Contributions of auriculotherapy in smoking cessation: a pilot study

Objective To evaluate the contribution of auriculotherapy in smoking cessation. Method Double-blind randomized controlled trial, conducted with 30 smokers allocated into two groups: Experimental Group (21 participants received 10 sessions of auriculotherapy at specific points for smoking) and Control Group (nine participants received auriculotherapy in points that have no effect on the focus of research). Results Auriculotherapy contributed in reducing the number of cigarettes smoked in 61.9% of participants (p=0.002), in reducing the difficult to abstain from smoking in places where it is forbidden by 38% (p=0.050) and in not smoking when ill 23.8% (p=0.025). Conclusion Given the efficacy only in terms of reducing the number of cigarettes smoked and other parameters, we suggest that future studies consider the use of auriculotherapy combined with other treatment methods, in order to achieve better results in cessation/abstinence.

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The effectiveness of an interactive organ donation education intervention for Dutch lower-educated students: a cluster randomized controlled trial

10.21203/rs.2.12387/v2 ◽

2019 ◽

Author(s):

Esther Steenaart ◽

Rik Crutzen ◽

Math JJM Candel ◽

Nanne K de Vries

Keyword(s):

Randomized Controlled Trial ◽

Organ Donation ◽

Controlled Trial ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Post Test ◽

Cluster Randomized ◽

And Control ◽

Experimental Group

Abstract Background: Organ donation registration rates remain low, especially among people with lower educational levels. An interactive educational intervention was developed to prepare lower-educated students in the Netherlands for making a well-informed decision about organ donation. This article reports on the effects of this intervention on the intention to register (i.e. the primary outcome in the study at hand) and beliefs regarding organ donation. Methods: The effectiveness was investigated in a post-test only cluster randomized controlled trial, in which the intervention was offered to the experimental group and after measurement also to the control group. Randomization to the experimental and control groups took place at a class level. Teachers of schools for intermediate vocational education who taught a course on Citizenship delivered three intervention elements (i.e. video fragments and discussion, quizzes with tailored feedback and exercise filling out a registration form) to their students during two 50-minute lessons. Results: A total of 1170 students participated in the trial and filled out a questionnaire (45 experimental and 43 control classes). Compared to the control group, students in the experimental group had higher odds of having positive registration intentions (OR=1.81; 95%CI [1.10-2.96]), their perceived knowledge was higher (B=.62; 95%CI [.23-1.01]) and they had higher intentions to talk to family members (B=.68; 95%CI [.28-1.08]) and friends (B=.36; 95%CI [.07-.66]) about organ donation. There were no effects on the choice students intended to register (OR=1.08; 95%CI [.67-1.73]). Conclusions: Providing education in a classroom setting is an effective tool in increasing registration intentions. Despite uncertainties about the effects on actual registration behavior, a larger scale dissemination of this intervention is recommended. Providing clear information and opening the discussion about organ donation is an important and promising first step towards higher registration rates. Trial registration: The Dutch Trial Register, NTR6771. Registered on 24 October 2017. https://www.trialregister.nl/trial/6557

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Laser Acupuncture Alleviates Symptoms and Improves Quality of Life in Women with Overactive Bladder: A Double-Blind, Pilot Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/1705964 ◽

2020 ◽

Vol 2020 ◽

pp. 1-11

Author(s):

Yu-Wei Chang ◽

Tsia-Shu Lo ◽

Hsin-Ning Chang ◽

Yi-Hsien Shiao ◽

Yuan-Chieh Yeh

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Overactive Bladder ◽

Controlled Trial ◽

Laser Acupuncture ◽

Control Group ◽

Double Blind ◽

Randomized Controlled ◽

Experimental Group

Objective. The aim of this study was to investigate the clinical efficacy of laser acupuncture for the treatment of women with overactive bladder (OAB) in Taiwan. Methods. A double-blind randomized controlled trial was conducted on female patients with OAB symptoms referred from gynecologists, and subjects were divided into two groups using blocked randomization. LaserPan (RJ-Laser, Germany) was applied to seven selected acupuncture points. The subjects received laser acupuncture 3 times per week for 3 weeks, 9 sessions in total. Basic patient data, Overactive Bladder Symptom Score (OABSS), Incontinence Impact Questionnaire (IIQ-7), and Urogenital Distress Inventory (UDI-6) scores were recorded prior to first treatment and at the end of 3rd, 6th, and 9th treatments. Results. Thirty patients were enrolled, and twenty-seven patients completed all treatments in this study. The OABSS total score of the experimental group decreased significantly by 3.13 (p≤0.001), 4.60 (p≤0.001), and 3.79 (p≤0.001) after 3rd, 6th, and 9th treatments, respectively, compared with that of the control group. The IIQ-7 score declined significantly from baseline by 4.57 (p=0.003) and 3.63 (p=0.023) after 3rd and 6th treatments, respectively, compared with that of the control group. Similarly, the UDI-6 score of the experimental group exhibited a significant decrease from baseline by 1.90 (p=0.042) and 2.25 (p=0.025) after 6th and 9th interventions, respectively, compared with that of the control group. Conclusions. This study demonstrates that laser acupuncture can alleviate OAB symptoms and improve quality of life. This noninvasive device could be an effective therapy for women with OAB.

