Publisher: Medip Academy   (Total: 12 journals)   [Sort by number of followers]

Showing 1 - 12 of 12 Journals sorted alphabetically
Intl. J. of Advances in Medicine     Open Access   (Followers: 5)
Intl. J. of Basic & Clinical Pharmacology     Open Access   (Followers: 4)
Intl. J. of Clinical Trials     Open Access   (Followers: 5)
Intl. J. of Community Medicine and Public Health     Open Access   (Followers: 8)
Intl. J. of Contemporary Pediatrics     Open Access   (Followers: 11)
Intl. J. of Otorhinolaryngology and Head and Neck Surgery     Open Access   (Followers: 1)
Intl. J. of Reproduction, Contraception, Obstetrics and Gynecology     Open Access   (Followers: 17)
Intl. J. of Research in Dermatology     Open Access   (Followers: 1)
Intl. J. of Research in Medical Sciences     Open Access   (Followers: 7)
Intl. J. of Research in Orthopaedics     Open Access   (Followers: 1)
Intl. J. of Scientific Reports     Open Access   (Followers: 4)
Intl. Surgery J.     Open Access   (Followers: 5)
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International Journal of Clinical Trials
Number of Followers: 5  

  This is an Open Access Journal Open Access journal
ISSN (Print) 2349-3240 - ISSN (Online) 2349-3259
Published by Medip Academy Homepage  [12 journals]
  • Comparison of the mean healing time of wound after vacuum assisted closure
           versus conventional dressing in diabetic foot ulcer patients

    • Authors: Mehwish Mooghal, Muhammad Usman, Wajiha Khan, Lal Bux Brohi, Asrar Ahmad, Kamran Rahim
      Pages: 273 - 277
      Abstract: Background: Diabetic foot ulcers (DFU’s) are chronic wounds in diabetics resulting from ischemia, angiogenesis defects and impaired immunity. Vacuum assisted closure (VAC) provides a new paradigm for diabetic wound dressing. This study compares the mean healing time of wound after VAC versus conventional dressing (CD) in DFU patients.Methods: This randomized controlled trial carried out at surgery department, at tertiary teaching hospital over a period from 28th February-27th August 2020. Total 60 patients of age (25-75 years), both genders having DFU were included. Patients were placed randomly into two groups i.e., group A (VAC therapy) and group B (CD), by using lottery method. Mean healing time noted in both groups. For statistical analysis, SPSS version 20.0 was used. Independent ‘t’ test used to compare the mean healing time of both groups and p≤0.05 considered significant. Effect modifiers were controlled through stratification and post-stratification independent ‘t’ test, to see their effect on healing time. P≤0.05 was considered significant.Results: The mean age of patients in group A was 53.13±9.09 years and in group B was 53.53±9.09 years. Out of 60 patients 41 (68.33%) were males and 19 (31.67%) were females. The mean healing time of wound in DFU patients after VAC closure (group A) was 12.07±2.15 days and after CD (group B) was 17.50±3.16 days with p=0.0001.Conclusions: Study concluded that mean healing time after VAC is less in DFU patients as compared to CD.
      PubDate: 2021-10-22
      DOI: 10.18203/2349-3259.ijct20214106
      Issue No: Vol. 8, No. 4 (2021)
       
  • Examining the effecting of a life-coaching intervention on breast cancer
           survivors’ post treatment adjustment: protocol of a parallel group
           randomized controlled trial

    • Authors: Sarkis Meterissian, Virginia Lee, Wing Lam Tock, Sophie Blondin, Christine Maheu
      Pages: 278 - 284
      Abstract: Background: The growing number of breast cancer survivors in the country has warranted health interventions targeted to mitigate the bio-psychosocial impact associated with a cancer diagnosis and the toxicities of oncological treatments. Life coaching is a widely adopted intervention strategy to promote an individual’s positive psychological adaptation, self-management, and self-confidence. This present study will investigate whether a life coaching intervention with group and individual coaching components can significantly improve quality of life (QoL) and post traumatic growth among breast cancer survivors.Methods: This study is a randomized controlled trial with three parallel study arms. A prospective sample size of 120 adult breast cancer survivors will be randomized into one of the three study groups either to receive: 1) group coaching following by individual coaching sessions; 2) group coaching sessions only; or 3) routine care. The primary outcome evaluates post traumatic growth and secondary outcomes assess QoL and fear of cancer recurrence (FCR). Data collection will occur at baseline (T0) and at 3 weeks (T1), and at 18 weeks (T2). A follow-up assessment will occur at 30 weeks (T3).Conclusions: This is the first randomized control trial to address post traumatic growth among breast cancer survivors using a life coaching intervention. If positive, the results of this study could inform intervention development that benefits the health of cancer survivors.Trial registration: This trial is ethically approved and registered with clinical trial registry (NCT05020561).
      PubDate: 2021-10-22
      DOI: 10.18203/2349-3259.ijct20214035
      Issue No: Vol. 8, No. 4 (2021)
       
