The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial

Abstract Background Psychosocial distress, depression, or anxiety can occur in up to 50% of women after a breast cancer diagnosis and mastectomy. The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction. Methods This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or placebo (coconut oil) throughout their hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards–Campbell Sleep Questionnaire, and the visual analogue scale. Results Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression (p = 0.21), sleep (p = 0.86), or pain (p = 0.30) scores. No adverse events (i.e., allergic reaction) were captured, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores (p < 0.001), while depression scores were significantly higher postoperatively as compared with preoperatively (p = 0.005). Conclusion In the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

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Water exchange-assisted vs. carbon dioxide-insufflated single-balloon enteroscopy: randomized controlled trial

Endoscopy ◽

10.1055/a-1459-4571 ◽

2021 ◽

Author(s):

Shaopeng Liu ◽

Tao Dong ◽

Yupeng Shi ◽

Hui Luo ◽

Xianmin Xue ◽

...

Keyword(s):

Carbon Dioxide ◽

Randomized Controlled Trial ◽

Adverse Events ◽

Water Exchange ◽

Controlled Trial ◽

Control Group ◽

Balloon Enteroscopy ◽

Randomized Controlled ◽

Single Balloon ◽

Single Balloon Enteroscopy

Background and study aims Single-balloon enteroscopy (SBE) is a valuable but difficult modality for the diagnosis and treatment of small-bowel diseases. The water exchange (WE) method has the advantage of facilitating intubation during colonoscopy. Here, we evaluated the effects of WE on procedure-related variables related to SBE. Patients and methods This randomized controlled trial was conducted in a tertiary-care referral center in China. Patients with attempt at total enteroscopy (ATE) were randomly allocated to undergo WE-assisted (WE group) or carbon dioxide-insufflated enteroscopy (CO2 group). All patients were planned to undergo both antegrade and retrograde procedures. The primary outcome was the total enteroscopy rate (TER). Secondary outcomes included maximal insertion depth, positive findings, procedural time and adverse events. Results In total, 110 patients were enrolled, with 55 in each group. Baseline characteristics between the two groups were comparable. TER was achieved in 58.2% (32/55) of the WE group and 36.4% (20/55) of the control group (p=0.022). The estimated intubation depth was 521.2±101.4 cm in the WE group and 481.6±95.2 cm in the CO2 group (p=0.037). The insertion time was prolonged in the WE group compared with CO2 group (178.9±45.1 min vs. 154.2±27.6 min, p<0.001). Endoscopic findings and adverse events were comparable between the two groups. Conclusions The WE method improved TER and increased intubation depth during SBE. The use of WE did not increase complications of enteroscopy. Clinical trial registation: https://clinicaltrials.gov/， NCT01942863.

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Pulsed Ultrasounds Reduce Pain and Disability, Increasing Rib Fracture Healing, in a Randomized Controlled Trial

Pain Medicine ◽

10.1093/pm/pny224 ◽

2018 ◽

Vol 20 (10) ◽

pp. 1980-1988

Author(s):

Norberto Santana-Rodríguez ◽

Bernardino Clavo ◽

Pedro Llontop ◽

María D Fiuza ◽

Joaquín Calatayud-Gastardi ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Adverse Events ◽

Controlled Trial ◽

Pain Medication ◽

Control Group ◽

Work Activity ◽

Randomized Controlled ◽

Medication Intake ◽

Bone Callus

AbstractIntroductionRib fractures are an important health issue worldwide, with significant, pain, morbidity, and disability for which only symptomatic treatment exists.ObjectivesBased on our previous experimental model, the objective of the current study was to assess for the first time whether pulsed ultrasound (PUS) application could have beneficial effects on humans.MethodsProspective, double-blinded, randomized, controlled trial of 51 patients. Four were excluded, and 47 were randomized into the control group (N = 23) or PUS group (N = 24). The control group received a PUS procedure without emission, and the PUS group received 1 Mhz, 0.5 W/cm2 for 1 min/cm2. Pain level, bone callus healing rate, physical and work activity, pain medication intake, and adverse events were blindly evaluated at baseline and one, three, and six months.ResultsThere were no significant differences at baseline between groups. PUS treatment significantly decreased pain by month 1 (P = 0.004), month 3 (P = 0.005), and month 6 (P = 0.025), significantly accelerated callus healing by month 1 (P = 0.013) and month 3 (P < 0.001), accelerated return to physical activity by month 3 (P = 0.036) and work activity (P = 0.001) by month 1, and considerably reduced pain medication intake by month 1 (P = 0.057) and month 3 (P = 0.017). No related adverse events were found in the PUS group.ConclusionsThis study is the first evidence that PUS treatment is capable of improving rib fracture outcome, significantly accelerating bone callus healing, and decreasing pain, time off due to both physical activity and convalescence period, and pain medication intake. It is a safe, efficient, and low-cost therapy that may become a new treatment for patients with stable rib fractures.

