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 ◽  
Psychological Interventions ◽  
Randomized Controlled ◽  
Pain Outcomes

Abstract Background: Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for a proper postoperative care. While several trials have investigated the analgesia 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 adults 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 27 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 on 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. Keywords: pain; postsurgical pain; virtual reality; psychological interventions; VR-based interventions; Trial registration status: ClinicalTrials, NCT03776344 . Retrospectively registered in December 14, 2018, https://clinicaltrials.gov/ct2/show/NCT03776344 .

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

2019 ◽  
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 ◽  
Successful Implementation ◽  
Randomized Controlled ◽  
Pain Outcomes

Abstract Background: Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for a proper postoperative care. While several trials have investigated the analgesia effect of traditional non-pharmacological treatments, such Cognitive Behaviors Therapies for pain after surgery, the newer ways of delivering psychological interventions are paucity 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 outcomes then standard care in adults patients following surgery. Methods: This is a protocol of a parallel RCT conducted in one community hospital. 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. A minimum of 27 patients is intended to 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 in-depth investigation on the effect of VR environments, the estimates of pain intensity will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment. Discussion: It has already been established that VR can improve the outcomes of pain treatment at burn patients. Successful implementation in post-operative settings has the potential to change the recovery trajectory of individuals with surgical interventions. However, the best mode of implementation in terms of efficacy, acceptability, and side effects is still unclear. The present trial will provide guidance for pain interventions to be implemented on large scale and will provide scientific support in discussing treatment options for individual patients. Trial registration status: ClinicalTrials, NCT03776344. Retrospectively registered in December 14, 2018, https://clinicaltrials.gov/ct2/show/NCT03776344.

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 Effects of the Preschool-Based Family-Involving DAGIS Intervention Program on Children’s Energy Balance-Related Behaviors and Self-Regulation Skills: A Clustered Randomized Controlled Trial

Nutrients ◽  
2020 ◽  
Vol 12 (9) ◽  
pp. 2599 ◽  
Author(s):  
Carola Ray ◽  
Rejane Figuereido ◽  
Henna Vepsäläinen ◽  
Reetta Lehto ◽  
Riikka Pajulahti ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Energy Balance ◽  
Repeated Measures ◽  
Screen Time ◽  
Controlled Trial ◽  
Self Regulation ◽  
Control Group ◽  
Randomized Controlled ◽  
Multicomponent Intervention

The study examines the effects of a preschool-based family-involving multicomponent intervention on children’s energy balance-related behaviors (EBRBs) such as food consumption, screen time and physical activity (PA), and self-regulation (SR) skills, and whether the intervention effects differed among children with low or high parental educational level (PEL) backgrounds. The Increased Health and Wellbeing in Preschools (DAGIS) intervention was conducted as a clustered randomized controlled trial, clustered at preschool level, over five months in 2017–2018. Altogether, 802 children aged 3–6 years in age participated. Parents reported children’s consumption of sugary everyday foods and beverages, sugary treats, fruits, and vegetables by a food frequency questionnaire, and screen time by a 7-day diary. Physical activity was assessed by a hip-worn accelerometer. Cognitive and emotional SR was reported in a questionnaire by parents. General linear mixed models with and without repeated measures were used as statistical methods. At follow-up, no differences were detected in EBRBs or SR skills between the intervention and control group, nor did differences emerge in children’s EBRBs between the intervention and the control groups when stratified by PEL. The improvement in cognitive SR skills among low PEL intervention children differed from low PEL control children, the significance being borderline. The DAGIS multicomponent intervention did not significantly affect children’s EBRBs or SR. Further sub-analyses and a comprehensive process evaluation may shed light on the non-significant findings.

scholarly journals A randomized controlled trial of a specific reminiscence approach to promote the well-being of nursing home residents with dementia

2004 ◽  
Vol 16 (1) ◽  
pp. 33-49 ◽  
Author(s):  
Claudia K. Y. Lai ◽  
Iris Chi ◽  
Jeanie Kayser-Jones
Keyword(s):  
Randomized Controlled Trial ◽  
Nursing Home ◽  
Repeated Measures ◽  
Comparison Group ◽  
Controlled Trial ◽  
Intervention Group ◽  
Nursing Home Residents ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled

