Clinical Research Directory

Effects of Laughter Yoga in the Third Trimester

Pregnancy is a physiological process during which a number of biological changes occur in a woman's body. This period represents an important turning point in the lives of women, whose reproductive capacity ensures the continuation of generations. While some women perceive pregnancy as a source of joy and happiness because of the anticipated arrival of a new family member, others may perceive it as a source of worry, anxious anticipation, and stress. In addition to physical and hormonal changes, expectant mothers experience numerous psychological and social changes during pregnancy. A woman's psychological state and experiences may influence the course of pregnancy, while pregnancy itself may also cause significant changes in her psychological state. Women who are unable to adequately adapt to these changes may experience various psychological problems due to pregnancy-related bodily changes and physical complaints, concerns about parenthood, changes in family and social roles, fear of childbirth, unwanted pregnancy and miscarriage, new challenges and needs arising from pregnancy, concerns and worries about the baby, parenting stress, low self-esteem, a persistent tendency toward negative thinking, lack of social support and social isolation, marital and partner-related problems, domestic violence, adverse life experiences, alcohol and tobacco use during pregnancy, chronic diseases, inadequate weight gain during pregnancy, exposure to sexual abuse, employment-related issues, and financial concerns. If these psychological problems arising during pregnancy are not resolved, emotional distress may continue to increase, potentially leading to stress and depression Symptoms of brain fog, such as forgetfulness and absent-mindedness, may occur once or twice during pregnancy or may persist throughout pregnancy. Brain fog may become more pronounced during periods of fatigue or irregular sleep, such as in the early or late stages of pregnancy. Studies conducted among pregnant women have shown that fluctuations in progesterone and estrogen during pregnancy may lead to impairments in attention, memory, and executive functioning because the brain is sensitive to changes in hormone levels. Laughter yoga (Laughter Therapy/Laughter Yoga), developed by Dr. Kataria, is a therapeutic method that combines yogic breathing techniques with laughter exercises. A systematic review reported that laughter yoga physiologically increases oxygenation, relaxes muscles, stimulates circulation and the immune system, increases endorphin release and thereby enhances the pain threshold and pain tolerance, strengthens mental functioning by reducing stress hormone levels, decreases depression and anxiety, improves sleep quality, and promotes psychological well-being by enhancing interpersonal relationships and social interaction. The literature highlights the positive physiological, psychological, and social effects of laughter on health. Although laughter yoga has increasingly been used in healthcare in recent years, positive outcomes have been reported across different age groups and health conditions. Laughter yoga performed with pregnant women has been reported to reduce the frequency of pregnancy-related symptoms and increase psychological well-being and prenatal attachment levels. However, no studies examining its effects on the outcomes addressed in the present study were identified in the literature. Therefore, this study aims to determine the effects of laughter yoga on perceived stress, psychosocial health, and brain fog among pregnant women in the third trimester. Keywords: laughter, pregnancy, stress, psychosocial health, brain fog

PS IVG : Psychosocial Determinants of Late-term Abortions (14-16 Weeks' