(Preprint)

2018 ◽  
Author(s):  
Connor Buffel ◽  
June van Aalst ◽  
Anne-Marie Bangels ◽  
Jaan Toelen ◽  
Karel Allegaert ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
User Experience ◽  
Ambulatory Surgery ◽  
Pilot Trial ◽  
Test Group ◽  
Small Sample ◽  
Preoperative Anxiety ◽  
Serious Game ◽  
Control Group ◽  
Adjunct Therapy

BACKGROUND As pediatric ambulatory surgeries are rising and existing methods to reduce perioperative anxiety and pain are lacking in this population, a serious game for health (SGH), CliniPup, was developed to address this unmet need. CliniPup was generated using the SERES framework for serious game development. OBJECTIVE To clinically evaluate CliniPup, an SGH, as an adjunct therapy to existing pharmacological interventions aimed at reducing perioperative anxiety and pain in children undergoing ambulatory surgery. METHODS CliniPup was evaluated in a prospective, randomized, controlled pilot trial in 20 children aged 6-10 years who underwent elective surgery, and their parents. Study participants were randomly assigned to the test (n=12) or control group (n=8). Children in the test group played CliniPup 2-days prior to surgery and children in the control group received standard of care. On the day of surgery, pediatric anxiety was measured with the modified Yale Preoperative Anxiety Scale (mYPAS) and parental anxiety was assessed with the State-Trait Anxiety Inventory (STAI). Pediatric postoperative pain was assessed by the Wong-Baker Faces Pain Rating Scale (WBFPRS). Child and parent user experience and satisfaction was also evaluated in the test group using structured questionnaires. RESULTS Despite the small sample, preoperative anxiety scores were significantly lower (P = .01) in children who played CliniPup prior to surgery, compared to controls. Parental preoperative anxiety scores were also lower in the test group (P = .10), but did not reach significance. No significant differences were observed in postoperative pain scores between groups (P = .54). The evaluation of user experience and satisfaction revealed that both children and parents were satisfied with CliniPup and would recommend the game to peers. CONCLUSIONS Results of the pilot trial introduce CliniPup as a potentially effective and attractive adjunct therapy, to reduce preoperative anxiety in children undergoing ambulatory surgery, with a trend towards positive impact on parental preoperative anxiety. These results support the use of the SERES framework to generate an evidence-based SGH, which results in positive health outcomes for patients. Based on these preliminary findings, we propose a research agenda to further develop and investigate this tool.

scholarly journals A Web-Based Serious Game for Health to Reduce Perioperative Anxiety and Pain in Children (CliniPup): Pilot Randomized Controlled Trial

10.2196/12431 ◽  
2019 ◽  
Vol 7 (2) ◽  
pp. e12431 ◽  
Author(s):  
Connor Buffel ◽  
June van Aalst ◽  
Anne-Marie Bangels ◽  
Jaan Toelen ◽  
Karel Allegaert ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
User Experience ◽  
Ambulatory Surgery ◽  
Pilot Trial ◽  
Test Group ◽  
Preoperative Anxiety ◽  
Serious Game ◽  
Control Group ◽  
Adjunct Therapy ◽  
Randomized Controlled

