Effects of Preoperative Oral Carbohydrate on Cirrhotic Patients under Endoscopic Therapy with Anesthesia: A Randomized Controlled Trial

Preoperative fasting causes significant perioperative discomfort in patients. Preoperative oral carbohydrate (POC) is an important element of the enhanced recovery after surgery protocol, but its effect on cirrhotic patients who tend to have abnormal gastric emptying remains unclarified. We investigated the influence of POC on gastric emptying and preprocedural well-being in cirrhotic patients. A prospective, randomized, controlled study of cirrhotic patients with gastroesophageal varices scheduled for elective therapeutic endoscopy under intravenous anesthesia was conducted. We enrolled 180 patients and divided them into three groups: those not supplemented with carbohydrates for 8 h before therapeutic endoscopy (control group) and those administered a carbohydrate beverage 2 h (2 h group) and 4 h (4 h group) before endoscopy. The residual gastric volume was quantified before anesthesia, gastric emptying was evaluated using gastric ultrasonography, and preprocedural well-being was assessed using the visual analogue scale (VAS). Preanesthesia gastric sonography scores were similar among the three groups. No patient had residual gastric volume > 1.5 ml / kg in the control and 4 h groups, but six patients (11%) had a residual gastric volume of >1.5 ml/kg in the 2 h group, hence were at a risk of regurgitation and aspiration. Moreover, VAS scores for six parameters (thirst, hunger, mouth dryness, nausea, vomiting, and fatigue) in the 2 h group and three parameters (thirst, hunger, and mouth dryness) in the 4 h group were significantly lower than those in the control group, suggesting a beneficial effect on cirrhotic patients’ well-being. Preoperative gastric peristaltic and operation scores, postoperative complications, length of hospital stay, and in-hospital expenses were not significantly different among the three groups. Our study indicated that avoiding preoperative fasting with oral carbohydrates administered 4 h before anesthesia can be achieved in cirrhotic patients. Further studies to assess whether POC can help improve postoperative outcomes in cirrhotic patients are needed.

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Effects of Preoperative Oral Carbohydrate on Cirrhotic Patients Under Endoscopic Therapy with Anesthesia: A Randomized Controlled Trial

10.21203/rs.3.rs-31402/v1 ◽

2020 ◽

Author(s):

Yan Wang ◽

Yichun Tu ◽

Zhenglv Liu ◽

Hui Li ◽

Hongtan Chen ◽

...

Keyword(s):

Gastric Emptying ◽

Endoscopic Therapy ◽

Well Being ◽

Gastric Volume ◽

Controlled Study ◽

Preoperative Fasting ◽

Residual Gastric Volume ◽

Mouth Dryness ◽

Vas Scores ◽

Cirrhotic Patients

Abstract Background: Preoperative fasting is a major cause of perioperative discomfort in patients. Addressing this problem by preoperative oral carbohydrate (POC) has been recommended as an important element of the enhanced recovery after surgery (ERAS) protocol, but its effect on cirrhotic patients who tend to show abnormalities in gastric emptying function has not yet been clarified. Our study aims to investigate the influence of POC on gastric empting and preoperative well-being in cirrhotic patients. Methods: A prospective, randomized and controlled study of cirrhotic patients with gastroesophageal varices scheduled for elective endoscopic therapy under intravenous anesthesia was conducted. 180 patients were enrolled in this study. Patients were divided into three groups: those not supplement with carbohydrate for 8h prior to endoscopic therapy (Control group), those given a carbohydrate beverage 2h (2h group) or 4h (4h group) prior to endoscopy. Gastric emptying was evaluated by gastric sonography score and collecting gastric content aspirated endoscopically before anesthesia. Stresses caused by examination associated fasting were evaluated by visual analogue scale (VAS) scores for six parameters (thirst, hunger, mouth dryness, nausea, vomit and weakness) preoperatively. Hemodynamic changes, peristole and postoperative complications were also recorded. Results: Before anesthesia, gastric sonography score was similar among three groups. In addition, no patient had residual gastric volume more than 1.5ml/kg in control and 4h group, but six patients (11%) reached a residual gastric volume of more than 1.5ml/kg in 2h group. Moreover, compared with control fasting, VAS scores for six parameters (thirst, hunger, mouth dryness, nausea, vomiting and fatigue) in 2h group and for three parameters (thirst, hunger and mouth dryness) in 4h group were both significantly lower. Gastric peristaltic score and operation score before operation, postoperative complication, lengths of hospital stay and in-hospital expense were not significantly different among three groups.Conclusions: For the first time, we demonstrate that avoiding preoperative fasting with oral carbohydrates given 4h prior to anesthesia can improve preoperative well-being feelings, without enhancing the risk of aspiration and regurgitation in cirrhotic patients. Our study adds knowledge for preoperative fasting guidelines in anesthesia for cirrhotic patients. Trial registration: This trial was registered at Clinicaltrials.gov under the number ChiCTR2000032394.

