scholarly journals The effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trial

2021 ◽  
Vol 29 (1) ◽  
Author(s):  
Lise Vilstrup Holm ◽  
Dorte Ejg Jarbøl ◽  
Henrik Wulff Christensen ◽  
Jens Søndergaard ◽  
Lise Hestbæk
Keyword(s):  
Treatment Group ◽  
Controlled Trial ◽  
Intervention Group ◽  
Chiropractic Care ◽  
Mean Difference ◽  
Control Group ◽  
Infantile Colic ◽  
Excessive Crying ◽  
Secondary Outcomes ◽  
Single Blind

Abstract Background Chiropractic care is commonly used to treat infantile colic. However large trials with parental blinding are missing. Therefore, the purpose of this study is to evaluate the effect of chiropractic care on infantile colic. Method This is a multicenter, single-blind randomized controlled trial conducted in four Danish chiropractic clinics, 2015–2019. Information was distributed in the maternity wards and by maternal and child health nurses. Children aged 2–14 weeks with unexplained excessive crying were recruited through home visits and randomized (1:1) to either chiropractic care or control group. Both groups attended the chiropractic clinic twice a week for 2 weeks. The intervention group received chiropractic care, while the control group was not treated. The parents were not present in the treatment room and unaware of their child’s allocation. The primary outcome was change in daily hours of crying before and after treatment. Secondary outcomes were changes in hours of sleep, hours being awake and content, gastrointestinal symptoms, colic status and satisfaction. All outcomes were based on parental diaries and a final questionnaire. Results Of 200 recruited children, 185 completed the trial (treatment group n = 96; control group n = 89). Duration of crying in the treatment group was reduced by 1.5 h compared with 1 h in the control group (mean difference − 0.6, 95% CI − 1.1 to − 0.1; P = 0.026), but when adjusted for baseline hours of crying, age and chiropractic clinic, the difference was not significant (P = 0.066). The proportion obtaining a clinically important reduction of 1 h of crying was 63% in the treatment group and 47% in the control group (p = 0.037), and NNT was 6.5. We found no effect on any of the secondary outcomes. Conclusion Excessive crying was reduced by half an hour in favor of the group receiving chiropractic care compared with the control group, but not at a statistically significant level after adjustments. From a clinical perspective, the mean difference between the groups was small, but there were large individual differences, which emphasizes the need to investigate if subgroups of children, e.g. those with musculoskeletal problems, benefit more than others from chiropractic care. Trial registration Clinical Trials NCT02595515, registered 2 November 2015

scholarly journals Hybrid Tele and In-Clinic Occupation Based Intervention to Improve Women’s Daily Participation after Breast Cancer: A Pilot Randomized Controlled Trial

2021 ◽  
Vol 18 (11) ◽  
pp. 5966
Author(s):  
Khawla Loubani ◽  
Rachel Kizony ◽  
Uzi Milman ◽  
Naomi Schreuer
Keyword(s):  
Breast Cancer ◽  
Cognitive Abilities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Performance Measure ◽  
Control Group ◽  
Activity Levels ◽  
Emotional Symptoms ◽  
Short Period ◽  
Secondary Outcomes

Background: Women after breast cancer (BC) cope with decreased daily participation and quality of life (QOL) due to physical, cognitive, and emotional symptoms. This study examined a hybrid occupation-based intervention, Managing Participation with Breast Cancer (MaP-BC), to improve daily participation in their meaningful activities. Methods: Thirty-five women after BC phase were randomly allocated to the MaP-BC intervention (n = 18) or control (n = 17) group (standard care only). Assessments were administered at baseline (T1), 6-week (T2), and 12-week (T3) post-T1. Main outcome: perceived performance and performance-satisfaction with meaningful activities according to the Canadian Occupational Performance Measure. Secondary outcomes: retained activity levels (Activity Card Sort), QOL (Functional Assessment of Cancer Therapy-Breast), cognitive abilities (Montreal Cognitive Assessment and Behavior Rating Inventory of Executive Function), and upper-extremity functioning (Disability of Arm, Shoulder, Hand). Results showed significant interaction (group x time) effects for the primary outcome in performance, F(2,66) = 29.54, p = 0.001, ɳP2 = 0.472, and satisfaction, F(2,66) = 37.15, p = 0.000, ɳP2 = 0.530. The intervention group improved more in performance, t = 5.51, p = 0.0001, d = 1.298, and satisfaction, t = −5.32, p = 0.0001, d = 1.254, than the control group between T1 and T2. Secondary outcomes demonstrated within-group improvements. Conclusion: MaP-BC, a comprehensive occupation-based hybrid intervention tailored to women’s functional daily needs after BC, improved participation in meaningful activities within a short period.

