scholarly journals Impact of perioperative use of GnRH agonist or dienogest on ovarian reserve after cystectomy for endometriomas: a randomized controlled trial

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Ayako Muraoka ◽  
Satoko Osuka ◽  
Atsushi Yabuki ◽  
Bayasula ◽  
Masato Yoshihara ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Ovarian Reserve ◽  
Controlled Trial ◽  
Hormonal Treatment ◽  
Perioperative Period ◽  
Inflammatory Reactions ◽  
Randomized Controlled ◽  
Link Type ◽  
Ovarian Endometrioma ◽  
Before And After

Abstract Background Ovarian endometrioma is a common gynecological disease that is often treated with surgery or hormonal treatment. Ovarian cystectomy, a surgical procedure for ovarian endometrioma, can result in impaired ovarian reserve. Methods We conducted a randomized controlled trial to evaluate the efficacy of hormonal treatment [gonadotropin-releasing hormone agonist (GnRHa) or dienogest (DNG)] for preserving ovarian reserve after cystectomy for ovarian endometrioma. The primary endpoint was the level of serum Anti-Müllerian hormone (AMH) as a marker of ovarian reserve. Results Before and after laparoscopic surgery, 22 patients in the GnRHa group and 27 patients in the DNG group were administered hormonal treatment for a total of 4 months. After 1-year follow-up, >60% of the patients in the DNG group retained over 70% of their pretreatment AMH levels, whereas no patient in the GnRHa group retained their AMH levels after cystectomy (P < 0.01). Interleukin-6 (IL-6) is a key cytokine involved in inflammation. Compared with the GnRHa group, patients in the DNG group had lower IL-6 levels at the end of treatment. Conclusions Our data revealed that DNG is more effective than GnRHa in preserving ovarian reserve after cystectomy of ovarian endometrioma. This is achieved through the reduction of the inflammatory response during the perioperative period and other endometriosis-related inflammatory reactions. Trial registration The registration number of this trial is UMIN-CTR, UMIN000018569, registered 6 August 2015, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021492, and Japan Registry of Clinical Trials, jRCTs041180140, registered 29 March 2019, https://jrct.niph.go.jp/en-latest-detail/jRCTs041180140. This randomized controlled trial was conducted in accordance with the CONSORT guidelines.

scholarly journals Effect of Capsaicin Atomization–Induced Cough on Sputum Excretion in Tracheotomized Patients After Hemorrhagic Stroke: A Randomized Controlled Trial

2021 ◽  
pp. 1-11
Author(s):  
Chao Wu ◽  
Yijie Zhang ◽  
Li Yang ◽  
Fang Shen ◽  
Chen Ma ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hemorrhagic Stroke ◽  
Controlled Trial ◽  
Intervention Group ◽  
Routine Care ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Link Type ◽  
Before And After

Background Timely and effective removal of respiratory secretions is of great significance for tracheotomized patients. The purpose of this study is to investigate the effectiveness of capsaicin nebulization to stimulate cough to promote early clearance of respiratory secretions in tracheotomized patients after hemorrhagic stroke. Method This study implemented a randomized controlled design. Sixty-three patients who were tracheotomized following a hemorrhagic stroke completed this randomized controlled trial. In the control group, 33 cases were given a routine care after tracheotomy. In the intervention group, 30 cases were given a capsaicin solution nebulization in addition to the routine care. The daily sputum output and the number of sputum suctioning were observed. The differences in sputum viscosity, cough function, and Clinical Pulmonary Infection Score (CPIS) were compared between the two groups before and after the intervention. Vital sign changes during capsaicin nebulization and suctioning were compared between the two groups in a pilot study. Results The daily sputum output of the capsaicin intervention group was significantly higher than that of the control group ( p < .05). The number of sputum suctioning of capsaicin group was less than that of the control group after intervention ( p < .05). The CPIS score of the capsaicin group was lower than that of the control group ( p < .05) after a 1-week intervention. Patients' heart rate, respiratory rate, and oxygen saturation during capsaicin nebulization were not statistically different from those during routine sputum suctioning ( p > .05). Conclusions Capsaicin atomization–induced cough can effectively promote sputum excretion of hemorrhagic stroke patients undergoing tracheotomy and has a good safety profile. The Clinical Trial registration number of this study is ChiCTR2000037772 ( http://www.chictr.org.cns ). Supplemental Material https://doi.org/10.23641/asha.16821352

