Clinical Research Directory

From Prevention to Treatment: How Biological Rhythms Can Maintain Perinatal Mental Health

Depression and anxiety are significant public health issues during pregnancy and the postnatal period, particularly affecting those in developing countries. Disruptions in biological rhythms, sleep problems, and low exposure to daylight are associated with a higher risk of these mental health issues. The perinatal period poses unique challenges to the temporal program, with evidence indicating that sleep disturbances significantly increase the risk of postnatal depression. A Randomised Clinical Trial (RCT) is being conducted to assess the effectiveness of Blue Light Therapy (BlueLT) in treating depressive and anxiety symptoms during the postpartum. The RCT will also investigate the alignment of rest-activity and internal body time as mediating factors. This study will focus on various chronobiological factors, including rest-activity rhythms, light exposure levels, temperature rhythms, sleep duration and phase, social jetlag, and BodyTime (assessed through a single blood sample). The goal is to recruit 50 women with postpartum depression, with 25 in the BlueLT intervention group and 25 in the ControlLT placebo group, alongside 100 healthy controls. The BlueLT device uses a short-wavelength LED lamp mainly composed by a wavelength peak on blue spectrum, while the ControlLT device has a dim long-wavelength LED. A Healthy Control group will also be included to account for changes unrelated to depression diagnosis or placebo/treatment effects. Exclusion criteria involve a history of major depressive or anxiety disorder, current psychotic disorder, night shift work, active suicidal thoughts, unstable medical conditions interfering with data collection, and newborns with severe health conditions. The study aims to evaluate the impact of BlueLT on postpartum depression and understand the role of chronobiological factors in the health/disease process.

Exercise-Assisted Ergonomic Training for Pain, Sleep, and Anxiety in Nursing Students: RCT

This randomized controlled trial aims to evaluate the effect of exercise-assisted ergonomic training on pain, sleep quality, and anxiety levels among nursing students. The study population consists of students enrolled in the Nursing Department of Kütahya Health Sciences University. Sixty participants will be recruited according to inclusion criteria and randomly assigned into intervention and control groups. The intervention group will receive a structured ergonomic training program combined with exercise sessions, including theoretical lectures and practical exercise videos delivered twice a week for four weeks. The control group will continue with their standard nursing curriculum without additional ergonomic or exercise support. Data will be collected using the Numeric Pain Rating Scale, Pittsburgh Sleep Quality Index, and State Anxiety Inventory before and after the intervention. The study is expected to provide evidence on the effectiveness of ergonomic and exercise-based strategies in reducing pain, improving sleep quality, and lowering anxiety among nursing students, supporting the integration of such programs into nursing education.

Low-Level Laser Auriculotherapy in the Treatment of Myogenic Temporomandibular Disorders and Anxiety

Summary: Low-level laser auriculotherapy (LLLT-AT) is a non-invasive technique that has gained attention for managing musculoskeletal pain and anxiety. Given the painful and emotional components of temporomandibular disorders (TMD), LLLT-AT may offer therapeutic benefits by stimulating auricular points associated with pain modulation and anxiety reduction. This randomized, placebo-controlled, two-arm clinical trial with blinded outcome assessors aims to evaluate the effects of LLLT-AT in individuals diagnosed with myogenic TMD (Axis I, Group I of the DC/TMD classification) and anxiety. The study will be conducted at the Physical Agents Laboratory of Universidad Andrés Bello. Eligible participants will include members of the university community with myogenic TMD (Axis I, Group I of the DC/TMD classification) and anxiety. Participants will be stratified by sex and randomly assigned to either an experimental group receiving LLLT-AT combined with a standardized myofascial release protocol or a control group receiving sham LLLT-AT with the same myofascial protocol. Interventions will be administered twice weekly for three weeks. Outcome measures will be collected at baseline, post-intervention, and at a four-week follow-up. Primary outcomes include pressure pain threshold (PPT), assessed by algometry, and anxiety level, measured using the GAD-7 scale. Secondary outcomes include maximum mouth opening range of motion (MMOROM) and mandibular functional limitation (MFL), assessed using the Jaw Functional Limitation Scale 8 (JFLS-8).

