scholarly journals Trial design and protocol of randomized controlled trial comparing the efficacy of oral mefenamic acid, paracetamol and placebo for analgesic prophylaxis in childhood vaccination (MAP VaC trial)

2021 ◽  
Vol 8 (3) ◽  
pp. 218
Author(s):  
Rachna Pasi ◽  
Thirunavukkarasu Arun Babu ◽  
Vinoth Kumar Kallidoss
Keyword(s):  
Randomized Controlled Trial ◽  
Mefenamic Acid ◽  
Vaccine Coverage ◽  
Controlled Trial ◽  
Childhood Vaccination ◽  
Vaccine Hesitancy ◽  
Immunization Schedule ◽  
Vaccine Administration ◽  
Randomized Controlled ◽  
National Immunization

<p class="abstract"><strong>Background:</strong> Needle related pain has been one of the most important concerns for parents of children receiving vaccination. Non-steroidal anti-inflammatory drugs (NSAIDs) like paracetamol and mefenamic acid have been commonly used as analgesics in pediatric population. However, prophylactic administration of these drugs for analgesia during vaccination has not been studied. The main objective of this study is to compare the efficacy of prophylactic paracetamol, mefenamic acid and placebo on needle pain associated with vaccination.</p><p class="abstract"><strong>Methods:</strong> This is a three-arm parallel, triple blind, randomized controlled trial. Children aged 6 weeks to 7 years who need immunization as per national immunization schedule and reporting to pediatric outpatient department (OPD) at tertiary level hospital, AIIMS Mangalagiri, Andhra Pradesh, will be included. All participants will be randomly allotted to any of the three groups by computer based block randomization. Each participant will be given any one of the three drugs as per their allocation. Vaccination will be done as per national immunization schedule after 30 minutes of drug administration. Face, legs, activity, cry, consolability (FLACC) scoring will be done immediately after vaccine administration and repeated at 15 minutes and 30 minutes. All personnel involved in randomization, drug and vaccine administration, FLACC scoring and statistical analysis will be blinded along with parents and children enrolled in the study.</p><p class="abstract"><strong>Conclusions: </strong>If this intervention study shows evidence of a difference between drug and placebo signifying reduction in vaccine related pain with these drugs, this will have a huge impact on National Immunization programme by improving compliance, vaccine coverage and by reducing vaccine hesitancy.</p><p class="abstract"><strong>Trial registration:</strong> Clinical trials registration number is CTRI/2021/01/030239.</p>

scholarly journals A randomized controlled trial of a video intervention shows evidence of increasing COVID-19 vaccination intention

2021 ◽  
Author(s):  
Leah S Witus ◽  
Erik Larson
Keyword(s):  
Randomized Controlled Trial ◽  
Parental Attitudes ◽  
Controlled Trial ◽  
Herd Immunity ◽  
Educational Interventions ◽  
Childhood Vaccination ◽  
Vaccine Hesitancy ◽  
Control Group ◽  
Information Control ◽  
Randomized Controlled

Increasing acceptance of COVID–19 vaccines is imperative for public health, as unvaccinated individuals may impede the ability to reach herd immunity. Previous research on educational interventions to overcome vaccine hesitancy have shown mixed effects in increasing vaccination intention, although much of this work has focused on parental attitudes toward childhood vaccination. In this study, we conducted a randomized controlled trial to investigate whether vaccination intention changes after viewing an animated YouTube video explaining how COVID–19 mRNA vaccines work. We exposed participants to one of four interventions — watching the video with a male narrator, watching the same video with a female narrator, reading the text of the transcript of the video, or receiving no information (control group). We found that participants who watched the version of the video with a male narrator expressed statistically significant increased vaccination intention compared to the control group. The video with a female narrator had more variation in results. As a whole, there was a non–significant increased vaccination intention when analyzing all participants who saw the video with a female narrator; however, for politically conservative participants there was decreased vaccination intention for this intervention, particularly at a threshold between being currently undecided and expressing probable interest. These results are encouraging for the ability of interventions as simple as YouTube videos to increase vaccination propensity, although the inconsistent response to the video with a female narrator demonstrates the potential for bias to affect how certain groups respond to different messengers.

scholarly journals A Non-Randomized Controlled Trial for the Effectiveness of the ‘Aibo’ Intervention Program for Distraction in Childhood Vaccination

