear Factor kappa B (NF-κB)/nod-like receptor family pyrin domain containing 3 (NLRP3)/Interleukin 1 beta (IL-1β) inhibition, and modulation of Toll-like receptor 4 (TLR4)/myeloid differentiation primary response 88 (MYD88)/NF-κB and Mitogen Activated Protein Kinase (MAPK) pathways. Immunomodulatory effects on T helper 17 (Th17)/regulatory T cell (Treg cell) balance and Glycogen synthase kinase-3 beta (GSK3-β) expression are also explored. Furthermore, the study addresses the role of IN in restoring intestinal microbiota diversity, reducing pathogenic bacteria, and increasing beneficial bacteria. The findings reveal that IN, particularly indirubin and indigo, demonstrates significant improvements in DAI score, colon length, mucosal damage, and macrophage infiltration in DSS-induced colitis mice. The anti-inflammatory effects are attributed to the activation of the AhR pathway, inhibition of inflammatory pathways, and modulation of immune responses. These results exhibit the potential of IN in IBD treatment. Notably, the restoration of intestinal microbiota diversity and balance further supports its efficacy. IN emerges as a promising and effective treatment for IBD, demonstrating anti-inflammatory effects and positive outcomes in preclinical studies. However, potential side effects necessitate further investigation for safe therapeutic development. The study underscores the need for future research to explore a broader range of active ingredients in IN to enhance therapeutic efficacy and safety.

The Effects of Weighted Vest During Task-Oriented Training on Gross Motor Performance and Balance Abilities of Children With Spastic Diplegia : A Randomized Clinical Trial Study (경직형 양마비 아동의 과제지향훈련 시 무게조끼 적용이 대동작 수행력과 균형 능력에 미치는 영향: 무작위배정 위약비교 연구)

  • Kwon, Hae-Yeon
    • The Journal of Korean Academy of Sensory Integration
    • /
    • v.15 no.2
    • /
    • pp.46-65
    • /
    • 2017
  • Objective : The purpose of this research is to find clinical effects of application of weighted vest during task-oriented training focused on gross motor performance and balance abilities of children with spastic diplegia. Methods : 34 subjects were divided by simple random sampling into two groups; experimental group (male : 9, female : 8, average age : 8.12) and placebo group (male : 9, female : 9, average age : 7.53). Both two groups underwent to 40 minute intervention, twice a week for 12 weeks. The intervention was task-oriented training focused on facilitating closed kinematic chain and multi-joint functional movement pattern. During the training, the experimental group received loaded-resistance weighted vest and placebo group also received weighted vest but without loaded-resistance. Participants in both groups underwent 8 to 10 reps of the task-oriented training and there were 3 minutes break time between tasks. There were pre-test of gross motor performance and balance abilities, and two times of post-tests were performed upon 6 weeks and 12 weeks after the intervention completed. And in final, an additional follow-up test was performed 12 weeks after the evaluation was finished in order to find any difference between the two groups over time. Results : There was significant difference in Gross Motor Performance Measure (GMPM) between two groups. It is found that average score of the experimental group increased more than the placebo group after 6 weeks and 12 weeks intervention (p<.05). There was significant difference in Pediatric Berg's Balance Scale (PBS) between two groups. It is found that average score of the experimental group increased more than the placebo group after 6 weeks and 12 weeks intervention (p<.05). Conclusion : Based on the results in this study, it is proposed that application of weighted vest into task-oriented training to facilitating closed kinematic chain and multi-joint movement can improve gross motor performance and balance abilities of children with cerebral palsy.