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Stress clinical trials

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NCT ID: NCT06316193 Not yet recruiting - Stress Clinical Trials

The Use of the Diary in Neonatal Pathology: a Mixed-method Study for Collecting and Analyzing the Experience of Parents and Health Care Personnel.

DiaPaNeo
Start date: April 15, 2024
Phase:
Study type: Observational

The study is mixed-methods (qualitative + quantitative observational cross-sectional) and the aims are to explore the use of diaries by parents of newborns admitted to Neonatal Pathology and to describe some variables related to their experience during their children's hospitalization, such as: stress level, postpartum depression and perceived support. The diary that will be analyzed is already part of current clinical practice. Study population: - Parents of premature infants with gestational age less than or equal to 35 weeks and infants with birth weight less than or equal to 2kg admitted to Neonatal Pathology of San Raffaele Hospital. - Health workers of the O.U. of Neonatal Pathology.

NCT ID: NCT06311188 Not yet recruiting - Stress Clinical Trials

Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness

Start date: June 30, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate justice-involved Black/African American female adolescents' (JI BAFAs; N=35) self-reported outcomes: stress, posttraumatic stress disorder (PTSD), recidivism, etc., as well as their parents/caregivers' (P/Cs; N=35) stress and pre- and post- intervention results along with their views of an adapted intervention.

NCT ID: NCT06308783 Not yet recruiting - Stress Clinical Trials

Diaphragmatic Breathing and Global Postural Reeducation on Stress and Sleep Quality in University Students

RPGBREATH23
Start date: May 5, 2024
Phase: N/A
Study type: Interventional

Introduction: Nowadays, the reduction of perceived stress and the improvement of sleep quality are considered fundamental aspects in the quality of life of both healthy subjects and patients with disease. Stress has become a pandemic in recent years due to the socio-labor demands faced by society. On the other hand, it has a direct relationship with the quality of sleep, its influence being bidirectional. In this regard, several tools have been reported for the management of these conditions. These include strategies such as yoga, mindfulness, diaphragmatic breathing (DR) or Pilates. On the other hand, other proposals such as global postural reeducation (GPR) lack evidence in the management of these conditions. Objectives: Compare the effects of a diaphragmatic breathing self-management program with global postural reeducation on stress and sleep quality in university students. Method: The study will be carried out with physiotherapy students of the University Francisco de Vitoria. The participants will be randomly divided into three groups: GPR group, DR group and control group. Perceived stress (Perceived Stress Scale - PSS14) and reported sleep quality (Pittsburgh Sleep Quality Index - PSQI) will be measured three times throughout the study: pre-intervention, 3 weeks after the start of the intervention and post-intervention. The intervention will last 6 weeks, during which time all participants will be required to complete the 5 Grade Scale (5GS) each morning. The GPR group will perform; Frog to the ground posture, while the DR group will follow a set breathing protocol at a 4/6 rhythm. Both GPR and DR will be performed 10 minutes before going to sleep. Ethical considerations: The principles of the 1964 Declaration of Helsinki will be followed. The proposed interventions are non-invasive, based on the combination of mild physical activity tools, body awareness and relaxation techniques. The dependent variables to be measured are based on clinimetric aspects, without any harm to the participants. Subjects will be asked to participate on a voluntary basis and may withdraw from the study at any time.

NCT ID: NCT06300112 Not yet recruiting - Stress Clinical Trials

Prenatal Yoga on Stress, Quality of Sexual Life and Sleep Level

Start date: March 15, 2024
Phase: N/A
Study type: Interventional

The study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Data will be collected with the "Personal Information Form", "Perceived Stress Scale" and "Sexual Quality of Life Questionnaire-Female". Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. The research predicts that yoga will reduce the stress perceived by pregnant women, increase the quality of sexual life and positively affect sleep patterns.

NCT ID: NCT06268106 Not yet recruiting - Anxiety Clinical Trials

Graphic Novel for Patients Undergoing EUS-FNB

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Endoscopy with endoscopic ultrasound (EUS) is a primary technique for diagnosing and treating severe pancreatic disorders. However, the procedure can cause fear and anxiety in patients, especially when a biopsy is involved. Graphic medicine, a form of visual storytelling that explores narratives of healthcare, is being used to alleviate this anxiety. This is a prospective single-center interventional pilot study with the aim to evaluate the impact of a novel graphic on the stress and behaviors of patients with pancreatic lesions undergoing EUS-FNB. The study will run for six months with the aim to enroll patients to llok for differences in the anxiety and stress levels. Enrolled patients will be randomly allocated to the test or control group, with the test group receiving a graphic novel to read while waiting for the procedure. Post-procedure, patients will complete the Beck Anxiety Inventory (BAI) and a modified version of the Depression Anxiety Stress Scales-21 (mDASS-21), now named mASS-14 (modified Anxiety Stress Scales-14), to assess anxiety and stress levels. This study is conducted according to the principles of the Declaration of Helsinki regarding experimentation involving human subjects, and written informed consent will be obtained from all participants before enrollment.