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Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17072465 ◽

2020 ◽

Vol 17 (7) ◽

pp. 2465

Author(s):

Alfonso Javier Ibáñez-Vera ◽

Jerónimo Carmelo García-Romero ◽

José Ramón Alvero-Cruz ◽

Rafael Lomas-Vega

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Sham Group ◽

Controlled Trial ◽

Depression Scale ◽

Physical Factor ◽

Control Group ◽

Local Pain ◽

Randomized Controlled ◽

Experimental Group

Monopolar dielectric radiofrequency (MDR) is a non-invasive treatment for pain based on the local application of electromagnetic signals. The study’s goal was to analyze the effects of MDR on the symptoms of fibromyalgia. For this aim, a randomized controlled trial was conducted on 66 female participants (aged 47 ± 17.7) diagnosed with fibromyalgia. Participants were randomly allocated to either an experimental group (n = 23), which received eight 20-minute sessions of MDR; a sham group, which received the same number of sessions of a sham MDR therapy (n = 22); or a control group (n = 21), which received usual care. The outcome variables included pain measured by the visual analogue scale (VAS), score on the hospital anxiety and depression scale (HADS) and quality of life measured by the combined index of fibromyalgia severity (ICAF). A large effect size was observed for the local pain (R2 = 0.46), total ICAF (R2 = 0.42) and ICAF physical factor scores (R2 = 0.38). Significant mean differences were found for the local pain (p = 0.025) and ICAF physical factor (p = 0.031) scores of the experimental group in comparison with the sham group. No statistically significant differences between groups were found in HADS. In conclusion, MDR is more effective than either sham treatment or usual care in the short-term improvement of pain and the physical wellbeing of participants with fibromyalgia.

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Comparison of a new versus standard removable offloading device in patients with neuropathic diabetic foot ulcers: a French national, multicentre, open-label randomized, controlled trial

BMJ Open Diabetes Research & Care ◽

10.1136/bmjdrc-2019-000954 ◽

2020 ◽

Vol 8 (1) ◽

pp. e000954

Author(s):

Louis Potier ◽

Maud François ◽

Dured Dardari ◽

Marilyne Feron ◽

Narimene Belhatem ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Adverse Events ◽

Diabetic Foot ◽

Primary Outcome ◽

Controlled Trial ◽

Control Group ◽

Foot And Ankle ◽

End Points ◽

Randomized Controlled ◽

Ankle Joints

IntroductionThe offloading is crucial to heal neuropathic diabetic foot ulcer (DFU). Removable offloading are the most used devices. Orthèse diabète is a new customized removable knee-high offloading device immobilizing foot and ankle joints, with some specific and innovative features that may improve offloading. We aimed to evaluate the efficiency of this device in DFU healing.Research, design and methodsThe evaluation of Offloading using a new removable ORTHOsis in DIABetic foot study is a French multicenter (13 centers) randomized controlled trial with blinded end points evaluation. Adults with neuropathic DFU were randomly assigned to either Orthèse Diabète (experimental device), or any type of conventional (usually used in France) removable offloading devices (control group). The primary outcome was the 3-month proportion of patients with fully healed DFU.ResultsAmong 112 randomized patients (men 78%, age 62±10 years), the primary outcome occurred in 19 (33%) participants using conventional device vs 19 (35%) Orthèse Diabète users (p=0.79). Study groups were also comparable in terms of prespecified secondary end points including occurrence of new DFU (25% vs 27% in conventional and experimental groups), ipsilateral lower-limb amputation (4% vs 10%) or infectious complications (14% vs 13%) (p>0.05 for all). Adverse events were comparable between groups, including 4 deaths unrelated to study allocation (1 sudden death, 2 ventricular arrhythmias and 1 pancreatic cancer). Adverse events believed to be related to the device were higher in the Orthèse Diabète group than in the control group (15% vs 4%). Orthèse Diabète was less frequently worn than conventional devices (46% vs 66%, p=0.04).ConclusionsOrthèse Diabète, a new removable offloading orthosis immobilizing foot and ankle joints did not show superiority compared with conventional removable devices in neuropathic DFU healing and cannot be recommended to heal DFU.Trial registration numberNCT01956162.