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The effectiveness of an interactive organ donation education intervention for Dutch lower-educated students: a cluster randomized controlled trial

Trials ◽

10.1186/s13063-019-3882-6 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Esther Steenaart ◽

Rik Crutzen ◽

Math J. J. M. Candel ◽

Nanne K. de Vries

Keyword(s):

Randomized Controlled Trial ◽

Organ Donation ◽

Controlled Trial ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Post Test ◽

Cluster Randomized ◽

And Control ◽

Experimental Group

Abstract Background Organ donation registration rates remain low, especially among people with lower educational levels. An interactive educational intervention was developed to prepare lower-educated students in the Netherlands for making a well-informed decision about organ donation. This article reports on the effects of this intervention on the intention to register (i.e., the primary outcome in the study at hand) and beliefs regarding organ donation. Materials and methods The effectiveness was investigated in a post-test-only cluster randomized controlled trial, in which the intervention was offered to the experimental group and after measurement also to the control group. Randomization to the experimental and control groups took place at a class level. Teachers of schools for Intermediate Vocational Education who taught a course on Citizenship delivered three intervention elements (i.e., video fragments and discussion, quizzes with tailored feedback and exercise filling out a registration form) to their students during two 50-min lessons. Results A total of 1170 students participated in the trial and filled out a questionnaire (45 experimental and 43 control classes). Compared to the control group, students in the experimental group had higher odds of having positive registration intentions (OR = 1.81; 95%CI [1.10–2.96]), their perceived knowledge was higher (B = 0.62; 95%CI [0.23–1.01]) and they had higher intentions to talk to family members (B = 0.68; 95%CI [0.28–1.08]) and friends (B = 0.36; 95%CI [0.07–0.66]) about organ donation. There were no effects on the choice students intended to register (OR = 1.08; 95%CI [0.67–1.73]). Conclusions Providing education in a classroom setting is an effective tool in increasing registration intentions. Despite uncertainties about the effects on actual registration behavior, a larger-scale dissemination of this intervention is recommended. Providing clear information and opening the discussion about organ donation is an important and promising first step towards higher registration rates. Trial registration The Dutch Trial Register, ID: NTR6771. Registered on 24 October 2017. https://www.trialregister.nl/trial/6557

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Changes in the cortisol and oxytocin levels of first-time pregnant women during interaction with an infant: a randomized controlled trial

BMC Pregnancy and Childbirth ◽

10.1186/s12884-021-03609-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Nozomi Sonoda ◽

Kaori Takahata ◽

Wataru Tarumi ◽

Kazuyuki Shinohara ◽

Shigeko Horiuchi

Keyword(s):

Randomized Controlled Trial ◽

Pregnant Women ◽

Salivary Cortisol ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Salivary Cortisol Level ◽

And Control ◽

First Time ◽

Experimental Group

Abstract Background During pregnancy, physiological, psychological, and social changes affect pregnant women’s childcare anxiety and childrearing behavior. However, there are scarce reports on hormonal evaluation related to such anxiety and behavior. Herein, we evaluated changes in salivary cortisol (primary outcome) and oxytocin (secondary outcome) levels of first-time pregnant women when interacting with an infant and discussed the relation of these changes to the women’s stress level. Methods This was a two-arm randomized controlled trial. Participants were randomly assigned using a web-based randomization system. The experimental group involved interaction with an infant for 30 min. The control group involved watching a DVD movie of an infant for 30 min. Saliva samples were collected at preintervention and postintervention. Saliva samples were assayed, and all data were compared between and within the groups using independent t-test and paired t-test with a two-sided 5% significance level. This study was approved by the Research Ethics Committee of St. Luke’s International University. Results A total of 102 women were randomly assigned to the experimental (n = 51) and control (n = 51) groups. Finally, 38 women in the experimental group and 42 women in the control group were analyzed. The salivary cortisol level significantly decreased after the interventions in both groups (t = 4.57, p = 0.00; t = 5.01, p = 0.00). However, there were no significant differences in the salivary cortisol (t = 0.349, p = 0.73) and oxytocin (t = − 1.945, p = 0.58) levels between the two groups. Conclusions The salivary cortisol level of first-time pregnant women significantly decreased in the experimental and control groups postintervention, although no significant difference was found between the two groups. Such decrease indicates stress reduction and release among these women. The absence of a significant increase in salivary oxytocin level in both groups may be related to the limitations of an insufficient number of samples that could be analyzed owing to the small saliva volume in some samples and the lack of adequate tactile stimulation of the intervention protocol. These results and procedural limitations provide useful insights into approaching subsequent studies aiming at continuously optimizing detection procedures. Trial registration UMIN000028471 (Clinical Trials Registry of University Hospital Information Network. July 31, 2017- Retrospectively registered.

