Acupuncture Efficacy on Ischemic Stroke Recovery

Background and Purpose— Acupuncture is a frequently used complementary treatment for ischemic stroke in China but the evidence available from previous randomized trials is inconclusive. The objective of this study was to assess the efficacy and safety of acupuncture in a more robustly designed larger scale trial. Methods— This is a multicenter, single-blinded, randomized controlled trial. Eight hundred sixty-two hospitalized patients with limb paralysis between 3 to 10 days after ischemic stroke onset were allocated acupuncture plus standard care or standard care alone. The acupuncture was applied 5 times per week for 3 to 4 weeks. The primary outcomes were defined as follows: (1) death/disability according to Barthel index and (2) death/institutional care at 6 months. Results— There was a tendency of fewer patients being dead or dependent in acupuncture group (80/385, 20.7%) than in control group (102/396, 25.8%) at 6 months (odds ratio, 0.75; 95% confidence interval, 0.54–1.05). The benefit was noted in subgroup receiving ≥10 sessions of acupuncture (odds ratio, 0.68; 95% confidence interval, 0.47–0.98). There was no statistical difference in death or institutional care between the 2 groups (odds ratio, 1.06; 95% confidence interval, 0.63–1.79). Severe adverse events occurred in 7.6% and 8.3% of patients in the 2 groups, respectively. Conclusions— Acupuncture seemed to be safe in the subacute phase of ischemic stroke. If the potential benefits observed are confirmed in future larger study, the health gain from wider use of the treatment could be substantial. Clinical Trial Registration— URL: http://www.chictr.org/en/ . Unique identifier: ChiCTR-TRC-11001353.

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Financial incentives for smoking cessation in pregnancy: multicentre randomised controlled trial

BMJ ◽

10.1136/bmj-2021-065217 ◽

2021 ◽

pp. e065217

Author(s):

Ivan Berlin ◽

Noémi Berlin ◽

Marie Malecot ◽

Martine Breton ◽

Florence Jusot ◽

...

Keyword(s):

Smoking Cessation ◽

Confidence Interval ◽

Financial Incentives ◽

Odds Ratio ◽

Financial Incentive ◽

Controlled Trial ◽

Abstinence Rate ◽

Control Group ◽

Smoking Abstinence ◽

Pregnant Smokers

AbstractObjectiveTo evaluate the efficacy of financial incentives dependent on continuous smoking abstinence on smoking cessation and birth outcomes among pregnant smokers.DesignSingle blind, randomised controlled trial.SettingFinancial Incentive for Smoking Cessation in Pregnancy (FISCP) trial in 18 maternity wards in France.Participants460 pregnant smokers aged at least 18 years who smoked ≤5 cigarettes/day or ≤3 roll-your-own cigarettes/day and had a pregnancy gestation of <18 weeks were randomised to a financial incentives group (n=231) or a control group (n=229).InterventionsParticipants in the financial incentives group received a voucher equivalent to €20 (£17; $23), and further progressively increasing vouchers at each study visit if they remained abstinent. Participants in the control group received no financial incentive for abstinence. All participants received a €20 show-up fee at each of six visits.Main outcome measuresThe main outcome measure was continuous smoking abstinence from the first post-quit date visit to visit 6, before delivery. Secondary outcomes in the mothers were point prevalence abstinence, time to smoking relapse, withdrawal symptoms, blood pressure, and alcohol and cannabis use in past 30 days. Secondary outcomes in the babies were gestational age at birth, birth characteristics (birth weight, length, head circumference, Apgar score), and a poor neonatal outcome—a composite measure of transfer to the neonatal unit, congenital malformation, convulsions, or perinatal death.ResultsMean age was 29 years. In the financial incentives and control groups, respectively, 137 (59%) and 148 (65%) were employed, 163 (71%) and 171 (75%) were in a relationship, and 41 (18%) and 31 (13%) were married. The participants had smoked a median of 60 cigarettes in the past seven days. The continuous abstinence rate was significantly higher in the financial incentives group (16%, 38/231) than control group (7%, 17/229): odds ratio 2.45 (95% confidence interval 1.34 to 4.49), P=0.004). The point prevalence abstinence rate was higher (4.61, 1.41 to 15.01, P=0.011), the median time to relapse was longer (visit 5 (interquartile range 3-6) and visit 4 (3-6), P<0.001)), and craving for tobacco was lower (β=−1.81, 95% confidence interval −3.55 to −0.08, P=0.04) in the financial incentives group than control group. Financial incentives were associated with a 7% reduction in the risk of a poor neonatal outcome: 4 babies (2%) in the financial incentives group and 18 babies (9%) in the control group: mean difference 14 (95% confidence interval 5 to 23), P=0.003. Post hoc analyses suggested that more babies in the financial incentives group had birth weights ≥2500 g than in the control group: unadjusted odds ratio 1.95 (95% confidence interval 0.99 to 3.85), P=0.055; sex adjusted odds ratio 2.05 (1.03 to 4.10), P=0.041; and sex and prematurity adjusted odds ratio 2.06 (0.90 to 4.71), P=0.086. As these are post hoc analyses, the results should be interpreted with caution.ConclusionsFinancial incentives to reward smoking abstinence compared with no financial incentives were associated with an increased abstinence rate in pregnant smokers. Financial incentives dependent on smoking abstinence could be implemented as a safe and effective intervention to help pregnant smokers quit smoking.Trial registrationClinicalTrials.gov NCT02606227.