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Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-020-04745-w ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Lisa M. Wintner ◽

◽

Johannes M. Giesinger ◽

Monika Sztankay ◽

Andrew Bottomley ◽

...

Keyword(s):

Clinical Trials ◽

Randomized Controlled Trial ◽

Adverse Event ◽

Adverse Events ◽

Controlled Trial ◽

Control Group ◽

Rater Reliability ◽

Randomized Controlled ◽

Patient Reported ◽

The Impact

Abstract Background In oncology, detection and tracking of adverse events are of top priority and rely mostly on the Common Terminology Criteria for Adverse Events (CTCAE). Besides, clinical trials use as well patient-reported outcomes (PROs) to assess those adverse events, which are only accessible through patient self-reporting, such as fatigue, pain, and sleep disorders. Especially those issues that are not visible from the outside are often misinterpreted and underestimated by mere provider ratings. This trial aims at evaluating the impact of providing PRO data to providers on the accuracy of adverse event assessment in terms of inter-rater reliability of CTCAE ratings. Methods The trial uses a cross-sectional, unblinded, randomized controlled trial design with two trial arms and a single assessment time point. Eligible patients (aged 18 and above, any cancer diagnosis, currently under treatment, inpatient or day clinic setting, present symptom burden, no psychiatric or mental problems, written informed consent) complete an electronic version of the EORTC QLQ-C30 and 16 additional questions taken from the EORTC Item Library. PRO data is immediately processed and made available to CTCAE rating providers for conducting their ratings during the medical encounter. Patients are randomly assigned 1:1 to the intervention group (providers see PRO results on the same screen as the CTCAE rating) and the control group (no access to PRO data during the CTCAE rating). A superiority analysis will compare the inter-rater reliability (using intra-class correlation (ICC) coefficients) between the control and the intervention groups for each adverse event evaluated. Discussion The presented trial will demonstrate potential benefits of using PRO measures to improve the reliability of CTCAE ratings in cancer trials and the identification of adverse events. The new insights gained may lead to a new strategy for evaluating adverse events in clinical trials by combining patient and provider ratings. This might also have implications for daily clinical practice and cancer registries. Trial registration ClinicalTrials.gov NCT04066868. Registered on August 26, 2019. Competence Center for Clinical Trials of the Medical University of Innsbruck 20190513-2007. Registered on May 14, 2019. (version 6.0, March 18, 2019)

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Evaluating Seeking Safety for Women in Prison: A Randomized Controlled Trial

Research on Social Work Practice ◽

10.1177/1049731517706550 ◽

2017 ◽

Vol 29 (3) ◽

pp. 281-290 ◽

Cited By ~ 3

Author(s):

Stephen J. Tripodi ◽

Annelise M. Mennicke ◽

Susan A. McCarter ◽

Katie Ropes

Keyword(s):

Randomized Controlled Trial ◽

Repeated Measures ◽

Controlled Trial ◽

Depression Scale ◽

Control Group ◽

Post Traumatic Stress ◽

Treatment As Usual ◽

Seeking Safety ◽

Randomized Controlled

Objective: This study assessed the effectiveness of Seeking Safety on depression and post-traumatic stress disorder (PTSD) with incarcerated women. Method: A randomized controlled trial ( N = 40) was used to analyze Seeking Safety’s effectiveness compared to a treatment-as-usual control group. Analyses of covariance were used to assess differences at posttest ( n = 33) and 4-month follow-up ( n = 29) while repeated measures analysis of variance was used to assess the influence of the intervention on changes over time ( n = 29). The researchers also analyzed individual participants’ scores from pretest to 4-month follow-up ( n = 29). Results: Both groups decreased their scores on the Center for Epidemiology Studies–Depression Scale and the PTSD Checklist, although improvement was greater for treatment group participants except for depression at 4-month follow-up. Conclusion: Results support the continued use of Seeking Safety as a helpful corrections-based intervention for women, but more research with larger sample sizes is needed to consider it an effective intervention.

