The effectiveness of a non-guided mindfulness application on perceived stress in a non-clinical Dutch population: a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Leonieke W Kranenburg ◽  
Jamie Gillis ◽  
Birgit Mayer ◽  
Witte JG Hoogendijk
Keyword(s):  
Randomized Controlled Trial ◽  
Perceived Stress ◽  
Psychological Symptoms ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Dutch Population ◽  
Randomized Controlled ◽  
Experimental Group

BACKGROUND Mindfulness has become increasingly popular and positive outcomes have been reported for mindfulness-based interventions (MBIs) to reduce stress. These findings make room for innovative perspectives on how MBIs could be applied, for instance through mHealth. OBJECTIVE The aim of this study is to investigate if a non-guided mindfulness mobile phone application can decrease perceived stress in a non-clinical Dutch population over the course of eight weeks, with follow-up at six months. METHODS A randomized controlled trial (RCT) was performed, comparing the experimental group that made use of a structured 8-week mHealth mindfulness program and a control group after 8 weeks, with follow-up after six months. Participants were recruited via a national television program. The primary outcome measure was perceived stress as measured by the Perceived Stress scale (PSS), secondary outcomes were symptoms of burnout (VAS) and psychological symptoms (measured by the four-dimensional symptom questionnaire ; 4DSQ at follow-up). Outcomes were analyzed using a multilevel regression model. RESULTS At baseline, 587 respondents were included. Results showed no differences between groups for the level of perceived stress. With regard to the secondary outcome measures, the VAS for emotional exhaustion and physical exhaustion showed statistically significant lower scores for the experimental group after 8 weeks (resp. p=.04 and p= .01), but not at follow-up. There were also no differences between groups found for psychological symptoms. CONCLUSIONS These findings do not support our hypothesis that using the mindfulness app would reduce stress levels. However, findings with regard to diminished exhaustion at 8 weeks are encouraging and require further investigation.

scholarly journals Effects of Virtual Reality Associated With Serious Games for Upper Limb Rehabilitation in Patients With Multiple Sclerosis. a Randomized Controlled Trial

2020 ◽  
Author(s):  
Alicia Cuesta-Gómez ◽  
Patricia Sanchez-Herrera Baeza ◽  
Edwin Daniel Oña-Simbaña ◽  
Alicia Martínez-Medina ◽  
Carmen Ortiz-Comino ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Serious Games ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance. Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment. Results : In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.

scholarly journals Effects of virtual reality associated with serious games for upper limb rehabilitation in patients with multiple sclerosis. A randomized controlled trial

2020 ◽  
Author(s):  
Alicia Cuesta-Gómez ◽  
Patricia Sanchez-Herrera Baeza ◽  
Edwin Daniel Oña-Simbaña ◽  
Alicia Martínez-Medina ◽  
Carmen Ortiz-Comino ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Serious Games ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance.Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment.Results: In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance. Trial registration: This randomized controlled trial has been registered at ClinicalTrials.gov Identifier: NCT04171908, Nov 2019.

scholarly journals Effects of Virtual Reality Associated With Serious Games for Upper Limb Rehabilitation in Patients With Multiple Sclerosis. a Randomized Controlled Trial

2020 ◽  
Author(s):  
Alicia Cuesta-Gómez ◽  
Patricia Sanchez-Herrera Baeza ◽  
Edwin Daniel Oña-Simbaña ◽  
Alicia Martínez-Medina ◽  
Carmen Ortiz-Comino ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Serious Games ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance. Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment. Results : In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.

scholarly journals Effect of Customized Insoles on Gait in Post-Stroke Hemiparetic Individuals: A Randomized Controlled Trial

Biology ◽  
2021 ◽  
Vol 10 (11) ◽  
pp. 1187
Author(s):  
Jie Wang ◽  
Lei Qiao ◽  
Long Yu ◽  
Yanmin Wang ◽  
Redha Taiar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stance Phase ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Gait Training ◽  
Secondary Outcome ◽  
Control Group ◽  
Stroke Patients ◽  
Randomized Controlled ◽  
Experimental Group