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Effect of tocilizumab on clinical outcomes at 15 days in patients with severe or critical coronavirus disease 2019: randomised controlled trial

BMJ ◽

10.1136/bmj.n84 ◽

2021 ◽

pp. n84 ◽

Cited By ~ 6

Author(s):

Viviane C Veiga ◽

João A G G Prats ◽

Danielle L C Farias ◽

Regis G Rosa ◽

Leticia K Dourado ◽

...

Keyword(s):

Mechanical Ventilation ◽

Confidence Interval ◽

Clinical Outcomes ◽

Odds Ratio ◽

Standard Care ◽

Controlled Trial ◽

Data Monitoring Committee ◽

Ordinal Scale ◽

Care Group ◽

Standard Care Group

Abstract Objective To determine whether tocilizumab improves clinical outcomes for patients with severe or critical coronavirus disease 2019 (covid-19). Design Randomised, open label trial. Setting Nine hospitals in Brazil, 8 May to 17 July 2020. Participants Adults with confirmed covid-19 who were receiving supplemental oxygen or mechanical ventilation and had abnormal levels of at least two serum biomarkers (C reactive protein, D dimer, lactate dehydrogenase, or ferritin). The data monitoring committee recommended stopping the trial early, after 129 patients had been enrolled, because of an increased number of deaths at 15 days in the tocilizumab group. Interventions Tocilizumab (single intravenous infusion of 8 mg/kg) plus standard care (n=65) versus standard care alone (n=64). Main outcome measure The primary outcome, clinical status measured at 15 days using a seven level ordinal scale, was analysed as a composite of death or mechanical ventilation because the assumption of odds proportionality was not met. Results A total of 129 patients were enrolled (mean age 57 (SD 14) years; 68% men) and all completed follow-up. All patients in the tocilizumab group and two in the standard care group received tocilizumab. 18 of 65 (28%) patients in the tocilizumab group and 13 of 64 (20%) in the standard care group were receiving mechanical ventilation or died at day 15 (odds ratio 1.54, 95% confidence interval 0.66 to 3.66; P=0.32). Death at 15 days occurred in 11 (17%) patients in the tocilizumab group compared with 2 (3%) in the standard care group (odds ratio 6.42, 95% confidence interval 1.59 to 43.2). Adverse events were reported in 29 of 67 (43%) patients who received tocilizumab and 21 of 62 (34%) who did not receive tocilizumab. Conclusions In patients with severe or critical covid-19, tocilizumab plus standard care was not superior to standard care alone in improving clinical outcomes at 15 days, and it might increase mortality. Trial registration ClinicalTrials.gov NCT04403685 .