Background As pediatric ambulatory surgeries are rising and existing methods to reduce perioperative anxiety and pain are lacking in this population, a serious game for health (SGH), CliniPup, was developed to address this unmet need. CliniPup was generated using the SERES framework for serious game development. Objective The goal of the research was to clinically evaluate CliniPup as an adjunct therapy to existing pharmacological interventions aimed at reducing perioperative anxiety and pain in children undergoing ambulatory surgery. Methods CliniPup was evaluated in a prospective randomized controlled pilot trial in 20 children aged 6 to 10 years who underwent elective surgery and their parents. Study participants were randomly assigned to the test (n=12) or control group (n=8). Children in the test group played CliniPup 2 days prior to surgery, and children in the control group received standard of care. On the day of surgery, pediatric anxiety was measured with the modified Yale Preoperative Anxiety Scale and parental anxiety was assessed with the State-Trait Anxiety Inventory. Pediatric postoperative pain was assessed by the Wong-Baker Faces Pain Rating Scale. Child and parent user experience and satisfaction were also evaluated in the test group using structured questionnaires. Results Despite the small sample, preoperative anxiety scores were significantly lower (P=.01) in children who played CliniPup prior to surgery compared to controls. Parental preoperative anxiety scores were also lower in the test group (P=.10) but did not reach significance. No significant differences were observed in postoperative pain scores between groups (P=.54). The evaluation of user experience and satisfaction revealed that both children and parents were satisfied with CliniPup and would recommend the game to peers. Conclusions Results of the pilot trial introduce CliniPup as a potentially effective and attractive adjunct therapy to reduce preoperative anxiety in children undergoing ambulatory surgery with a trend toward positive impact on parental preoperative anxiety. These results support the use of the SERES framework to generate an evidence-based SGH that results in positive health outcomes for patients. Based on these preliminary findings, we propose a research agenda to further develop and investigate this tool. Trial Registration ClinicalTrials.gov NCT03874442; https://clinicaltrials.gov/ct2/show/NCT03874442 (Archived by WebCite at http://www.webcitation.org/78KZab8qc)

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 Clinical Evaluation of a Novel Technology for Oral Patient-Controlled Analgesia, the PCoA® Acute Device, for Hospitalized Patients with Postoperative Pain, in Pilot Feasibility Study

2017 ◽  
Vol 2017 ◽  
pp. 1-12 ◽  
Author(s):  
Stefan Wirz ◽  
Stefan Conrad ◽  
Ronit Shtrichman ◽  
Kai Schimo ◽  
Eva Hoffmann
Keyword(s):  
Postoperative Pain ◽  
Elective Surgery ◽  
Test Group ◽  
Medication Administration ◽  
Control Group ◽  
Medical Centers ◽  
Novel Technology ◽  
Pain Scores ◽  
Pain Ratings ◽  
Pilot Feasibility Study

Background. Acute postoperative pain delays recovery and increases morbidity and mortality. Traditional administration of postoperative analgesics by nurses is often inefficient. The present study evaluated the safety, efficacy, and usability of a novel, patient-controlled analgesic dispenser, the PCoA Acute. Methods. A controlled pilot study was conducted at three medical centers. Patients scheduled for elective surgery were enrolled into two groups, both taking oral analgesics: a control group (n=43), opioids dispensed by nurses, and a test group (n=27), opioids dispensed via the PCoA Acute. Pill intake data were recorded. Pain ratings at rest and during movement were surveyed. Results. No severe adverse events were recorded. Average pill intake time was reduced from 8 : 58 minutes in the control group to 1 : 17 minutes in the test group (P value < 0.05). The test group took 67% more pills than the control group, indicating enhanced compliance. Pain scores were significantly lower for patients in the test group (P value < 0.05). Over 90% of PCoA Acute users were satisfied with its use. Conclusions. The study confirmed that PCoA Acute is safe and effective. It is well accepted by patients and medical staff. Its use can optimize pain medication administration.

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.

Effects of the Preoperative Administration of Dexketoprofen Trometamol on Pain and Swelling After Implant Surgery: A Randomized, Double-Blind Controlled Trial

2018 ◽  
Vol 44 (2) ◽  
pp. 122-129
Author(s):  
Arturo Sánchez-Pérez ◽  
Jesús Muñoz-Peñalver ◽  
María José Moya-Villaescusa ◽  
Carmen Sánchez-Matás
Keyword(s):  
Placebo Group ◽  
Postoperative Pain ◽  
Controlled Trial ◽  
Test Group ◽  
Control Group ◽  
Double Blind ◽  
Implant Surgery ◽  
Lower Pain ◽  
Dexketoprofen Trometamol ◽  
Group A

