International Journal of Clinical Trials

The effectiveness of video feedback intervention on mother-infant interactional quality for women with perinatal mental health illnesses: protocol for a pilot randomised control trial

2024-02-16T22:32:17+0530

Background: The literature strongly suggests that early parent-child relational interventions for at-risk dyads can support healthy infant development and attachment security. Video Feedback (VF) is a widely used attachment-based intervention, but evidence for its effectiveness with mother-baby dyads where there is maternal psychopathology remains limited.

Methods: This study constitutes a two-armed pilot randomised controlled trial aimed at evaluating the feasibility, acceptability, and preliminary benefits of Video Interaction Guidance (VIG), a type of VF, on mother-child dyadic interactional quality for postpartum women and their infants in Malta. Participants must be mothers with a baby aged 0-12 months who meet criteria for one or more mental health disorders on diagnostic interview. Exclusions are severe maternal mental illness, active drug dependence, being in receipt of in-patient care or therapy, or inability to speak English or Maltese. Consenting, eligible mothers are randomly allocated (minimised by infant age, relationship and employment status, and number of children at home), to either 3 cycles of one-to-one VIG intervention and treatment-as-usual (TAU), or to TAU only. Outcome assessors are blind to study arm allocation. The primary outcomes are parental sensitivity and dyadic synchrony coded using the CARE-index. Secondary outcomes are maternal depression and anxiety, bonding experience, capacity for reflective functioning, and well-being.

Conclusions: This is the first study on the preliminary effectiveness of VIG within perinatal services in Malta. Findings should guide future larger scale, definitive RCTs and subsequently inform health policy and management decisions in perinatal and infant mental health care.

Trial registration: Registered 16th March 2023 in ISRCTN registry (Trial ID: ISRCTN26320951).

Efficacy of 5% methylene blue photodynamic therapy in the treatment of potentially malignant oral disorders: a randomized, double-blind, controlled trial

2024-04-30T23:56:46+0530

Background: Potentially malignant oral disorders (PMOD) play a vital role in the secondary prevention of oral cancer, especially considering the difficulty in identifying specific risk factors. Oral leukoplakia (OL), the most common PMOD, has a variable malignant transformation rate. Photodynamic therapy (PDT) emerges as a promising alternative in treating these conditions. This approach is particularly valuable for extensive lesions or patients with contraindications to conventional treatments. Despite promising results, the choice of photosensitizer agent still lacks consensus. The aim of this study is to evaluate the efficacy of PDT with 5% methylene blue compared to 20% aminolevulinic acid (ALA) in the treatment of OL.

Methods: This is a randomized, controlled, double-blind clinical trial with a non-inferiority testing approach. Patients will be allocated into two groups: leukoplakia experimental group (PDT with methylene blue) and leukoplakia control group (PDT with ALA). The analysis of results will be based on primary outcomes (clinical remission) and secondary outcomes (histological/cytological worsening, lesion appearance, symptoms, function, psychological impact, economic impact, treatment adherence, and adverse effects). Allocation will be performed in a randomized and stratified manner, ensuring equivalence between groups. Cost-effectiveness analysis will consider the direct costs of treatment from both professional and patient perspectives.

Conclusions: This study aims to contribute to the establishment of an effective, safe, and accessible treatment protocol for the most prevalent PMOD, filling an important gap in the scientific literature and providing guidelines for future clinical practices.

Assessing hypotension incidence and dosing strategies of sacubitril/valsartan in real-world heart failure management: protocol for a retrospective, multicentre and cohort study

2024-06-03T18:51:02+0530

Background: The burden of heart failure (HF) and hypertension in India underscores the need for effective management strategies. Sacubitril/valsartan, an angiotensin receptor neprilysin inhibitor (ARNi), has emerged as a pivotal therapy for HF with reduced ejection fraction (HFrEF). However, concerns about hypotension often hinder optimal dosing in clinical practice. The primary objective of this study is to observe the incidence of hypotension in HFrEF patients and to evaluate the best clinical practice to achieve an optimal tolerated dose of sacubitril/valsartan without treatment discontinuation. Secondary objectives include evaluating treatment outcomes, tolerability, and factors influencing dosing adjustments.