scholarly journals Effectiveness of interactive augmented reality-based telerehabilitation in patients with adhesive capsulitis: protocol for a multi-center randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Seung Mi Yeo ◽  
Ji Young Lim ◽  
Jong Geol Do ◽  
Jae-Young Lim ◽  
Jong In Lee ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Physical Therapy ◽  
Augmented Reality ◽  
Controlled Trial ◽  
Adhesive Capsulitis ◽  
Performance Measure ◽  
Home Exercise ◽  
Randomized Controlled ◽  
Link Type ◽  
Home Based

Abstract Background As the primary treatment for adhesive capsulitis, intensive and accurate home exercise is as important as physical therapy in hospitals. Augmented reality (AR)-based telerehabilitation has been implemented recently in various musculoskeletal conditions to increase patient compliance and enable patients to exercise with the correct posture. The objective of this study is to present a protocol for investigating the additive effect of interactive AR-based telerehabilitation in comparison with the usual care for patients with adhesive capsulitis. Methods This study presents the protocol of a prospective, multi-center, single-blinded, two-armed randomized controlled trial (RCT). One hundred patients with stage I or II adhesive capsulitis will be recruited at the physical medicine and rehabilitation clinic. Patients will be randomly divided into two groups with 1:1 allocation. The intervention group will receive 3 months of hospital-based physical therapy in conjunction with home-based telerehabilitation. The control group will receive 3 months of hospital-based physical therapy in conjunction with a home-based exercise described in a brochure provided by the hospital. The primary outcome will be the change in passive range of motion (ROM) of the affected shoulder joint from baseline to 12 weeks after baseline assessment. The secondary outcomes will be active ROM, pain measured with the numeric rating scale, shoulder pain and disability index, 36-Item Short Form Survey, EuroQoL-5D-5L, and Canadian Occupational Performance Measure. Discussion This will be the first RCT study protocol to investigate the effect of telerehabilitation in patients with adhesive capsulitis. The result of this RCT will determine whether AR-based telerehabilitation is more effective than a brochure-based home exercise program and will provide evidence of the usefulness of “telerehabilitation” using hardware (IoT) and software (monitoring platform) technologies to develop “digital therapeutics” for the future. Trial registration This trial was retrospectively registered at the Clinicaltrials.gov website on 20 March 2020, with the identifier NCT04316130.

scholarly journals Effects of the Suboccipital Muscle Inhibition Technique on the Range of Motion of the Ankle Joint and Balance According to Its Application Duration: A Randomized Controlled Trial

Healthcare ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 646
Author(s):  
Han-Sol Kang ◽  
Hyung-Wook Kwon ◽  
Di-gud Kim ◽  
Kwang-Rak Park ◽  
Suk-Chan Hahm ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Range Of Motion ◽  
Ankle Joint ◽  
Controlled Trial ◽  
Balance Test ◽  
Randomized Controlled ◽  
Active Range Of Motion ◽  
Before And After ◽  
Muscle Inhibition ◽  
Inhibition Technique

