scholarly journals Motivation-Enhancing Psychotherapy for Inpatients With Anorexia Nervosa (MANNA): A Randomized Controlled Pilot Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Katrin Ziser ◽  
Nadine Rheindorf ◽  
Katharina Keifenheim ◽  
Sandra Becker ◽  
Gaby Resmark ◽  
...  
Keyword(s):  
Anorexia Nervosa ◽  
Pilot Study ◽  
Therapeutic Alliance ◽  
Inpatient Treatment ◽  
Readiness To Change ◽  
Pilot Trial ◽  
Intervention Group ◽  
Small Sample ◽  
Treatment As Usual ◽  
Randomized Controlled

Patients with anorexia nervosa (AN) are frequently characterized by an unstable readiness to change and high ambivalence toward treatment. Enhancing readiness to behavioral change therefore plays an essential role for adherence to treatment especially for severely ill patients treated in inpatient settings. Therefore, a novel 10 week program for the individual psychotherapy sessions was designed using elements from motivational interviewing to be applied within the multidisciplinary inpatient treatment for patients with AN. In a randomized controlled pilot trial, N = 22 patients with AN received either the new intervention or treatment as usual in one of two recruiting university hospitals. Readiness to change, eating disorder pathology, therapeutic alliance as well as acceptance and feasibility of the new intervention were measured from patients and therapists in week 1, 5, and 10 of inpatient treatment. Results confirm acceptance and feasibility of the MANNA intervention as evaluated by patients as well as therapists. Patients receiving the new intervention completed their inpatient treatment significantly more often on regular terms than patients receiving treatment as usual. No differences between the groups could be found concerning therapeutic alliance during and at the end of treatment and readiness to change. Absolute numbers of BMI increase indicate a larger increase in the intervention group albeit not significant in this pilot study sample. Limitations of the study such as the small sample size as well as possible adaptions and advancements of the intervention that need to be examined in a larger clinical trial of efficacy are discussed. This phase II study is registered with the German Clinical Trials Register (DRKS) under the trial number DRKS00015639.

The Effect of Reflexology on Lactation in Women Who Had Cesarean Section: A Randomized Controlled Pilot Study

2021 ◽  
pp. 1-8
Author(s):  
Sevde Aksu ◽  
Pelin Palas Karaca
Keyword(s):  
Pilot Study ◽  
Cesarean Section ◽  
Intervention Group ◽  
Control Group ◽  
Breast Pain ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Right ◽  
Documentation Tool ◽  
And Control

<b><i>Aim:</i></b> The research was conducted as a randomized controlled pilot study to evaluate the effects of reflexology on lactation in mothers who delivered by cesarean section (CS). <b><i>Methods:</i></b> A single-blind randomized controlled experimental study was conducted with a total of 60 postpartum women in the reflexology application (<i>n</i> = 30) and control groups (<i>n</i> = 30). After the CS, the mothers in the control group were given approximately 3-h routine nursing care after recovering from the effects of anesthesia; the introductory information form was applied, and the Breastfeeding Charting System and Documentation Tool (LATCH) and visual analog scale (VAS) for the signs of the onset of lactation were implemented on the first and second days. Reflexology was applied to the women in the intervention group after an average of 3 h following the mother’s condition had become stable and she had recovered from the effects of anesthesia. Reflexology was applied a total of 20 min – 10 min for the right foot, 10 min for the left foot – twice a day with 8-h intervals on the first and second days after CS. After the last reflexology application, the LATCH and VAS for the signs of the onset of lactation were applied. <b><i>Results:</i></b> Of the women, 70% breastfed their babies within 60 min after delivery; 46.7% of the mothers received breastfeeding training and 81.7% needed support for breastfeeding after the CS. The LATCH breastfeeding scores of the women in the intervention group on both days were significantly higher compared to those of the women in the control group (<i>p</i> &#x3c; 0.001). On the first day after the CS, apart from breast pain, there was no significant difference between the two groups in terms of breast heat and breast tension (<i>p</i> &#x3e; 0.05). On the second day after the CS, apart from breast tension, there was no significant difference between the groups in terms of breast heat and breast pain (<i>p</i> &#x3c; 0.05). In the study, women in the intervention group were found to have higher scores in terms of all three symptoms compared to the control group (<i>p</i> &#x3c; 0.05). <b><i>Conclusions:</i></b> In the study, it was determined that LATCH scores and signs of the onset of breastfeeding increased in the mothers who received reflexology after CS.