Methods: This is the protocol of a retrospective, multicentre cohort study aimed at assessing real-world usage patterns of sacubitril/valsartan among Indian HFrEF patients. Patients aged 18-80 years diagnosed with HFrEF (left ventricular ejection fraction (LVEF) ≤40%) and initiated on sacubitril/valsartan between November 2023 and May 2024 will be included. Baseline and follow-up data, including demographics, medical history, and treatment outcomes, will be analysed using appropriate statistical tests. Data from approximately 150 healthcare facilities will be collected using a structured case report form (CRF). The study was initiated in February 2024. As of manuscript submission, 1039 individuals have been enrolled on the study. Data collection is expected to continue until the end of June 2024.

Conclusions: This study aims to contribute valuable insights into optimizing sacubitril/valsartan therapy for HFrEF patients in India, addressing concerns about hypotension and dosage optimization. The study seeks to inform clinical practice and enhance patient care by elucidating real-world usage patterns and outcomes.

Immediate effects of bandha hasta utthanasana on cerebral hemodynamics in healthy individuals: a protocol for randomized controlled trial

2024-01-30T15:38:17+0530

Background: Functional near-infrared spectroscopy (fNIRS) is a tool to measure variations in cerebral hemodynamics. The study investigates the physiological changes in cerebral blood flow before, during, and after the practice of bantha hasta utthanasana among healthy participants.

Methods: The proposed study is a hospital-based randomized controlled trial comparing bantha hasta utthanasana with the control group. A total of 60 participants will be randomly divided into an intervention group (n=30) and a control group (n=30) as per inclusion and exclusion criteria. The intervention group will practice bantha hasta utthanasana for 10 minutes. The control group will be instructed to sit for 10 minutes. Functional near-infrared spectroscopy will be performed before (5 minutes), during (10 minutes), and after (5 minutes) the practice in both groups.

Conclusions: This study protocol aims to investigate whether the practice of bandha hasta utthanasana can enhance cerebral hemodynamics. The research seeks to determine if this simple practice can be used to manage individuals with cerebral hemodynamic impairment and potentially prevent such issues in the future.

Trial Registration: CTRI/2023/10/059039.

Effect of mind sound resonance technique on physiological and psychological parameters among geriatric population: a structured study protocol for a randomized controlled trial

2024-03-27T23:58:16+0530

Background: Aging involves physical, psychological, and social changes, including chronic non-communicable pathologies and HPA axis dysfunction. Yoga can manage these issues, while mind sound resonance technique (MSRT) can alleviate stress, anxiety, and improve psychomotor function. This study aims to report the methodology for three months of MSRT sessions and their impact on physiological and psychological parameters in the geriatric population.

Methods: A randomized controlled trial will involve 80 participants aged 60-75 years, divided into an intervention group and a control group. The intervention group will receive 45 minutes of MSRT sessions daily for 90 days, while the control group will not receive any intervention. Post-intervention assessment will be taken and compared with the control group after 90 days.

Conclusions: MSRT, having a dual benefit as meditative and relaxation component, has been shown to improve the physiological and psychological well-being of the geriatric population, with expected outcomes including improved cardio-autonomic, pulmonary, neurocognitive, and psychological functions and changes in serum stress markers.

Trial registration (CTRI): CTRI/2024/02/062308.

Perception of decentralized clinical trials and home nursing in oncology clinical research: insights from a survey of clinical research professionals across experimental sites

2024-03-15T15:02:33+0530

Background: Post-COVID-19, rapid technological progress enabled remote healthcare interactions, fostering DCT activities. Sponsors and sites adapted by digitizing traditional model, utilizing wearables and home nursing. However, challenges like staff oversight and logistics demand careful evaluation for regulatory compliance.

Methods: Italian association of medical oncology's study coordinators working group, in collaboration with Italian group of data managers, conducted an anonymous online survey among Italian oncology professionals. Survey aimed to explore their perceptions of remote patient monitoring, trial activities, and home nursing in oncology clinical trials.

Results: Out of 111 professionals (42.3% coordinators, 27.0% physicians, 18.8% nurses), 29.7% lacked prior experience in remote patient data capture, while 61.3% had low or medium experience. On a 0-10 VAS scale, 58.6% found remote modalities very useful, with high scores (8-10) for various remote activities like quality of life data capture (71.2%), vital signs transmission (66.7%), and home nursing tasks (65.8%). Regarding home nursing in oncology clinical trials 73.0% of participants (n=81) have declared no previous experience. However this remote activity is considered highly useful for tasks such as biological samples collection (76.6%), vital signs collection (73.9%), quality of life evaluation (71.2%), and adverse events monitoring (65.8%).

