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Preoperative information for ICU patients to reduce anxiety during and after the ICU-stay: protocol of a randomized controlled trial [NCT00151554].

ABSTRACT: BACKGROUND:According to current evidence and psychological theorizing proper information giving seems to be a promising way to reduce patient anxiety. In the case of surgical patients, admission to the intensive care unit (ICU) is strongly associated with uncertainty, unpredictability and anxiety for the patient. Thus, ICU specific information could have a high clinical impact. This study investigates the potential benefits of a specifically designed ICU-related information program for patients who undergo elective cardiac, abdominal or thoracic surgery and are scheduled for ICU stay. METHODS/DESIGN:The trial is designed as a prospective randomized controlled trial including an intervention and a control group. The control group receives the standard preparation currently conducted by surgeons and anesthetists. The intervention group additionally receives a standardized information program with specific procedural, sensory and coping information about the ICU.A measurable clinical relevant difference regarding anxiety will be expected after discharge from ICU. Power calculation (alpha = 0.05; beta = 0.20; Delta = 8.50 score points) resulted in a required sample size of N = 120 cardiac surgical patients (n = 60 vs. n = 60). Furthermore, N = 20 abdominal or thoracic surgical patients will be recruited (n = 10 vs. n = 10) to gain insight to a possible generalization to other patient groups. Additionally the moderating effect of specific patient attributes (need for cognition, high trait anxiety) will be investigated to identify certain patient groups which benefit most. DISCUSSION:The proposed study promises to strengthen evidence on effects of a specific, concise information program that addresses the information needs of patients scheduled for ICU stay.

SUBMITTER: Berg A

PROVIDER: S-EPMC1431533 | biostudies-literature | 2006 Mar

REPOSITORIES: biostudies-literature

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Preoperative information for ICU patients to reduce anxiety during and after the ICU-stay: protocol of a randomized controlled trial [NCT00151554].

Berg Almuth A Fleischer Steffen S Koller Michael M Neubert Thomas R TR

BMC nursing 20060308

<h4>Background</h4>According to current evidence and psychological theorizing proper information giving seems to be a promising way to reduce patient anxiety. In the case of surgical patients, admission to the intensive care unit (ICU) is strongly associated with uncertainty, unpredictability and anxiety for the patient. Thus, ICU specific information could have a high clinical impact. This study investigates the potential benefits of a specifically designed ICU-related information program for p ...[more]

PMID: 16524468

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Project description:Communication and information in order to reduce anxiety in the intensive care unit (ICU) has been described as area needing improvement. Therefore, the aim of this trial was to evaluate whether a structured information program that intensifies information given in standard care process reduces anxiety in ICU patients.Multicenter, two-armed, non-blinded, parallel-group randomized controlled trial in hospitals in the cities of Marburg, Halle, and Stuttgart (Germany). The trial was performed in cardiac surgery, general surgery, and internal medicine ICUs. Two-hundred and eleven elective and non-elective ICU patients were enrolled in the study (intervention group, n?=?104; control group, n?=?107). The experimental intervention comprised a single episode of structured oral information that was given in addition to standard care and covered two main parts: (1) A more standardized part about predefined ICU specific aspects - mainly procedural, sensory and coping information, and (2) an individualized part about fears and questions of the patient. The control group received a non-specific episodic conversation of similar length additional to standard care. Both conversations took place at the beginning of the ICU stay and lasted 10-15 minutes. Study nurses administered both interventions. The primary outcome ICU-related anxiety (CINT-Score, 0-100 pts., higher scores indicate higher anxiety) was assessed after admission to a regular ward.The primary outcome could be measured in 82 intervention group participants and 90 control group participants resulting in mean values of 20.4 (SD 14.4) compared to 20.8 (SD 14.7) and a mean difference of -0.2 (CI 95% -4.5 to 4.1).A structured information intervention additional to standard care during ICU stay had no demonstrated additional benefit compared to an unspecific communication of similar duration. Reduction of anxiety in ICU patients will probably require more continuous approaches to information giving and communication.ClinicalTrials.gov NCT00764933.

Project description:BackgroundAnxiety levels before cesarean delivery (CD) can lead to a negative birth experience, which may influence several aspects of the woman's life in the long term. Improving preoperative information may lower preoperative anxiety and lead to a more positive birth experience.ObjectiveThis study aimed to determine whether a virtual reality (VR) video in addition to standard preoperative information decreases anxiety levels before a planned CD.MethodsWomen scheduled to undergo term elective CD were recruited from the outpatient clinic. They were randomized and stratified based on history of emergency CD (yes or no). All participants received standard preoperative information (folder leaflets and counseling by the obstetrician); the VR group additionally watched the VR video showing all aspects of CD such as the ward admission, operating theater, spinal analgesia, and moment of birth. The primary outcome measure was a change in score on the Visual Analogue Scale for Anxiety (ΔVAS-A) measured at admission for CD, compared with the baseline VAS-A score.ResultsA total of 97 women were included for analysis. The baseline characteristics were similar in both groups, except for a significantly higher level of education in the control group. There was no significant decrease in the VAS-A score of the women in the VR group (n=49) compared with those in the control group (n=48; ΔVAS-A=1.0; P=.08; 95% CI -0.1 to 2.0). Subgroup analysis for the group of women with a history of emergency CD showed a trend toward decreased preoperative anxiety, despite the small sample size of this subgroup (n=17; P=.06). Of the 26 participants who provided completed questionnaires, 22 (85%) in the VR group reported feeling more prepared after seeing the VR video; of the 24 participants' partners who completed the questionnaires, 19 (79%) agreed with the participants. No discomfort or motion sickness was reported.ConclusionsA VR video may help patients and their partners feel better prepared when planning a CD. This study showed that VR does not lead to a decrease in preoperative anxiety. However, subgroups such as women with a history of emergency CD may benefit from VR videos.Trial registrationInternational Standard Randomised Controlled Trial Number (ISRCTN) 74794447; http://www.isrctn.com/ISRCTN74794447 (retrospectively registered).