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

Metabolites ◽  
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.

scholarly journals Pre-exposure prophylaxis adherence with real-time adherence feedback and partner HIV self-testing: A pilot trial among postpartum women

2021 ◽  
Author(s):  
Dvora L Joseph Davey ◽  
Kathryn Dovel ◽  
Rufaro Mvududu ◽  
Dorothy Nyemba ◽  
Nyiko Mashele ◽  
...  
Keyword(s):  
Pilot Study ◽  
Real Time ◽  
Pilot Trial ◽  
Intervention Group ◽  
Standard Of Care ◽  
Postpartum Women ◽  
Care Clinic ◽  
The Past ◽  
Self Testing ◽  
Exposure Prophylaxis

Background: Pre-exposure prophylaxis (PrEP) is safe and effective in postpartum women. HIV self-testing (HIVST) for partners combined with biofeedback counselling through real-time adherence measures may improve daily PrEP use among postpartum women. Methods: Between August 2020 and April 2021 we conducted a pilot study in one primary care clinic in Cape Town, South Africa. We randomized postpartum women who initiated PrEP in pregnancy 1:1 to the intervention group (HIVST + biofeedback counselling following urine tenofovir test) or to standard of care (facility-based HIV tests and routine counselling without biofeedback). The outcomes of interest were PrEP adherence in the past 48-72hours via urine tenofovir tests and partner HIV testing, measured 1-month after randomisation. Secondary outcomes included proportion of partners who tested for HIV and discrepancy between self-reported PrEP adherence and urine tenofovir result. Results: We enrolled 106 women (median age=26 years; median months postpartum=2). Almost half of women reported having sex since giving birth (48%); 76% of those reported condomless sex at last sex. At enrolment most women (72%) reported missing <2 doses in the past 7-days; 36% of women had tenofovir present in her urine (no significant differences by arm). One month after enrolment, 62% (n=33) of women in the intervention arm had tenofovir present in their urine compared to 34% (n=18) in the standard of care arm (RR=1.83; 95% CI=1.19, 2.82). Two-thirds of women in the intervention arm reported that her partner tested for HIV (66%; n=35); compared to 17% (n=9) in the standard of care arm (RR=3.89; 95% CI=2.08, 7.27). The proportion of women with a discrepant adherence result (self-reported good recent adherence with no tenofovir in urine test) was significantly lower in the intervention group (n=8; 17%) compared to the standard of care group (n=24; 46%) (RR=0.33; 95% CI=0.17, 0.67). No social or clinical adverse events were reported in the intervention arm. Conclusions: In this pilot study, HIVST for partners and biofeedback counseling increased levels of recent PrEP adherence, pointing to the importance of these interventions to support PrEP use in this population.

scholarly journals Sauna Yoga Superiorly Improves Flexibility, Strength, and Balance: A Two-Armed Randomized Controlled Trial in Healthy Older Adults

2019 ◽  
Vol 16 (19) ◽  
pp. 3721 ◽  
Author(s):  
Bucht ◽  
Donath
Keyword(s):  
Large Scale ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Intervention Group ◽  
Control Group ◽  
Minimization Method ◽  
Important Indicator ◽  
Randomized Controlled ◽  
Eyes Closed ◽  
Healthy Elderly

