Effectiveness of preoperative tour to a simulated anaesthesia induction at operating theatre in reducing preoperative anxiety in children and their parents: a pragmatic, single-blinded, randomised controlled trial/ King Fahad Medical City

2021 ◽  
pp. bmjstel-2020-000707
Author(s):  
Hussein Battah ◽  
Usamah AlZoraigi ◽  
Firas Shubbak
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Anxiety Level ◽  
Preoperative Anxiety ◽  
Operating Theatre ◽  
Anaesthesia Induction ◽  
Significant Difference ◽  
Anxiety Levels ◽  
Children’S Anxiety ◽  
Randomised Controlled

ObjectiveTo evaluate the effectiveness of a preoperative tour to a simulated anaesthesia induction at operating theatre on reducing children’s and parents’ preoperative anxiety.DesignA pragmatic, single-centre, assessor-blinded, randomised controlled trial.SettingIn preoperative anaesthesia clinic and the operating room at a tertiary care centre in Saudi Arabia.ParticipantsOne hundred and sixteen children–parents dyads (pairs) (n=57) intervention group (IG); (n=59) control group (CG) with children aged 4–14 years who were planned for day case procedures under general anaesthesia.InterventionsParticipants’ dyads were randomly allocated through a computer to receive either a preoperative tour to a real operating theatre and simulate anaesthesia induction or standard of care.Main outcome measureThe primary study outcome was children’s anxiety levels as measured by the modified-Yale Preoperative Anxiety Scale (m-YPAS), and the parent’s anxiety level as assessed by the Beck Anxiety Inventory Scale. The children’s anxiety levels were measured at two time points, the preoperative holding area (T0) and before the anaesthesia induction (T1), and the parents’ anxiety level was measured after the anaesthesia induction. The secondary outcomes were the prevalence of preoperative anxiety and children’s somatic signs of anxiety including heart rate and systolic blood pressure.ResultsThe Mann-Whitney U test of m-YPAS scores showed significant differences in the children’s anxiety levels between the CG and IG at T0 (Z −5.009); p<0.01) and T1 (Z −6.599); p<0.01). BIAS analysis revealed a significant difference in the parents’ anxiety level between the CG and IG (Z −4.353); p<0.01). The prevalence of children’s anxiety was reported by 55 (93.2%) in the CG compared with 25 (43.9%) in the IG, with a statistically significant difference (p<0.001).ConclusionThe preoperative simulated anaesthesia induction was effective in reducing preoperative anxiety in children and their parents.

TERAPI MUSIK DAN TINGKAT KECEMASAN PASIEN PREOPERASI

2016 ◽  
Vol 5 (1) ◽  
pp. 1-6
Author(s):  
Wenny Savitri ◽  
Nani Fidayanti ◽  
Paulus Subiyanto
Keyword(s):  
Music Therapy ◽  
Intervention Group ◽  
Complementary Therapy ◽  
T Test ◽  
Anxiety Level ◽  
Preoperative Anxiety ◽  
Control Group ◽  
Music Intervention ◽  
Significant Difference ◽  
Anxiety Levels

Background: Surgery is one of medical interventions which can cause fear, anxiety, and stressed because of its effects toward the integrity of body and soul. Nurses have significant roles in any preoperative care which is helping patients to decrease preoperative anxiety by using complementary therapy. The use of music therapy as one of the complementary therapies is not common in Indonesia. Therefore, scientific studies to prove the role of this therapy to decrease the level of anxiety of pre-operative patients is needed. Objective: To investigate the effects of music therapy in reducing anxiety levels of preoperative patients. Methods: A quasy experimental study with pre-test and post-test design with control group was applied to 50 respondents from medical ward in Panembahan Senopati Hospital of Yogyakarta who met the inclusion criteria.Dara were then analyzed by using t-test statistical analysis. Results: The control group showed the increased value of anxiety level of0.8 without music intervention (t= - 1503, df = 24, p<.05), whereas the intervention group showed the decreased value of anxiety level of -5.52 (t=5.081, df=24, p<.05). Meanwhile the independent t-test results for both groups showed a significant difference between group (t= 3,373, df=48, p<.05). Conclusion: Music therapy has significant effect in reducing preoperative anxiety levels of patients. Keywords: anxiety, preoperative, music therapy

Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

2021 ◽  
pp. 112070002110057
Author(s):  
Niels H Bech ◽  
Inger N Sierevelt ◽  
Sheryl de Waard ◽  
Boudijn S H Joling ◽  
Gino M M J Kerkhoffs ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Femoroacetabular Impingement ◽  
Hip Arthroscopy ◽  
Controlled Trial ◽  
Poor Quality ◽  
Control Group ◽  
Treatment Groups ◽  
Significant Difference ◽  
Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p  > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

scholarly journals The Effects of Time-Restricted Eating versus Standard Dietary Advice on Weight, Metabolic Health and the Consumption of Processed Food: A Pragmatic Randomised Controlled Trial in Community-Based Adults

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 1042
Author(s):  
Nicholas Phillips ◽  
Julie Mareschal ◽  
Nathalie Schwab ◽  
Emily Manoogian ◽  
Sylvie Borloz ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Metabolic Health ◽  
Dietary Advice ◽  
Processed Food ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Weight loss is key to controlling the increasing prevalence of metabolic syndrome (MS) and its components, i.e., central obesity, hypertension, prediabetes and dyslipidaemia. The goals of our study were two-fold. First, we characterised the relationships between eating duration, unprocessed and processed food consumption and metabolic health. During 4 weeks of observation, 213 adults used a smartphone application to record food and drink consumption, which was annotated for food processing levels following the NOVA classification. Low consumption of unprocessed food and low physical activity showed significant associations with multiple MS components. Second, in a pragmatic randomised controlled trial, we compared the metabolic benefits of 12 h time-restricted eating (TRE) to standard dietary advice (SDA) in 54 adults with an eating duration > 14 h and at least one MS component. After 6 months, those randomised to TRE lost 1.6% of initial body weight (SD 2.9, p = 0.01), compared to the absence of weight loss with SDA (−1.1%, SD 3.5, p = 0.19). There was no significant difference in weight loss between TRE and SDA (between-group difference −0.88%, 95% confidence interval −3.1 to 1.3, p = 0.43). Our results show the potential of smartphone records to predict metabolic health and highlight that further research is needed to improve individual responses to TRE such as a shorter eating window or its actual clock time.

scholarly journals Music to prevent deliriUm during neuroSurgerY (MUSYC) Clinical trial: a study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e048270
Author(s):  
Pablo Kappen ◽  
Johannes Jeekel ◽  
Clemens M F Dirven ◽  
M Klimek ◽  
Steven Kushner ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Randomised Controlled Trial ◽  
Medical Center ◽  
Controlled Trial ◽  
Clinical Care ◽  
Preoperative Anxiety ◽  
Control Group ◽  
Neurosurgical Procedures ◽  
Depth Of Anaesthesia ◽  
Randomised Controlled

IntroductionDelirium is a neurocognitive disorder characterised by an acute and temporary decline of mental status affecting attention, awareness, cognition, language and visuospatial ability. The underlying pathophysiology is driven by neuroinflammation and cellular oxidative stress.Delirium is a serious complication following neurosurgical procedures with a reported incidence varying between 4% and 44% and has been associated with increased length of hospital stay, increased amount of reoperations, increased costs and mortality.Perioperative music has been reported to reduce preoperative anxiety, postoperative pain and opioid usage, and attenuates stress response caused by surgery. We hypothesize that this beneficial effect of music on a combination of delirium eliciting factors might reduce delirium incidence following neurosurgery and subsequently improve clinical outcomes.MethodsThis protocol concerns a single-centred prospective randomised controlled trial with 6 months follow-up. All adult patients undergoing a craniotomy at the Erasmus Medical Center in Rotterdam are eligible. The music group will receive recorded music through an overear headphone before, during and after surgery until postoperative day 3. Patients can choose from music playlists, offered based on music importance questionnaires administered at baseline. The control group will receive standard of clinical careDelirium is assessed by the Delirium Observation Scale and confirmed by a delirium-expert psychiatrist according to the DSM-5 criteria. Risk factors correlated with the onset of delirium, such as cognitive function at baseline, preoperative anxiety, perioperative medication use, depth of anaesthesia and postoperative pain, and delirium-related health outcomes such as length of stay, daily function, quality of life (ie, EQ-5D, EORTC questionnaires), costs and cost-effectiveness are collected.Ethics and disseminationThis study is being conducted in accordance with the Declaration of Helsinki. The Medical Ethics Review Board of Erasmus University Medical Center Rotterdam, The Netherlands, approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations.Trial registration numbersNL8503 and NCT04649450.

scholarly journals Evaluating the effectiveness of a group-based resilience intervention versus psychoeducation for emergency responders in England: A randomised controlled trial