Conclusions: Electronic devices for remote data capture are prevalent in oncology trials, positively perceived by a significant portion of staff. Remote data collection correlates with improved workload perception. Although home nursing is less common in Italy, healthcare professionals show a positive perception, indicating potential benefits for clinical trial efficiency and workload improvement.

B12 deficiency epidemic? Should B12 level lower limit reference values be decreased?

2024-03-27T03:10:01+0530

Background: This study aims to examine B12 levels in general in our society, to determine the rates of B12 deficiency, and to determine and recommend new B12 reference range values according to current data.

Methods: A total of 16497 patients who were admitted to our secondary care hospital for various reasons in the three-year period between January 2021 and December 2023 and whose B12 levels were tested in their serum were included in the study. B12 levels of all patients were measured in the hospital biochemistry laboratory on Architect i1000SR and i2000 SR (Abbott diagnostics, Ireland) devices.

Results: The reference ranges for B12 levels, determined as 2.5% and 97.5%, were 130-1084 pg/ml for adult men, and as 137-993 pg/ml for adult women. Considering 200 pg/ml as the normal lower limit for B12 level, low levels were found in 14.6% of all patients.

Conclusions: Our study is one of the rare studies in which B12 reference ranges are investigated up-to-date with a large patient participation. Our findings showed that the rate of B12 deficiency in the society is very high compared to the generally accepted reference lower limit values, that B12 levels in the society are very low compared to these reference values, and perhaps that the reference lower limit values may need to be reduced to 149-138 pg/ml in individuals under 18 years of age, 130-137 pg/ml in adults, and 123-125 pg/ml in the elderly.

Perception of ethics committee members and investigators on implementation of e-EC software for ethics committees

2024-02-09T20:09:39+0530

Background: An e-EC software (Create 4) was introduced since past 4 years at few institutional ethics committees (EC) in India. The software provided facilities for submission, online review and communication between investigator and EC. The study was to assess the perception of different stakeholders: investigators, chairperson, member secretary (MS), EC members, administrative staff regarding their experiences of using software, challenges faced and recommendations for improvisation.

Methods: Following approval of the institutional EC, the participants were enrolled after obtaining their written informed consent. The questionnaires specifically designed and validated for each category of investigators, EC members and administrative staff were administered. Strict confidentiality was maintained. The data was analysed using descriptive statistics.

Results: A total of 64 stakeholders who participated, there were 34 investigators, 18 EC members, 2 Chairpersons, 4 member secretaries, 6 administrative staff. The e-software was accepted well by majority of the stakeholders. Overall, the software was found to be user-friendly. A few challenges faced were: lack of adequate training for investigators and new EC members, inconvenience faced while downloading study documents one by one and the need to ensure uninterrupted internet access at workplace. The user ECs should ensure that the investigators and EC members are tech-savvy and they receive prior training. It was suggested that there needs to be an autofill option built-in while uploading document/s.

Conclusions: E-software was found to be useful by the stakeholders and provided suggestions to optimize its us.

Perioperative management of hyperglycemic patients undergoing surgery: an observational cross sectional study in a tertiary care hospital

2024-02-12T17:30:02+0530

Background: Diabetes poses an additional risk during anesthesia, yet there is a lack of sufficient Indian data on perioperative antidiabetic drug use and its implications. This droves us to conduct the study.

Methods: Cross-sectional, observational study, conducted in a tertiary care hospital's general surgery and orthopaedics wards. Data collected from the first anaesthetist visit to 24 hours postoperative period included antidiabetic medications, anesthesia drugs, blood sugar levels, co-morbidities, concomitant medications, and intravenous (IV) fluids. Descriptive statistics and parametric tests were used for analysis.

Results: The study comprised 180 patients (62.8% males, median age 56 years), with diabetes duration predominantly between 1-5 years (28.3%). Preoperatively, metformin was the most prescribed oral hypoglycemic agent (72.2%), decreasing to 56.67% postoperatively. Intraoperatively, only 1.6% received insulin, while 98.4% received no drugs. Common postoperative antidiabetic agents included insulin BD (n=48). General surgery (73.3%) and orthopedics (26.7%) contributed 132 and 48 patients, respectively, with spinal anesthesia (68.3%) and bupivacaine (75.4%) being most prevalent. Blood glucose during surgery was effectively monitored. Hypertension (52.8%) was the most common co-morbidity, and Ringer lactate (60.8%) was the predominant IV fluid.

