INTRODUCTION: The non-intoxicating plant-derived cannabinoid, cannabidiol (CBD), has demonstrated therapeutic potential in a number of clinical conditions. Most successful clinical trials have used relatively high (≥300 mg) oral doses of CBD. Relatively few studies have investigated the efficacy of lower (<300 mg) oral doses, typical of those available in over-the-counter CBD products. METHODS: We present a protocol for a randomised, double-blind, placebo-controlled, parallel-group clinical trial investigating the effects of a low oral dose (150 mg) of CBD on acute psychosocial stress, situational anxiety, motion sickness and cybersickness in healthy individuals. Participants (n=74) will receive 150 mg of CBD or a matched placebo 90 min before completing three virtual reality (VR) challenges (tasks) designed to induce transient stress and motion sickness: (a) a 15 min 'Public Speaking' task; (b) a 5 min 'Walk the Plank' task (above a sheer drop); and (c) a 5 min 'Rollercoaster Ride' task. The primary outcomes will be self-reported stress and nausea measured on 100 mm Visual Analogue Scales. Secondary outcomes will include salivary cortisol concentrations, skin conductance, heart rate and vomiting episodes (if any). Statistical analyses will test the hypothesis that CBD reduces nausea and attenuates subjective, endocrine and physiological responses to stress compared with placebo. This study will indicate whether low-dose oral CBD has positive effects in reducing acute psychosocial stress, situational anxiety, motion sickness and cybersickness. ETHICS AND DISSEMINATION: The University of Sydney Human Research Ethics Committee has granted approval (2023/307, version 1.6, 16 February 2024). Study findings will be disseminated in a peer-reviewed journal and at academic conferences. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12623000872639).
- MeSH
- dvojitá slepá metoda MeSH
- kanabidiol * terapeutické užití MeSH
- kinetózy * farmakoterapie MeSH
- lidé MeSH
- nauzea farmakoterapie MeSH
- psychický stres MeSH
- randomizované kontrolované studie jako téma MeSH
- úzkost farmakoterapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
- Geografické názvy
- Austrálie MeSH
Aim: This study aims to assess the effectiveness of ATHP-HC on the severity of nausea and vomiting, relaxation state, brainwaves, and quality of life in women with Nausea and Vomiting in Pregnancy (NVP). Methods: A quasi-experimental study was conducted on 62 pregnant women randomly allocated into intervention and control groups using a pre-post-test. Researchers provided ATHP-HC to the intervention group and Cirebon Gamelan audio therapy to the control group. The research instruments included PUQE-24-hour scoring, measurement of vital signs, brainwaves using NeuroSky MindWave Mobile II, and WHOQOL-BREF. The data collected were processed with SPSS version 24.0 and analyzed using the statistical formula paired t-test. Results: The results of the study showed that there were significant differences between nausea and vomiting scores (p = 0.000), relaxation levels (p = 0.003 in the intervention group and p = 0.000 in the control group), and quality of life (p = 0.000), before and after the treatment in the intervention group and the control group. There was a significant difference in the state of relaxation after the intervention in the two groups of respondents (p = 0.001). There was no significant difference in the proportion of increased meditation in the two groups of respondents (p = 0.707). Conclusion: As relaxation and meditation music, ATHP-HC can be a complementary therapy for pregnant women to overcome NVP.
- MeSH
- kvalita života MeSH
- lidé MeSH
- mozkové vlny MeSH
- muzikoterapie * metody MeSH
- nauzea terapie MeSH
- nervový systém - fyziologické jevy MeSH
- průzkumy a dotazníky MeSH
- relaxace MeSH
- statistika jako téma MeSH
- těhotenství * MeSH
- zvracení terapie MeSH
- Check Tag
- lidé MeSH
- těhotenství * MeSH
- ženské pohlaví MeSH
- Publikační typ
- klinická studie MeSH
Cieľ: Zamerali sme sa na anestéziu a jej vplyv na psychické rozpoloženie pacientov. Dizajn: Sledovali sme vzťah medzi výskytom nepríjemných zážitkov pacientov počas anestézie a demografickými údajmi. Metódy: Súbor tvorilo 219 pacientov po anestézii. Pre interpretáciu výsledkov sme vypočítali jednoduché frekvencie, percentuálne hodnotenie súboru, aritmetický priemer, medián a modus. Dotazníky sme pacientom administrovali v Univerzitnej nemocnici Bratislava od novembra 2010 do marca 2011. Výsledky: Najdôležitejšími výsledkami je zistenie vzťahu medzi jednotlivými nepríjemnými zážitkami a vekom pacientov, kde sme štatistickú významnosť zistili u nepríjemných zážitkov, ako je spomienka bez bolesti (p = 0,015), vracanie (p = 0,029), svalová slabosť (p = 0,048) a bolesť hlavy (p = 0,015); a pri hodnotení vzťahu medzi výskytom nepríjemných zážitkov a pohlavím, kde sme zistili štatisticky významný vzťah vo výskyte nevoľnosti (p = 0,000), problémov s dýchaním (p = 0,048), vracaním (p = 0,015), bolesti v operačnej rane (p = 0,001) a svalovej slabosti (p = 0,003). Záver: Výsledky potvrdzujú vzťah medzi výskytom nepríjemných zážitkov pacientov počas anestézie a ich demografickými údajmi. Na základe našich zistení navrhujeme vytvorenie protokolov predoperačnej prípravy so zameraním sa na identifikáciu najčastejších nepríjemných zážitkov u pacientov súvisiacich s anestéziou.