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0241704
Author(s):  
Jennifer Wild ◽  
Shama El-Salahi ◽  
Michelle Degli Esposti ◽  
Graham R. Thew
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Self Report ◽  
Post Traumatic Stress ◽  
Emergency Responders ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Resilience Intervention

Background Emergency responders are routinely exposed to traumatic critical incidents and other occupational stressors that place them at higher risk of mental ill health compared to the general population. There is some evidence to suggest that resilience training may improve emergency responders’ wellbeing and related health outcomes. The aim of this study was to evaluate the effectiveness of a tertiary service resilience intervention compared to psychoeducation for improving psychological outcomes among emergency workers. Methods We conducted a multicentre, parallel-group, randomised controlled trial. Minim software was used to randomly allocate police, ambulance, fire, and search and rescue services personnel, who were not suffering from depression or post-traumatic stress disorder, to Mind’s group intervention or to online psychoeducation on a 3:1 basis. The resilience intervention was group-based and included stress management and mindfulness tools for reducing stress. It was delivered by trained staff at nine centres across England in six sessions, one per week for six weeks. The comparison intervention was psychoeducation about stress and mental health delivered online, one module per week for six weeks. Primary outcomes were assessed by self-report and included wellbeing, resilience, self-efficacy, problem-solving, social capital, confidence in managing mental health, and number of days off work due to illness. Follow-up was conducted at three months. Blinding of participants, researchers and outcome assessment was not possible due to the type of interventions. Results A total of 430 participants (resilience intervention N = 317; psychoeducation N = 113) were randomised and included in intent-to-treat analyses. Linear Mixed-Effects Models did not show a significant difference between the interventions, at either the post-intervention or follow-up time points, on any outcome measure. Conclusions The limited success of this intervention is consistent with the wider literature. Future refinements to the intervention may benefit from targeting predictors of resilience and mental ill health. Trial registration ISRCTN registry, ISRCTN79407277.

scholarly journals Email-based promotion of self-help for subthreshold depression: Mood Memos randomised controlled trial

2012 ◽  
Vol 200 (5) ◽  
pp. 412-418 ◽  
Author(s):  
Amy J. Morgan ◽  
Anthony F. Jorm ◽  
Andrew J. Mackinnon
Keyword(s):  
Major Depression ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Active Group ◽  
Depression Symptoms ◽  
Number Needed To Treat ◽  
Subthreshold Depression ◽  
Self Help ◽  
Significant Difference ◽  
Randomised Controlled

BackgroundSubthreshold depression is common, impairs functioning and increases the risk of major depression. Improving self-help coping strategies could help subthreshold depression and prevent major depression.AimsTo test the effectiveness of an automated email-based campaign promoting self-help behaviours.MethodA randomised controlled trial was conducted through the website: www.moodmemos.com. Participants received automated emails twice weekly for 6 weeks containing advice about self-help strategies. Emails containing general information about depression served as a control. The principal outcome was depression symptom level on the nine-item Patient Health Questionnaire (PHQ-9) (trial registration: ACTRN12609000925246).ResultsThe study recruited 1326 adults with subthreshold depression. There was a small significant difference in depression symptoms at post-intervention, favouring the active group (d = 0.17, 95% CI 0.01–0.34). There was a lower, although non-significant, risk of major depression in the active group (number needed to treat (NNT) 25, 95% CI 11 to ∞ to NNT(harm) 57).ConclusionsEmails promoting self-help strategies were beneficial. Internet delivery of self-help messages affords a low-cost, easily disseminated and highly automated approach for indicated prevention of depression.

Developing and Validating a Sham Acupuncture Needle

2009 ◽  
Vol 27 (3) ◽  
pp. 118-122 ◽  
Author(s):  
Elizabeth A Tough ◽  
Adrian R White ◽  
Suzanne H Richards ◽  
Brian Lord ◽  
John L Campbell
Keyword(s):  
Randomised Controlled Trial ◽  
Trigger Point ◽  
Controlled Trial ◽  
Sham Acupuncture ◽  
Previous Experience ◽  
Credibility Scale ◽  
Significant Difference ◽  
Sham Intervention ◽  
Sham Acupuncture Group ◽  
Randomised Controlled