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Metabolic resuscitation therapy in critically Ill patients with sepsis and septic shock: A Prospective Randomized Controlled Trial

10.21203/rs.3.rs-140461/v1 ◽

2021 ◽

Author(s):

Fang Feng ◽

Huyong Yang ◽

Weiwei Yang ◽

Min Li ◽

Yu Chen

Keyword(s):

Septic Shock ◽

Randomized Controlled Trial ◽

Mortality Rate ◽

Controlled Trial ◽

Control Group ◽

Icu Mortality ◽

Randomized Controlled ◽

Sepsis And Septic Shock ◽

And Control ◽

Experimental Group

Abstract ObjectiveTo further clarify the effectiveness and potential pathophysiological principles of metabolic resuscitation therapy in critically ill patients with sepsis and septic shock.MethodsProspective randomized controlled trial. Patients with sepsis and septic shock who were admitted to the ICU from Sep. 2019 to Mar. 2020 were prospectively enrolled. According to the computerized random sequence table, patients were randomly divided into the experimental group and the control group. All patients with sepsis were included in the research of cluster of initial therapy. The experimental group received metabolic resuscitation: vitamin C (1.5 g in an intravenous infusion q6h for 3 days), vitamin B1 (200 mg in an intramuscular injection q12h for 3 days), and hydrocortisone (50 mg in an intravenous infusion q6h for 7 days).ResultsOne hundred thirty-six patients with sepsis and septic shock were included in our study. Pneumonia was the main cause of sepsis and septic shock, including 33 (49%) and 41 (60%) patients in the experimental group and control group, respectively, and gram-negative bacilli were the main pathogenic bacteria (112/136, 82.4%). The ICU length of stay for the experimental group and the control group was 9 (7–12) and 11 (9–14) days, respectively, P = 0.002. The duration of vasoactive drugs (hours) was 20.8 ± 9.9 and 46.7 ± 12.8, respectively, P༜0.001. The 6-hour lactate clearance rate was 66.2% (55.5, 76.7) and 30.1% (15.6, 50) in the experimental group and control group, respectively, P = 0.000. The 72-hour PCT clearance rate was 70% (57.5, 80.3) and 40.7% (24.8, 52.2), respectively, P = 0.001. The ICU mortality rate was 8.8% (6/68) and 15% (15/68), respectively, P = 0.033.ConclusionsMetabolic resuscitation therapy is beneficial for patients with sepsis and septic shock, shortening the length of ICU stay, reducing the duration of vasopressor use, and reducing the ICU mortality rate of patients with sepsis and septic shock. However, large, multi-center, prospective randomized controlled trials are needed to further verify these results.Trial registrationChiCTR, ChiCTR1900026084. Registered 20 September 2019 - prospective registered, http://www.chictr.org.cn/edit.aspx?pid=40910&htm=4

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A Collaborative Deprescribing Intervention in a Subacute Medical Outpatient Clinic: A Pilot Randomized Controlled Trial

Metabolites ◽

10.3390/metabo11040204 ◽

2021 ◽

Vol 11 (4) ◽

pp. 204

Author(s):

Anissa Aharaz ◽

Jens Henning Rasmussen ◽

Helle Bach Ølgaard McNulty ◽

Arne Cyron ◽

Pia Keinicke Fabricius ◽

...