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MINDFULNESS TRAINING FOR CAREGIVERS OF ALZHEIMER PATIENTS: PRELIMINARY RESULTS OF A RANDOMIZED CONTROLLED TRIAL

Innovation in Aging ◽

10.1093/geroni/igz038.3159 ◽

2019 ◽

Vol 3 (Supplement_1) ◽

pp. S860-S860

Author(s):

Miriam Hurtado Pomares ◽

Daniel Mendialdua Canales ◽

Paula Peral Gómez ◽

Cristina Espinosa Sempere ◽

Iris Juárez Leal ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Pilot Study ◽

Controlled Trial ◽

Neuropsychiatric Symptoms ◽

Depression Scale ◽

Neuropsychiatric Disorders ◽

Anxiety And Depression ◽

Control Group ◽

Depression Symptoms ◽

Randomized Controlled

Abstract Mindfulness Based Health Care (MBHC) provides meditation techniques that may help to mitigate negative impact of dementia caregiving. We conducted a pilot randomized controlled trial with two parallel groups including 42 caregivers of Alzheimer patients (21 pairs). MBHC group learned the practice of mindfulness meditation once a week through 8 classes; control group did not receive any therapy. Anxiety and depression symptoms were the primary outcomes assessed in two occasions, i.e. at baseline and the end of the program, using the Hospital Anxiety and Depression scale respectively. Neuropsychiatric disorders of Alzheimer patients were also measured with Neuropsychiatric Inventory-Questionnaire. The details of the randomized controlled trial were described in clinicaltrial.gov NCT03858283. In this abstract, we presented the results of a pilot study conducted with 42 caregivers. Robust linear regression using MM-type estimator was performed to evaluate the changes in neuropsychiatric disorders in patients and anxiety and depression symptoms in caregivers adjusting for Score of Scale Global Deterioration. We observed that, compared to the control group, the MBHC group showed a tendency to a reduction in the total score Neuropsychiatric Inventor (β=-5.20; CI 95%: -10.47; 0.07) and the depression symptoms in the caregivers (β=-2.30; CI 95%: -5.43; 0.83). However, no changes were observed in the anxiety symptoms of the caregivers. In conclusion, the results of this pilot study suggested a positive effective on the reduction of neuropsychiatric symptoms in patents as well as on the depression in the caregivers. Nevertheless, these findings should be confirmed in a further complete study.

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Effect of acupuncture on insomnia in menopausal women: A Study protocol for a Randomized Controlled Trial

10.21203/rs.1.11/v1 ◽

2018 ◽

Author(s):

Shanshan Li ◽

Ping Yin ◽

Xuan Yin ◽

Anna Bogachko ◽

Tingting Liang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Treatment Protocol ◽

Depression Scale ◽

Menopausal Transition ◽

Syndrome Differentiation ◽

Control Group ◽

Randomized Controlled ◽

Self Rating ◽

Menopausal Women

Abstract Background: China today has high occurrences of insomnia in perimenopausal women. Some studies have shown that acupuncture might be effective in treating primary insomnia and insomnia related to depression and stroke. Although there are some programs supporting insomnia during the menopausal transition, there are few randomized controlled trials to provide evidence regarding their effectiveness. We design a randomized controlled trial of suitable sample size to verify the effectiveness of acupuncture in patients with insomnia during the menopausal transition and to form an optimized acupuncture treatment protocol. Method/Design: In this randomized, single-site, single-blind, placebo-controlled trial, 84 eligible patients will be recruited and randomly assigned to either the acupuncture group (n = 42) or the sham control group (n = 42) in a 1:1 ratio. Participants will receive a total of 18 sessions of treatment for eight consecutive weeks. Treatments will be given three times per week in the first four weeks, twice a week for the next two weeks and finally treatment once weekly for the final two weeks. Treatment will utilize eight main acupoints (GV20, GV24, GV29, RN6, RN4, SP6, HT7, EX-HN22), and extra two acupoints based on syndrome differentiation. The primary outcome will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will be measured by sleep parameters recorded in the Actigraphy (SE, TST, SA), Insomnia Severity Index (ISI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS) and Menopause Quality of Life (Men-QOL). The primary outcomes will be assessed at baseline, week four, week eight, and first and the third month following the end of treatment. Discussion: If the results confirm that acupuncture is effective and safe for the treatment on insomnia in menopausal women, this positive outcome could provide evidence for clinical application.