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Acupuncture with Rehabilitation in the Treatment of Ischemic Stroke Recovery: A Randomized Controlled Trial

10.21203/rs.2.177/v2 ◽

2019 ◽

Author(s):

Lixia Li ◽

Weifeng Zhu ◽

Guohua Lin ◽

Chuyun Chen ◽

Donghui Tang ◽

...

Keyword(s):

Ischemic Stroke ◽

Controlled Trial ◽

Stroke Recovery ◽

Control Group ◽

Acupuncture Points ◽

Modified Ashworth Scale ◽

Significant Difference ◽

Scale Scores ◽

Before And After ◽

Ashworth Scale

Abstract Background: Acupuncture is a well known treatment for ischemic stroke recovery, but evidence of its effectiveness remains limited. Methods: Rehabilitation training was provided to a control group. In Arm 1 and Arm 2, acupoint schemes were determined by a consensus of acupuncture experts and previous clinical research. Arm 1 was based on an acupoint summary of ancient literature, and Arm 2 was based on the summary of effective acupuncture points from modern RCT literature. Acupuncture was given on the acupoint. After acupuncture, the needles were left in for 30 minutes, and checked every 10 minutes. The three groups received treatment once a day, 5 times a week, for 2 weeks. The primary outcome was the National Institute of Health stroke scale (NIHSS), and the secondary outcomes were the Barthel index (BI) and the modified Ashworth scale (MAS). Outcomes were observed in patients both before and after treatment. Results: A total of 497 patients with ischemic stroke were randomized into either Arm 1 (159 cases), Arm 2 (173 cases) or a control group (165 cases). After 2 weeks of treatment, the NIHSS scores for Arm 1 were lower than those of the control group (P=0.017); the BI scores were higher in Arm 2 than they were in the control group (P=0.020). Additionally, there was no significant difference between Arm 1 and the control group for either the BI scores or the modified Ashworth scale scores (P>0.05). Conclusion: The clinical efficacy of Arm 1 and Arm 2 (acupuncture groups) was superior to that of the control group.

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Acupuncture versus Rehabilitation in the Treatment of Ischemic Stroke Recovery: A Randomized Controlled Trial

10.21203/rs.2.177/v1 ◽

2019 ◽

Author(s):

Lixia Li ◽

Weifeng Zhu ◽

Guohua Lin ◽

Chuyun Chen ◽

Donghui Tang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Ischemic Stroke ◽

Controlled Trial ◽

Stroke Recovery ◽

Control Group ◽

Acupuncture Points ◽

Randomized Controlled ◽

Modified Ashworth Scale ◽

Significant Difference ◽

Ashworth Scale

Abstract Background: Acupuncture is a treatment for ischemic stroke recovery, but evidence of its effectiveness remains limited. Methods: A total of 497 patients with ischemic stroke were randomized into Arm 1 (159 cases), Arm 2 (173 cases) and a control group (165 cases). In the control group, rehabilitation training was provided. In Arm 1 and Arm 2, acupoint schemes were determined by the consensus of acupuncture experts and previous clinical research. Arm 1 was based on an acupoint summary of ancient literature, and Arm 2 was based on the summary of effective acupuncture points in modern RCT literature. The treatment was given with conventional acupuncture at the appropriate position. After acupuncture, the needles were left in for 30 minutes, and checked every 10 minutes. The three groups received treatment once a day, 5 times a week, for 2 weeks. The primary outcome were the National Institute of Health stroke scale (NIHSS), and the secondary outcomes were the Barthel index (BI) and modified Ashworth scale (MAS). Outcomes were observed in patients both before and after treatment. Results: After 2 weeks of treatment, there was no significant difference between Arm 1 and the control group for either the BI scores or the modified Ashworth scale scores (P>0.05). However, the NIHSS scores of Arm 1 were lower than those of the control group (P=0.017); the BI scores were higher in Arm 2 than they were in the control group (P=0.020). Conclusion: The clinical efficacy of Arm 1 and Arm 2 (acupuncture groups) was superior to that of the control group. Trial Registration: Chinese Clinical Trial Registry: ChiCTR-IOR-16008627, Registered 11 June 2016, http://www.chictr.org.cn/index.aspx. Keywords: Acupuncture; ischemic stroke; randomized controlled trial (RCT)