2021 ◽  
Author(s):  
Kyoko Tanaka ◽  
Maoko Hayakawa ◽  
Chihiro Noda ◽  
Moemi Nakamura ◽  
Akio Nakamura ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intervention Program ◽  
Controlled Trial ◽  
Intervention Group ◽  
Behavioral Observation ◽  
Childhood Vaccination ◽  
Control Group ◽  
Randomized Controlled ◽  
Study Results ◽  
Face Scale

Abstract Procedures and actions such as injections and immobilization cause pain and distress to children. In the pediatric field, there is a need for interventions and support to alleviate the pain and distress caused by such medical procedures. In recent years, the introduction of robots as a means of distraction has begun to be attempted. In this study, we conducted a non-randomized controlled trial to examine the effect of intervention using ‘aibo’, a dog-like robot which has artificial intelligence (AI), to promote distraction in children after vaccination. As a result, 57 children (32 in the intervention group) participated in the study. Results of a t-test with the control group showed that the intervention group using aibo had significantly less pain following the post-vaccination intervention than the control group using stuffed dog (Face Scale, t(55) = 2.582, p = .0125; Behavioral Observation Scale, t(55) = 2.772, p = .00759). The results support the hypothesis that the aibo intervention group will be less distressed and able to calm down more quickly after vaccination than the control group. Conclusion : AI-powered aibo interventions that allow for interactive interaction can be an effective distraction method during painful procedures such as vaccinations.

Effects of Mefenamic Acid Versus Quince on Menorrhagia and Quality of Life: A Randomized Controlled Trial

2017 ◽  
Vol 19 (10) ◽  
Author(s):  
Pari Rahi ◽  
Mojgan Mirghafourvand ◽  
Sakineh Mohammad-Alizadeh-Charandabi ◽  
Yousef Javadzadeh
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Mefenamic Acid ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Acid Versus

scholarly journals Mefenamic Acid for the Prevention of Bleeding and Spotting From Depot-medroxyprogesterone Acetate: A Randomized Controlled Trial

2021 ◽  
Vol 9 (4) ◽  
pp. 291-294
Author(s):  
Jen Sothornwit ◽  
Yuthapong Werawatakul ◽  
Orathai Saenbon
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Medroxyprogesterone Acetate ◽  
Mefenamic Acid ◽  
Controlled Trial ◽  
Acid Group ◽  
Self Report ◽  
Controlled Study ◽  
Depot Medroxyprogesterone Acetate ◽  
Randomized Controlled

Objectives: To evaluate the efficacy of mefenamic acid for the reduction of bleeding and spotting in post-partum women initiating the use of depot-medroxyprogesterone acetate (DMPA) for contraception. Materials and Methods: This double-blind, placebo-controlled study included postpartum breastfeeding women in Khon Kaen, Thailand. Mefenamic acid or placebo was administered over the first 12 weeks of DMPA use. Then, participants completed a self-report bleeding diary. Results: Forty women, initiating the use of DMPA for postpartum contraception, were randomized to mefenamic acid (n=20) or placebo (n=20) group. The study was discontinued after 27 months because of suboptimal enrollment. The mefenamic acid group was less likely to have prolonged bleeding compared to placebo although this was not statistically significant (37.5% vs. 50%, respectively, P = 0.491). DMPA discontinuation rates were high at 50% in both groups although no participants in the mefenamic acid group stopped using DMPA due to bleeding side effects. Conclusions: The high discontinuation rates in the postpartum use of DMPA are attributed to the occurrence of bleeding/spotting side effects. Although mefenamic acid prophylaxis appeared to be beneficial to some women, a larger randomized controlled trial is required to confirm the effectiveness of this approach.

Decreasing vaccine hesitancy with extended health knowledge: Evidence from a longitudinal randomized controlled trial.

2021 ◽  
Vol 40 (2) ◽  
pp. 77-88
Author(s):  
Sarah Eitze ◽  
◽  
Dorothee Heinemeier ◽  
Nora Katharina Schmid-Küpke ◽  
Cornelia Betsch
Keyword(s):  
Randomized Controlled Trial ◽  
Health Knowledge ◽  
Controlled Trial ◽  
Vaccine Hesitancy ◽  
Randomized Controlled
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