scholarly journals Evaluating cochlear insertion trauma and hearing preservation after cochlear implantation (CIPRES): a study protocol for a randomized single-blind controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Saad Jwair ◽  
Ralf A. Boerboom ◽  
Huib Versnel ◽  
Robert J. Stokroos ◽  
Hans G. X. M. Thomeer
Keyword(s):  
Randomized Controlled Trial ◽  
Surgical Approach ◽  
Controlled Trial ◽  
Treatment Options ◽  
Round Window ◽  
Electrode Array ◽  
Hearing Preservation ◽  
Residual Hearing ◽  
Structure Preservation ◽  
Randomized Controlled

Abstract Background In order to preserve residual hearing in patients with sensorineural hearing loss (SNHL) who receive a cochlear implant (CI), insertion trauma to the delicate structures of the cochlea needs to be minimized. The surgical approach comprises the conventional mastoidectomy-posterior tympanotomy (MPT) to arrive at the middle ear, followed by either a cochleostomy (CO) or the round window (RW) approach. Both techniques have their benefits and disadvantages. Another important aspect in structure preservation is the design of the electrode array. Two different designs are used: a “straight” lateral wall lying electrode array (LW) or a “pre-curved” perimodiolar lying electrode array (PM). Interestingly, until now, the best surgical approach and design of the implant is uncertain. Our hypothesis is that there is a difference in hearing preservation outcomes between the four possible treatment options. Methods We designed a monocenter, multi-arm, randomized controlled trial to compare insertion trauma between four groups of patients, with each group having a unique combination of an electrode array type (LW or PM) and surgical approach (RW or CO). In total, 48 patients will be randomized into one of these four intervention groups. Our primary objective is the comparison of postoperative hearing preservation between these four groups. Secondly, we aim to assess structure preservation (i.e., scalar translocation, with basilar membrane disruption or tip fold-over of array) for each group. Thirdly, we will compare objective outcomes of hearing and structure preservation by way of electrocochleography (ECochG). Discussion Cochlear implantation by way of a cochleostomy or round window approach, using different electrode array types, is the standard medical care for patients with severe to profound bilateral sensorineural hearing loss, as it is a relatively simple and low-risk procedure that greatly benefits patients. However, loss of residual hearing remains a problem. This trial is the first randomized controlled trial that evaluates the effect of cochlear insertion trauma of several CI treatment options on hearing preservation. Trial registration Netherlands Trial Register (NTR) NL8586. Registered on 4 May 2020. Retrospectively registered; 3/48 participants were included before registration.

scholarly journals Evaluating cochlear insertion trauma and hearing preservation after cochlear implantation (CIPRES): A study protocol for a randomised single blind controlled trial

2020 ◽  
Author(s):  
Saad Jwair ◽  
Ralf Boerboom ◽  
Huib Versnel ◽  
Robert Stokroos ◽  
Hans Thomeer
Keyword(s):  
Randomized Controlled Trial ◽  
Hearing Loss ◽  
Surgical Approach ◽  
Controlled Trial ◽  
Round Window ◽  
Electrode Array ◽  
Hearing Preservation ◽  
Residual Hearing ◽  
Structure Preservation ◽  
Randomized Controlled

Abstract BackgroundIn order to preserve residual hearing in patients with sensorineural hearing loss (SNHL) who receive a cochlear implant (CI), insertion trauma to the delicate structures of the cochlea needs to be minimized. The surgical approach comprises the conventional mastoidectomy-posterior tympanotomy (MPT) to arrive at the middle ear, followed by either a cochleostomy (CO) or the round window (RW) approach. Both techniques have their benefits and disadvantages. Another important aspect in structure preservation is the design of the electrode array. Two different designs are used: a ‘straight’ lateral wall lying electrode array (LW), or a ‘pre-curved’ perimodiolar lying electrode array (PM). Interestingly, until now, the best surgical approach and design of the implant is uncertain. Our hypothesis is that the combination of a RW approach and a LW lying electrode array minimizes insertion trauma, leading to better hearing outcome for SNHL patients. MethodsWe designed a monocenter, 2x2, randomized controlled trial to compare insertion trauma between four groups of patients, with each group having a unique combination of electrode array type (LW or PM) and surgical approach (RW or CO). In total, 48 patients will be randomized into one of these four intervention groups. Our primary objective is comparison of postoperative hearing preservation between these four groups. Secondly, we aim to assess structure preservation (i.e., scalar transposition, with basilar membrane disruption or tip fold-over of array) for each group. Thirdly, we will compare objective outcomes of hearing and structure preservation by way of electrocochleography (ECochG).DiscussionCochlear implantation by way of a cochleostomy or round window approach, using different electrode array types, is the standard medical care for patients with severe to profound bilateral sensorineural hearing loss, as it is a relative simple and low-risk procedure that greatly benefits patients. However, loss of residual hearing remains a problem. This trial is the first randomized controlled trial that evaluates the effect of cochlear insertion trauma of several CI treatment options on hearing preservation. Trial registrationThis trial is registered in the Netherlands Trial Register (NTR) (www.trialregister.nl): NL8586, date of registration: 4th of May 2020. Retrospectively registered; 3/48 participants were included before registration.