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Inquiry Based Stress Reduction (IBSR) Improves Overall Stuttering Experience among Adults Who Stutter: A Randomized Controlled Trial

Journal of Clinical Medicine ◽

10.3390/jcm10102187 ◽

2021 ◽

Vol 10 (10) ◽

pp. 2187

Author(s):

Omrit Feldman ◽

Eran Goldstien ◽

Benjamin Rolnik ◽

Ariel B. Ganz ◽

Shahar Lev-Ari

Keyword(s):

Quality Of Life ◽

Stress Reduction ◽

Satisfaction With Life ◽

Psychological Flexibility ◽

Well Being ◽

The United States ◽

Control Group ◽

Randomized Controlled ◽

Adults Who Stutter

Stuttering is a speech disorder that can cause disturbances in the timing and flow of speech. In addition to being a communication disorder, stuttering is often accompanied by a reduction in the quality of life and has impacts on social status, mental well-being, self-acceptance, and the chances of integration into the labor market. The Inquiry Based Stress Reduction (IBSR) program, developed in the United States by Byron Katie in 1986, is the clinical application of “The Work” method (Thework.com) and represents an emerging mindfulness and cognitive-reframing method. IBSR has been demonstrated to improve mental health and well-being in adults and may alleviate psychological and psychosocial symptoms of stuttering. The purpose of this trial was to examine the effect of a 12-week IBSR intervention on the overall stuttering experience and indicators of anxiety, psychological flexibility, and well-being among adults who stutter (AWS). This study was a randomized controlled clinical trial. Participants were randomized to IBSR (n = 28) and control (n = 28) groups. Validated questionnaires of overall stuttering experience (OASES-A), anxiety (STAI), psychological flexibility (PFQ), and satisfaction with life (SWLS) were completed before, after, and one month after the intervention. An intention-to-treat approach was implemented for analysis. Our results show that participants in the IBSR intervention group exhibited a greater improvement in their overall stuttering experience as compared to the control group, as well as in general information on stuttering awareness and perception, reactions to stuttering, communication in daily situations, and quality of life. In addition, we found a greater reduction in anxiety levels and an increase in satisfaction-with-life scores in the IBSR group. These results indicate that IBSR can improve the overall stuttering experience.

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Foam Rolling Elicits Neuronal Relaxation Patterns Distinct from Manual Massage: A Randomized Controlled Trial

Brain Sciences ◽

10.3390/brainsci11060818 ◽

2021 ◽

Vol 11 (6) ◽

pp. 818

Author(s):

Yann Kerautret ◽

Aymeric Guillot ◽

Sébastien Daligault ◽

Franck Di Rienzo

Keyword(s):

Skin Conductance ◽

Muscle Pain ◽

Controlled Trial ◽

Muscle Relaxation ◽

Well Being ◽

Self Report ◽

Controlled Study ◽

Control Group ◽

Foam Rolling ◽

Randomized Controlled

The present double-blinded, randomized controlled study sought to compare the effects of a full-body manual massage (MM) and a foam rolling (FR) intervention on subjective and objective indexes of performance and well-being. A total of 65 healthy individuals were randomly allocated to an FR, MM, or a control group who received a cognitively oriented relaxation routine. Self-report ratings of perceived anxiety, muscle relaxation, and muscle pain were used to index changes in affect and physical sensations. The sit-and-reach and toe-touch tests, as well as a mental calculation task, were used to index motor and cognitive performances, respectively. We also conducted resting-state electroencephalography and continuous skin conductance recordings before and after the experimental intervention. Both FR and MM groups exhibited neural synchronization of alpha and beta oscillations during the posttest. Skin conductance increased from the pretest to the posttest in the relaxation group, but decreased in the FR group. All interventions improved range of motion, although only the MM group outperformed the relaxation group for the toe-touch performance. MM was associated with reduced muscle pain and increased muscle relaxation. Reduced perceived anxiety after the intervention was observed in the FR group only. Overall, MM and FR both improved objective and subjective indexes of performance and well-being. Differences between the two massage interventions are discussed in relation to the effects of pressure stimulation on autonomic regulations and the proactive vs. retroactive nature of FR, compared to MM.