Purpose: We focused on anaesthesia and its impact on patients' mental mood. Design: We followed the relationship between the occurrence of unpleasant experiences of patients during anaesthesia and demographic data. Methods: The group consisted of 219 patients after anaesthesia. We administered questionnaires to patients at the University Hospital Bratislava between November 2010 and March 2011. Results: The most important results are the subsequent investigation of the relationship between individual unpleasant experiences and the age of the patients, where we found statistical significance in unpleasant experiences such as recall without pain (p = 0.015), vomiting (p = 0.029), muscle weakness (p = 0.048), and headache (p = 0.015); and when evaluating the relationship between the incidence of unpleasant experiences and sex, we found a statistically significant relationship in the incidence of nausea (p = 0.000), breathing problems (p = 0.048), vomiting (p = 0.015), pain in the surgical wound (p = 0.001), and muscle weakness (p = 0.003). Conclusion: Results confirm the relationship between the occurrence of unpleasant experiences of patients during anaesthesia and their demographic data. Based on our findings, we propose creating protocols for preoperative preparation, focusing on identifying the most common unpleasant experiences in patients related to anaesthesia.
Pooperační nevolnost a zvracení (PONV) je častou pooperační komplikací, která postihuje 20-30 % dětí, u vysoce rizikových výkonů stoupá incidence až k 80 %. PONV vedle subjektivního dyskomfortu zvyšuje pooperační morbiditu a ohrožuje dítě dehydratací, dehiscencí operační rány a následným krvácením. Dochází k prodloužení pobytu na dospávacím pokoji a celkové doby hospitalizace. Management PONV spočívá v identifikaci rizikových pacientů a zahájení adekvátní prevence. Lékem volby je dexametazon nebo ondansetron, u vysoce rizikových dětí jejich kombinace. V případě selhání prevence je indikace k podání antiemetika z jiné farmakologické skupiny.
Postoperative nausea and vomiting (PONV) is a common postoperative complication with overall incidence of 20-30 %, however, with high risk procedures it increases up to 80 %. PONV is the main cause of the patient ́s discomfort, worsens perioperative morbidity and put the child at risk of dehydratation, dehiscence of surgical wound and bleeding. PONV prolongs the lenght of stay (PACU, in-hospital care). The cornerstone of PONV management is the identification of high risk pediatric patients and an adequate pre-operative pharmacological prevention. Dexamethasone and ondansetron (or their combination) are the first line medications. In case of failure, rescue therapy should be provided with other pharmacological agents.
- MeSH
- antiemetika MeSH
- dexamethason aplikace a dávkování terapeutické užití MeSH
- dítě MeSH
- lidé MeSH
- ondansetron aplikace a dávkování terapeutické užití MeSH
- pooperační nevolnost a zvracení * diagnóza farmakoterapie prevence a kontrola MeSH
- rizikové faktory MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- Publikační typ
- přehledy MeSH
This is the primary report of the randomized, placebo-controlled phase 3 BRIGHT AML 1019 clinical trial of glasdegib in combination with intensive chemotherapy (cytarabine and daunorubicin) or non-intensive chemotherapy (azacitidine) in patients with untreated acute myeloid leukemia. Overall survival (primary endpoint) was similar between the glasdegib and placebo arms in the intensive (n = 404; hazard ratio [HR] 1.05; 95% confidence interval [CI]: 0.782-1.408; two-sided p = 0.749) and non-intensive (n = 325; HR 0.99; 95% CI: 0.768-1.289; two-sided p = 0.969) studies. The proportion of patients who experienced treatment-emergent adverse events was similar for glasdegib versus placebo (intensive: 99.0% vs. 98.5%; non-intensive: 99.4% vs. 98.8%). The most common treatment-emergent adverse events were nausea, febrile neutropenia, and anemia in the intensive study and anemia, constipation, and nausea in the non-intensive study. The addition of glasdegib to either cytarabine and daunorubicin or azacitidine did not significantly improve overall survival and the primary efficacy endpoint for the BRIGHT AML 1019 phase 3 trial was not met. Clinical trial registration: ClinicalTrials.gov: NCT03416179.