The fear of postoperative pain is often mentioned by patients as one of the factors that is most frequently associated with dental implants. To reduce this factor, a single oral dose of 25 mg dexketoprofen trometamol (DKT) or placebo was administered 15 minutes before implant surgery. One hundred patients who required single-implant treatments were randomly assigned to 1 of 2 blinded groups. The patients in the test group were given 25 mg DKT (DKT group), and those in the control group were given 500 mg vitamin C as a placebo (PLACEBO group). A subjective visual analogue scale of 100 mm in length was used to evaluate pain. Inflammation and complications were assessed using a 5-point Likert scale. An analysis of variance, t-tests, and a Mann-Whitney U test were performed. Among the 100 patients, 83 completed the study (there were 8 dropouts in the PLACEBO group and 9 in the DKT group). The patients who received DKT reported a lower pain intensity during the immediate postoperative period. The inflammatory response was weaker in the DKT group than the control group at 48 hours, but bleeding was greater. There were no other complications in either of the groups. In conclusion, the preemptive use of 25 mg soluble DKT administered orally 15 minutes before implant surgery can reduce the severity of immediate postoperative pain.

scholarly journals Effect of magnesium supplementation on emergence delirium and postoperative pain in children undergoing strabismus surgery: a prospective randomised controlled study

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Ji-Hyun Lee ◽  
Seungeun Choi ◽  
Minkyoo Lee ◽  
Young-Eun Jang ◽  
Eun-Hee Kim ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Randomized Study ◽  
Strabismus Surgery ◽  
Preoperative Anxiety ◽  
Controlled Study ◽  
Control Group ◽  
Magnesium Supplementation ◽  
Emergence Period ◽  
Emergence Delirium ◽  
Respiratory Events

Abstract Background The benefits of intraoperative magnesium supplementation have been reported. In this prospective, randomized study, the effects of magnesium supplementation during general anaesthesia on emergence delirium and postoperative pain in children were evaluated. Methods A total of 66 children aged 2 to 5 years who underwent strabismus surgery were assigned to the magnesium or to the control group. Preoperative anxiety was assessed using the modified Yale Preoperative Anxiety Scale. After anaesthesia induction, the magnesium group received an initial loading dose of 30 mg/kg magnesium sulphate over 10 min and, then, continuous infusion of 10 mg/kg per h until 10 min before the end of the surgery. The control group received an equal volume of normal saline via the same regimen. The Paediatric Anaesthesia Emergence Delirium (PAED) score, pain score, and respiratory events were assessed at the postanaesthetic care unit. Results Data obtained from 65 children were analyzed. The PAED and pain scores of the two groups did not differ significantly. There were 26 of 33 (78.8%) and 27 of 32 (84.4%) children with emergence delirium in the control and the magnesium groups, respectively (odds ratio 0.69, 95% CI 0.19–2.44; p = 0.561). The preoperative anxiety score was not significantly correlated with the PAED score. The incidence of respiratory events during the emergence period did not differ significantly between the two groups. Conclusions Magnesium supplementation during anaesthesia had no significant effects on the incidence of emergence delirium or postoperative pain in children undergoing strabismus surgery. Trial registration ClinicalTrials.gov (NCT03132701). Prospectively registered May 8, 2017.

scholarly journals Magnesium Supplementation and Postoperative Recovery Quality in Children Undergoing Strabismus Surgery: A Prospective, Randomised, Controlled Study

2020 ◽  
Author(s):  
Ji-Hyun Lee ◽  
Seungeun Choi ◽  
Minkyoo Lee ◽  
Young-Eun Jang ◽  
Eun-Hee Kim ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Strabismus Surgery ◽  
Preoperative Anxiety ◽  
Controlled Study ◽  
Control Group ◽  
Anesthesia Induction ◽  
Emergence Agitation ◽  
Magnesium Supplementation ◽  
Respiratory Events ◽  
Postanesthetic Care Unit