Background: To date, no firm conclusions can be reached regarding the effectiveness of reminiscence for dementia. Researchers have emphasized that there is an urgent need for more systematic research in the area.Objective and Method: A single-blinded, parallel-groups (one intervention, one comparison, and one no-intervention group) randomized controlled trial (RCT) was adopted to investigate whether a specific reminiscence program leads to higher levels of psychosocial well-being in nursing home residents with dementia. The intervention adopted a life-story approach, while the comparison group provided friendly discussions to control for any changes in outcome as a result of social contacts and attention. The Social Engagement Scale (SES) and Well-being/Ill-being Scale (WIB) were the outcome measures used. The outcomes of the groups were examined with reference to the baseline (T0), immediately (T1), and six weeks (T2) after intervention. The final sample had 101 subjects (control group: n=30; comparison group: n=35; intervention group: n=36). Using multivariate analysis with repeated measures, no significant differences in outcome were found between groups at either T1 or T2. Wilcoxon signed rank tests were performed for each group comparing outcomes between T1 and T0, T2 and T1, and T2 and T0. Significant differences were observed in the intervention group when comparing T1 and T0 WIB (p=.014), but not for the other groups.Conclusion: Although the intervention did not lead to significant differences between the three groups over time, there was a significant improvement in psychosocial well-being for the intervention group.

scholarly journals Testing the Effects of a Virtual Reality Game for Aggressive Impulse Management: A Preliminary Randomized Controlled Trial among Forensic Psychiatric Outpatients

2021 ◽  
Vol 11 (11) ◽  
pp. 1484
Author(s):  
Danique Smeijers ◽  
Erik H. Bulten ◽  
Robbert-Jan Verkes ◽  
Sander L. Koole
Keyword(s):  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Controlled Trial ◽  
Self Report ◽  
Clinical Settings ◽  
Psychiatric Outpatients ◽  
Self Reflection ◽  
Aggression Replacement Training ◽  
Randomized Controlled ◽  
Forensic Psychiatric

Prior laboratory experiments among healthy samples found that training avoidance movements to angry faces may lower anger and aggression, especially people high in trait anger. To enrich this training and make it more suitable for clinical applications, the present researchers developed it into a Virtual Reality Game for Aggressive Impulse Management (VR-GAIME). The current study examined the effects of this training in a randomized controlled trial among forensic psychiatric outpatients with aggression regulation problems (N = 30). In addition to the aggression replacement training, patients played either the VR-GAIME or a control game. Aggressive behavior was measured pre-, half-way, and post-treatment via self-report and clinicians ratings. No difference was found between the VR-GAIME and the control game. However, the participants reported gaining more insight into their own behavior and that of others. Future VR intervention tools in clinical settings may capitalize more on their benefits for self-reflection within interpersonal settings.

A randomized controlled trial of the use of self-help materials in addition to standard general practice treatment of depression compared to standard treatment alone

2005 ◽  
Vol 36 (3) ◽  
pp. 325-333 ◽  
Author(s):  
PAUL SALKOVSKIS ◽  
KATHARINE RIMES ◽  
DEBORAH STEPHENSON ◽  
GERALD SACKS ◽  
JAN SCOTT
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Social Adjustment ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Control Group ◽  
Global Functioning ◽  
Randomized Controlled ◽  
Self Help ◽  
Treatment Of Depression

Background. The purpose of the study was to examine whether the addition of a brief individual self-help package to standard primary-care treatment of depression with antidepressants is associated with any additional improvements in clinical outcome.Method. Individuals with major depressive disorder who were prescribed an antidepressant were recruited through their general practitioner (GP) and allocated randomly to standard treatment alone or standard treatment plus self-help. Assessments of symptoms, social adjustment, global functioning, satisfaction with treatment and knowledge about the management of the disorder were completed at three time points over 26 weeks.Results. One hundred and twelve individuals agreed to participate and 96 met criteria for inclusion in the randomized controlled trial. Subjects in both treatment conditions improved substantially over the study period; the mean Beck Depression Inventory (BDI) score fell from 27·3 to 13·9 in the intention-to-treat analysis. There were no between group differences in outcome on any of the primary outcome measures, nor did these approach even marginal significance. Patients and GPs were highly satisfied with the self-help programme, and the intervention as compared to the control group reported significantly greater improvements in knowledge about depression and satisfaction with information received about depression.Conclusions. An individualized self-help package improved perceived knowledge about depression but did not have identifiable effects on outcome when offered to patients treated in primary care. The study was sufficiently well powered to detect relatively small effects.