scholarly journals Treatment of Subacromial Impingement Syndrome: Platelet-Rich Plasma or Exercise Therapy? A Randomized Controlled Trial

2017 ◽  
Vol 5 (5) ◽  
pp. 232596711770236 ◽  
Author(s):  
Parisa Nejati ◽  
Armita Ghahremaninia ◽  
Farrokh Naderi ◽  
Safoora Gharibzadeh ◽  
Ali Mazaherinezhad
Keyword(s):  
Randomized Controlled Trial ◽  
Exercise Therapy ◽  
Muscle Force ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Treatment Options ◽  
Impingement Syndrome ◽  
Subacromial Impingement Syndrome ◽  
Subacromial Impingement ◽  
Randomized Controlled

Background: Subacromial impingement syndrome (SAIS) is the most common disorder of the shoulder. The evidence for the effectiveness of treatment options is inconclusive and limited. Therefore, there is a need for more evidence in this regard, particularly for long-term outcomes. Hypothesis: Platelet-rich plasma (PRP) would be an effective method in treating subacromial impingement. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This was a single-blinded randomized clinical trial with 1-, 3-, and 6-month follow-up. Sixty-two patients were randomly placed into 2 groups, receiving either PRP or exercise therapy. The outcome parameters were pain, shoulder range of motion (ROM), muscle force, functionality, and magnetic resonance imaging findings. Results: Both treatment options significantly reduced pain and increased shoulder ROM compared with baseline measurements. Both treatments also significantly improved functionality. However, the treatment choices were not significantly effective in improving muscle force. Trend analysis revealed that in the first and third months, exercise therapy was superior to PRP in pain, shoulder flexion and abduction, and functionality. However, in the sixth month, only shoulder abduction and total Western Ontario Rotator Cuff score were significantly different between the 2 groups. Conclusion: Both PRP injection and exercise therapy were effective in reducing pain and disability in patients with SAIS, with exercise therapy proving more effective.

Providing information about the effectiveness of treatment options to depressed people in the community: a randomized controlled trial of effects on mental health literacy, help-seeking and symptoms

2003 ◽  
Vol 33 (6) ◽  
pp. 1071-1079 ◽  
Author(s):  
A. F. JORM ◽  
K. M. GRIFFITHS ◽  
H. CHRISTENSEN ◽  
A. E. KORTEN ◽  
R. A. PARSLOW ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Help Seeking ◽  
Mental Health Literacy ◽  
Controlled Trial ◽  
Treatment Options ◽  
Evidence Based ◽  
Symptom Change ◽  
Professional Help ◽  
Randomized Controlled

Background. Many people who are depressed do not receive any professional help and their beliefs about the helpfulness of treatment do not always correspond with those of health professionals. To facilitate choices about treatment, the present study examined the effects of providing depressed people in the community with evidence on whether various treatment options work.Method. A randomized controlled trial was carried out with 1094 persons selected at random from the community who screened positive for depressive symptoms and agreed to participate. Participants were mailed either an evidence-based consumer guide to treatments for depression or, as a control, a general brochure on depression. Outcomes were the rated usefulness of the information provided, changes in attitudes to depression treatments, actions taken to reduce depression, and changes in depressive symptoms, anxiety symptoms and disability.Results. Participants rated the evidence-based consumer guide as more useful than the control brochure. Attitudes to some treatments changed. Improvements in symptoms and disability did not differ significantly between interventions.Conclusion. Providing people who are depressed with evidence on which treatments work produces some changes in attitudes and behaviour. However, this intervention may need to be enhanced if it is to produce symptom change.