Keyword(s):

Pilot Study ◽

Controlled Trial ◽

Inappropriate Medication ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Patient Interviews ◽

Number Of Patients ◽

Multimorbid Patients ◽

And Control

Medication deprescribing is essential to prevent inappropriate medication use in multimorbid patients. However, experience of deprescribing in Danish Subacute Medical Outpatient Clinics (SMOCs) is limited. The objective of our pilot study was to evaluate the feasibility and sustainability of a collaborative deprescribing intervention by a pharmacist and a physician to multimorbid patients in a SMOC. A randomized controlled pilot study was conducted, with phone follow-up at 30 and 365+ days. A senior pharmacist performed a systematic deprescribing intervention using the Screening Tool of Older Persons’ potentially inappropriate Prescriptions (STOPP) criteria, the Danish deprescribing list, and patient interviews. A senior physician received the proposed recommendations and decided which should be implemented. The main outcome was the number of patients having ≥1 medication where deprescribing status was sustained 30 days after inclusion. Out of 76 eligible patients, 72 (95%) were included and 67 (93%) completed the study (57% male; mean age 73 years; mean number of 10 prescribed medications). Nineteen patients (56%) in the intervention group and four (12%) in the control group had ≥1 medication where deprescribing status was sustained 30 days after inclusion (p = 0.015). In total, 37 medications were deprescribed in the intervention group and five in the control group. At 365+ days after inclusion, 97% and 100% of the deprescribed medications were sustained in the intervention and control groups, respectively. The three most frequently deprescribed medication groups were analgesics, cardiovascular, and gastrointestinal medications. In conclusion, a collaborative deprescribing intervention for multimorbid patients was feasible and resulted in sustainable deprescribing of medication in a SMOC.

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The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2020-0245 ◽

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.

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Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double‐blind randomized controlled trial

World Psychiatry ◽

10.1002/wps.20905 ◽

2021 ◽

Vol 20 (3) ◽

pp. 397-404

Author(s):

Abraham Zangen ◽

Hagar Moshe ◽

Diana Martinez ◽

Noam Barnea‐Ygael ◽

Tanya Vapnik ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Transcranial Magnetic Stimulation ◽

Magnetic Stimulation ◽

Repetitive Transcranial Magnetic Stimulation ◽

Controlled Trial ◽

Double Blind ◽

Randomized Controlled

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Neurofeedback for tinnitus: Study protocol for a double-blind randomized controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both the sound perception and the psychological distress, in a cohort of chronic tinnitus sufferers

10.21203/rs.2.12838/v1 ◽

2019 ◽

Author(s):

Martin Jensen ◽

Eva Hüttenrauch ◽

Jennifer Schmidt ◽

Gerhard Andersson ◽

Mira-Lynn Chavanon ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Control Group ◽

Neurofeedback Training ◽

Double Blind ◽

Sound Perception ◽

Active Comparator ◽

Randomized Controlled ◽

Tinnitus Distress ◽

Training Protocol

Abstract Background Tinnitus is a very common condition, which for some can have debilitating psychological consequences. Although some interventions are helpful in learning how to cope better with the tinnitus, at present there is no cure. Neurofeedback is an emerging treatment modality in tinnitus. Previous studies, utilizing an alpha/delta training protocol have shown promise. However, they were characterized by small sample sizes and lack of neurofeedback control conditions. Therefore, the aim of this study is to investigate, if an alpha/delta neurofeedback training protocol, compared to beta/theta neurofeedback or a diary control group, is effective in reducing, not only the tinnitus sound perception, but also the psychological symptoms associated with the condition. Methods The study is designed as a three-armed, single-blinded randomized controlled trial. Participants are randomly assigned to either an established neurofeedback protocol for tinnitus (alpha/delta training), another neurofeedback protocol as active comparator (beta/theta training) or diary control group. In the four-week intervention period, participants in both neurofeedback groups undergo ten sessions, whereas participants in the diary control group complete a diary bi-weekly. The primary outcomes are between group differences in tinnitus sound percept change, as measured with the Tinnitus Magnitude Index (TMI) and changes in tinnitus distress, measured with the Tinnitus Handicap Inventory (THI), four weeks post baseline. Secondary outcome measures include changes in tinnitus distress, sleep quality, depressive symptoms and whether neurofeedback leads to specific power changes in the trained frequency bands. Discussion This is the first double-blind, randomized controlled trial examining the efficacy of an alpha/delta neurofeedback training protocol in reducing the tinnitus sound percept and the distress associated with the condition. Compared to former studies, the present study is designed to assess both the specificity of an alpha/delta neurofeedback training protocol by including an active comparator, beta/theta neurofeedback training, and in addition to control for placebo effects by inclusion of a diary control group. We hope this study contributes not only to our understanding of the neurological underpinnings of tinnitus, but also to the potentiality of neurofeedback as a therapeutic agent.

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