  • Comparing skill enhanced and standard cognitive behavioral therapy for
           depression: a protocol for a randomized trial

    • Authors: Samuel T. Murphy, Daniel R. Strunk, Brooklynn Bailey, Graham C. Bartels, Lisa N. Vittorio, Megan L. Whelen, Robert J. Zhou
      Pages: 285 - 291
      Abstract: Background: Cognitive behavioral therapy (CBT) features prominently among the first-line treatments for depression. The development of CBT skills is associated with both symptom reductions and reduced risk for relapse, suggesting that improvements in CBT skills might be important to the benefits of CBT. Nonetheless, standard CBT places modest emphasis on the development of these skills.Methods: In this paper, we describe a randomized clinical trial testing the benefits of a variation of CBT that places greater emphasis on teaching patients CBT skills and makes patients' independent use of these skills a central therapeutic goal. Patients in this study (75 per condition) are being randomized to 12 weeks of standard or skill enhanced CBT for depression. The primary outcomes are change in symptoms and change in CBT skills. We will also evaluate the process of change in the treatments.Conclusions: This study has the potential to suggest an approach to enhancing CBT outcomes through greater focus on patients developing and independently using CBT skills. It will also provide an important context for understanding the role that CBT skills play in the therapeutic outcomes of CBT.Trial registration: The trial has been registered in ClinicalTrials.gov. Registration number: NCT04673513; registered on 17 December 2020.
      PubDate: 2021-10-22
      DOI: 10.18203/2349-3259.ijct20214107
      Issue No: Vol. 8, No. 4 (2021)
       
  • Consumer focused education on acetaminophen side effects, inadequate
           outcomes and weaning for individuals with low back pain: protocol for a
           feasibility study

    • Authors: Thomas Patterson, Justin Turner Turner, Danijela Gnjidic, Barbara Mintzes, Melissa Baysari, Carol Bennett, Lisa Bywaters, Ornella Clavisi, Manuela Ferreira, Paula Beckenkamp, Paulo Ferreira
      Pages: 292 - 300
      Abstract: Background: Prescription and over the counter medications, such as paracetamol, account for a significant proportion of the direct and indirect costs in managing low back pain (LBP). Existing research has not only questioned the efficacy of paracetamol use for musculoskeletal conditions such as LBP, but also its safety. No previous study has investigated the feasibility of a pharmacological education tool for individuals using paracetamol to manage their LBP. The aims of this study are to investigate: (1) the acceptability and experience of participants with the pharmacological education tool, (2) feasibility of recruitment, data collection and outcome measure completion, and (3) participant’s willingness to participate in a randomised control trial.Methods: This will be a single group repeated measures study design recruiting individuals from community organisations. Included participants will be over 18 years, experiencing acute, chronic or recurrent episodes of LBP and self-report consumption of paracetamol for pain relief weekly for at least one month. This study will be open for recruitment from June 2021 to August 2021.Conclusions: Our findings will inform the feasibility of conducting a larger randomised controlled trial. This study will be judged as feasible to proceed to a full trial based if, 1) recruitment sources are each able to enrol at least 20 participants into the study within three months of initial advertisement, 2) the majority of participants find the study and intervention experience as acceptable, and 3) there is less than 20% of missing data for the primary outcomes, and a minimum of 85% follow-up rate for enrolled participants.
      PubDate: 2021-10-22
      DOI: 10.18203/2349-3259.ijct20214108
      Issue No: Vol. 8, No. 4 (2021)
       
  • The effect of post colonoscopy abdominal massage on abdominal pain,
           distension, discomfort and patient satisfaction: a randomized controlled
           study protocol

    • Authors: Dilek Ozturk, Aysel Gurkan
      Pages: 301 - 307
      Abstract: Background: Abdominal pain, distension, and discomfort are the most frequently seen side effects after colonoscopy. These side effects can cause physical and mental results and increased workloads and care costs. Additionally, the satisfaction of the patients with the colonoscopy process may affect their willingness to undergo repeated colonoscopies in the future which may be required for the surveillance of colon malignity. Currently, there are no studies evaluating the effects of abdominal massage on post colonoscopy these abdominal symptoms. The aim of the study was to evaluate the effect of post colonoscopy abdominal massage on abdominal pain, distension, discomfort, and patient satisfaction.Methods: This study was designed as a prospective randomized controlled study. Participants meeting inclusion criteria will be assigned to intervention and control groups using a random number generator. Participants assigned to the intervention group will receive abdominal massages twice a day after colonoscopy, and participants assigned to the control group will receive only ‘routine care’. The abdominal pain, distension, discomfort, and satisfaction levels of the patients will be evaluated using the Visual analogue scale.Conclusions: New approaches are needed to improve the physiological and psychological health levels of patients after colonoscopy and help them return to their daily life activities and social lives faster. The trial will provide valuable evidence to inform clinical application and help evaluate the effects of the use of the relevant intervention.Trial registration: Clinical trials registration number NCT04979351.
      PubDate: 2021-10-22
      DOI: 10.18203/2349-3259.ijct20214109
      Issue No: Vol. 8, No. 4 (2021)
       