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572Randomized Controlled Trial Investigating the Effect of an Educational Intervention on Paternal Postpartum Depression Risk

International Journal of Epidemiology ◽

10.1093/ije/dyab168.305 ◽

2021 ◽

Vol 50 (Supplement_1) ◽

Author(s):

Yuichi Ichinose ◽

Kevin Urayama ◽

Makoto Okamura ◽

Naomi Sugiura ◽

Maiko Suto ◽

...

Keyword(s):

Confidence Interval ◽

Educational Intervention ◽

Odds Ratio ◽

Controlled Trial ◽

Intervention Group ◽

Significant Risk ◽

Depression Scale ◽

Control Group ◽

Parallel Group ◽

And Control

Abstract Background Postpartum paternal depression (PPPD) is under-acknowledged worldwide compared to maternal depression, despite PPPD prevalence being reported to be just as high. Although PPPD has clear health consequences, even on other family members, preventive methods have been under-studied. We investigated the association between an educational intervention and risk of PPPD. Methods We performed a parallel-group, randomized controlled trial in an obstetrics clinic in Japan that included expecting fathers and their pregnant partners at 28-32 weeks gestation. The intervention comprised an educational booklet created for fathers that was distributed during pregnancy. For the primary outcome, Edinburg Postnatal Depression Scale (EPDS) was administered at one and three months post-delivery, and EPDS of 8 or greater was considered at risk for depression. Results In total, the intervention and control groups comprised 286 and 282 couples, respectively. At follow-up, depressive symptoms were observed in 7.2% of fathers in the intervention group and 9.8% in the control group (odds ratio [OR] = 0.71, 95% confidence interval [CI] = 0.36-1.36). Logistic regression in an adjusted analysis showed a reduced, but non-significant risk of PPPD (odds ratio=0.61, 95% confidence interval=0.31-1.20). Conclusions In the first PPPD intervention study of its kind in Japan, our study suggests that distributing the educational booklet to fathers may be helpful in general, but may not be enough to significantly influence the risk of a major condition like PPPD. Key messages A more personalized preventive approach beyond the simple administration of a booklet may be necessary to significantly impact PPPD occurrences.

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Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial

BMC Infectious Diseases ◽

10.1186/s12879-021-06356-5 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Marouf Alhalabi ◽

Mohammed Waleed Alassi ◽

Kamal Alaa Eddin ◽

Khaled Cheha

Keyword(s):

Clinical Trial ◽

Helicobacter Pylori ◽

Confidence Interval ◽

Odds Ratio ◽

Controlled Trial ◽

Helicobacter Pylori Infection ◽

First Line ◽

Link Type ◽

Syrian Population

Abstract Background Antibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. Settings and design An open-label, randomised, parallel, superiority clinical trial. Methods We randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test 8 weeks after completing the treatment. Results Thirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454–4.146]. According to PPA, the eradication rates were 78.9%, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394–3.774]. We didn’t report serious adverse effects. Conclusions Levofloxacin concomitant therapy wasn’t superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population. Trial registration We registered this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier-NCT04348786, date:29-January-2020).

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Do Children Who Experience Laryngospasm Have an Increased Risk of Upper Respiratory Tract Infection?