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Preventing Adverse Events of Chemotherapy for Gastrointestinal Cancer by Educating Patients about the Nocebo Effect: A Randomized-controlled Trial

10.21203/rs.3.rs-926779/v1 ◽

2021 ◽

Author(s):

Twyla L. Michnevich ◽

Yiqi Pan ◽

Armin Hendi ◽

Karin Oechsle ◽

Alexander Stein ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Adverse Events ◽

Gastrointestinal Cancer ◽

Controlled Trial ◽

Mean Difference ◽

Control Group ◽

Nocebo Effect ◽

Randomized Controlled ◽

Education Group ◽

Patient Reported

Abstract Background: Adverse events of chemotherapy may be caused by pharmacodynamics or psychological factors such as negative expectations, which constitute nocebo effects. In a randomized controlled trial, we examined whether educating patients about the nocebo effect is efficacious in reducing the intensity of self-reported adverse events. Methods: N = 49 and n = 51 patients (mean age: 60.2 years, 65% male, 54% UICC tumour stage IV) with newly-diagnosed gastrointestinal cancer were allocated to a nocebo education and attention control group, respectively.Results: GLM with adjustments for tumour staging and distress indicated that intensity of adverse events differed at 12-weeks after onset of chemotherapy (mean difference: 4.04, 95% CI [0.72, 7.36], p = .02, d = 0.48), with lower levels in the nocebo education group. Of these,). This was attributable to less non-specific adverse events (mean difference: 0.39, 95% CI [0.04, 0.73], p = .03, d = 0.44) and a trend towards less specific adverse events in the nocebo education group (mean difference: 0.36, 95% CI [-0.02, 0.74], p = .07, d = 0.37). We found no difference in adverse events at 10-days follow-up, perceived control of adverse events, or tendency to misattribute non-specific symptoms to the chemotherapy. Conclusions: This study provides first proof-of-concept evidence for the efficacy of a brief information session in preventing adverse events of chemotherapy. However, results regarding patient-reported outcomes cannot rule out response biases. Informing patients about the nocebo effect may be an innovative and clinically feasible intervention for reducing the burden of adverse events.Trial registration: retrospectively registered on March 27, 2018 to the German Clinical Trial Register (ID: DRKS00009501).

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Protocol violations in López-Medina et al.: 38 switched ivermectin (IVM) and placebo doses, failure of blinding, widespread IVM sales OTC in Cali, and nearly identical AEs for the IVM and control groups

10.31219/osf.io/u7ewz ◽

2021 ◽

Author(s):

David Scheim ◽

Jennifer A. Hibberd ◽

Juan Chamie-Quintero

Keyword(s):

Randomized Controlled Trial ◽

Adverse Events ◽

Controlled Trial ◽

Control Group ◽

High Dose ◽

Control Groups ◽

Over The Counter ◽

Randomized Controlled ◽

Widespread Availability ◽

And Control

A randomized controlled trial for treatment of mild cases of COVID-19 conducted in Cali, Colombia reported no statistically significant differences in outcomes for its ivermectin (IVM) and placebo arms. A striking anomaly, however, was that certain adverse events (AEs) that are distinctive for the study’s high-dose IVM use occurred at nearly identical rates in its IVM and placebo arms. The backdrop for these indicators of IVM use in study controls was widespread sales of IVM for COVID-19 in the Cali area during the study period, with 1.6 IVM doses sold over the counter for each case of COVID-19. The study compounded these risks of contamination of the control arm with critical errors in blinding and segregation of IVM v. placebo doses. A labeling error substituted IVM for placebo doses of 38 patients. Also, 5% dextrose solution was used for several weeks as a placebo, easily distinguishable from bitter tasting IVM. Given widespread availability and sales of IVM in Cali, lapses in segregation and blinding of IVM and control doses, and IVM-characteristic AEs in controls, the integrity of the study’s control arm was violated. Some useful information can nevertheless be salvaged from outcomes of this study’s IVM treatment arm, which had 0 deaths and generally mild symptoms, with AEs typical for high-dose IVM (replicated in the control group) that were generally mild and transient.

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