Conclusions: Adequate perioperative antidiabetic management was observed in hyperglycemic patients.

A randomized clinical study comparing Trupler skin stapler and Trulon polyamide suture in post-surgical skin closure during orthopaedic and open abdominal surgeries

2024-04-29T13:34:21+0530

Background: The increasing demand for accelerated rehabilitation and shorter hospital stays emphasizes the importance of effective post-surgical skin closure techniques. Orthopaedic and open abdominal surgeries commonly use metal staples or polyamide sutures for wound closure. Surgical site infections (SSIs) remain a significant concern, impacting patient outcomes and healthcare costs.

Methods: This prospective, randomized, single-centre trial aimed to compare clinical outcomes in 140 adult patients, randomized between Trupler skin stapler and Trulon polyamide sutures, undergoing orthopaedic and open abdominal surgeries. The primary endpoint was the incidence of SSI according to CDC criteria. Secondary outcomes included wound complications, post-operative pain, patient satisfaction, cosmetic appearance, time taken for closure, ease of use, and safety of the interventions.

Results: The primary endpoint did not show any significant difference in the number of SSIs between the two groups. Both groups experienced wound complications, but the stapler group showed less severe outcomes. The stapler group demonstrated improved time efficiency and ease of closure, leading to reduced post-operative pain and higher patient satisfaction. Cosmetic outcomes were superior in the stapler group. Adverse events were reported in both groups, with a slightly higher incidence in the suture group.

Conclusions: The Trupler skin stapler demonstrated advantages over Trulon polyamide sutures for wound closure. Despite similar SSI rates, the stapler group experienced improved time efficiency, lower post-operative pain, higher patient satisfaction, and superior cosmetic outcomes. The study supports the preference for Trupler skin stapler for wound closure in orthopaedic and open abdominal surgeries.

Conservative therapy and physiotherapy in children with toe walking: a systematic review

2024-05-21T03:26:53+0530

The purpose of this systematic review was to study all the randomized controlled trials on the effects of conservative treatment and physiotherapy programs on children with toe walking. A literature search was performed in the databases: PubMed, Scopus, PsychInfo, SportDiscus, and ResearchGate. Toe-walking and toe walking were the keywords searched. Furthermore, explicit inclusion and exclusion criteria were established, and the research selection procedure was carried out by two distinct reviewers. The physiotherapy evidence data-base (PEDro) scale was used to assess the quality of the final studies included in the systematic review. Out of the total of 2079 studies initially identified, 6 studies were finally included. The results showed that physiotherapy interventions and conservative therapy, such as botulinum toxin, ankle foot orthosis or foot orthosis and electric stimulation therapy can help reduce toe walking especially when these methods are combined with classic physiotherapeutic exercises and stretches. Conservative treatment and physiotherapy have positive effect on children who have toe walking symptoms. However, further research is needed in this area to determine the most effective treatment methods to reduce the symptoms of toe walking and find the best treatment to improve the daily lives of these patients, focusing on avoiding surgical procedures.

The effectiveness of the therapeutic exercise Clinical Pilates in adult patients with multiple sclerosis: a systematic review

2024-06-07T16:24:25+0530

Existing literature supports various forms of exercise as appropriate for treating people with multiple sclerosis (MS) with mild or more severe symptoms. In recent years, Pilates is a form of therapeutic exercise used more and more often in rehabilitating people with MS. The purpose of this systematic review is to explore the effectiveness of the clinical Pilates method in adult people with MS. Research was performed in 4 scientific databases (PubMed/MEDLINE, ScienceDirect, PEDro and Scopus) using the following keywords: multiple sclerosis, MS, Pilates and Clinical Pilates. Inclusion criteria were studies randomized controlled, written in English, published in 2012-2022, with adult people with MS and where the intervention should have been only the Pilates method and the results had to be relevant to physiotherapy. The methodological quality of the studies included was assessed by PEDro Scale. From a total of 329 initial records, only 12 studies were included. Results show that Pilates can improve balance, gait, functionality, physical and cognitive capacity, quality of life and body composition in adult people with MS and with mild to moderate disability. Fatigue, anxiety and depression levels did not show clear improvement after the application of the Pilates exercises in comparison with other therapeutic exercises. Pilates is a safe method of exercise for adult people with MS and can improve many symptoms. It is necessary more research to be conducted so that the effectiveness of the Pilates exercises be explored further on different parameters in patients with MS, like fatigue.