scholarly journals Self-Regulation in Children with Neurodevelopmental Disorders “SR-MRehab: Un Colegio Emocionante”: A Protocol Study

2020 ◽  
Vol 17 (12) ◽  
pp. 4198
Author(s):  
Dulce Romero-Ayuso ◽  
Pablo Alcántara-Vázquez ◽  
Ana Almenara-García ◽  
Irene Nuñez-Camarero ◽  
José Matías Triviño-Juárez ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Neurodevelopmental Disorders ◽  
Controlled Trial ◽  
Self Regulation ◽  
Control Group ◽  
Intervention Process ◽  
Before And After ◽  
Cognitive Modulation ◽  
Protocol Study ◽  
Natural Way

Self-regulation refers to the ability to control and modulate behavior, and it can include both emotional and cognitive modulation. Children with neurodevelopmental disorders may show difficulties in self-regulation. The main objective of this study is to improve self-regulation skills in children between 6 and 11 years of age with neurodevelopmental disorders. Methodology: A randomized controlled trial will be conducted with the use of “SR-MRehab: Un colegio emocionante”, based on a non-immersive virtual reality system where virtual objects can be managed by children in a natural way using their hands. Children will be recruited from several schools of Granada (Spain) and they will be randomly allocated to two groups. An assessment will be conducted before and after the intervention and 24 weeks after the end of the intervention process. The experimental group will receive the intervention using virtual reality. The control group will receive a standard self-regulation program. Both interventions will be performed once a week for a total of 10 sessions. Changes in self-regulation, as well as the acceptability of technology with the use of SR-MRehab, will be evaluated. The results will be published and will provide evidence regarding the use of this type of intervention in children with neurodevelopmental disorders. Trial registration: Registered with code NCT04418921.

scholarly journals A Virtual Reality based intervention for surgical patients: study protocol of a randomized controlled trial

2020 ◽  
Author(s):  
Raluca Georgescu ◽  
Anca Dobrean ◽  
Cristina Alina Silaghi ◽  
Horațiu Silaghi
Keyword(s):  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Repeated Measures ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Self Report ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Outcomes ◽  
Before And After

Abstract Background: Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for proper postoperative care. While several trials have investigated the analgesic effect of traditional non-pharmacological treatments, such as Cognitive Behaviors Therapies, the newer ways of delivering psychological interventions for pain after surgery are scarcely investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through Virtual Reality (VR) along with the standard pharmacological treatment return better pain relief outcomes than standard care in adult patients following surgery. Methods: This is a protocol of a parallel RCT conducted in one community hospital. In order to test the efficacy of VR environments for reducing pain intensity, in the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. It is intended that a minimum of 30 patients be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing an in-depth investigation of the effect of VR environments, the primary outcome will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment.

scholarly journals A Virtual Reality based intervention for surgical patients: study protocol of a randomized controlled trial

2021 ◽  
Author(s):  
Raluca Georgescu ◽  
Anca Dobrean ◽  
Cristina Alina Silaghi ◽  
Horațiu Silaghi
Keyword(s):  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Repeated Measures ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Self Report ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Outcomes ◽  
Before And After

Abstract Background: Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for proper postoperative care. While several trials have investigated the analgesic effect of traditional non-pharmacological treatments, such as Cognitive Behaviors Therapies, the newer ways of delivering psychological interventions for pain after surgery are scarcely investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through Virtual Reality (VR) along with the standard pharmacological treatment return better pain relief outcomes than standard care in adult patients following surgery. Methods: This is a protocol of a parallel RCT conducted in one community hospital. In order to test the efficacy of VR environments for reducing pain intensity, in the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. It is intended that a minimum of 30 patients be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing an in-depth investigation of the effect of VR environments, the primary outcome will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment. Trial registration ClinicalTrials.gov, NCT03776344. Registered on December 14, 2018.

scholarly journals A virtual reality-based intervention for surgical patients: study protocol of a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Raluca Diana Georgescu ◽  
Anca Dobrean ◽  
Cristina Alina Silaghi ◽  
Horatiu Silaghi
Keyword(s):  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Repeated Measures ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Self Report ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Outcomes ◽  
Before And After