Background: Insoles have been widely applied to many diseases, but stroke involves complex problems and there is a paucity of research on the application of insoles in stroke patients. Aim: To evaluate the effect of customized insoles on gait in patients with hemiplegia. Design: A randomized controlled trial. Setting: Rehabilitation department of a hospital. Population: A total of 50 stroke patients were randomized into an experimental group (n = 25) or a control group (n = 25). Methods: Both groups received conventional gait training, which was conducted five times a week, every 40 min for four weeks and patients in the experimental group were required to wear customized insoles for at least 1 h per day for four weeks. The primary outcome measure was the Tinetti Gait Scale (TGS) and the secondary outcome measures were the plantar pressure test, 6-min walking test (6MWT), lower extremity Fugl–Meyer assessment (FMA-LE), Berg Balance Scale (BBS), and the modified Barthel index (MBI). Results: Compared to the control group, there were significant increases in the experimental group after four weeks (p = 0.014) and at the four week follow-up (p = 0.001) in the change in TGS, weight-bearing on the involved side (p = 0.012) or forefoot (p = 0.028) when standing, weight-bearing on the involved side (p = 0.01 6) or forefoot (p = 0.043) when walking, early stance phase (p = 0.023) and mid stance phase (p = 0.013) on the involved side, FMA-LE (p = 0.029), BBS (p = 0.005), and MBI (p = 0.009), but there were no differences in the late stance phase (p = 0.472) on the involved side when walking or in the 6MWT (p = 0.069). Conclusions: Customized insoles had great efficacy in enhancing gait performance in stroke patients.

scholarly journals Acupuncture for osteoporosis: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
M Huang ◽  
MX Lai ◽  
XY Wang ◽  
YF Wang ◽  
J Yang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Primary Osteoporosis ◽  
Randomized Controlled ◽  
Acupuncture And Moxibustion ◽  
One Year ◽  
Experimental Group

Abstract Background: The rapid increase in the prevalence of osteoporosis and the rate of fractures after osteoporosis indicates that osteoporosis has become a serious global public health problem. A recent meta-analysis showed that oral alendronate and parenteral injection of zoledronate had no statistical significance in preventing postmenopausal hip fractures. Acupuncture and moxibustion are widely used in the treatment of osteoporosis due to their good analgesic effects. Early observation showed that integral adjustment of acupuncture and moxibustion therapy could improve the quality of life of patients with osteoporosis and prevent the occurrence of osteoporosis fractures. As the observation period of fracture is too long, it is necessary to carry out a large and strictly designed multi-center randomized trial covering the risk factors of fracture and fracture induction, so as to evaluate the effectiveness of acupuncture and moxibustion in the treatment of primary osteoporosis.Methods/Design: A multicenter randomized controlled trial will be performed in three hospitals. 312 participants patients within primary osteoporosis will be divided into an experimental group and a control group randomly. The experimental group is treated with acupuncture and western medicine while the control group is treated with Western medicine. All the patients will receive a 3-month treatment and 6-month,and one year follow-ups. The primary outcome is the bone mineral density (BMD), the secondary outcome is Bone-derived alkaline phosphatase(BALP), bone glaprotein(BGP), visual pain scale score(VAS),Traditional Chinese Medicine (TCM) syndrome scores, quality of daily life score(QOL) and adverse events. Outcome measures (including primary and secondary outcome measures) are collected at baseline,3 months of the intervention, Causes and number of falls are collected at 6 months and one year after the intervention.Discussion: This study will provide clinical evidence for the treatment of primary osteoporosis with holistic adjustment acupuncture. This study will evaluate the synergistic effect of acupuncture treatment for primary osteoporosis and provide evidence for clinical treatment.Trial registration: This trial was registed at Chinese Clinical Trial Registry, registration date: 5 August 2018.URL:http://www.chictr.org.cn,registration number:ChiCTR1800017581.

scholarly journals Effects Of Virtual Reality Associated With Serious Games For Upper Limb Rehabilitation In Patients With Multiple Sclerosis: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Alicia Cuesta-Gómez ◽  
Patricia Sanchez-Herrera Baeza ◽  
Edwin Daniel Oña-Simbaña ◽  
Alicia Martínez-Medina ◽  
Carmen Ortiz-Comino ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Serious Games ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance.Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment.Results: In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.