Besides strength and balance, flexibility is an important indicator of health-related physical fitness. Thus, the aim of this two-armed randomized controlled pilot trial was to investigate whether sauna yoga at a moderate temperature (50 °C) beneficially affects flexibility, strength, balance, and quality of life (QOL) in healthy elderly community dwellers. Participants were randomly assigned to an intervention group (INT, n = 11, age: 68.7 ± 5.9) or control group (CON, n = 12, age: 69.3 ± 4.9), using the minimization method. Age, physical activity, gender, and the primary outcome flexibility were used as strata for group allocation. Both groups completed similar exercises in the sauna over eight weeks. Only the INT group was exposed to moderate temperatures of 50 °C. Large and statistically significant improvement in favor of the sauna group (INT) was observed for the chair sit-and-reach test (INT: +83%, CON +3%, p = 0.028, nр² = 0.24). The shoulder and lateral spine flexibility were not relevantly affected. Strength in the lower extremities merely showed a tendency to significant changes (INT: 16%, CON: 3%, p = 0.061, nр² = 0.181). Additionally, balance abilities, with eyes closed, improved (INT: 187%, CON +58%, p = 0.056, nр² = 0.189) in favor of the INT group. QOL only improved in favor of the INT for environmental dimension (INT: +7%, CON: 0%, p = 0.034, nр² = 0.227). These first but preliminary findings indicate that sauna yoga may serve as a promising and feasible means to improve flexibility in elderly people. Strength and balance do not meaningfully benefit from a sauna environment, although strength improved to a slightly higher extent in the sauna group. Future large-scale research is needed to elucidate underlying mechanisms and corroborate these findings

scholarly journals Fructus MumeFormula in the Treatment of Type 2 Diabetes Mellitus: A Randomized Controlled Pilot Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Xiang Tu ◽  
ChunGuang Xie ◽  
Fei Wang ◽  
Qiu Chen ◽  
ZhiHuang Zuo ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Blood Glucose ◽  
Pilot Study ◽  
Controlled Trial ◽  
Glycosylated Hemoglobin ◽  
Pilot Trial ◽  
Randomized Controlled

Background. “Fructus Mumeor Dark Plum” (pilule form) has been used for many years in Traditional Chinese Medicine (TCM) and may be a valid treatment for type 2 diabetes mellitus (T2DM).Aim. One aspect toward efficacy validation is the evaluation of the blood glucose-lowering effect ofFructus Mume(FM) with T2DM patients in a randomized controlled trial (RCT).Methods. This pilot study uses a RCT procedure to assess efficacy ofFMand Metformin. The trial was for 12 weeks, with 80 T2DM subjects. Both groups were standardized in their diet and exercise routine. Comparisons of several variables were analyzed.Results. No significant differences were found between groups in the fasting and postprandial glucose levels although both had significant decreases. The values of glycosylated hemoglobin were significantly reduced in both groups. For patients whose body mass index (BMI) was <23, neitherFMnor Metformin had an effect on BMI; for those with a BMI between 23 and 25 or the BMI was >25, bothFMand Metformin significantly reduce the BMI.Conclusions. In this pilot study, it was demonstrated thatFructus Mumeformula may reduce the levels of blood glucose in patients with type 2 diabetes.

scholarly journals Improvements on Clinical Status of Adolescents With Anorexia Nervosa in Inpatient and Day Hospital Treatment: A Retrospective Pilot Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Valeria Zanna ◽  
Giulia Cinelli ◽  
Michela Criscuolo ◽  
Annamaria Caramadre ◽  
Maria Chiara Castiglioni ◽  
...  
Keyword(s):  
Heart Rate ◽  
Anorexia Nervosa ◽  
Pilot Study ◽  
Treatment Program ◽  
Inpatient Treatment ◽  
Inpatient Care ◽  
Clinical Status ◽  
Hospital Costs ◽  
Hospital Treatment ◽  
Day Hospital

Introduction: Medical and psychiatric complications and treatment compliance are important considerations in determining the treatment program for patients with severe anorexia nervosa (AN). Clinical practice guidelines agree that an outpatient program is the first choice for the treatment of most eating disorders, but vary in supporting these programs for AN. However, inpatient care is known to be costly and the risk of relapse and readmission is high. This pilot study aimed to describe the first data on an Italian partial hospitalization care program for AN adolescents [high-level care treatment (HLCT)], evaluating its impact on patients' clinical status, average hospitalization time, and the hospital costs compared to inpatient treatment (IP).Methods: For this retrospective pilot study, we have selected a group of 34 females with AN aged 11–18 years, divided between those who followed inpatient treatment and those who received HLCT treatment; they were matched for age and severity. We investigated the differences in treatment and outcomes between the two groups in terms of heart rate, length of treatment, weight gain, psychological characteristics, and hospital costs. Statistics for non-parametric distributions were used to compare the two groups.Results: No differences between the two groups were found at admission. At discharge, patients in the HLCT group presented a lower number of in-hospital treatment days, a higher increase of weight, and a significant improvement in outcomes compared to the inpatient group. No significant differences were found in heart rate and hospital costs.Conclusions: This study represents a first comparison between inpatient care and the HLCT treatment program, which suggests that day hospital treatment could represent a meeting point between inpatient and outpatient treatment, combining the merits of both forms of treatment. Further studies are needed in order to better investigate the different treatment programs for severe AN in adolescence.