Anesthesiology ◽

10.1097/00000542-199609000-00005 ◽

1996 ◽

Vol 85 (3) ◽

pp. 475-480. ◽

Cited By ~ 107

Author(s):

Mark S. Schreiner ◽

Irene O'Hara ◽

Dorothea A. Markakis ◽

George D. Politis

Keyword(s):

Confidence Interval ◽

Respiratory Infection ◽

Odds Ratio ◽

Signs And Symptoms ◽

Control Group ◽

Upper Respiratory Tract ◽

Upper Respiratory Infection ◽

Airway Surgery ◽

Increased Risk ◽

Upper Respiratory

Background Laryngospasm is the most frequently reported respiratory complication associated with upper respiratory infection and general anesthesia in retrospective studies, but prospective studies have failed to demonstrate any increase in risk. Methods A case-control study was performed to examine whether children with laryngospasm were more likely to have an upper respiratory infection on the day of surgery. The parents of all patients (N = 15,183) who were admitted through the day surgery unit were asked if their child had an active or recent (within 2 weeks of surgery) upper respiratory infection and were questioned about specific signs and symptoms to determine if the child met Tait and Knight's definition of an upper respiratory infection. Control subjects were randomly selected from patients whose surgery had occurred within 1 day of the laryngospasm event. Results Patients who developed laryngospasm (N = 123) were 2.05 times (95% confidence interval 1.21-3.45) more likely to have an active upper respiratory infection as defined by their parents than the 492 patients in the control group (P < or = 0.01). The development of laryngospasm was not related to Tait and Knight's definition for an upper respiratory infection or to recent upper respiratory infection. Children with laryngospasm were more likely to be younger (odds ratio = 0.92, 95% confidence interval 0.87-0.99), to be scheduled for airway surgery (odds ratio = 2.08, 95% confidence interval 1.21-3.59), and to have their anesthesia supervised by a less experienced anesthesiologist (odds ratio = 1.69, 95% confidence interval 1.04-2.7) than children in the control group. Conclusion Laryngospasm was more likely to occur in children with an active upper respiratory infection, children who were younger, children who were undergoing airway surgery, and children whose anesthesia were supervised by less experienced anesthesiologists. Understanding the risk factors and the magnitude of the likely risk should help clinicians make the decision as to whether to anesthetize children with upper respiratory infection.

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Mobile Health to Improve Adherence and Patient Experience in Heart Transplantation Recipients: The mHeart Trial

Healthcare ◽

10.3390/healthcare9040463 ◽

2021 ◽

Vol 9 (4) ◽

pp. 463

Author(s):

Mar Gomis-Pastor ◽

Sonia Mirabet Perez ◽

Eulalia Roig Minguell ◽

Vicenç Brossa Loidi ◽

Laura Lopez Lopez ◽

...

Keyword(s):

Heart Transplantation ◽

Patient Experience ◽

Mobile Application ◽

Standard Care ◽

Controlled Trial ◽

Intervention Group ◽

Group Versus ◽

Control Group ◽

P Value ◽

Adherence Score

Non-adherence after heart transplantation (HTx) is a significant problem. The main objective of this study was to evaluate if a mHealth strategy is more effective than standard care in improving adherence and patients’ experience in heart transplant recipients. Methods: This was a single-center, randomized controlled trial (RCT) in adult recipients >1.5 years post-HTx. Participants were randomized to standard care (control group) or to the mHeart Strategy (intervention group). For patients randomized to the mHeart strategy, multifaceted theory-based interventions were provided during the study period to optimize therapy management using the mHeart mobile application. Patient experience regarding their medication regimens were evaluated in a face-to-face interview. Medication adherence was assessed by performing self-reported questionnaires. A composite adherence score that included the SMAQ questionnaire, the coefficient of variation of drug levels and missing visits was also reported. Results: A total of 134 HTx recipients were randomized (intervention N = 71; control N = 63). Mean follow-up was 1.6 (SD 0.6) years. Improvement in adherence from baseline was significantly higher in the intervention group versus the control group according to the SMAQ questionnaire (85% vs. 46%, OR = 6.7 (2.9; 15.8), p-value < 0.001) and the composite score (51% vs. 23%, OR = 0.3 (0.1; 0.6), p-value = 0.001). Patients’ experiences with their drug therapy including knowledge of their medication timing intakes (p-value = 0.019) and the drug indications or uses that they remembered (p-value = 0.003) significantly improved in the intervention versus the control group. Conclusions: In our study, the mHealth-based strategy significantly improved adherence and patient beliefs regarding their medication regimens among the HTx population. The mHeart mobile application was used as a feasible tool for providing long-term, tailor-made interventions to HTx recipients to improve the goals assessed.