This study aimed to investigate the effects of suboccipital muscle inhibition technique (SMIT) on active range of motion (AROM) of the ankle joint, lunge angle (LA), and balance in healthy adults, according to the duration of its application. A total of 80 participants were randomly allocated to the 4-min suboccipital muscle inhibition (SMI) group (SMI_4M, n = 20), 8-min SMI group (n = 20), 4-min sham-SMI (SSMI) group (n = 20), and 8-min SSMI group (n = 20). Accordingly, the SMIT and sham SMIT were applied for 4 min or 8 min in the respective groups. AROM of dorsiflexion and LA were assessed, and a single leg balance test (SLBT) was performed before and after the intervention. AROM (4 min, p < 0.001; 8 min, p < 0.001), LA (4 min, p < 0.001; 8 min, p < 0.001), and SLBT (4 min, p < 0.001; 8 min, p < 0.001) significantly improved after SMI application. Compared with the SSMI group, the SMI group showed a significant increase in AROM (p < 0.001), LA (p < 0.001), and SLBT (p < 0.001). Except for SLBT (p = 0.016), there were no significant interactions between intervention and application duration. The results suggest that the SMIT, at durations of both 4 and 8 min, could be effective tools for improving AROM, LA, and balance.

scholarly journals The ACTyourCHANGE study protocol: promoting a healthy lifestyle in patients with obesity with Acceptance and Commitment Therapy—a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anna Guerrini Usubini ◽  
Roberto Cattivelli ◽  
Emanuele Maria Giusti ◽  
Francesco Vailati Riboni ◽  
Giorgia Varallo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Acceptance And Commitment Therapy ◽  
Mechanism Of Action ◽  
Healthy Lifestyle ◽  
Controlled Trial ◽  
Psychological Flexibility ◽  
Randomized Controlled ◽  
Link Type ◽  
Commitment Therapy ◽  
Acceptance And Commitment

Abstract Background As treatment of choice in promoting psychological flexibility, Acceptance and Commitment Therapy (ACT) was found to be effective in several conditions, and among different populations, including weight management in individuals with obesity. However, the mechanism of action of psychological flexibility is less known. The aim of the present study is, within the context of a brief ACT intervention for behavioral change and behavioral maintenance of a healthy lifestyle in a sample of inpatients with obesity, to explore the effect of each subcomponent of the psychological flexibility model on treatment processes and outcomes. Methods A randomized controlled trial will be conducted. Ninety Italian adult inpatients with obesity attending a rehabilitation program for weight loss will be randomly allocated into three experimental conditions targeting respectively each subcomponent of the psychological flexibility model: group Engage focused on values-oriented behaviors, group Openness focused on acceptance and cognitive defusion, and group Awareness focused on being present and aware of thoughts, feelings, and behaviors at every moment. Weight, BMI (kg/m2), the Psychological General Well-Being Inventory (PGWBI), the Outcome Questionnaire-45.2 (OQ-45.2), the Depression Anxiety and Stress Scale (DASS-21), the Difficulties in Emotion Regulation Scale (DERS), the Dutch Eating Behaviors Questionnaire (DEBQ), the Brief Values Inventory (BVI), the Committed Action Questionnaire (CAQ), the Italian-Cognitive Fusion Questionnaire (I-CFQ), the Five Facet Mindfulness Questionnaire (FFMQ), and the Acceptance and Action Questionnaire (AAQ-II) will be assessed at the beginning (time 0), at the end of psychological intervention (time 1), and after 3 (time 2) and 6 months (time 3) and 9 months (time 4) from discharge. During the following month after discharge, outpatients will be monitored in their adherence to a healthy lifestyle, using a wearable device. To assess the effectiveness of the intervention, mixed between-within 3 (conditions) × 4 (times) repeated measure ANOVAs will be conducted to examine changes from time 0 to time 1, 2, 3, and 4 in means of weight, BMI, and means of scores PGWBI, OQ-45.2, DASS, DERS, DEBQ, AAQ-II, BVI, CAQ, I-CFQ, and FFMQ, between three groups. Discussion This study will contribute to clarify the mechanism of action of each subcomponent of the psychological flexibility model and understand its impact on the promotion of a healthy lifestyle. Trial registration ClinicalTrials.govNCT04474509. Registered on July 4, 2020

scholarly journals Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

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

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.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

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