Intergenerational Study of War-Affected Youth

War-related violence is a leading driver of mental disorders and illness affecting children in low- and middle-income countries (LMICs). Parents exposed early in life to war-related violence and loss are at risk for mental health problems and may pass risks to their offspring. The study posits that war-related trauma alters the stress-response circuitry in ways that endure into adulthood and affect the next generation. This will be the first investigation in a 20-year longitudinal study to examine mechanisms that link parental war-related trauma exposure and subsequent mental health problems to risk for mental disorders in offspring. This study will extend the first intergenerational study of war in Sub-Saharan Africa (R01HD073349) to focus on children (aged 7-24) born to war-affected parents. Assessments of behavioral and biological indicators of the Research Domain Criteria (RDoC)-linked constructs of self-regulation and stress reactivity will be collected, including autonomic nervous system reactivity, inflammation, and telomere length as well as sophisticated observations of parent-child interactions and synchrony. These measures will be utilized to identify potentially modifiable risk and protective processes both to inform the development of screening tools to identify families at risk for poor child mental health and to be deployed as active ingredients of interventions to reduce transmission of mental health problems to children of war-affected parents. This follow-up study involves the following activities: 1. Pilot to assess measure performance and field test study protocols. 1. Translation and adaptation of newly selected measures 2. Pilot study of new child and adult measures with 36 caregivers and 60 children in a district of Sierra Leone unlinked to participants to test the feasibility and validity of new tools. 2. Fifth wave of data collection from war-affected youth who are now parents and their children aged 7-24. 1. Household tracking and re-enrollment of 145 households that were formerly enrolled in the Longitudinal Study of War-Affected Youth (LSWAY; T1: 2002, T2: 2004, T3: 2008, T4: 2016). 2. Quantitative (full sample) and qualitative (subsample) data collection with 145 households who were enrolled in T4 LSWAY, including war-affected youth who are now parents, their intimate partners, and their children aged 7-24. Through these activities, the investigators will test three overarching hypotheses: 1. Childhood war-related trauma exposure will be associated with mental difficulties (anxiety, depression, post-traumatic stress, disruptions of emotion regulation). 2. Poor mental health in war-affected parents will be associated with emotional and behavioral disruptions in biological offspring. 3. Risk and protective factors across the social ecology may serve as intervention targets to mitigate the effects of parental war-related trauma on behavioral disruptions and stress physiology, both within and across generations.

App Delivered Brief Mindfulness Intervention for Surgical Patients

This will be a single-site, five-arm, parallel group randomized control trial involving patients undergoing knee or hip replacement surgery. The investigators will compare five different styles of 5-minute, audio-recoded mindfulness practices delivered via app 7 days before to surgery, 2 days before to surgery, 2 days after surgery, and 6 days after surgery.

The Effect of Therapeutic Play on Anxiety and Fear Levels in Children With Diabetes

The study will be conducted using a randomized controlled method. Children with type 1 diabetes who are admitted to the Pediatric Endocrinology Service will be divided into two groups by randomization method. Following randomization, children in the experimental group will play a therapeutic game before their subcutaneous insulin treatment. In the subcutaneous insulin treatment of the children in the control group, the routine practice of the clinic will be applied. Anxiety and fear levels of all children in the experimental and control groups will be evaluated before and after subcutaneous insulin treatment.

Perioperative Anxiety Risk Factors in Parents of Children Undergoing Thoracic Surgery

Risk factors associated with perioperative anxiety in parents of pediatric patients undergoing thoracic surgery are unknown. It is therefore necessary to identify them in order to better understand, above all, modifiable factors. This will allow the implementation of psychological interventions tailored to the individual needs of parents to strengthen their coping mechanisms before surgery, and thus facilitate the recovery process of their children after surgery. The purpose of the study is: 1. assessment of the level of anxiety experienced by parents before and after thoracic surgery, 2. assessment of risk factors for parents' perioperative anxiety, 3. assessment of the relationship between parents' perioperative anxiety and satisfaction with postoperative analgesia

Evaluation of an Anxiety Reduction Tool During Thyroid Biopsies

Patients undergoing thyroid biopsy under local anesthetic will be asked to fill out a questionnaire that evaluates their anxiety level before and after their procedure. Patients will be randomly assigned to either use an anxiety reducing tool (stress balls in each hand) to take their mind off the procedure or will not receive an anxiety reducing tool.

The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients

Aim: The goal of this randomized controlled trial is to detect the effect of using multimedia during the informed consent process on the anxiety of parents of orchiopexy patients. Parents (primary caregivers) of the patients who underwent orchiopexy surgery are included in the study. The main question it aims to answer is: • Does the use of multimedia during the preoperative consent process affect the anxiety level of parents of patients undergoing orchiopexy surgery?