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THE EFFECT OF GASTRIC GAS EMPTYING ON THE RESIDUAL GASTRIC VOLUME IN MECHANICALLY-VENTILATED INTENSIVE CARE UNIT PATIENTS FED THROUGH NASOGASTRIC TUBES: A RANDOMIZED, SINGLE-BLIND, CLINICAL TRIAL

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2018.v11i9.27667 ◽

2018 ◽

Vol 11 (9) ◽

pp. 492

Author(s):

Ali Mohammadpour ◽

Mousa Sajadi ◽

Somayyeh Maghami ◽

Hossein Soltani

Keyword(s):

Clinical Trial ◽

Gastric Volume ◽

Control Group ◽

Case Group ◽

Mechanically Ventilated ◽

Mechanically Ventilated Patients ◽

Residual Gastric Volume ◽

Nasogastric Tubes ◽

Single Blind ◽

Ventilated Patients

Objective: Increased gastric residual volume is a complication of enteral nutrition intolerance that leads to gastrointestinal complications such as nausea, vomiting, and aspiration pneumonia. The present study was conducted to determine the effect of gastric gas emptying on the residual gastric volume in mechanically-ventilated patients fed through nasogastric tubes.Methods: This randomized, single-blind, clinical trial was conducted on two groups of patients in the intensive care unit (ICU) of Kamyab Hospital of Mashhad. A total of 64 patients were randomly divided into a case and a control group. In the case group, the gastric gases accumulated through the nasogastric tube were emptied by applying palm pressure on the epigastric region. The control group did not undergo this intervention but received the routine care provided in the ward. Data were collected using a demographic questionnaire and a form containing records of the patients’ residual gastric volume and disease-related information. The residual gastric volume was measured and compared in the two groups before and after the intervention. Data were analyzed in SPSS-19 using the Chi-square test, the independent t-test, and the repeated measures ANOVA at the significance level of 5%.Results: The residual gastric volume did not differ significantly between the two groups before the intervention (p=0.14); after the intervention; however, a significant reduction was observed in the case group compared to the controls (p=0.007).Conclusion: Gastric gas emptying helps reduce the residual gastric volume in mechanically-ventilated patients fed through nasogastric tubes. Further studies are recommended to further ensure the benefits of this method.

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Effects of self-conditioning techniques in promoting weight loss in patients with severe obesity: a randomized controlled trial protocol

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20170304 ◽

2017 ◽

Vol 4 (1) ◽

pp. 20 ◽

Cited By ~ 1

Author(s):

Simona Bo ◽

Farnaz Rahimi ◽

Bice Properzi ◽

Giuseppe Regaldo ◽

Ilaria Goitre ◽

...

Keyword(s):

Weight Loss ◽

Standard Care ◽

Traditional Approach ◽

Controlled Trial ◽

Well Being ◽

Control Group ◽

Randomized Controlled ◽

Rapid Induction ◽

Conditioning Approach

Background: Obesity is a worldwide epidemic; most obese individuals who lose weight after lifestyle educative treatments, soon regain it. Our aim is to evaluate the effectiveness of a training to teach self-conditioning technique (self-hypnosis) added to standard care in determining weight loss compared with standard care in patients with obesityMethods: This randomized controlled open trial will recruit 120 obese patients (BMI 35-50 Kg/m2), aged 20-70 years. The control group will receive a traditional approach: diet + exercise + behavioral recommendations. The experimental group will receive self-conditioning techniques + traditional approach.Three individual sessions of hypnosis with rapid-induction techniques will be administered by trained personnel. All the participants of both groups will be assessed at three, six, nine and twelve months after randomization. The primary outcome is weight loss difference between groups at 12 months after randomization; secondary outcomes are changes in adherence to dietetic and exercise recommendations, appetite and satisfaction/well-being, waist circumference and body fat, blood pressure and blood metabolic and inflammatory variables.Conclusions: The results of this trial will assess whether a self-conditioning approach, based on self-hypnosis, is able to help participants to modulate unhealthy patterns of eating and sustain weight loss in the long term.

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Az ortopédiai nagyműtétek során alkalmazott terápiás szuggesztiók hatása a beteg gyógyulására

Orvosi Hetilap ◽

10.1556/650.2018.31213 ◽

2018 ◽

Vol 159 (48) ◽

pp. 2011-2020 ◽

Cited By ~ 1

Author(s):

Csenge Szeverényi ◽

Zoltán Csernátony ◽

Ágnes Balogh ◽

Tünde Simon ◽

Zoltán Kekecs ◽

...