scholarly journals Effect of Hope-oriented group counseling on mental health of infertile women with failed IVF cycles: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Roya Rahimi ◽  
Shirin Hasanpour ◽  
Mojgan. Mirghafourvand ◽  
Khalil Esmaeilpour
Keyword(s):  
Mental Health ◽  
Confidence Interval ◽  
Group Counseling ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mean Difference ◽  
Control Group ◽  
The Mean ◽  
And Control

Abstract Background Considering the prevalence of infertility in the community and the consequences of failure of infertility treatments on women’s mental health, interventions that can control stress, anxiety and depression in infertile women with a history of IVF failure will be very helpful. This study aimed to determine the effects of hope-oriented group counseling on mental health (primary outcome) and quality of life (QoL) (secondary outcome) of women with failed IVF cycles. Method This randomized controlled trial was conducted on 60 women with failed IVF cycles visiting Infertility Clinic at Al-Zahra Teaching Hospital of Tabriz- Iran. Participants were allocated to the intervention group (n = 30) and control group (n = 30) based on a randomized block design. Hope-oriented group counseling was provided to the intervention group in six 45–60 min sessions (once a week). The control group only received routine care to undergo another IVF cycle. The Depression Anxiety Stress Scale-21 (DASS-21) and the SF-12 Quality of Life Scale were filled out by interviewing the participants before the intervention and one week and one month after the intervention. After intervention 26 participants in each group were included in the analysis. Results There was no significant difference between the intervention and control groups in the socio-demographic profile of participants (P > 0.05). The post-intervention mean score of stress (adjusted mean difference = − 1.7, 95% confidence interval: − 3.2 to − 0.3, P = 0.018) and depression (adjusted mean difference = − 1.3, 95% confidence interval: − 4.7 to − 1.5, P < 0.001) was significantly lower in the intervention group compared to the control. Although the mean anxiety score was lower in the intervention group compared to the control, the difference between them was not statistically significant (adjusted mean difference = − 1.1, 95% confidence interval: − 2.6 to 0.4, P = 0.153). The mean score of QoL was significantly higher in the intervention group than that of the control group (adjusted mean difference = 6.9, 95% confidence interval: 5.1 to 8.8, P < 0.001). Conclusion Hope-oriented group counseling was effective in reducing stress and depression and improving QoL in women with failed IVF cycles. It is recommended to use this counseling approach, along with other methods, to improve the mental health of women with failed IVF cycles. Trial registration TCT Registration Number: TCTR 20191017003, registered on October 17, 2019.

Effects of a home-based physical training and activity promotion program in community-dwelling older persons with cognitive impairment after discharge from rehabilitation: A randomized controlled trial

2022 ◽  
Author(s):  
Phoebe Ullrich ◽  
Christian Werner ◽  
Anton Schönstein ◽  
Martin Bongartz ◽  
Tobias Eckert ◽  
...  
Keyword(s):  
Physical Training ◽  
Controlled Trial ◽  
Intervention Group ◽  
Physical Capacity ◽  
Control Group ◽  
Promotion Program ◽  
Home Based ◽  
Activity Promotion ◽  
Secondary Outcomes

Abstract Background Older people with cognitive impairment (CI) are at high risk for mobility limitations and adverse outcomes after discharge from geriatric rehabilitation settings. Study aim was to estimate the effects of a specifically designed home-based physical training and activity promotion program on physical capacity, different aspects of physical activity (PA), and psychosocial status. Methods Patients with mild-to-moderate CI (Mini-Mental State Examination [MMSE]: 17-26 points) discharged home after rehabilitation were included in this randomized, double-blind, placebo-controlled trial with a 12-week intervention and 12-week follow-up period. The intervention group performed a CI-specific, autonomous, home-based strength, balance and walking training supported by tailored motivational strategies to foster training adherence and promote PA. The control group participated in an unspecific motor placebo activity. Primary outcomes were physical capacity (Short Physical Performance Battery [SPPB]) and PA (sensor-based activity time). Results Among 118 randomized participants (82.3±6.0 years) with CI (MMSE: 23.3±2.4) and high levels of multi-morbidity, those participants undergoing home-based training demonstrated superior outcomes to the control group in SPPB (mean difference between groups 1.9 points; 95%-CI: 1.0-2.8; p&lt;.001), with persistent benefits over the follow-up (1.3 points; 95%-CI: 0.4-2.2; p&lt;.001). There were no differences in PA across any time points. Among secondary outcomes, fear of falling and activity avoidance behavior were reduced in the intervention group at all time points, life-space mobility improved short-term. Conclusions Study results demonstrate clinically important benefits of an individually tailored autonomous physical training and activity promotion program on physical capacity and secondary outcomes in different domains in a vulnerable, multi-morbid population.