scholarly journals Transcutaneous electrical acupoint stimulation for high-normal blood pressure: study protocol for a randomized controlled pilot trial

2020 ◽  
Author(s):  
Yu Wang ◽  
Guang-Xia Shi ◽  
Zhong-Xue Tian ◽  
Jun-Hong Liu ◽  
You-Sheng Qi ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Lifestyle Modification ◽  
Pilot Trial ◽  
Intervention Group ◽  
Normal Blood ◽  
Control Group ◽  
Normal Blood Pressure ◽  
Randomized Controlled ◽  
Acupoint Stimulation

Abstract Background:High-normal blood pressure (BP) is associated with increased all-cause, cardiovascular mortality and frequently progresses to hypertension. Transcutaneous electrical acupoint stimulation (TEAS) might be a non-pharmaceutical therapy option to control BP. This trial aims to determine the efficacy effectiveness and safety of TEAS combined with lifestyle modification for high-normal BP. Methods/design:This prospective, randomized and parallel clinical trial will be conducted in a community service center in China. Sixty participants with high-normal BP will be randomly allocated to receive TEAS plus lifestyle modification (intervention group) or lifestyle modification alone (control group) in a 1:1 ratio. In addition to lifestyle modification, the intervention group will receive TEAS at four acupoints for 30 minutes, 4 times weekly for 12 weeks for a total of 48 sessions at home. The control group will receive same lifestyle modification but no TEAS. The primary outcome will be the change in mean systolic blood pressure at 12-week from the baseline measurement. Secondary outcomes include the change of mean diastolic blood pressure, proportion of subjects with progression to hypertension, quality of life, physical activity, body mass index and waist circumference. Adverse events during the trial will be monitored.Discussion:This trial will explore the feasibility and provide potential evidence for the efficacy effectiveness and safety of TEAS plus lifestyle modification for high-normal BP. Furthermore, this pilot trial is being undertaken to determine the feasibility of a full scale definitive randomized controlled trial. The results of this study will be published in a peer-reviewed journal.Trial registration:Chinese Clinical Trial Registry, ChiCTR 1900024982. Registered on August 6, 2019.

scholarly journals Evaluation of FunFRIENDS program in prevention of anxiety in Brazilian children: a randomized controlled pilot trial

2020 ◽  
Vol 25 (11) ◽  
pp. 4497-4508
Author(s):  
Lina Maria Herrera Nunez Rivero ◽  
André Luiz Monezi Andrade ◽  
Larissa Zeggio Perez Figueredo ◽  
Bruno de Oliveira Pinheiro ◽  
Denise De Micheli
Keyword(s):  
Pilot Trial ◽  
Intervention Group ◽  
Anxiety Symptoms ◽  
Future Research ◽  
Control Group ◽  
Behavioral Profile ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Allocation Ratio ◽  
The City

Abstract This study aimed to evaluate the effects of the FunFRIENDS protocol on anxiety symptoms, internalizing problems and prosocial behavior in 4- to 5-year old children. Participated of this study 43 children with an allocation ratio of 1:1 between groups (Intervention Group [IG], N = 21; Control Group [CG], N = 22) from a public school in the city of Sao Paulo participated in the study. Behaviors were evaluated by using standardized questionnaires (PAS, CBCL, SDQ, SCBE) assessing the behavioral profile of the children at three different periods; baseline (T0), one month (T1) and three months (T2) after the intervention. It was observed a reduction in the intensity of anxiety symptoms in the IG after the intervention but with no significant effect. Overall, there were no significant differences between the IG and the CG in most behaviors on all periods evaluated. On both Intention-to-Treat analyses also it was not detected significant effects of the intervention. This is the first Brazilian study evaluating the effects of FunFRIENDS program and the implications of these findings are discussed and its significance for future research.

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