Music Therapy on State Anxiety Levels and Well-being During Chemotherapy

Introduction: Many cancer patients experience high levels of anxiety during chemotherapy, which can negatively impact their mental health and physiological, emotional, and spiritual well-being. Various complementary therapies exist to mitigate these effects, including music therapy. Although preliminary evidence supports the positive effects of music therapy and music-based interventions in chemotherapy, few studies report live group interventions conducted by accredited music therapists. Objective: To determine the effect of a single session of live group music therapy on state anxiety levels and well-being in adult cancer patients undergoing chemotherapy. Methodology: This study is a multicenter, randomized clinical trial with two arms. The intervention group will receive standard care plus a live group music therapy session, while the control group will receive standard care only. The primary outcome measure is the State-Trait Anxiety Inventory (STAI-E), and the secondary outcome measure is well-being, assessed using the Well-being Numerical Rating Scales (WB-NRSs). The scales will be administered before and after each intervention. The sample size is 102 patients. Expected Results: This study aims to improve the psycho-emotional health and well-being of cancer patients during chemotherapy, thereby enhancing the quality of care.

Effectiveness of Heart Rate Variability Biofeedback Training Versus a Meditation Program in Reducing Stress Levels in University Undergraduate Students.

The objective of this trial is to evaluate the efficacy of a heart rate variability biofeedback training protocol, compared to a guided meditation program and a control group, in reducing stress and anxiety levels among university undergraduate students.

Heart Rate Variability and Anxiety During Urinary Bladder Catheterization

This is a prospective, randomised study investigating the physical and psychological experience of intermittent catheterization in adult individuals following spinal cord injury (SCI).

The Supplementation Therapy in Autism and Response to Treatment Study

In addition to the "core" symptoms of ASD (i.e., impaired communication, impaired reciprocal social interaction and restricted, repetitive and stereotyped patterns of behaviors or interests), it is estimated that up to 70% of autistic people present at least one comorbid psychiatric disorder, leading to a deterioration in quality of life, a greater demand for support and worse prognosis and outcome. Anxiety and depressive symptoms would seem to be more present in individuals with Level 1 ASD, requiring their prioritisation against core symptoms. To date, the first-line treatment for autistic patients with comorbid depressive and/or anxiety symptoms is still debated and it is not always clear whether they may or may not benefit from psychotherapeutic and conventional psychopharmacological approaches. As such, growing evidence strengthens the therapeutic potential of the endocannabinoid (eCB) system modulation and of eCB-like compounds. The aim of this study is to provide a response to an unmet clinical need in this framework of psychic vulnerability by initiating oral therapy with palmitoylethanolamide (PEA), a nutraceutical/food supplement with proven anti-inflammatory and neuroprotective properties. Indeed, many conditions of psychological distress are thought to be underpinned by systemic inflammatory and/or neuroinflammatory processes, on which PEA has shown remarkable efficacy, including through modulation of the immune response and the interaction between the endocannabinoid system and the gut-microbiota-brain axis. The trial we are proposing is a 12-week open-label phase 2 study involving the daily intake of PEA 600 mg, at a dosage of 1 tablet/day. This study will be conducted at the Unit of Psychiatry of Santa Maria della Misericordia Udine University Hospital. Through this study, we wish to evaluate: the ability of PEA to alleviate symptoms of psychic distress (i.e., anxiety and/or depression) in Level 1 autistic adults; the safety and tolerability of sustained intake of PEA in Level 1 autistic adults; and the biological basis of PEA functioning. The study involves taking PEA orally once daily (600 mg daily) at the same time as a meal during the initial 12-week phase. Upon completion of the initial phase, subjects will be offered to enter an extension phase of the trial of an additional 24 weeks to assess treatment stability, with the possibility of titration of PEA to 1200 mg daily based on observed clinical compensation. Each participant will be on PEA treatment for up to 36 weeks. During the course of the study, periodic clinical re-evaluations will be conducted at our Day-Hospital setting. The trial will unfold through one screening visit, one baseline visit, and two follow-up visits (FUP, 4 weeks and 12 weeks apart). The patient will be administered standardized interviews by a qualified investigating physician; clinical objective examination, collection of blood and urine samples for standard hematochemical investigations, collection of blood and stool samples for analysis of some biological markers of interest, monitoring of adherence to therapy intake, side effects, and adverse effects will also be performed during the follow-up visits. The nutraceutical PEA will be dispensed by the clinical investigators at each follow-up visit.