Evaluating Seeking Safety for Women in Prison: A Randomized Controlled Trial

2017 ◽  
Vol 29 (3) ◽  
pp. 281-290 ◽  
Author(s):  
Stephen J. Tripodi ◽  
Annelise M. Mennicke ◽  
Susan A. McCarter ◽  
Katie Ropes
Keyword(s):  
Randomized Controlled Trial ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Post Traumatic Stress ◽  
Treatment As Usual ◽  
Seeking Safety ◽  
Randomized Controlled

Objective: This study assessed the effectiveness of Seeking Safety on depression and post-traumatic stress disorder (PTSD) with incarcerated women. Method: A randomized controlled trial ( N = 40) was used to analyze Seeking Safety’s effectiveness compared to a treatment-as-usual control group. Analyses of covariance were used to assess differences at posttest ( n = 33) and 4-month follow-up ( n = 29) while repeated measures analysis of variance was used to assess the influence of the intervention on changes over time ( n = 29). The researchers also analyzed individual participants’ scores from pretest to 4-month follow-up ( n = 29). Results: Both groups decreased their scores on the Center for Epidemiology Studies–Depression Scale and the PTSD Checklist, although improvement was greater for treatment group participants except for depression at 4-month follow-up. Conclusion: Results support the continued use of Seeking Safety as a helpful corrections-based intervention for women, but more research with larger sample sizes is needed to consider it an effective intervention.

Effects of momentary self-monitoring on empowerment in a randomized controlled trial in patients with depression

2015 ◽  
Vol 30 (8) ◽  
pp. 900-906 ◽  
Author(s):  
C.J.P. Simons ◽  
J.A. Hartmann ◽  
I. Kramer ◽  
C. Menne-Lothmann ◽  
P. Höhn ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Group Treatment ◽  
Antidepressant Treatment ◽  
Controlled Trial ◽  
Self Report ◽  
Control Group ◽  
Self Monitoring ◽  
Randomized Controlled ◽  
Experimental Group ◽  
Reliable Increase

AbstractBackgroundInterventions based on the experience sampling method (ESM) are ideally suited to provide insight into personal, contextualized affective patterns in the flow of daily life. Recently, we showed that an ESM-intervention focusing on positive affect was associated with a decrease in symptoms in patients with depression. The aim of the present study was to examine whether ESM-intervention increased patient empowerment.MethodsDepressed out-patients (n = 102) receiving psychopharmacological treatment who had participated in a randomized controlled trial with three arms: (i) an experimental group receiving six weeks of ESM self-monitoring combined with weekly feedback sessions, (ii) a pseudo-experimental group participating in six weeks of ESM self-monitoring without feedback, and (iii) a control group (treatment as usual only). Patients were recruited in the Netherlands between January 2010 and February 2012. Self-report empowerment scores were obtained pre- and post-intervention.ResultsThere was an effect of group × assessment period, indicating that the experimental (B = 7.26, P = 0.061, d = 0.44, statistically imprecise) and pseudo-experimental group (B = 11.19, P = 0.003, d = 0.76) increased more in reported empowerment compared to the control group. In the pseudo-experimental group, 29% of the participants showed a statistically reliable increase in empowerment score and 0% reliable decrease compared to 17% reliable increase and 21% reliable decrease in the control group. The experimental group showed 19% reliable increase and 4% reliable decrease.ConclusionsThese findings tentatively suggest that self-monitoring to complement standard antidepressant treatment may increase patients’ feelings of empowerment. Further research is necessary to investigate long-term empowering effects of self-monitoring in combination with person-tailored feedback.

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