NCT ID: NCT06252883 Not yet recruiting - Stress Clinical Trials

Impact of Serial Bedside Video Calls on Stress Level in Parents of Infants Admitted to NICU

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

The goal of this randomized prospective interventional study is to determine if serial bedside video calls w/audio feature to NICU parents in addition to the routine phone and/or bedside updates can reduce parental stress level. The main question it aims to answer is if the impact of audio-visual calls to nicu parents can improve parent-infant relationship in the form of reduced parental anxiety/stress level. Participants will be parents of infants admitted to NICU for more than seven (7) days. Parents in Group A will receive serial video call communication, 2-3 days a week in addition to the daily phone and/or bedside updates. Parents in Group B will receive daily phone and/or bedside updates per our NICU routine. Parents will complete a series of questionnaires (PSS-NICU, STAI Y-1 & 2 and MSPSS) at 3 designated periods during an 8-week time frame. Researchers will compare Group A (intervention group) and Group B (control group) to see if there is any difference in the stress levels in relation to the intervention (serial video calls) at the end of the study time frame.

NCT ID: NCT06248762 Not yet recruiting - Stress Clinical Trials

PPI and Mindfulness App for Parents of Children With a NDD

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

An app based on positive psychology and mindfulness to support the mental well-being of parents of children with a Neurodevelopmental Disorder (NDD) was developed and will be evaluated on effectiveness.

NCT ID: NCT06243783 Not yet recruiting - Stress Clinical Trials

Impact of Stress on Brain Energy Metabolism

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Background: Stress plays an essential role in the pathophysiology of mental disorders. However, individual differences in the vulnerability to acute and repeated stress are not well understood. Aim: This work aims to investigate individual differences in glucose metabolism and directional connectivity regulating the neuronal stress response. Design: 68 healthy volunteers will undergo two simultaneous PET/MRI measurements one week apart. Participants will complete the Montreal Imaging Stress Test during each measurement and in-between. Effects of stress on cognitive performance will be assessed using the n-back working memory task. Individual cortisol levels will be acquired to identify stress (non)responders as well as (non)habituators. Implications: This work will characterize differences between stress responders vs. non-responders and stress habituators vs. non-habituators in terms of energy metabolism and network connectivity. This individual difference in the stress response may represent an important cornerstone for future evaluation of patients with mental disorders.

NCT ID: NCT06213298 Not yet recruiting - Depression Clinical Trials

Effect of Kava on Anxiety and Stress in Cancer Survivors

Start date: June 1, 2024
Phase: Early Phase 1
Study type: Interventional

This is a pilot, two-arm, randomized, blinded, placebo-controlled cross-over clinical trial to study the safety and effect of 14 days of kava on anxiety and physiologic stress in survivors of cancer and its treatment. Participants will be randomized to take either kava first or placebo first. Kava 75 mg or placebo will be taken three time daily (TID) for 14 days (Period 1), followed by a washout period of 14-28 days. Thereafter, the participant will take either placebo or kava TID for 14 days (Period 2), whichever he/she did not take in Period 1.

NCT ID: NCT06192368 Not yet recruiting - Stress Clinical Trials

Virtual Reality Program to Reduce Stress in Neonatal Nurses

INSPIRE
Start date: January 8, 2024
Phase: N/A
Study type: Interventional

Background: In the context of neonatal care, the increasing complexity of medical interventions poses challenges to nurses, contributing to elevated workplace stress. This stress can impact the well-being of nurses and the overall quality of patient care. Despite the documented significance of workplace stress, there is a scarcity of research on effective stress management interventions for neonatal care nurses. This pilot study aims to explore the feasibility, acceptability, and preliminary effects of a virtual reality (VR) intervention on stress reduction among nurses in the neonatal intensive care unit (NICU) at CHU Sainte-Justine. Methods: A randomized intra-subject clinical trial will be conducted, involving 30 NICU nurses and nurse assistants. Participants will act as their own controls, receiving both experimental (VR) and control (tablet gaming) interventions in a random sequence. The study will assess the feasibility of the interventions, clinical trial procedures, and participant satisfaction. Stress levels will be measured using the State-Trait Anxiety Inventory (Trait subscale), Nurse Stress Scale, Stress Numerical Rating Scale-11, and salivary alpha-amylase. Additionally, participants will provide sociodemographic information, and the study will evaluate the perceived clinical workload during intervention sessions. Interventions: The study will employ Paperplane Therapeutics' VR program, INSPIRE, designed to offer a multisensory relaxation experience. The control intervention involves tablet gaming during breaks. Both interventions will be 15 minutes in duration, implemented over five weeks. Results: The study aims to provide insights into the feasibility, acceptability, and preliminary effects of VR-based stress management interventions for NICU nurses. Data analysis will involve statistical comparisons of stress measures between VR and control interventions, contributing to the evidence base for implementing workplace stress reduction programs. Conclusion: This research addresses a critical gap in the literature by investigating the potential benefits of VR interventions for stress reduction among NICU nurses. If successful, this approach could enhance workplace well-being, job satisfaction, and overall nursing care quality, leading to broader implications for stress management strategies in healthcare settings.