A randomised controlled study of mindfulness meditation versus relaxation therapy in the management of tinnitus

AbstractObjective:Psychotherapeutic interventions have been adopted effectively in the management of tinnitus for a long time. This study compared mindfulness meditation and relaxation therapy for management of tinnitus.Methods:In this randomised controlled trial, patients were recruited for five sessions of mindfulness meditation or five sessions of relaxation therapy. Patients’ responses were evaluated using the Tinnitus Reaction Questionnaire as a primary outcome measure, and the Hospital Anxiety and Depression Scale, visual analogue scale and a health status indicator as secondary outcome measures.Results:A total of 86 patients were recruited. Thirty-four patients completed mindfulness meditation and 27 patients completed relaxation therapy. Statistically significant improvement was seen in all outcome measures except the health status indicator in both treatment groups. The change in treatment scores was greater in the mindfulness meditation group than in the relaxation therapy group.Conclusion:This study suggests that although both mindfulness meditation and relaxation therapy are effective in the management of tinnitus, mindfulness meditation is superior to relaxation therapy.

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Metformin and N-acetyl Cysteine in Polycystic Ovarian Syndrome–-A Comparative Study

Indian Journal of Clinical Medicine ◽

10.1177/117739361000100002 ◽

2010 ◽

Vol 1 ◽

pp. 117739361000100 ◽

Cited By ~ 5

Author(s):

Kar Gayatri ◽

Jena Saubhagya Kumar ◽

Behera Basanta Kumar

Keyword(s):

Outcome Measures ◽

Clinical Features ◽

Polycystic Ovarian Syndrome ◽

Secondary Outcome ◽

Controlled Study ◽

Chi Square ◽

Hormonal Profile ◽

Acetyl Cysteine ◽

Randomised Controlled ◽

Ovarian Syndrome

Objective To compare the effects of Metformin with N-acetyl cysteine in polycystic ovarian syndrome (PCOS). Methods A prospective, randomised controlled study was conducted in the Department of Obstetrics and Gynaecology in a Medical College and General Hospital. Total 115 cases of polycystic ovarian syndrome presenting with different complaints were selected for the study. Fifty nine cases were treated with Metformin (Group-M) and other 56 with N-acetyl cysteine (Group-N). Primary outcome measures are improvement in clinical features and biochemical profile, where as secondary outcome measures are improvement in hormonal profile and ultrasonographic findings. Statistical analysis was done by Z test and Chi square test. Results From each group, 50 patients were ultimately evaluated. There was significant improvement in some of the clinical features like weight gain, acne and hirsutism in group-N ( P < 0.05), but there was no significant change in other features like oligomenorrhea, amenorrhoea and infertility. The biochemical markers of insulin resistance like fasting insulin, fasting glucose/insulin ratio and HOMA-IR were significantly reduced in group-N. Hormone levels like serum LH, FSH, TT and LH/FSH ratio was significantly decreased in group-N, but FT, FT/TT ratio and SHBG were similar in both the groups. Ultrasonographic findings were similar in both the groups. Conclusion N-acetyl Cysteine had better improvement in clinical, biochemical and hormonal profile than Metformin in PCOS patients. It can be used as a substitute for insulin reducing medications in treatment of PCOS patients, considering its limited adverse effects.

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Caregiver burden versus intensity of anxiety and depression symptoms in parents of children with cerebral palsy as well as factors potentially differentiating the level of burden: a cross-sectional study (Poland)

BMJ Open ◽

10.1136/bmjopen-2019-036494 ◽

2021 ◽

Vol 11 (6) ◽

pp. e036494

Author(s):

Barbara Gugała

Keyword(s):