scholarly journals Efficacy and safety of the extracorporeal shock wave therapy in patients with postherpetic neuralgia: study protocol of a randomized controlled trial

2020 ◽  
Author(s):  
Lu Chen ◽  
Ruihao Zhou ◽  
Fuguo Sun ◽  
Yan Weng ◽  
Ling Ye ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Postherpetic Neuralgia ◽  
Controlled Trial ◽  
Interventional Therapy ◽  
Secondary Outcome ◽  
Control Group ◽  
Medication Therapy ◽  
Randomized Controlled ◽  
Self Rating ◽  
Experimental Group

Abstract Background: Postherpetic neuralgia (PHN) is one of the most common chronic neuropathic pain, which seriously affected the quality of the life due to the severity of pain and the poor response to the current treatment. The main management strategies of PHN include medication therapy and invasive interventional therapy. However, there are lots of side effects. It is meaningful to find another effective and safe treatment for PHN. Methods: A single-center, randomized, single-blind clinical trial will be held. A total of 98 participants will be randomly divided into control group and experimental group in a 1:1 ratio. Patients in control group will receive conventional treatment including medication therapy and invasive interventional therapy. The experimental group will be treated with extracorporeal shockwave therapy (ESWT) in addition to conventional therapy. The primary outcome is visual analogue scale (VAS), secondary outcome contains 36-item short-form health survey (SF-36), self-rating anxiety Scale (SAS), self-rating depression scale (SDS) and Pittsburgh sleep quality index (PSQI). Assessors who are blinded to the randomization will collect data during the intervention period at baseline, 1 weeks, 4 weeks, and 12 weeks in this study. The plasma levels of TNF-α、IL-6 in patients will be detected before and after ESWT to explore part of the biochemical mechanism of ESWT for the treatment of PHN. Discussion: This randomized controlled trial will be held to evaluate the actual effectiveness and safety of ESWT in patients with PHN, and thus provide clinical evidences for its application in the PHN management and explore the potential mechanism of this treatment. Trial registration: www.ChiCTR.org.cn, identifier: ChiCTR1900025828. Registered on 10th September 2019.

scholarly journals Chinese Massage Combined with Herbal Ointment for Athletes with Nonspecific Low Back Pain: A Randomized Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Ling Jun Kong ◽  
Min Fang ◽  
Hong Sheng Zhan ◽  
Wei An Yuan ◽  
Ji Ming Tao ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Controlled Trial ◽  
Muscle Stiffness ◽  
Secondary Outcome ◽  
Control Group ◽  
Low Back ◽  
Randomized Controlled ◽  
Experimental Group

Non-specific low back pain (NLBP) is an increasing health problem for athletes. This randomized controlled trial was designed to investigate the effects of Chinese massage combined with herbal ointment for NLBP. 110 athletes with NLBP were randomly assigned to experimental group with Chinese massage combined with herbal ointment or control group with simple massage therapy. The primary outcome was pain by Chinese Short Form McGill Pain Questionnaire (C-SFMPQ). The secondary outcome was local muscle stiffness by Myotonometer. After 4 weeks, the experimental group experienced significant improvements in C-SFMPQ and in local muscle stiffness compared with control group (between-group difference in mean change from baseline, −1.24 points,P=0.005in sensory scores; −3.14 points,P<0.001in affective scores; −4.39 points,P<0.001in total scores; −0.64 points,P=0.002in VAS; −1.04 points,P=0.005in local muscle stiffness during relaxation state). The difference remained at one month followup, but it was only significant in affective scores (−2.83 points,P<0.001) at three months followup. No adverse events were observed. These findings suggest that Chinese massage combined with herbal ointment may be a beneficial complementary and alternative therapy for athletes with NLBP.