scholarly journals Developing and Testing the Effectiveness of a Novel Online Integrated Treatment for Problem Gambling and Tobacco Smoking: A Protocol for a Randomized Controlled Trial

2020 ◽  
Author(s):  
Elena Bilevicius ◽  
Alanna Single ◽  
Chris Baumgartner ◽  
Van Bui ◽  
Tyler Kempe ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Problem Gambling ◽  
Tobacco Smoking ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Treatment Options ◽  
Integrated Treatment ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Gambling Activities

Abstract Background: Gambling and tobacco smoking are highly comorbid among North American adults. However, there is a paucity of treatment options that are integrated (i.e., targeting both gambling and tobacco smoking simultaneously), accessible, and evidence based.Methods: The aim of this two-arm randomized controlled trial is to examine the effectiveness of an online, self-guided integrated treatment for problem gambling and tobacco smoking. A target sample of 214 participants will be recruited and be randomized into either an eight-week integrated or gambling-only control condition. Both conditions will consist of seven online modules following cognitive behavioral therapy and motivational interviewing principles. Our three primary outcomes are (1) number of days gambled, (2) money spent on gambling activities, and (3) time spent in gambling activities. Secondary outcomes include gambling disorder symptoms, cigarette use, and nicotine dependence symptoms. Assessments will be completed at baseline, at completion (i.e., eight-weeks from baseline), and follow-up (i.e., 24-weeks from baseline). Generalized linear mixed modelling will be used to evaluate our primary and secondary outcomes. We expect that participants receiving online integrated treatment will show larger reductions in gambling relative to those receiving a control gambling only intervention. We further hypothesize that reductions in smoking will mediate these group differences.Discussion: The rates of problem gambling and tobacco smoking are high in North America; yet, the treatment options for both are limited, with no integrated treatments available. If supported, our intervention will be a cost-effective and accessible way to improve treatments for co-occurring problem gambling and tobacco use.Trial registration: Clinicaltrials.gov; ID NCT03614884. Registered August 3, 2019;

scholarly journals The Effects of Tai Chi on Grade 1 Hypertension: A Study Protocol for a Randomized Controlled Trial

2019 ◽  
Author(s):  
Sang Hyun Lee ◽  
Byung-Jun Kim ◽  
In-Hwa Park ◽  
Eui-Hyoung Hwang ◽  
Eun Ju Park ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Tai Chi ◽  
Salt Intake ◽  
Controlled Trial ◽  
Treatment Options ◽  
Treatment Method ◽  
Care Group ◽  
Randomized Controlled

Abstract Background Medication is generally recommended to reduce the morbidity and mortality caused by cardiovascular disease in hypertensive patients. However, considering the difficulties and economic factors associated with long-term medication, interest in tai chi as an exercise treatment method has been recently increasing in Korean medical practice. Numerous studies have suggested that tai chi can be used to treat various diseases and affect psychosomatic factors such as anxiety. This study aims to evaluate the effect of tai chi in reducing blood pressure among grade 1 hypertensive patients.Methods In this randomized, active-controlled, assessor-blinded, two parallel-armed trial, 80 grade 1 hypertension patients will be recruited and randomly assigned to the usual care group or to the tai chi group (n = 40 in each group). Subjects who voluntarily signed a study agreement will be educated to manage their own blood pressure by restricting salt intake, losing weight, moderating alcohol consumption, performing exercise, and regulating dietary intake at their first visit. In addition to self-management, the tai chi group will perform two 60-minute tai chi sessions per week for a total of 8 weeks. Blood pressure will be measured as the primary outcome. In addition, body composition, heart rate, and the perceived strength and difficulty of the exercise will be measured as secondary outcomes.Discussion This study intends to conduct a randomized controlled trial of tai chi, which is not widely practiced in Korea. This study will provide valuable data on the effects of tai chi on hypertension, to inform non-pharmaceutical treatment options for this disorder.