Cerebral Palsy ◽

Health Status ◽

Caregiver Burden ◽

Depression Scale ◽

Secondary Outcome ◽

Anxiety And Depression ◽

Depression Symptoms ◽

Emotional Involvement ◽

Children With Cerebral Palsy ◽

General Strain

ObjectivesTo assess the relationship between caregiver burden and severity of symptoms of anxiety/depression in parents of children with cerebral palsy (CP), and to identify factors differentiating the level of caregiver burden.SettingRegional rehabilitation centres in South-Eastern Poland.ParticipantsThe study involved 190 parents of children with CP, that is, 138 women and 52 men.Primary and secondary outcome measuresCaregiver burden was assessed using Caregiver Burden Scale (CBS), while the intensity of anxiety and depression symptoms was measured using Hospital Anxiety and Depression Scale (HADS). Potential predictors were examined using Gross Motor Function Classification System for Cerebral Palsy (GMFCS), Barthel Index (BI) as well as a questionnaire focusing on the characteristics of the child, the parent and the family. The analyses applied Pearson’s linear correlation coefficient as well as multiple regression analysis.ResultsAll the CBS measures are significantly correlated to HADS-A (anxiety) and HADS-D (depression). Intensity of anxiety is most visibly linked to CBS measures of disappointment and environment (p<0.0001), while severity of depression is related to emotional involvement and general strain (p<0.0001). The factors differentiating caregiver burden measure in the subscales of general strain (p<0.0001) and social isolation (p<0.0001) include the child’s age and BI, and the parent’s health status; in the subscale of disappointment (p<0.0001)—the child’s age, BI, GMFCS, as well as the parent’s age and health status; in the subscale of emotional involvement (p=0.0007)—BI, and the parent’s health status; in the subscale of environment (p=0.0002)—the child’s age and BI.ConclusionsThere is a positive linear relationship between the caregiver burden measures and severity of anxiety and depression. Effort should be made to relieve caregiver burden in parents of children with CP.

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Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-042627 ◽

2021 ◽

Vol 11 (3) ◽

pp. e042627

Author(s):

María Reina-Bueno ◽

María del Carmen Vázquez-Bautista ◽

Inmaculada C Palomo-Toucedo ◽

Gabriel Domínguez-Maldonado ◽

José Manuel Castillo-López ◽

...

Keyword(s):

Quality Of Life ◽

Randomised Controlled Trial ◽

Outcome Measures ◽

Controlled Trial ◽

Secondary Outcome ◽

Foot Orthoses ◽

Systemic Lupus ◽

Custom Made ◽

Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

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Effect of pelvic laparoscopic implantation of neuroprosthesis in spinal cord injured subjects: a 1-year prospective randomized controlled study

Spinal Cord ◽

10.1038/s41393-021-00693-7 ◽

2021 ◽

Author(s):

Helge Kasch ◽

Uffe Schou Løve ◽

Anette Bach Jønsson ◽

Kaare Eg Severinsen ◽

Marc Possover ◽

...

Keyword(s):

Spinal Cord ◽

Spinal Cord Injury ◽

Outcome Measures ◽

Outcome Measure ◽

Secondary Outcome ◽

Controlled Study ◽

Control Group ◽

Walking Ability ◽

Data Set ◽

Cord Injury

Abstract Study design 1-year prospective RCT. Objective Examine the effect of implantable pulse generator and low-frequency stimulation of the pelvic nerves using laparoscopic implantation of neuroprosthesis (LION) compared with neuromuscular electrical stimulation (NMES) in SCI. Methods Inclusion criteria: traumatic spinal cord injury (SCI), age 18–55 years, neurological level-of-injury Th4–L1, time-since-injury >1 year, and AIS-grades A–B. Participants were randomized to (A) LION procedure or (B) control group receiving NMES. Primary outcome measure: Walking Index for Spinal Cord Injury (WISCI-II), which is a SCI specific outcome measure assessing ability to ambulate. Secondary outcome measures: Spinal Cord Independence Measure III (SCIM III), Patient Global Impression of Change (PGIC), Penn Spasm Frequency Scale (PSFS), severity of spasticity measured by Numeric Rating Scale (NRS-11); International Spinal Cord Injury data sets-Quality of Life Basic Data Set (QoLBDS), and Brief Pain Inventory (BPI). Results Seventeen SCI individuals, AIS grade A, neurological level ranging from Th4–L1, were randomized to the study. One individual was excluded prior to intervention. Eight participants (7 males) with a mean age (SD) of 35.5 (12.4) years were allocated to the LION procedure, 8 participants (7 males) with age of 38.8 (15.1) years were allocated to NMES. Significantly, 5 LION group participants gained 1 point on the WISCI II scale, (p < 0.013; Fisher´s exact test). WISCI II scale score did not change in controls. No significant changes were observed in the secondary outcome measures. Conclusion The LION procedure is a promising new treatment for individuals with SCI with significant one-year improvement in walking ability.