Meridian Cuffing Exercises Improved Functional Fitness and Cardiopulmonary Functioning of Community Older Adults

2018 ◽  
Vol 29 (1) ◽  
pp. 37-47 ◽  
Author(s):  
Hsiao-Ting Tung ◽  
Chi-Chieh Lai ◽  
Kuei-Min Chen ◽  
Han-Ya Tsai
Keyword(s):  
Older Adults ◽  
Community Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Fitness ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Study Intervention ◽  
Single Blind

This study was aimed to test the effects of a meridian cuffing exercise, the Healthy Beat Acupunch (HBA) regimen, on the functional fitness and cardiopulmonary functioning of community older adults. A single-blind, cluster randomized controlled trial was conducted. We randomly allocated eight community care centers to the intervention or control group and recruited 228 participants who completed the study (intervention: four centers, n = 111; control: four centers, n = 117). The intervention group underwent a 40-min session of HBA regimen 3 times per week for 6 months. Functional fitness and cardiopulmonary functioning were assessed at baseline, 3 months, and 6 months of the intervention. The intervention group demonstrated significantly greater improvements in functional fitness and cardiopulmonary functioning than the control group between baseline and either 3 months or 6 months. We suggest that activities designed to promote health among community older adults include acupunch exercises.

scholarly journals Mindful gratitude journaling: psychological distress, quality of life and suffering in advanced cancer: a randomised controlled trial

2021 ◽  
pp. bmjspcare-2021-003068
Author(s):  
Ting Ting Tan ◽  
Maw Pin Tan ◽  
Chee Loong Lam ◽  
Ee Chin Loh ◽  
David Paul Capelle ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psychological Distress ◽  
Randomised Controlled Trial ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mean Difference ◽  
Control Group ◽  
Randomised Controlled

ContextNumerous studies have shown that gratitude can reduce stress and improve quality of life.ObjectiveOur study aimed to examine the effect of mindful gratitude journaling on suffering, psychological distress and quality of life of patients with advanced cancer.MethodsWe conducted a parallel-group, blinded, randomised controlled trial at the University of Malaya Medical Centre, Malaysia. Ninety-two adult patients with advanced cancer, and an overall suffering score ≥4/10 based on the Suffering Pictogram were recruited and randomly assigned to either a mindful gratitude journaling group (N=49) or a routine journaling group (N=43).ResultsAfter 1 week, there were significant reductions in the overall suffering score from the baseline in both the intervention group (mean difference in overall suffering score=−2.0, 95% CI=−2.7 to −1.4, t=−6.125, p=0.000) and the control group (mean difference in overall suffering score=−1.6, 95% CI=−2.3 to −0.8, t=−4.106, p=0.037). There were also significant improvements in the total Hospital Anxiety and Depression Scale score (mean difference=−3.4, 95% CI=−5.3 to −1.5, t=−3.525, p=0.000) and the total Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being score (mean difference=7.3, 95% CI=1.5 to 13.1, t=2.460, p=0.014) in the intervention group after 7 days, but not in the control group.ConclusionThe results provide evidence that 7 days of mindful gratitude journaling could positively affect the state of suffering, psychological distress and quality of life of patients with advanced cancer.Trial registration numberThe trial was registered with the Australian and New Zealand Clinical Trials Registry (ACTRN1261800172191) and conducted in accordance with the Declaration of Helsinki.

scholarly journals A randomized controlled trial of the effect of supervised progressive cross-continuum strength training and protein supplementation in older medical patients: the STAND-Cph trial

2019 ◽  
Author(s):  
Mette Merete Pedersen ◽  
Janne Petersen ◽  
Nina Beyer ◽  
Helle Gybel Juul-Larsen ◽  
Pia Søe Jensen ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Strength Training ◽  
Intervention Group ◽  
Lower Extremities ◽  
Protein Supplementation ◽  
Mean Difference ◽  
Control Group ◽  
Medical Patients ◽  
Daily Number ◽  
Secondary Outcomes