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The Effect of Intraoperative Magnesium Sulphate Infusion on Emergence Agitation after Ambulatory Ophthalmic Surgery in Children

Journal of Clinical Medicine ◽

10.3390/jcm9124126 ◽

2020 ◽

Vol 9 (12) ◽

pp. 4126

Author(s):

Yea-Ji Lee ◽

Bo-Young Kim ◽

Jae-Hee Park ◽

Sae-Yeon Kim ◽

Hee-Yeon Park ◽

...

Keyword(s):

Confidence Interval ◽

Continuous Infusion ◽

Magnesium Sulphate ◽

Odds Ratio ◽

Isotonic Saline ◽

Control Group ◽

Loading Dose ◽

Emergence Agitation ◽

Ophthalmic Surgery ◽

Paediatric Patients

This study investigated whether intraoperative infusion of magnesium sulphate reduces the incidence of emergence agitation (EA) in paediatric patients who undergo ambulatory ophthalmic surgery using the Paediatric Anaesthesia Emergence Delirium (PAED) scale. Ninety-two paediatric patients who were scheduled for elective ophthalmic surgery were randomly allocated to two groups: control or magnesium. In the magnesium group, patients received an initial intravenous loading dose of 30 mg/kg of 10% solution of magnesium sulphate over 10 min and then a continuous infusion of 10 mg/kg×h during the surgery. In the control group, an equal volume of 0.9% isotonic saline was administered in the same way as in the magnesium group. The PAED scale was assessed at 15-min intervals until the PAED score reached below 10 at the postanaesthetic care unit. EA was defined as a PAED score of 10 or higher. Of the 86 patients recruited, 44 and 42 were allocated to the control and magnesium groups, respectively. The incidence of EA was 77.3% in the control group and 57.1% in the magnesium group (odds ratio, 0.392; 95% confidence interval, 0.154 to 0.997; p = 0.046). The intraoperative infusion of magnesium sulphate significantly reduced the incidence of EA.

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The effect of therapeutic listening on anxiety and fear among surgical patients: randomized controlled trial

Revista Latino-Americana de Enfermagem ◽

10.1590/1518-8345.2438.3027 ◽

2018 ◽

Vol 26 (0) ◽

Author(s):

Ana Cláudia Mesquita Garcia ◽

Talita Prado Simão-Miranda ◽

Ana Maria Pimenta Carvalho ◽

Paula Condé Lamparelli Elias ◽

Maria da Graça Pereira ◽

...

Keyword(s):

Heart Rate ◽

Randomized Controlled Trial ◽

State Anxiety ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Clinical Trial Registration ◽

Physiological Variables ◽

Randomized Controlled ◽

Therapeutic Listening

ABSTRACT Objective: To investigate the effect of therapeutic listening on state anxiety and surgical fears in preoperative colorectal cancer patients. Method: A randomized controlled trial with 50 patients randomly allocated in the intervention group (therapeutic listening) (n = 25) or in the control group (n = 25). The study evaluated the changes in the variables state anxiety, surgical fears and physiological variables (salivary alpha-amylase, salivary cortisol, heart rate, respiratory rate and blood pressure). Results: In the comparison of the variables in the control and intervention groups in pre- and post-intervention, differences between the two periods for the variables cortisol (p=0.043), heart rate (p=0.034) and surgical fears (p=0.030) were found in the control group, which presented reduction in the values of these variables. Conclusion: There was no reduction in the levels of the variables state anxiety and surgical fears resulting from the therapeutic listening intervention, either through the physiological or psychological indicators. However, the contact with the researcher during data collection, without stimulus to reflect on the situation, may have generated the results of the control group. Clinical Trial Registration: NCT02455128.

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