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Randomised controlled study of two counselling models at the Swedish alcohol helpline: Effectiveness and sustainability outcomes at 12-month follow-up

Nordic Studies on Alcohol and Drugs ◽

10.1177/14550725211007823 ◽

2021 ◽

pp. 145507252110078

Author(s):

Thi-Thuy-Dung Nguyen ◽

Eleonor Säfsten ◽

Filip Andersson ◽

Maria Rosaria Galanti

Keyword(s):

Alcohol Use ◽

Usual Care ◽

Secondary Outcome ◽

Controlled Study ◽

Risk Level ◽

Care Group ◽

Structured Intervention ◽

Randomised Controlled ◽

Level Reduction

Aim: This two-arm parallel randomised controlled trial explored the effectiveness of a brief counselling model compared with the usual multi-session counselling at an alcohol telephone helpline. Methods: A total of 320 callers who contacted the Swedish Alcohol Helpline (SAH) because of hazardous or harmful alcohol use were randomised to either brief structured intervention (self-help booklet plus one proactive call) or usual care (multi-session telephone counselling). The primary outcome was a downward shift in risk level at 12-month follow-up compared with baseline, based on self-reports. Sustained risk level reduction throughout the whole follow-up was also assessed as secondary outcome. Results: Both interventions were significantly associated with a shift to a lower level of risky alcohol use (75% among participants in the brief structured intervention, and 70% in the usual care group) after 12 months. There was no difference between the two interventions in the proportions changing alcohol use or sustaining risk level reduction. Conclusion: In the context of telephone helplines, minimal and extended interventions appear to be equally effective in promoting long-term change in alcohol use.

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Comparison of efficacy and safety between electroacupuncture at ‘four sacral points’ and conventional electroacupuncture for the treatment of urinary incontinence after stroke: study protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-021783 ◽

2018 ◽

Vol 8 (11) ◽

pp. e021783 ◽

Cited By ~ 1

Author(s):

Shan Chen ◽

Siyou Wang ◽

Lihua Xuan ◽

Hanti Lu ◽

Zhikai Hu ◽

...

Keyword(s):