Project description:BackgroundEven though the importance of preparing patients for a surgical event is recognized, there are still gaps about the benefit of improving functional capacity by walking during the waiting time among patients scheduled for non-cardiac surgery. The aim of this study was to evaluate the impact of pre-surgical walking in-hospital length of stay, early ambulation, and the appearance of complications after surgery among patients scheduled for non-cardiac surgery.MethodsA two-arm, single- blinded randomized controlled trial was developed from May 2016 to August 2017. Eligible outpatients scheduled for non-cardiac surgery, capable of walking, were randomized (2:1 ratio) to receive a prescription of walking 150 min/week during the whole pre-surgical waiting time (n = 249) or conventional care (n = 119). The primary outcome was the difference in hospital length of stay, and secondary results were time to first ambulation during hospitalization, description of ischemic events during hospitalization and after six months of hospital discharge, and the walking continuation. We performed an intention to treat analysis and compared length of stay between both groups by Kaplan-Meier estimator (log-rank test).ResultsThere were no significant differences in the length of hospital stay between both groups (log-rank test p = 0.367) and no differences in the first ambulation time during hospitalization (log-rank test p = 0.299). Similar rates of postoperative complications were observed in both groups, but patients in the intervention group continued to practice walking six months after discharge (p < 0.001).ConclusionOur study is the first clinical trial evaluating the impact of walking before non-cardiac surgery in the length of stay, early ambulation, and complications after surgery. Prescription of walking for patients before non-cardiac surgery had no significant effect in reducing the length of stay, and early ambulation. The results become a crucial element for further investigation.Trial registrationPAMP-Phase2 was registered in ClinicalTrials.gov NCT03213496 on July 11, 2017.

Project description:A relevant innovation about sedation of long-term Intensive Care Unit (ICU) patients is the 'conscious target': patients should be awake even during the critical phases of illness. Enteral sedative administration is nowadays unusual, even though the gastrointestinal tract works soon after ICU admission. The enteral approach cannot produce deep sedation; however, it is as adequate as the intravenous one, if the target is to keep patients awake and adapted to the environment, and has fewer side effects and lower costs.A randomized, controlled, multicenter, single-blind trial comparing enteral and intravenous sedative treatments has been done in 12 Italian ICUs. The main objective was to achieve and maintain the desired sedation level: observed RASS = target RASS ± 1. Three hundred high-risk patients were planned to be randomly assigned to receive either intravenous propofol/midazolam or enteral melatonin/hydroxyzine/lorazepam. Group assignment occurred through online minimization process, in order to balance variables potentially influencing the outcomes (age, sex, SAPS II, type of admission, kidney failure, chronic obstructive pulmonary disease, sepsis) between groups. Once per shift, the staff recorded neurological monitoring using validated tools. Three flowcharts for pain, sedation, and delirium have been proposed; they have been designed to treat potentially correctable factors first, and, only once excluded, to administer neuroactive drugs. The study lasted from January 24 to December 31, 2012. A total of 348 patients have been randomized, through a centralized website, using a specific software expressly designed for this study. The created network of ICUs included a mix of both university and non-university hospitals, with different experience in managing enteral sedation. A dedicated free-access website was also created, in both Italian and English, for continuous education of ICU staff through CME courses.This 'educational research' project aims both to compare two sedative strategies and to highlight the need for a profound cultural change, improving outcomes by keeping critically-ill patients awake.Clinicaltrials.gov #NCT01360346.

Project description:Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged, thereby leading to increased cost. A recent randomized controlled trial showed that the consumption of regular black coffee after colectomy is associated with a significantly faster resumption of intestinal motility. The mechanism by which coffee stimulates intestinal motility is unknown, but caffeine seems to be the most likely stimulating agent. Thus, the effect of caffeine on postoperative bowel activity after colon surgery will be analyzed in this trial, herein referred to as CaCo.Patients scheduled for elective laparoscopic colectomy or upper rectum resection are eligible to participate in this double-blinded, placebo-controlled, randomized trial. Patients fulfilling all inclusion criteria will be allocated after the surgical procedure to one of three treatment arms: 100 mg caffeine, 200 mg caffeine, or placebo (corn starch). Patients will take the capsules containing the study medication three times daily with a meal. The primary endpoint of the study is the time to a solid bowel movement. The study treatment will be stopped after the patient produces a solid bowel movement or has taken ten capsules, whichever occurs first. To determine the colonic passage time, patients will take a capsule with radiopaque markers at breakfast for the first 3 days after surgery. On the fourth day, the location of the markers will be determined with an abdominal X-ray scan. Further secondary objectives are the postoperative morbidity and mortality, well-being, sleeping behavior, and length of hospital stay. The study size was calculated to be 180 patients with an interim analysis occurring after 60 patients.From a previous study investigating coffee, evidence exists that caffeine might have a positive influence on the postoperative bowel activity. This double-blinded, placebo-controlled, randomized trial tries to show that caffeine will shorten the postoperative bowel paralysis and, thus, will improve recovery and shorten the hospital stay after colon surgery.Clinicaltrials.gov NCT02510911 Swiss National Clinical Trials Portal SNCTP000001131.

Dataset Information

Preoperative information for ICU patients to reduce anxiety during and after the ICU-stay: protocol of a randomized controlled trial [NCT00151554].

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Preoperative information for ICU patients to reduce anxiety during and after the ICU-stay: protocol of a randomized controlled trial [NCT00151554].

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