Objectives To develop a sham needle device and test its credibility as a control for acupuncture when used in a randomised controlled trial of myofascial trigger point needling in patients with whiplash associated pain. Methods Sham needles were developed by blunting true acupuncture needles. Whiplash injured patients (<16 weeks duration) were randomly allocated to receive either true acupuncture or the “placebo” sham needle control. The true and sham needling interventions were delivered using the same standardised procedure. Patients were informed that they would receive either real or placebo needles, and asked (i) to state which treatment they believed they had received (treatment belief); (ii) to complete the four item Borkovec and Nau self-assessment credibility scale. Results were compared between groups and the analysis explored whether a patient's previous experience of acupuncture was related to their treatment belief. Other outcomes of the study will be reported elsewhere. Results 20 patients received the true acupuncture and 21 received the sham. There was no significant difference between the treatment beliefs of the two groups (χ 2 = 1.51; p>0.2) nor in the mean item scores on the Borkovec and Nau credibility scale (t test, p values ranged from 0.38 to 0.87). Of the patients in the sham acupuncture group who had previous experience of acupuncture, none recorded receiving the sham intervention. Conclusion Within the context of this pilot study, the sham acupuncture intervention was found to be a credible control for acupuncture. This supports its use in a planned, definitive, randomised controlled trial on a similar whiplash injured population.

Abstract TP233: Are Baseline Characteristics of Stroke Patients Included Into an Observational Study Similar to Patients Included Into a Randomised Controlled Trial?

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Anna Schulte ◽  
Falko Jürries ◽  
Anna Messerschmid ◽  
Nico Behnke ◽  
Jan Liman ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Stroke Severity ◽  
Stroke Patients ◽  
Exclusion Criteria ◽  
Observational Trial ◽  
Significant Difference ◽  
Baseline Characteristics ◽  
Randomised Controlled

Introduction: Undiagnosed atrial fibrillation (UAF) is a major burden in ischemic stroke. However, randomised trials have partly shown astonishingly low AF detection rates (e. g. in the CRYSTAL-AF study). This may be due to differences in baseline and stroke characteristics between studies. Hypothesis: We hypothesized that stroke patients in a randomised controlled trial have less severe strokes than patients in an observational trial with similar inclusion and exclusion criteria. Methods: We used data from the Find-AF observational (NCT 01855035) and the Find-AF randomised controlled trial (ISRCTN 46104198). We included only patients at study site Goettingen of the Find-AF randomised controlled trial (n=153) and only included patients from the Find-AF observational trial that fulfilled the inclusion/exclusion criteria of Find-AF randomised (n=90). We compared baseline characteristics of screened versus included patients in Find-AF randomised and baseline characteristics and stroke severity parameters between both studies. Data are shown as mean (Standard Deviation) or Median (25%; 75% percentile) and were compared by chi-square, t-test or Mann-Whitney U test. Results: Table 1 shows as comparison between baseline characteristics of both studies Comparing patients fulfilling the inclusion/exclusion criteria of Find-AF randomised, but unwilling to give informed consent to randomised patients showed a significant difference in age (77 ± 11 vs. 74 ± 8; p< 0.001), but no difference in gender (p=0.581). Conclusions: Both studies included patients similar in age, gender and many comorbidities. Major differences occurred in NIHSS and MRS. As NIHSS is a predictor of atrial fibrillation, randomized controlled trials investigating AF detection should include a minimum NIHSS to avoid a selection bias towards less severe strokes.

scholarly journals The effectiveness of preoperative individual information on reducing anxiety and pain after hysterectomy: A randomized controlled trial

2019 ◽  
Vol 10 (1) ◽  
pp. 67
Author(s):  
Hrønn Thorn ◽  
Lisbeth Uhrenfeldt
Keyword(s):  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Controlled Trial ◽  
Anxiety Level ◽  
Preoperative Anxiety ◽  
Control Group ◽  
Study Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Individual Information

Background and objective: Preoperative anxiety among gynecological patients is well-known and has a direct correlation with postoperative pain. By minimizing preoperative anxiety, the level of postoperative pain may decrease.  The purpose of this study was to evaluate the effect of preoperative structured information and dialogue on patients' anxiety and postoperative pain.Methods: A single-center non-blinded randomized controlled trial. Forty-six women scheduled for hysterectomy were allocated either to the study group or the control group.  The study group was given individual information at a preoperative consultation while the control group was given information at admittance. The main outcome was anxiety level and postoperative pain.Results: Forty participants (study group = 20; control group = 20) were analyzed. No statistically significant difference was found in anxiety level within the first 24 h postoperatively or in postoperative pain within four weeks between the groups.Conclusions: Preoperative individual information and dialogue did not result in significant effects in reducing anxiety level nor did it result in lower postoperative pain score.

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