Urinary Incontinence ◽

Randomised Controlled Trial ◽

Medical Care ◽

Outcome Measures ◽

Pudendal Nerve ◽

Controlled Trial ◽

Secondary Outcome ◽

Efficacy And Safety ◽

Routine Medical Care ◽

Randomised Controlled

IntroductionElectroacupuncture at ‘four sacral points’, also known as electrical pudendal nerve stimulation therapy, combines the advantages of pudendal nerve neuromodulation and the technique of deep insertion of long acupuncture needles. It has been used to treat stress urinary incontinence, female urgency-frequency syndrome, idiopathic urgency urinary incontinence and neurological bladders in previous studies. Here, we describe the protocol for a randomised controlled trial for evaluation of the efficacy and safety of electroacupuncture at ‘four sacral points’ for the management of urinary incontinence after stroke.Methods and analysisThis is an open-label randomised controlled trial with blinded assessments and analyses. A total of 140 eligible patients will be randomly allocated to two groups. The treatment group (n=70) will receive electroacupuncture at ‘four sacral points’ along with routine medical care, while the control group will receive conventional electroacupuncture along with routine medical care. Twenty treatment sessions will occur over a period of 4 weeks. The primary outcome measures will be the self-recorded findings in an incontinent episode diary at baseline and at 4 weeks after baseline. The secondary outcome measures will be the International Consultation on Incontinence Questionnaire Urinary Incontinence—Short Form (ICIQ-UI SF) score and the Barthel Activities of Daily Living Index (Barthel ADL Index) score at baseline and at 4 and 28 weeks after baseline.Ethics and disseminationThis protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (approval No. 2018-K-059–01). Written informed consent will be obtained from each participant. The results of the study will be published in peer-reviewed journals.Trial registration numberChiCTR-IOR-17012847; Pre-result.

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Effects of golf training on cognition in older adults: a randomised controlled trial

Journal of Epidemiology & Community Health ◽

10.1136/jech-2017-210052 ◽

2018 ◽

Vol 72 (10) ◽

pp. 944-950 ◽

Cited By ~ 5

Author(s):

Hiroyuki Shimada ◽

Sangyoon Lee ◽

Masahiro Akishita ◽

Koichi Kozaki ◽

Katsuya Iijima ◽

...

Keyword(s):

Older Adults ◽

Randomised Controlled Trial ◽

Outcome Measures ◽

Controlled Trial ◽

Training Group ◽

Community Dwelling ◽

Secondary Outcome ◽

Control Group ◽

Logical Memory ◽

Randomised Controlled

BackgroundAlthough research indicates that a physically active lifestyle has the potential to prevent cognitive decline and dementia, the optimal type of physical activity/exercise remains unclear. The present study aimed to determine the cognitive benefits of a golf-training programme in community-dwelling older adults.MethodsWe conducted a randomised controlled trial between August 2016 and June 2017 at a general golf course. Participants included 106 Japanese adults aged 65 and older. Participants were randomly assigned to either a 24-week (90–120 min sessions/week) golf-training group or a health education control group. Postintervention changes in Mini-mental State Examination (MMSE) and National Centre for Geriatrics and Gerontology-Functional Assessment Tool scores were regarded as primary outcome measures. Secondary outcome measures included changes in physical performance and Geriatric Depression Scale (GDS) scores.ResultsA total of 100 participants (golf training, n=53; control, n=47) completed the assessments after the 24-week intervention period. The adherence to the golf programme was 96.2% (51/53 participants). Analysis using linear mixed models revealed that the golf training group exhibited significantly greater improvements in immediate logical memory (p=0.033), delayed logical memory (p=0.009) and composite logical memory (p=0.013) scores than the control group. However, no significant changes in MMSE, word memory, Trail Making Test or Symbol Digital Substitution Test scores were observed. In addition, no significant changes in grip strength, walking speed or GDS were observed.ConclusionsGolf-based exercise interventions may improve logical memory in older adults, but no significant changes in other cognitive tests. Further follow-up investigations are required to determine whether the observed effects are associated with delayed onset of mild cognitive impairment or Alzheimer’s disease in older adults.Trial registration numberUMIN-CTR UMIN000024797; Pre-results.

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Effects of exercise interventions on cardiovascular health in individuals with chronic, motor complete spinal cord injury: protocol for a randomised controlled trial [Cardiovascular Health/Outcomes: Improvements Created by Exercise and education in SCI (CHOICES) Study]

BMJ Open ◽

10.1136/bmjopen-2018-023540 ◽

2019 ◽

Vol 9 (1) ◽

pp. e023540 ◽

Cited By ~ 7

Author(s):

Andrei V Krassioukov ◽

Katharine D Currie ◽

Michèle Hubli ◽

Tom E Nightingale ◽

Abdullah A Alrashidi ◽

...