Abstract Background: During hospitalization, older adults (+65) are inactive, which puts them at risk of functional decline and loss of independence. Systematic strength training can prevent loss of functional performance and combining strength training with protein supplementation may enhance the response on muscle mass and strength . However, we lack knowledge about the effect of strength training commenced during hospitalization and continued after discharge in older medical patients. This assessor-blinded, randomized study investigated the effect of a simple, supervised strength training program for the lower extremities, combined with post-training protein supplementation during hospitalization and in the home setting for 4 weeks after discharge on change in mobility in older medical patients. Methods: Older medical patients (≥65 yrs) admitted acutely from their home to the Emergency Department were randomized to either standard care or supervised progressive strength training and an oral protein supplement during hospitalization and at home 3 days/week for 4 weeks after discharge. The primary outcome was between-group difference in change in mobility from baseline to 4 weeks after discharge assessed by the De Morton Mobility Index, which assesses bed mobility, chair mobility, static and dynamic balance, and walking. Secondary outcomes were 24-hour mobility, lower extremity strength, gait speed, grip strength and Activities of Daily Living. Results: Eighty-five patients were randomized to an intervention group (N=43) or a control group (N=42). In the intervention group, 43% were highly compliant with the intervention. Our intention to treat analysis revealed no between-group difference in mobility (mean difference in change from baseline to 4 weeks: -4.17 (95 % CI: -11.09;2.74; p=0.24) nor in any of the secondary outcomes. The per protocol analysis showed that the intervention group increased significantly more in the daily number of steps taken compared to the control group (mean difference in change from baseline to 4 weeks: 1033.4 steps (95 % CI: 4.1;2062.7), p=0.049, adjusted for mobility at baseline and length of stay; 1032.8 steps (95% CI: 3.6;2061.9), p=0.049, adjusted for mobility at baseline, length of stay and steps at baseline). Conclusions: Simple supervised strength training for the lower extremities, combined with protein supplementation initiated during hospitalization and continued at home for 4 weeks after discharge was not superior to usual care on change in mobility at 4 weeks in older medical patients. For the secondary outcome, daily number of steps, high compliance with the intervention resulted in a higher daily number of steps. Less than half of the patients were compliant with the intervention indicating that a simpler intervention might be needed. Trial registration: NCT01964482, https://clinicaltrials.gov/ct2/show/NCT01964482 , registration date: October 14, 2013, trial protocol: PubMed ID (PMID): 27039381.

scholarly journals INOVASIA Study: A Randomized Open Controlled Trial to Evaluate Prophylactic Pravastatin in the Prevention of Preeclampsia and its Effects on sFlt1/PLGF Levels in Pregnant Women at High Risk of Developing Preeclampsia

2021 ◽  
Author(s):  
Muhammad Ilham Aldika Akbar ◽  
Angelina Yosediputra ◽  
Raditya Eri Pratama ◽  
Nur Lailatul Fadhilah ◽  
Sulistyowati Sulistyowati ◽  
...  
Keyword(s):  
High Risk ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Perinatal Outcomes ◽  
Clinical Risk Factor ◽  
Control Group ◽  
Significant Deterioration ◽  
Secondary Outcomes ◽  
Plgf Ratio

Objectives The study aim is to evaluate the effect of pravastatin to prevent preeclampsia (PE) in pregnant women at a high risk of developing preeclampsia and the maternal and perinatal outcomes and the sFlt1/PLGF ratio in the Surabaya cohort of the INOVASIA trial. Setting This study involved 2 academic hospital (a tertiary and secondary center) in Surabaya, Indonesia. Participants Pregnant women at a high risk of developing PE were recruited and randomized into an intervention group (40) and a control group (40). The inclusion criteria consisted of pregnant women with positive clinical risk factor and abnormal uterine artery doppler examination at 10-20 weeks gestational age. Inteventions The control group received low dose aspirin (80 mg/day) and calcium (1 g/day), while the intervention group received additional pravastatin (20 mg twice daily) starting from 14-20 weeks gestation until delivery. Research blood samples were collected before the first dose of pravastatin, and just before delivery. Primary and Secondary Outcomes The primary outcome was the rate of maternal preeclampsia, secondary outcomes included maternal-perinatal outcomes and sFlt-1, PLGF, sFlt-1/PlGF ratio and sEng levels. Results The rate of preeclampsia was (non-significantly) lower in the pravastatin group compared with the control group (17.5% vs 35%). The pravastatin group also had a (non-significant) lower rate of severe preeclampsia, HELLP syndrome, acute kidney injury and severe hypertension. The rate of (iatrogenic) preterm delivery was significantly lower (p 0.048) in the pravastatin group (n=4) compared with the controls (n=12). Neonates in the pravastatin group had significantly higher birthweights, higher Apgar scores, and lower composite neonatal morbidity and NICU admission rates. All biomarkers show a significant deterioration in the control group compared with non-significant changes in the pravastatin group. Conclusions Pravastatin holds promise in the secondary prevention of preeclampsia and placenta-mediated adverse perinatal outcomes by improving the anti-angiogenic/pro-angiogenic imbalance. Trial Registration Clinical Trial Gov (ID: NCT03648970)