Abstract Background Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for proper postoperative care. While several trials have investigated the analgesic effect of traditional non-pharmacological treatments, such as cognitive behavior therapies, the newer ways of delivering psychological interventions for pain after surgery are scarcely investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through virtual reality (VR) along with the standard pharmacological treatment return better pain relief outcomes than standard care in adult patients following surgery. Methods This is a protocol of a parallel RCT conducted in one community hospital. In order to test the efficacy of VR environments for reducing pain intensity, in the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. It is intended that a minimum of 30 patients be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing an in-depth investigation of the effect of VR environments, the primary outcome will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment.

scholarly journals Toe Clearance Rehabilitative Slippers for Older Adults With Fall Risk: A Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
pp. 215145932110291
Author(s):  
Atsuko Satoh ◽  
Yukoh Kudoh ◽  
Sangun Lee ◽  
Masumi Saitoh ◽  
Miwa Miura ◽  
...  
Keyword(s):  
Older Adults ◽  
Fall Risk ◽  
Controlled Trial ◽  
Intervention Group ◽  
Berg Balance Scale ◽  
Control Group ◽  
Mobility Assessment ◽  
Before And After ◽  
Day Services ◽  
And Control

Introduction: To evaluate fall-prevention rehabilitative slippers for use by self-caring, independent older adults. Materials and Methods: This assessor-blinded, randomized, and controlled 1-year study included 59 self-caring, independent participants (49 women) who attended day services. The mean age of participants was 84.0 ± 5.3 years. Participants were randomly selected from 8 nursing homes. We tested slippers top-weighted with a lead bead (200, 300, or 400 g). Intervention group participants walked while wearing the slippers for 10-20 min, 1-3 days/week at the day service center. Fall risk was measured using the Berg Balance Scale and the Tinetti Performance-Oriented Mobility Assessment (POMA) before and at 3-month intervals after the intervention/control phase. Results: After 12 months, the intervention group demonstrated significant improvement. Berg Balance and POMA compared to the control group ( p < .05 p < .01, respectively). Mobility scores improved significantly for both measurements in the intervention group before and after ( p < .01), but the control group had significantly lower scores. Discussion: Overall, falls decreased in the intervention group from 10 to 7, and control group falls increased from 9 to 16 ( p = .02). No adverse events related to the intervention were reported. Conclusions: Rehabilitation training slippers may reduce falls in older adults.

scholarly journals Enhancing Patient Experience in Office-Based Laryngology Procedures With Passive Virtual Reality

OTO Open ◽  
2021 ◽  
Vol 5 (1) ◽  
pp. 2473974X2097502
Author(s):  
Joseph Chang ◽  
Sen Ninan ◽  
Katherine Liu ◽  
Alfred Marc Iloreta ◽  
Diana Kirke ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Local Anesthesia ◽  
Controlled Trial ◽  
Care Center ◽  
Tertiary Care ◽  
Depression Scale ◽  
Control Group ◽  
Procedure Time ◽  
Pain Scores ◽  
Distress Scale

Objectives Virtual reality (VR) has been used as nonpharmacologic anxiolysis benefiting patients undergoing office-based procedures. There is little research on VR use in laryngology. This study aims to determine the efficacy of VR as anxiolysis for patients undergoing in-office laryngotracheal procedures. Study Design Randomized controlled trial. Setting Tertiary care center. Methods Adult patients undergoing office-based larynx and trachea injections, biopsy, or laser ablation were recruited and randomized to receive standard care with local anesthesia only or local anesthesia with adjunctive VR. Primary end point was procedural anxiety measured by the Subjective Units of Distress Scale (SUDS). Subjective pain, measured using a visual analog scale, satisfaction scores, and procedure time, and baseline anxiety, measured using the Hospital Anxiety and Depression Scale (HADS), were also collected. Results Eight patients were randomized to the control group and 8 to the VR group. SUDS scores were lower in the VR group than in the control group with mean values of 26.25 and 53.13, respectively ( P = .037). Baseline HADS scores did not differ between groups. There were no statistically significant differences in pain, satisfaction, or procedure time. Average satisfaction scores in VR and control groups were 6.44 and 6.25, respectively ( P = .770). Average pain scores were 3.53 and 2.64, respectively ( P = .434). Conclusion This pilot study suggests that VR distraction may be used as an adjunctive measure to decrease patient anxiety during office-based laryngology procedures. Procedures performed using standard local anesthesia resulted in low pain scores and high satisfaction scores even without adjunctive VR analgesia. Level of Evidence 1

The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Asieh Mehdipour ◽  
Parvin Abedi ◽  
Somayeh Ansari ◽  
Maryam Dastoorpoor
Keyword(s):  
Randomized Controlled Trial ◽  
Postmenopausal Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Moderate Depression ◽  
Before And After ◽  
The Mean ◽  
And Control