Keyword(s):

Physical Activity ◽

Spinal Cord ◽

Spinal Cord Injury ◽

Arterial Stiffness ◽

Outcome Measures ◽

Cardiovascular Health ◽

Secondary Outcome ◽

Exercise Interventions ◽

Cord Injury ◽

Randomised Controlled

IntroductionRecent studies demonstrate that cardiovascular diseases and associated complications are the leading cause of morbidity and mortality in individuals with spinal cord injury (SCI). Abnormal arterial stiffness, defined by a carotid–to-femoral pulse wave velocity (cfPWV) ≥10 m/s, is a recognised risk factor for heart disease in individuals with SCI. There is a paucity of studies assessing the efficacy of conventional training modalities on arterial stiffness and other cardiovascular outcomes in this population. Therefore, this study aims to compare the efficacy of arm cycle ergometry training (ACET) and body weight-supported treadmill training (BWSTT) on reducing arterial stiffness in individuals with chronic motor complete, high-level (above the sixth thoracic segment) SCI.Methods and analysisThis is a multicentre, randomised, controlled, clinical trial. Eligible participants will be randomly assigned (1:1) into either ACET or BWSTT groups. Sixty participants with chronic (>1 year) SCI will be recruited from three sites in Canada (Vancouver, Toronto and Hamilton). Participants in each group will exercise three times per week up to 30 min and 60 min for ACET and BWSTT, respectively, over the period of 6 months. The primary outcome measure will be change in arterial stiffness (cfPWV) from baseline. Secondary outcome measures will include comprehensive assessments of: (1) cardiovascular parameters, (2) autonomic function, (3) body composition, (4) blood haematological and metabolic profiles, (5) cardiorespiratory fitness and (6) quality of life (QOL) and physical activity outcomes. Outcome measures will be assessed at baseline, 3 months, 6 months and 12 months (only QOL and physical activity outcomes). Statistical analyses will apply linear-mixed modelling to determine the training (time), group (ACET vs BWSTT) and interaction (time × group) effects on all outcomes.Ethics and disseminationEthical approval was obtained from all three participating sites. Primary and secondary outcome data will be submitted for publication in peer-reviewed journals and widely disseminated.Trial registration numberNCT01718977; Pre-results.Trial statusRecruitment for this study began on January 2013 and the first participant was randomized on April 2013. Recruitment stopped on October 2018.

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A feasibility randomised controlled trial of short-term fasting prior to CAPOX chemotherapy for stage 2/3 colorectal cancer: SWiFT protocol

Pilot and Feasibility Studies ◽

10.1186/s40814-019-0505-7 ◽

2019 ◽

Vol 5 (1) ◽

Cited By ~ 1

Author(s):

Ellie Shingler ◽

Claire Perks ◽

Georgia Herbert ◽

Andy Ness ◽

Charlotte Atkinson

Keyword(s):

