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Stress clinical trials

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NCT ID: NCT06398860 Not yet recruiting - Stress Clinical Trials

A Tool for Integration of Work Environment and Patient Safety Management at Work

SIOHPS
Start date: August 2024
Phase: N/A
Study type: Interventional

The evidence unequivocally supports the association between work environment and patient safety. The negative impact of working conditions on both employee health and quality of care highlights the potential benefits of integrating these areas. It is therefore suggested that integrated systematic occupational health and patient safety management are crucial in managing the challenges faced by healthcare services today. The project aims to assess the effectiveness and cost-effectiveness of a structured method for systematic and integrated occupational safety and health and patient safety management systems (SIOHPS). A process evaluation will be conducted alongside the main study to determine the intervention's specific outcomes and provide transferable guidance to a wider context. The intervention is designed to support both systematic occupational health and patient safety management systems using a Safety II-perspective. The intervention is comprised of several core components, including education to staff, support-functions and management, daily team reflections; as well as audit and feedback. A stepped wedge cluster-controlled design (SWD) will be used, with workplaces as clusters. The SWD will consist of three steps, with four clusters crossing over from the control to the intervention group at each step. All clusters will start as controls. At least twelve healthcare units with at least thirty employees per workplace from two different regions in Sweden will participate in the intervention. Workplaces that provide round-the-clock care are invited to participate in the study. Exclusion criteria are units with plans to implement any other occupational health and/or patient safety improvement work during the project period. At the individual level, inclusion criteria for employees include at least 50% of full-time work at the workplace. The SIOHPS project will contribute to the existing theory on safety culture interventions by considering the integration of these areas. The goal is to contribute to a safe environment for both employees and patients.

NCT ID: NCT06393790 Not yet recruiting - Stress Clinical Trials

Strength Training Protocol in Fibromyalgia Women

FM PROTOCOL
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Physical exercise is an effective tool for the prevention of various chronic diseases. Fibromyalgia (FM) is a common chronic pain condition, in which patients may also experience a variety of other symptoms, including sleep disturbances, fatigue, stiffness, frequent episodes of pain and mental health problems, as well as possible gastrointestinal disorders. Furthermore, according to the American College of Rheumatology, such a generalised non-joint pain state occurs for at least three months in duration, predominantly in women over 50 years of age. In turn, chronic fatigue syndrome (CFS) presents as a disease characterised by persistent and debilitating fatigue lasting at least six months. The origin of FM and CFS is unknown, although alterations in the central nervous system (CNS), as well as abnormalities in muscle physiology and immune/inflammatory response are suggested as the main causes. In addition, most patients with FM are sedentary and in poor physical condition, exacerbated by pain, fatigue or depression, which can limit their daily activities and affect their quality of life and work opportunities. In this regard, physical exercise is considered the most important non-pharmacological strategy for the treatment of FM; however, many clinically relevant questions remain unanswered regarding the most effective approach to exercise therapy in FM patients. Therefore, the main objective of this project is to analyse the possible physical and mental benefits of a physical exercise programme in people diagnosed with fibromyalgia and/or chronic fatigue syndrome.

NCT ID: NCT06381479 Recruiting - Stress Clinical Trials

Exploring the Effects of Probiotics on Workplace Related Stress Symptoms

Start date: April 19, 2024
Phase: N/A
Study type: Interventional

There is still a lack of research to explore the interaction between high-pressure workers and probiotics to improve the intestinal microbiota, sleep, inflammation and anti-oxidation. A total of 120 subjects are expected to be recruited and divided into two groups of 60 subjects, receiving probiotics or placebo, and completing a 8-week trial period.