- MeSH
- akutní myeloidní leukemie * MeSH
- anemie * farmakoterapie MeSH
- azacytidin terapeutické užití MeSH
- cytarabin MeSH
- daunomycin MeSH
- lidé MeSH
- nauzea farmakoterapie MeSH
- protokoly antitumorózní kombinované chemoterapie škodlivé účinky MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- randomizované kontrolované studie MeSH
Postdischarge nausea and vomiting (PDNV) cause substantial pediatric morbidity with potentially serious postoperative complications. However, few studies have addressed PDNV prevention and treatment in pediatric patients. Here we searched the literature and processed it in a narrative review describing PDNV incidence, risk factors, and management in pediatric patients.. A successful strategy for reducing PDNV considers both the pharmacokinetics of the antiemetic agents and the principle of multimodal prophylaxis, utilizing agents of different pharmacologic classes. Since many highly effective antiemetic agents have relatively short half-lives, a different approach must be used to prevent PDNV. A combination of oral and intravenous medications with longer half-lives, such as palonosetron or aprepitant, can be used. In addition, we designed a prospective observational study with the primary objective of determining PDNV incidence. In our study group of 205 children, the overall PDNV incidence was 14.6% (30 of 205), including 21 children suffering from nausea and 9 suffering from vomiting.
- MeSH
- antiemetika * terapeutické užití MeSH
- dítě MeSH
- lidé MeSH
- následná péče MeSH
- pooperační nevolnost a zvracení prevence a kontrola farmakoterapie MeSH
- pozorovací studie jako téma MeSH
- propuštění pacienta MeSH
- prospektivní studie MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
Elevated levels of nausea and vomiting in pregnancy (NVP) and disgust sensitivity have been observed in the first trimester and both are thought to have a protective function for the mother and her fetus. Their aetiology is not clear, however, with previous studies attributing elevated NVP and disgust to various factors including endocrine changes, immunological changes, and psychological variables. To date, no study has directly assessed the relationship between disgust and NVP. Here, we prospectively collected two independent samples (S1 and S2; n1 = 201, n2 = 391) of women in the first trimester of pregnancy, who completed the Index of Nausea, Vomiting, and Retching and the Disgust Scale-Revised. We also measured free β-human chorionic gonadotropin (hCG) and pregnancy-associated plasma protein A (PAPP-A) in maternal serum. Our results did not confirm any association between NVP and disgust; in addition, they indicate that NVP and disgust may have different proximate causes. Disgust sensitivity was significantly negatively correlated with free β-hCG and (only in S1) with PAPP-A. In contrast, NVP was significantly positively associated with free β-hCG levels and (only in S1) with PAPP-A. While low hCG levels seem to be an important indicator for activation of the behavioral immune system in the first trimester, increased hCG levels play a role in stronger symptoms of NVP, a result consistent with previous studies. Levels of PAPP-A are likely part of a larger network of immunological and endocrine responses and do not appear to provide sufficient information for predicting women's NVP and disgust sensitivity.
- MeSH
- biologické markery MeSH
- komplikace těhotenství * MeSH
- lidé MeSH
- lidský choriogonadotropin, beta podjednotka MeSH
- nauzea etiologie MeSH
- odpor * MeSH
- první trimestr těhotenství MeSH
- těhotenský plazmatický protein A metabolismus MeSH
- těhotenství MeSH
- zvracení etiologie MeSH
- Check Tag
- lidé MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Klíčová slova
- Natrium phosphoricum,
- MeSH
- homeopatie * MeSH
- lidé středního věku MeSH
- lidé MeSH
- materia medica MeSH
- nauzea terapie MeSH
- průjem * terapie MeSH
- rinitida * terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
- populární práce MeSH
BACKGROUND: A recent study focusing on dietary predictors of nausea and vomiting in pregnancy (NVP) found that women with higher levels of partner support, and those who had used oral contraception (OC) when they met the father, both tended to report less severe NVP compared with previous non-users or those with less supportive partners. We provide a further test of these factors, using a large sample of women from four countries who retrospectively scored their NVP experience during their first pregnancy. METHODS: We recruited women who had at least one child to participate in a retrospective online survey. In total 2321 women completed our questionnaire including items on demographics, hormonal contraception, NVP, and partner support. We used general linear models and path analysis to analyse our data. RESULTS: Women who had used OC when they met the father of their first child tended to report lower levels of NVP, but the effect size was small and did not survive adding the participant's country to the model. There was no relationship between NVP and partner support in couples who were still together, but there was a significant effect among those couples that had since separated: women whose ex-partner had been relatively supportive reported less severe NVP. Additional analyses showed that women who were older during their first pregnancy reported less severe NVP, and there were also robust differences between countries. CONCLUSIONS: These results provide further evidence for multiple influences on women's experience of NVP symptoms, including levels of perceived partner support.
- MeSH
- antikoncepce metody psychologie MeSH
- antikoncepční chování psychologie MeSH
- charakteristiky rodiny MeSH
- dítě MeSH
- internet MeSH
- komplikace těhotenství * etiologie prevence a kontrola psychologie MeSH
- kontraceptiva orální * aplikace a dávkování terapeutické užití MeSH
- lidé MeSH
- nauzea * etiologie prevence a kontrola psychologie MeSH
- retrospektivní studie MeSH
- sexuální partneři * psychologie MeSH
- sociální opora * psychologie MeSH
- těhotenství MeSH
- zdravotnické přehledy MeSH
- zvracení * etiologie prevence a kontrola psychologie MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- srovnávací studie MeSH