Abstract Objectives Postmenopausal women are at greater risk of depression. Depression may negatively affect the quality of life of women. An emotional freedom technique (EFT) is an evidence-based therapy combining cognitive and exposure components with acupressure. This study aimed to evaluate the effect of EFT on depression in postmenopausal women. Methods This was a randomized controlled trial in which 88 women with mild to moderate depression recruited from a menopausal clinic in Ahvaz, Iran, and randomly assigned into two groups of EFT (n=44) and control for sham therapy (n=44). Women in the EFT group received two sessions of training and asked to continue EFT for 8 weeks, one time per day. The Beck Depression Inventory (BDI2) completed by women before and after the intervention. The control group received training on sham acupressure points similar to the intervention group. Data collected using a demographic and BDI2. Women requested to complete the BDI2 before and after the intervention. The independent t-test, chi-square, and ANCOVA were used to analyze data. Results The mean depression score in the intervention group reduced from 20.93 ± 4.6 to 10.96 ± 4.38 in comparison to the control group that reduced from 19.18 ± 2.79 to 17.01 ± 6.05 after intervention (p=0.001). After the 8 week intervention, the frequency of moderate depression decreased from 56.8 to 9.35% in the intervention and from 50 to 29.5% in the control group. In total, 63.4 and 34.15% in the intervention and control groups were free of depression respectively after the intervention (p<0.001). Conclusions The results of this study showed that using EFT for 8 weeks could significantly reduce the mean score of depression in postmenopausal women. Using this method in public health centers for postmenopausal women is recommended.

Efficacy of EMDR Therapy on the Pain Intensity and Subjective Distress of Cancer Patients

2021 ◽  
Vol 15 (1) ◽  
pp. 18-28
Author(s):  
Naeem Abdi ◽  
Mohammad Malekzadeh ◽  
Zhila Fereidouni ◽  
Mohammad Behnammoghadam ◽  
Parisa Zaj ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Rating Scale ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Sampling Technique ◽  
Control Group ◽  
Subjective Distress ◽  
Patients With Cancer ◽  
Before And After ◽  
Emdr Therapy

The present study was carried out to investigate the efficacy of eye movement desensitization and reprocessing (EMDR) therapy in treating pain and subjective distress of patients with cancer. A randomized controlled trial was performed on patients with cancer suffering from moderate to severe cancer pain in Yasuj, Iran, in 2019 and 2020. Sixty patients aged 30–60 years who fulfilled the inclusion criteria were selected using a consensus sampling technique. Patients were randomly assigned to EMDR therapy or control groups based on random block allocation. EMDR therapy was administered in six to eight daily 1-hour sessions. The control group received the standard treatment provided by the hospital. A Numeric Pain-Rating Scale (NRS) and the Subjective Units of Disturbance Scale (SUDS) were used to assess pain and subjective distress before and after the intervention in each session. The collected data were analyzed by descriptive statistics, chi-square test, and independent t test using Statistical Package for the Social Sciences (SPSS) version 24. The mean pain intensity and subjective distress score in the experimental group before and after the EMDR intervention were significantly reduced (p < .001). In the control group, no decreases in NRS and SUDS scores occurred at any time (p > .05). Differences in pain scores between the groups were statistically significant (p < .001). EMDR can effectively and sustainably reduce the pain and subjective distress experienced by patients with cancer. Thus, EMDR is a recommended therapeutic option to mitigate pain and subjective distress among patients with cancer.

scholarly journals EFFECTS OF EXERCISE ON PHYSICAL FITNESS AND ANTHROPOMETRIC VARIABLES IN EX-CRACK COCAINE USERS

2017 ◽  
Vol 23 (4) ◽  
pp. 284-289
Author(s):  
Jéssica Abatti Martins ◽  
Ana Maria Volpato ◽  
Vanise dos Santos Ferreira Viero ◽  
Antonio Jose Grande ◽  
Leonardo Roever ◽  
...  
Keyword(s):  
Body Composition ◽  
Physical Fitness ◽  
Crack Cocaine ◽  
Controlled Trial ◽  
Exercise Group ◽  
Control Group ◽  
Beneficial Effects ◽  
Before And After ◽  
Cocaine Users ◽  
Total Body