NCT ID: NCT06379074 Not yet recruiting - Stress Clinical Trials

Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health

MOTHERS
Start date: May 6, 2024
Phase: N/A
Study type: Interventional

Improving maternal mental health is a worldwide health priority. Nevertheless, several scientific sources highlighted lack of empirical data which could drive clinical practice. The present project addresses psychobiological mechanisms leading to peripartum mental disorders. It focuses on one key risk factor for psychopathology, which is poor sleep continuity. The project aims to describe the link between maternal poor sleep quality and the cascade of events which may enhance vulnerability to stress and risk for mental disorders and to evaluate the efficacy of an online automated psychological prenatal intervention directed to sleep problems in preventing these negative outcomes.

NCT ID: NCT06378801 Active, not recruiting - Stress Clinical Trials

Radicle Relaxation 24: A Study of Health and Wellness Products on Stress and Related Health Outcomes

Start date: February 29, 2024
Phase: N/A
Study type: Interventional

A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on stress and related health outcomes

NCT ID: NCT06378567 Not yet recruiting - Stress Clinical Trials

A Study to Assess the Effects of Dietary Supplement Drinks on Sleep, Stress and Mood

Start date: April 2024
Phase: N/A
Study type: Interventional

A home placement, randomized, double blind, placebo-controlled, study to determine the effect of dietary liquid shot beverage products on self-reported measures of sleep, stress and mood on generally healthy participants with current self-reported mild/moderate sleep difficulties (but not clinical insomnia) and mild/moderate stress.

NCT ID: NCT06378554 Not yet recruiting - Depression Clinical Trials

Cereset Research for Performance Improvement in a Hospital Nursing Unit

Start date: May 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to explore whether an implementation process composed of offering CR to staff in a single hospital nursing unit has any potential impact on unit-level quality measures post-implementation.

NCT ID: NCT06374407 Not yet recruiting - Obesity Clinical Trials

The MIND-GUT Digital Pilot Intervention Study

MINDGUT
Start date: June 2024
Phase: N/A
Study type: Interventional

This 12-week pilot study aims to evaluate the feasibility and effectiveness of a dietary intervention targeting diet, obesity, mental health, and the gut microbiome in promoting weight loss and enhancing mental health among obese men and women aged 30-50. Participants, excluding those with specific medical conditions, will be randomly assigned to either an intervention or control group using a meal planning smartphone app. Clinical assessments will include anthropometry, mental health questionnaires, dietary recalls, and stool sample collections. The study's endpoints include program retention, adherence, changes in body weight, mental health, and gut microbiome diversity. Statistical analyses will evaluate intervention effects and the potential mediating roles of the gut microbiome. This pilot study has implications for health policies, public healthcare, digital health companies, and the biotech and pharmacology industries. Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations.

NCT ID: NCT06365645 Not yet recruiting - Stress Clinical Trials

Feasibility & Acceptability of App-based Cognitive Behavioral Therapy for Postpartum Depression Prevention

Start date: May 2024
Phase: N/A
Study type: Interventional

Postpartum depression (PPD) affects up 10-15% of mothers overall, but the rate of PPD can be as high as 25% among mothers with personal or obstetric risk factors. The Mothers & Babies Program (MB) is a cognitive behavioral therapy (CBT)-based program that has been shown to prevent PPD among high-risk mothers without a prior history of depression. MB has been so consistently effective that the United States Preventive Services Task Force recommends this program be given to high-risk pregnant patients. Originally designed to be given in-person and via groups, MB has been adapted to be given in person one-on-one in clinic or at home and via text message. However, MB has yet to be adapted to a smartphone application (app). Via evidence-based qualitative research and end-user centered design, MB has been adapted to a novel app, M.Bapp. This study aims to examine the feasibility and acceptability of M.Bapp as a study intervention for perinatal patients as well as provide preliminary estimates of effect for the intervention.

NCT ID: NCT06364228 Not yet recruiting - Stress Clinical Trials

Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

Start date: July 2024
Phase: Phase 2
Study type: Interventional

The proposed study is a double-blind, randomized, placebo-controlled study of intranasal oxytocin (OXT) to determine its efficacy in improving quality of life and reducing stress in caregivers to persons with dementia. Planned enrollment is 32 subjects over 2 years.