Abstract Background: The benefits of intraoperative magnesium supplementation have been reported. In this prospective, randomized study, the effects of magnesium supplementation during general anesthesia on emergence agitation and postoperative pain in children were evaluated.Methods: A total of 66 children aged 2 to 5 years who underwent strabismus surgery were assigned to the magnesium or to the control group. Preoperative anxiety was assessed using the modified Yale Preoperative Anxiety Scale. After anesthesia induction, the magnesium group received an initial loading dose of 30 mg/kg magnesium sulphate over 10 min and, then, continuous infusion of 10 mg/kg per h until 10 min before the end of the surgery. The control group received an equal volume of normal saline via the same regimen. The Pediatric Anesthesia Emergence Delirium (PAED) score, pain score, and respiratory events were assessed at the postanesthetic care unit.Results: Data obtained from 65 children were analyzed. The PAED and pain scores of the two groups did not differ significantly. There were 26 of 33 (78.8%) and 27 of 32 (84.4%) children with emergence agitation in the control and the magnesium groups, respectively (odds ratio 0.69, 95% CI 0.19–2.44; p = 0.561). The preoperative anxiety score was not significantly correlated with the PAED score. The incidence of respiratory events during the emergence period did not differ significantly between the two groups. Conclusions: Magnesium supplementation during anesthesia had no significant effects on the incidence of emergence agitation or postoperative pain in children undergoing strabismus surgery.Clinical trial registry: ClinicalTrials.gov (NCT03132701)

High-Volume, Low-Concentration Intraperitoneal Bupivacaine Study in Emergency Laparoscopic Cholecystectomy: A Double-Blinded, Prospective Randomized Clinical Trial

2020 ◽  
pp. 155335062091419
Author(s):  
Alpen Yahya Gumusoglu ◽  
Sina Ferahman ◽  
Mehmet Emin Gunes ◽  
Ahmet Surek ◽  
Serhan Yilmaz ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Laparoscopic Cholecystectomy ◽  
Postoperative Pain ◽  
Shoulder Pain ◽  
Test Group ◽  
High Volume ◽  
Control Group ◽  
Low Concentration ◽  
Analgesic Consumption ◽  
Intraperitoneal Bupivacaine

Background. Laparoscopic cholecystectomy (LC) often results in postoperative pain, especially in the abdomen. Intraperitoneal local anesthesia (IPLA) reduces pain after LC. Acute cholecystitis–associated inflammation, increased gallbladder wall thickness, dissection difficulties, and a longer operative time are several reasons for assuming a benefit in pain scores in urgent LC with IPLA application. The aim was to determine the postoperative analgesic efficacy of high-volume, low-dose intraperitoneal bupivacaine in urgent LC. Materials and Methods. Fifty-seven patients who were American Society of Anesthesiologists physical status I or II were randomly assigned to receive either normal saline (control group) or intraperitoneal bupivacaine (test group) at the beginning or end of urgent LC. The primary outcome was the postoperative pain score of the Visual Analogue Scale (VAS). The secondary outcomes included Visual Rating Prince Henry Scale (VRS), patient satisfaction, and analgesic consumption. Results. Postoperative VAS scores at the first and fourth hours were significantly lower in the test group than in the control group ( P < .001). Postoperative VRS scores at the first, fourth, and eighth hours were significantly lower in the test group than in the control group ( P < .001, P = .002, P = .004, respectively). Analgesic use was significantly higher in the control group at the first postoperative hour ( P < .001). Shoulder pain was significantly lower, and patient satisfaction was significantly higher in the test group relative to the control group (both P < .001). Conclusion. High-volume, low-concentration intraperitoneal bupivacaine resulted in better postoperative pain control and reduced incidence of shoulder pain and analgesic consumption in urgent LC.

scholarly journals Effect of Pregabalin on Preoperative Anxiety and Postoperative Pain in Spine Surgery: A Randomized Controlled Study

2018 ◽  
Vol 05 (01) ◽  
pp. 8-14
Author(s):  
Rahul Yadav ◽  
Rajeeb K. Mishra ◽  
Arvind Chaturvedi ◽  
Girija P. Rath
Keyword(s):  
Side Effects ◽  
Postoperative Pain ◽  
Spine Surgery ◽  
Postoperative Nausea And Vomiting ◽  
Preoperative Anxiety ◽  
Controlled Study ◽  
Lumbar Spine Surgery ◽  
Control Group ◽  
Vas Score ◽  
Fentanyl Consumption

