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

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

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 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

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.

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.

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 Passive Accessory Joint Mobilization on Acute Ankle Inversion Sprains

2001 ◽  
Vol 81 (4) ◽  
pp. 984-994 ◽  
Author(s):  
Toni Green ◽  
Kathryn Refshauge ◽  
Jack Crosbie ◽  
Roger Adams
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Step Length ◽  
Control Group ◽  
Joint Mobilization ◽  
Randomized Controlled ◽  
Ankle Inversion ◽  
Before And After ◽  
Experimental Group ◽  
Support Time

Abstract Background and Purpose. Passive joint mobilization is commonly used by physical therapists as an intervention for acute ankle inversion sprains. A randomized controlled trial with blinded assessors was conducted to investigate the effect of a specific joint mobilization, the anteroposterior glide on the talus, on increasing pain-free dorsiflexion and 3 gait variables: stride speed (gait speed), step length, and single support time. Subjects. Forty-one subjects with acute ankle inversion sprains (&lt;72 hours) and no other injury to the lower limb entered the trial. Methods. Subjects were randomly assigned to 1 of 2 treatment groups. The control group received a protocol of rest, ice, compression, and elevation (RICE). The experimental group received the anteroposterior mobilization, using a force that avoided incurring any increase in pain, in addition to the RICE protocol. Subjects in both groups were treated every second day for a maximum of 2 weeks or until the discharge criteria were met, and all subjects were given a home program of continued RICE application. Outcomes were measured before and after each treatment. Results. The results showed that the experimental group required fewer treatment sessions than the control group to achieve full pain-free dorsiflexion. The experimental group had greater improvement in range of movement before and after each of the first 3 treatment sessions. The experimental group also had greater increases in stride speed during the first and third treatment sessions. Discussion and Conclusion. Addition of a talocrural mobilization to the RICE protocol in the management of ankle inversion injuries necessitated fewer treatments to achieve pain-free dorsiflexion and to improve stride speed more than RICE alone. Improvement in step length symmetry and single support time was similar in both groups.

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.

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