ABSTRACT Introduction: Worldwide cocaine use in all its various forms is increasing; cocaine users exceeded 17 million in the world. In Brazil, this data is also alarming. A survey conducted in 2010 found that the country has more than 900,000 crack-cocaine users. Objective: To evaluate the effects of exercise on anthropometric variables and components of physical fitness in ex-crack cocaine users. Methods: Randomized controlled trial with 20 men, divided into exercise group (n=10) and control group (n=10), admitted to a detoxification center. We assessed the physical fitness components related to health (cardiorespiratory endurance, flexibility, muscular strength/endurance, and body composition) before and after the physical training program. Results: The exercise contributed to the maintenance of anthropometric variables, while the control group had an increased in total body fat and visceral fat. Regarding physical fitness, resistance training led to the increase of most variables studied, particularly strength and cardiorespiratory capacity. On the other hand, the VO2max and the strength of the sedentary subjects were reduced (P<0.05). Conclusion: The exercise showed beneficial effects on the components of physical fitness and maintenance of body composition.

scholarly journals A randomized, placebo-controlled trial of intravenous gammaglobulin in alloimmunized thrombocytopenic patients

Blood ◽  
1990 ◽  
Vol 75 (1) ◽  
pp. 313-316 ◽  
Author(s):  
T Kickler ◽  
HG Braine ◽  
S Piantadosi ◽  
PM Ness ◽  
JH Herman ◽  
...  
Keyword(s):  
Platelet Transfusion ◽  
Controlled Trial ◽  
Parameter Estimate ◽  
Control Group ◽  
Platelet Recovery ◽  
Mean Values ◽  
Blinded Study ◽  
Before And After ◽  
Study Population ◽  
Intravenous Gammaglobulin

Abstract In a placebo-controlled, randomized blinded study, we evaluated the efficacy of intravenous gammaglobulin (IV-IgG) in alloimmunized thrombocytopenic patients. IV-IgG was administered at a dose of 400 mg/kg for 5 days. An incompatible platelet transfusion from the same donor was used before and after treatment. Seven patients received IV- IgG and five patients received placebo. Although platelet recovery in 1 to 6 hours was satisfactory in five patients after IV-IgG treatment, 24- hour survival was not improved in most patients. None of the patients receiving the placebo achieved satisfactory 1-hour platelet-corrected count increments (CCIs). By t test, the posttreatment mean values 1 hour after transfusion CCIs in the IV-IgG group were significantly greater than in the control group (8,413 v 1,050, P less than .007). Using a regression model to adjust for any distributional assumptions of the study population, the parameter estimate for IV-IgG treatment was positive, indicating that IV-IgG treatment is associated with higher CCIs. Although IV-IgG may improve 1-hour platelet recovery, clinical benefit was not demonstrated since 24-hour survival was not improved. IV-IgG treatment before unmatched platelet transfusions should not be considered as a replacement for HLA-compatible platelets in alloimmunized patients.

Implementation of a rhythm and movement intervention to support self-regulation skills of preschool-aged children in disadvantaged communities

2019 ◽  
Vol 47 (6) ◽  
pp. 800-820 ◽  
Author(s):  
Kate E. Williams ◽  
Donna Berthelsen
Keyword(s):  
Executive Function ◽  
School Readiness ◽  
Emotional Regulation ◽  
School Achievement ◽  
Self Regulation ◽  
Intervention Group ◽  
Control Group ◽  
Disadvantaged Communities ◽  
Path Analyses ◽  
Before And After

Self-regulation skills are an important predictor of school readiness and early school achievement. Research identifies that experiences of early stress in disadvantaged households can affect young children’s brain architecture, often manifested in poor self-regulatory functioning. Although there are documented benefits of coordinated movement activities to improve self-regulation, few interventions have focused exclusively on music and rhythmic activities. This study explores the effectiveness of a preschool intervention, delivered across 8 weeks, which focused on coordinated rhythmic movement with music to improve self-regulation and executive function. The study involved 113 children across three preschools in disadvantaged communities. The intervention group received 16 sessions of a rhythm and movement program over 8 weeks, whereas the control group undertook the usual preschool program. Executive functions were directly assessed, and teachers reported on children’s self-regulation before and after the intervention. Path analyses found positive intervention effects for emotional regulation reported by teachers and, for boys, on the measure of shifting in the executive function assessment. Teacher-reported cognitive and behavioral regulation also improved in one research site. These early findings suggest that a rhythm and movement intervention has the potential to support the development of self-regulation skills in preschool; however, further research is required.

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