Keyword(s):

Perioperative Period ◽

Well Being ◽

Controlled Study ◽

Control Group ◽

Physician Communication ◽

Replacement Surgery ◽

Randomized Controlled ◽

Medication Consumption ◽

Communication Method ◽

The Mean

Abstract: Introduction and aim: Hip and knee replacement surgery is very demanding for patients. Medication consumption is further increased by perioperative anxiety. Besides pain killer and anxiolytic medications, patients’ recovery can be enhanced by applying therapeutic suggestions, which are easily applicable during the patient–physician communication. Method: In our prospective, randomized, controlled study we examined the effects of positive suggestions on patients undergoing hip or knee arthroplasty in spinal anaesthesia. Members of the suggestion group received the therapeutic suggestions during a pre-surgery physician visit, and by listening to an audio recording during surgery. Results: Compared to the control group (n = 50), in the suggestion group (n = 45) the need of medication (pain killer and adjuvant pain medication) during the surgery was lower (p = 0.037), the mean change from baseline in the well-being of the patients was better on the 2nd [1.31 (0.57; 2.04); p<0.001] and 4th [0.97 (0.23; 1.7); p = 0.011] postoperative day and less transfusion had to be administered (OR: 2.37; p = 0.004). However, there was no difference between the two groups in the postoperative need of medications, in the length of hospitalisation and in the frequency of complications. Conslusion: Our results indicate that the administration of therapeutic suggestions in the perioperative period may be beneficial for orthopaedic surgery patients. Orv Hetil. 2018; 159(48): 2011–2020.

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The Effectiveness of Traditional Chinese Yijinjing Qigong Exercise for the Patients With Knee Osteoarthritis on the Pain, Dysfunction, and Mood Disorder: A Pilot Randomized Controlled Trial

Frontiers in Medicine ◽

10.3389/fmed.2021.792436 ◽

2022 ◽

Vol 8 ◽

Author(s):

Shuaipan Zhang ◽

Guangxin Guo ◽

Xing Li ◽

Fei Yao ◽

Zhiwei Wu ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Outcome Measurement ◽

Controlled Trial ◽

Well Being ◽

Functional Mobility ◽

Exercise Session ◽

Control Group ◽

Serious Adverse Events ◽

Clinical Trial Registration ◽

Randomized Controlled

Background: Although traditional Chinese Yijinjing Qigong Exercise (YJJQE) is popularly used in China, to alleviate symptoms of people with knee osteoarthritis (KOA), no randomized controlled trials (RCTs) are available to evaluate the effects of YJJQE in patients with KOA. The purpose of this trial is to assess the clinical efficacy of YJJQE for patients with KOA.Methods: A total of 50 participants clinically diagnosed with KOA are randomly (1:1) assigned to the YJJQE group (n = 25) and to the stretching training exercise (STE) group (n = 25), for a 40-min exercise session twice a week for 12 weeks. All outcome measures are collected at baseline and at 12-week ending intervention, which includes the primary outcomes of Western Ontario and McMaster Universities Osteoarthritis Index Scale (WOMAC), the secondary outcomes of visual analog scale (VAS), mental component summary (MCS), physical component summary (PCS), Beck depression inventory (BDI), perceived stress scale (PSS), Berg balance scale (BBS), and the Gait functional mobility data.Results: The YJJQE group did not have any significant changes compared to the control group on the WOMAC score after the 12-week intervention (P > 0.05), though the YJJQE group demonstrated better performance in MCS, BDI, and PSS (P = 0.002, P = 0.001, and P = 0.026, respectively) than the control group. No serious adverse events occurred in either group, and only mild muscle soreness was reported during both exercise treatments.Conclusion: Because no difference between both groups was shown, with regards to the primary outcome measurement (WOMAC), it can hardly explain that the YJJQE had an advantageous effect on patients experiencing the pain and dysfunction of knee osteoarthritis. However, compared to the control group, YJJQE appeared to be associated with improvements in psychological well-being including reduced stress, anxiety, depression, and mood disturbance to manage KOA. Further trials with larger sample sizes and follow-up studies will be required.Clinical Trial Registration:https://www.chictr.org.cn/edit.aspx?pid=60357&htm=4, ChiCTR2000037256.