The influence of expectation modification in knee arthroplasty on satisfaction of patients: a randomized controlled trial

2021 ◽  
Vol 103-B (4) ◽  
pp. 619-626
Author(s):  
Jaap J. Tolk ◽  
Rob P. A. Janssen ◽  
Tsjitske M. Haanstra ◽  
M. C. van der Steen ◽  
Sita M. A. Bierma-Zeinstra ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mean Difference ◽  
Treatment Result ◽  
Control Group ◽  
Preoperative Education ◽  
Randomized Controlled ◽  
Preoperative Expectations

Aims Meeting preoperative expectations is known to be of major influence on postoperative satisfaction after total knee arthroplasty (TKA). Improved management of expectation, resulting in more realistic expectations can potentially lead to higher postoperative satisfaction. The objective of this study was to assess the effect of an additional preoperative education module, addressing realistic expectations for long-term functional recovery, on postoperative satisfaction and expectation fulfilment. Methods In total, 204 primary TKA patients with osteoarthritis were enrolled in this randomized controlled trial (RCT). Patients were allocated to either usual preoperative education (control group) or usual education plus an additional module on realistic expectations (intervention group). Primary outcome was being very satisfied (numerical rating scale for satisfaction ≥ 8) with the treatment result at 12 months' follow-up. Other outcomes were change in preoperative expectations and postoperative expectation fulfilment. Results A total of 187 patients (91.7%) were available for analysis at follow-up. In the intention-to-treat analysis, 58.5% (55/94) of patients were very satisfied with the treatment result in the control group, and 69.9% (65/93) of patients in the intervention group (adjusted odds ratio (AOR) 1.72, 95% confidence interval (CI) 0.90 to 3.29). A per-protocol analysis for patients who attended the education session (92.0%, n = 172) showed that 56.9% (49/86) of patients were very satisfied in the control group and 74.4% (61/86) in the intervention group (AOR 2.44, 95% CI 1.21 to 4.91). After preoperative education, the expectation scores in the intervention group were significantly lower (mean difference -6.9 (95% CI -10.2 to -3.6)) and did not alter in the control group (mean difference 0.5 (95% CI -2.9 to 3.9)). Overall, fulfilment of expectations at 12 months was significantly higher in the intervention group (mean difference 11.4% (95% CI 2.3 to 20.5)). Conclusion Improved preoperative patient education can modify patient expectations, resulting in higher postoperative fulfilment of expectation and higher satisfaction in the group that attended the preoperative education. This is the first RCT to confirm the potential of improved expectation management on satisfaction after TKA. Cite this article: Bone Joint J 2021;103-B(4):619–626.

scholarly journals Hippotherapy for patients with multiple sclerosis: A multicenter randomized controlled trial (MS-HIPPO)

2017 ◽  
Vol 24 (10) ◽  
pp. 1375-1382 ◽  
Author(s):  
Vanessa Vermöhlen ◽  
Petra Schiller ◽  
Sabine Schickendantz ◽  
Marion Drache ◽  
Sabine Hussack ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mean Difference ◽  
Control Group ◽  
Health Score ◽  
Multicenter Randomized Controlled Trial

Background: Evidence-based complementary treatment options for multiple sclerosis (MS) are limited. Objective: To investigate the effect of hippotherapy plus standard care versus standard care alone in MS patients. Methods: A total of 70 adults with MS were recruited in five German centers and randomly allocated to the intervention group (12 weeks of hippotherapy) or the control group. Primary outcome was the change in the Berg Balance Scale (BBS) after 12 weeks, and further outcome measures included fatigue, pain, quality of life, and spasticity. Results: Covariance analysis of the primary endpoint resulted in a mean difference in BBS change of 2.33 (95% confidence interval (CI): 0.03–4.63, p = 0.047) between intervention ( n = 32) and control ( n = 38) groups. Benefit on BBS was largest for the subgroup with an Expanded Disability Status Scale (EDSS) ⩾ 5 (5.1, p = 0.001). Fatigue (−6.8, p = 0.02) and spasticity (−0.9, p = 0.03) improved in the intervention group. The mean difference in change between groups was 12.0 ( p < 0.001) in physical health score and 14.4 ( p < 0.001) in mental health score of Multiple Sclerosis Quality of Life-54 (MSQoL-54). Conclusion: Hippotherapy plus standard care, while below the threshold of a minimal clinically important difference, significantly improved balance and also fatigue, spasticity, and quality of life in MS patients.

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