scholarly journals Assessing the Efficacy of an Educational Smartphone or Tablet App With Subdivided and Interactive Content to Increase Patients’ Medical Knowledge: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Thomas Timmers ◽  
Loes Janssen ◽  
Yvette Pronk ◽  
Babette C van der Zwaard ◽  
Sander Koëter ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Treatment Options ◽  
Intervention Group ◽  
Control Group ◽  
Perceived Knowledge ◽  
Actual Knowledge ◽  
Positive Effects ◽  
Randomized Controlled

BACKGROUND Modern health care focuses on shared decision making (SDM) because of its positive effects on patient satisfaction, therapy compliance, and outcomes. Patients’ knowledge about their illness and available treatment options, gained through medical education, is one of the key drivers for SDM. Current patient education relies heavily on medical consultation and is known to be ineffective. OBJECTIVE This study aimed to determine whether providing patients with information in a subdivided, categorized, and interactive manner via an educational app for smartphone or tablet might increase the knowledge of their illness. METHODS A surgeon-blinded randomized controlled trial was conducted with 213 patients who were referred to 1 of the 6 Dutch hospitals by their general practitioner owing to knee complaints that were indicative of knee osteoarthritis. An interactive app that, in addition to standard care, actively sends informative and pertinent content to patients about their illness on a daily basis by means of push notifications in the week before their consultation. The primary outcome was the level of perceived and actual knowledge that patients had about their knee complaints and the relevant treatment options after the intervention. RESULTS In total, 122 patients were enrolled in the control group and 91 in the intervention group. After the intervention, the level of actual knowledge (measured on a 0-36 scale) was 52% higher in the app group (26.4 vs 17.4, P<.001). Moreover, within the app group, the level of perceived knowledge (measured on a 0-25 scale) increased by 22% during the week within the app group (from 13.5 to 16.5, P<.001), compared with no gain in the control group. CONCLUSIONS Actively offering patients information in a subdivided (per day), categorized (per theme), and interactive (video and quiz questions) manner significantly increases the level of perceived knowledge and demonstrates a higher level of actual knowledge, compared with standard care educational practices. CLINICALTRIAL International Standard Randomized Controlled Trial Number ISRCTN98629372; http://www.isrctn.com/ISRCTN98629372 (Archived by WebCite at http://www.webcitation.org/73F5trZbb)

scholarly journals Developing and Testing the Effectiveness of a Novel Online Integrated Treatment for Problem Gambling and Tobacco Smoking: A Protocol for an Open Label Randomized Controlled Trial

2020 ◽  
Author(s):  
Elena Bilevicius ◽  
Alanna Single ◽  
Chris Baumgartner ◽  
Van Bui ◽  
Tyler Kempe ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Problem Gambling ◽  
Tobacco Smoking ◽  
Controlled Trial ◽  
Treatment Options ◽  
Integrated Treatment ◽  
Open Label ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Gambling Activities

Abstract Background: Gambling and tobacco smoking are highly comorbid among North American adults. However, there is a paucity of treatment options that are integrated (i.e., targeting both gambling and tobacco smoking simultaneously), accessible, and evidence based. Methods: The aim of this two-arm open label randomized controlled trial is to examine the effectiveness of an online, self-guided integrated treatment for problem gambling and tobacco smoking. A target sample of 214 participants will be recruited and be randomized into either an eight-week integrated or gambling-only control condition. Both conditions will consist of seven online modules following cognitive behavioral therapy and motivational interviewing principles. Our three primary outcomes are (1) number of days gambled, (2) money spent on gambling activities, and (3) time spent in gambling activities. Secondary outcomes include gambling disorder symptoms, cigarette use, and nicotine dependence symptoms. Assessments will be completed at baseline, at completion (i.e., eight-weeks from baseline), and follow-up (i.e., 24-weeks from baseline). Generalized linear mixed modelling will be used to evaluate our primary and secondary outcomes. We expect that participants receiving online integrated treatment will show larger reductions in gambling relative to those receiving a control gambling only intervention. We further hypothesize that reductions in smoking will mediate these group differences. Discussion: The rates of problem gambling and tobacco smoking are high in North America; yet, the treatment options for both are limited, with no integrated treatments available. If supported, our pilot study will be a cost-effective and accessible way to improve treatments for co-occurring problem gambling and tobacco use. Trial registration: Clinicaltrials.gov; ID NCT03614884. Registered August 3, 2019; https://clinicaltrials.gov/ct2/show/NCT03614884?term=keough&rank=1

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