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Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

10.2196/preprints.34409 ◽

2021 ◽

Author(s):

Kathleen P. O'Hora ◽

Raquel A. Osorno ◽

Dena Sadeghi-Bahmani ◽

Mateo Lopez ◽

Allison Morehouse ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Early Treatment ◽

Controlled Trial ◽

Well Being ◽

Control Group ◽

Randomized Controlled ◽

The Impact ◽

Insomnia Symptoms

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

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Acceptance and commitment therapy for the treatment of depression in persons with physical disability: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215520923135 ◽

2020 ◽

Vol 34 (7) ◽

pp. 938-947 ◽

Cited By ~ 1

Author(s):

Mehdi Zemestani ◽

Sharmin Mozaffari

Keyword(s):

Emotion Regulation ◽

Depressive Symptoms ◽

Controlled Trial ◽

Psychological Flexibility ◽

Well Being ◽

Control Group ◽

Psychological Well Being ◽

Randomized Controlled ◽

Acceptance And Commitment ◽

Experimental Group

Objective: To evaluate the effectiveness of acceptance and commitment therapy (ACT) on depressive symptoms in physically disabled persons. Design: Randomized controlled trial. Setting: State welfare organization in Kamyaran, Kurdistan, Iran. Participants: Fifty-two physically disabled participants with a primary diagnosis of depression were randomly assigned to either ACT or control groups. Interventions: Participants in the ACT group ( n = 23) received eight weekly 90-minute group sessions based on standard ACT protocol for depression. Participants in the control group ( n = 29) received psychoeducation regarding depression. Main measures: Measures were recorded at baseline, eight weeks (end of treatment), and 16 weeks (follow-up). The outcomes were the change in the depressive symptoms, measured by Beck Depression Inventory-II (BDI-II), psychological flexibility, emotion regulation, and psychological well-being measured by Acceptance and Action Questionnaire-II (AAQ-II), Emotion Regulation Questionnaire (ERQ), and Scales of Psychological Well-Being (SPWB), respectively. Results: After eight weeks, significant changes in depressive symptoms was observed in the experimental group (ACT –10.39 ± 0.79 vs control 0.66 ± 0.68, P < 0.001). Compared to the control group, the experimental group also showed significant improvement in psychological flexibility (ACT 8.13 ± 0.52 vs control –0.03 ± 0.51, P < 0.001), adaptive emotion regulation strategies (ACT 10.74 ± 0.62 vs control 0.03 ± 1.03, P < 0.001), and psychological well-being (ACT 66.95 ± 4.01 vs control –1.90 ± 1.04, P < 0.001). Conclusion: Compared with control group, ACT significantly reduced the participants’ depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability.

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The Effect of Ultraviolet B Irradiation Compared with Oral Vitamin D Supplementation on the Well-being of Nursing Home Residents with Dementia: A Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17051684 ◽

2020 ◽

Vol 17 (5) ◽

pp. 1684

Author(s):

Bistra I. Veleva ◽

Monique A. A. Caljouw ◽

Jenny T. van der Steen ◽

Bart J. A. Mertens ◽

Victor G. M. Chel ◽

...

Keyword(s):

Vitamin D ◽

Nursing Home ◽

Nursing Home Residents ◽

Well Being ◽

Vitamin D Supplementation ◽

Mean Difference ◽

Ultraviolet B ◽

Control Group ◽

Bone Homeostasis ◽

Randomized Controlled

There are indications that ultraviolet B (UVB) exposure has beneficial effects on well-being through mechanisms other than vitamin D synthesis alone. We conducted a randomized controlled multicenter trial to compare the effects of UVB light and vitamin D supplementation (VD) in terms of the well-being of nursing home residents with dementia. Participants were randomly assigned to the intervention group (UVB group, n = 41; half-body UVB irradiation, twice weekly over 6 months, with 1 standard erythema dose (SED)) or to the control group (VD group, n = 37; 5600 International units (IU) cholecalciferol supplementation once a week). The main outcome was well-being, measured by the Cohen-Mansfield Agitation Inventory (CMAI) and the Cornell scale for depression in dementia at 0, 3, and 6 months. Secondary outcomes were QUALIDEM quality of life domains and biochemical parameters of bone homeostasis. Intention-to-treat analysis with linear mixed modeling showed no significant between-group differences on agitation (p = 0.431) or depressive symptoms (p = 0.982). At six months, the UVB group showed less restless/tense behavior compared to the VD group (mean difference of the mean change scores 2.2, 95% CI 0.8 to 3.6; p = 0.003 for group x time interaction) and lower serum 25(OH)D3 concentration (estimated mean difference - 21.9, 95% CI −32.6 to −11.2; p = 0.003 for group difference). The exposure of nursing home residents with dementia to UVB light showed no positive benefits in terms of wellbeing. UVB treatment may have a positive effect on the restless/tense behavior characteristic of advanced dementia but more research is needed to confirm this finding.

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