Abstract Background Pregabalin is a gabapentinoid which has been shown to possess analgesic and anxiolytic properties. The present study aimed to assess the efficacy of a single dose of pregabalin on postoperative pain and preoperative anxiety in patients undergoing lumbar spine surgery. Materials and Methods Sixty adults posted for elective lumbar laminectomy and discectomy were randomly assigned to one of the three groups; Group C received placebo capsules, Group PI received pregabalin 150 mg, and Group P2 received pregabalin 300 mg capsules, 2 h prior to induction of anesthesia. The levels of anxiety and pain were assessed with respective 100 mm visual analog scale (VAS) score. Postoperative fentanyl consumption and occurrence of side effects were recorded. All patients were observed for 8 h, postoperatively. Results There was a significant reduction in preoperative anxiety in both pregabalin groups as compared to control group (p = 0.001). VAS score for pain (at rest and during movement) was significantly decreased at all time intervals in both PI and P2 groups as compared to control (p < 0.05). Fentanyl consumption in the postoperative period was significantly reduced in pregabalin groups as compared to control (p = 0.001). The level of sedation was higher in P2 group in the first 4 h (p < 0.05). The occurrence of postoperative nausea and vomiting was more in control group as compared to the pregabalin groups (p = 0.018). The incidence of dizziness and blurring of vision was significantly more in P2 group. Conclusion Single preoperative dose of pregabalin 150 or 300 mg was effective in reducing preoperative anxiety, postoperative pain and total fentanyl consumption in patients undergoing lumbar laminectomy and discectomy. However, the incidence of postoperative side effects such as sedation, dizziness and visual blurring was more in patients who received pregabalin 300 mg.

scholarly journals Does regularly playing serious gaming improve cognitive functioning of seniors in care facilities? Controlled Effectiveness Trial on a Representative German Sample. (Preprint)

2021 ◽  
Author(s):  
Jana Kleschnitzki ◽  
Luzi Beyer ◽  
Reinhard Beyer ◽  
Inga Großmann
Keyword(s):  
Cognitive Abilities ◽  
Serious Games ◽  
Intervention Group ◽  
Small Sample ◽  
Serious Game ◽  
Control Group ◽  
Ageing Population ◽  
Mixed Anova ◽  
Significant Difference ◽  
Care Facilities

BACKGROUND Exergames have not only found to have enhancing and preventative effects on physical but also on cognitive abilities in healthy older adults. Yet, there are just few results on effects for older seniors with age-related low physical and/or cognitive impairments. Their special needs were considered when designing and using innovate technology for the field of prevention, especially being relevant due to the continuously ageing population. OBJECTIVE In this controlled trial, we test a serious game with various modules specifically designed for seniors in care homes, the so-called MemoreBox. METHODS Over a period of one year and four points in time 1.000 seniors were tested in their cognitive abilities via the Mini-Mental-Status-Test. Half used the serious games three times a week for one hour and half did not. The objective data from the games gave us the opportunity to divide the intervention-group through identify those who played regularly. RESULTS The sample consists of an intervention group (n=56) and a control group (n=55) that does not play. Due to the technical data, a second intervention group (n=38) could be identified within the original intervention group, which carried out the study design correctly according to plan. The are no noteworthy differences between the demographic and main variables of the overall sample. The large reduction in the sample size is due to the effects of the corona-situation, in the middle of the survey (Drop-Out 88,9%). The Confidence Interval was set at 5%. The mixed ANOVA between the cognitive abilities of the IG and the CG couldn’t show a significant difference between time an group F(2,710,295,379) = 1.942, p <.129, partial η² = .018. The same for the mixed ANOVA between the cognitive abilities of the IG2 und CG F(3.273) = 2.574, p <.054, partial η² = .028, but with a clear tendencies and a significant difference between the two groups after 9 month of intervention t(88.1) = - 2,394, p = .021. CONCLUSIONS The results of this paper basically report something like the current research situation and the tendency for the intervention to be effective on the cognitive abilities of seniors can be formulated, provided that they regularly play the serious games of the MemoreBox. The small sample, the non-existent RCT and the no significance at an α= 5% suggest additional, further research. Establishing a preventively effective tool as part of standard care in nursing homes by means of an easy-to-use serious game would be a relieving contribution to the weakened health system, in which there is a lack of activating offers for senior citizens in (partially) inpatient care facilities. CLINICALTRIAL German Clinical Trials Register (DRKS), DRKS00016633

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