Colorectal Cancer ◽

Randomised Controlled Trial ◽

Outcome Measures ◽

Controlled Trial ◽

Trial Registration ◽

Secondary Outcome ◽

Dietary Advice ◽

Short Term ◽

Feasibility Randomised Controlled Trial ◽

Randomised Controlled

Abstract Background Capecitabine and oxaliplatin (CAPOX) chemotherapy is a standard treatment for stage 2/3 colorectal cancer. Treatment is associated with dose-limiting toxicities such as neutropenia, vomiting, diarrhoea, and stomatitis. Short-term fasting prior to chemotherapy may help protect normal cells from the toxic effects of chemotherapy by allowing them to conserve energy for maintenance and repair. However, there is a lack of evidence to support the efficacy of short-term fasting in protecting against chemotherapy-related toxicities in humans, and it is not known whether people due to undergo chemotherapy will be willing and able to follow a short-term fast. Preliminary data confirming this is feasible are required before adequately powered trials can be designed and conducted. Methods The short-term, water only, fasting trial (SWiFT) is a two-armed feasibility randomised controlled trial, aiming to recruit 30 people scheduled to begin routine treatment with CAPOX chemotherapy for stage 2/3 colorectal cancer. Participants will be randomly allocated, in a 1:1 ratio, to either a 36-h fast or standard dietary advice prior to chemotherapy administration for the first 3 cycles of chemotherapy. The primary outcome measures will assess the feasibility of the trial and include: adherence to intervention, recruitment, retention, and data completion rates as well as the acceptability of the intervention which will be qualitatively assessed. The secondary outcome measures aim to provide further information on possible outcomes of interest for a definitive trial and include side effects of chemotherapy, quality of life, markers of cellular metabolism and inflammation, appetite, and sarcopenia. Discussion It is not known whether it is possible to recruit to a trial of short-term fasting in this population, or whether participants would be able to adhere to the intervention. Therefore, we aim to test the feasibility of a pre-chemotherapy, 36-h, water-only fast in people receiving CAPOX chemotherapy for stage 2/3 colorectal cancer. Trial registration This trial has been registered with the ISRCTN Registry. Trial registration no: ISRCTN17994717. Date of registration: 23 October 2018. URL: http://www.isrctn.com/ISRCTN17994717

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Effect of a real-time feedback smartphone application (TCPRLink) on the quality of telephone-assisted CPR performed by trained laypeople in China: a manikin-based randomised controlled study

BMJ Open ◽

10.1136/bmjopen-2020-038813 ◽

2020 ◽

Vol 10 (10) ◽

pp. e038813

Author(s):

Xuejie Dong ◽

Lin Zhang ◽

Helge Myklebust ◽

Tonje Soraas Birkenes ◽

Zhi-Jie Zheng

Keyword(s):

Real Time ◽

Real Life ◽

Smartphone Application ◽

Secondary Outcome ◽

Controlled Study ◽

Feedback Group ◽

Randomised Controlled Study ◽

Release Ratio ◽

Randomised Controlled ◽

Off Time

ObjectivesTo determine the effect of a free smartphone application (TCPRLink) that provides real-time monitoring and audiovisual feedback on chest compressions (CC) on trained layperson telephone-assisted cardiopulmonary resuscitation (T-CPR) performance.DesignA manikin-based randomised controlled study.SettingThis study was conducted at a multidisciplinary university and a community centre in China.ParticipantsOne hundred and eighty-six adult participants (age 18–65 years) with T-CPR training experience were randomly assigned to the TCPRLink (n=94) and T-CPR (n=92) groups with age stratification.InterventionsWe compared the participants’ performance for 6 min of CC in a simulated T-CPR scenario both at the baseline and after 3 months.Primary and secondary outcome measuresThe primary outcomes were the CC rate and proportion of adequate CC rate (100–120 min−1). The secondary outcomes included the proportion of participants counting the CC rhythm, time to first CC, CC depth, hands-off time and CC full-release ratio.ResultsParticipants in the TCPRLink feedback group more consistently performed CC with higher rate, both initially and 3 months later (median 111 (IQR 109–113) vs 108 (103–112) min−1, p=0.002 and 111 (109–113) vs 108 (105–112) min−1, p<0.001, respectively), with less need to count the rhythm (21.3% vs 41.3%, p=0.003% and 7% vs 22.6%, p=0.004, respectively) compared with the T-CPR group. There were no significant differences in time to the first CC, hands-off time or CC full-release ratio. Among 55–65 year group, the CC depth was deeper in the TCPRLink group than in the TCPR group (47.1±9.6 vs 38.5±8.7 mm, p=0.001 and 44.7±10.1 vs 39.3±10.8 mm, p=0.07, respectively).ConclusionsThe TCPRLink application improved T-CPR quality in trained laypersons to provide more effective CCs and lighten the load of counting out the CC with the dispatcher in a simulated T-CPR scenario. Further investigations are required to confirm this effectiveness in real-life resuscitation attempts.

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