  • Effect of a suite of aggression management modules on health professions
           student knowledge, skills and confidence: an investigator-blinded,
           parallel-group randomised controlled trial protocol

    • Authors: Steven Lau, Katrina Recoche, Robyn Fairhall, Cameron Gosling, Bernadette Hayman, Primrose Lentin, Jim Snipe, Shelley Turner, Caroline Wright, Allie Ford, Kristin Lo
      Pages: 308 - 314
      Abstract: Background: Incidents of aggression are increasing in healthcare. Students are at higher risk of being on the receiving end of client aggression due to their lack of experience. Students also do not feel prepared to manage these situations.Methods: Students of health professions in the School of Primary and Allied Health Care will be eligible and contacted within lectures/via the learning management system Moodle. A randomised controlled trial (RCT) will be conducted to evaluate a suite of online aggression management modules for health professions students prior to entering their clinical years of study. If students are able to undertake face to face simulations they will be assessed by academic staff members using the English modified de-escalating aggressive behaviour scale (EMDABS). Mock clients will assess the students using the consultation and relational empathy (CARE) measure. Students will complete a self-assessment using the confidence with coping with patient aggression instrument and a knowledge questionnaire.Conlusions: This RCT will provide novel information on the effectiveness of delivering a suite of online aggression management modules to health professions students. There are three separate modules each of approximately 30 minutes duration such that the attention of students is maintained. The three modules are: 1. Recognising and preventing aggression-the basics, 2. Responding to aggression-the basics, 3. Aggression in healthcare-the basics (Case study).Trial registration number: This trial has been registered with the Australian and New Zealand clinical trials registry (ANZCTR) ACTRN12621000382875.
      PubDate: 2021-10-22
      DOI: 10.18203/2349-3259.ijct20214110
      Issue No: Vol. 8, No. 4 (2021)
       
  • Effect of active warming during general anaesthesia on post-operative body
           temperature, shivering, thermal comfort, pain, nausea and vomiting in
           adult patients: a randomized clinical trials protocol

    • Authors: Özlem Şahin Akboğa, Aysel Gürkan
      Pages: 315 - 322
      Abstract: Background: This study aims to investigate the effects of individual and combined use of intraoperative forced-air warming and warmed intravenous and irrigation fluids on post-operative body temperature, shivering, thermal comfort, pain, nausea and vomiting in adult patients receiving general anaesthesia.Methods: This is a randomised controlled clinical trial. A 2x2 factorial design will used in the experiment. Eligible patients will be randomly assigned to one of four groups. We attempt to report this randomized controlled trial to comply with the spirit. The study population will consist of 120 adult patients receiving general anaesthesia at university hospitals in Turkey. After the induction of anaesthesia, the first group (n=30) will be warmed with only forced-air warming device, the second group (n=30) will receive only warmed intravenous and irrigation fluids, forced-air warming as well as warmed intravenous (IV) and irrigation fluids will be applied to the third group (n=30), the fourth group (n=30) will consist of the control group without any intervention. Blood and blood products to be applied intraoperatively to all groups will be heated to 37°C.Conclusions: The primary outcome measures are post-operative body temperature, shivering, thermal comfort, pain, nausea and vomiting. The primary results will be subjected to a one-way analysis of variance for covariant such as amount of bleeding and volume of intraoperative fluids.Trial registration: The trial has been registered in clinical trials: https://clinicaltrials.gov/. Registration number: NCT04907617).
      PubDate: 2021-10-22
      DOI: 10.18203/2349-3259.ijct20214111
      Issue No: Vol. 8, No. 4 (2021)
       
  • Overview of clinical data management and statistical analysis of
           bioequivalence study

    • Authors: Kala N. G., O. Shruti, Aishwarya B. M.
      Pages: 323 - 329
      Abstract: Owing to the demands of both pharmaceutical industry and the regulatory authorities’ clinical data management (CDM) field came into practice. CDM plays a vital role in the study data gathering stage of clinical research. In order to meet this goal, specialized tools i.e. software applications are used to maintain audit trials that offer easy identification and resolution of data discrepancies even in huge and complex clinical trials. Hence a proper and effective clinical data management is required for generating high-quality, accurate, reliable and statistically sound dataset. Such dataset are relatively easy to interpret which is a key step in statistical analysis of a bioequivalence study. Performance of a thorough analysis is dependent on the quality of the trial data. This review highlights how data is processed after it is captured through eCRF, data validation, data cleaning and statistical analysis specially focused on Bioequivalence studies.
      PubDate: 2021-10-22
      DOI: 10.18203/2349-3259.ijct20214112
      Issue No: Vol. 8, No. 4 (2021)
       
 
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