A Randomized Controlled Trial of the Prevent Alcohol and Risk-Related Trauma in Youth Program in Reducing Alcohol-Related Harms in Young Naval Trainees

2021 ◽  
Author(s):  
Jason R Watterson ◽  
Belinda Gabbe ◽  
Paul Dietze ◽  
Jeffrey V Rosenfeld
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Risky Drinking ◽  
Awareness Training ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Audit Score

ABSTRACT Background The aim of this study was to test whether participation in an alcohol risk reduction program known as Prevent Alcohol and Risk-Related Trauma in Youth (P.A.R.T.Y.) is effective in reducing the prevalence of risky drinking at 12 months’ post-intervention in a sample of Royal Australian Navy (RAN) trainees. Methods A non-blinded randomized controlled trial of 952 RAN trainees comparing two forms of P.A.R.T.Y. plus RAN annual alcohol and other drug awareness training with annual alcohol and other drugs awareness training only (Control). Participants were screened at baseline and at 12-month follow-up using the Alcohol Use Disorders Identification Test (AUDIT). Participants were randomized to one of three arms: (1) in-hospital P.A.R.T.Y program, (2) on-base P.A.R.T.Y. program, or (3) control. The primary outcome measure was the percentage of participants reporting an AUDIT score of 8 or above at 12 months in each group. A secondary outcome considered was reports of alcohol-related incidents in the 12-month follow-up. Results There was no difference in the risk of reporting an AUDIT score of 8 or above in either the in-hospital (Relative Risk (RR) 0.96, 95% CI: 0.75-1.23; P = .75) or on-base (RR 1.11, 95% CI: 0.89-1.369; P = 0.35) intervention groups, compared to the control group. Compared to the on-base group, there was no difference in the risk of reporting an AUDIT score of 8 or above in the in-hospital group (RR 1.16, 95% CI: 0.90-1.48; P = .24). The rate of reporting an alcohol-related incident was not different for the in-hospital (Hazard Ratio (HR) 0.60, 95% CI: 0.27-1.33; P = .21) or on-base (HR 0.50, 95% CI: 0.21-1.16; P = .11) intervention groups when compared to the control group. Conclusion Participation in either an on-base or an in-hospital P.A.R.T.Y. program did not affect the proportion of naval trainee participants screening positive for risky drinking on the AUDIT.

scholarly journals Effect of Customized Insoles on Gait in Post-stroke Hemiparetic Individuals: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Jie Wang ◽  
Lei Qiao ◽  
Long Yu ◽  
Yanmin Wang ◽  
Ying Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stance Phase ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Adjunctive Treatment ◽  
Secondary Outcome ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background: Insoles were considered to be a beneficial adjunctive treatment option for gait rehabilitation, which could provide a proper basic support for walking. The purpose of this study was to evaluate the effect of customized insoles (Jiangsu Suyun Medical Equipment Co. Ltd, Jiangsu, China) on the gait of patients with hemiplegia.Methods: This randomized controlled trial was set in the rehabilitation department of a hospital. A total of 50 stroke patients were randomized into an experimental group (n=25) or a control group (n=25). Both groups received 40-min conventional gait training, which was conducted 5 times a week, for 4 weeks and patients in the experimental group were required to wear customized insoles for at least 1 h per day for 4 weeks. The primary outcome measure was Tinetti Gait Scale (TGS), which was assessed three times(baseline[T0], 4 weeks from baseline[T1] and 4 weeks after completion of the intervention[T2]), and the secondary outcome measures were the plantar pressure test, 6-min walking test (6MWT), Lower Extremity Fugl-Meyer assessment (FMA-LE), Berg Balance Scale (BBS) and Barthel Index (BI), which was assessed twice(baseline[T0] and 4 weeks from baseline[T1]).Results: Compared to the control group, there were significant increases in the experimental group after 4 weeks(P = 0.014) and 4 weeks follow-up(P = 0.001) in the change of TGS, weight-bearing on the involved side (P = 0.012) or forefoot (P =0.028) when standing, weight-bearing on the involved side (P = 0.016) or forefoot (P = 0.043) when walking, early stance phase (P = 0.023) and mid stance phase (P = 0.013) on the involved side, FMA-LE (P = 0.029), BBS (P = 0.005) and BI (P = 0.009), but no difference in late stance phase (P = 0.472) on the involved side when walking and in the 6MWT (P = 0.069).Conclusions: Customized insoles had great efficacy in enhancing gait performance.Clinical Trial Registration: ChiCTR1900024843.Registered 30 July 2019，http://www.chictr.org.cn/edit.aspx?pid=41003&htm=4.

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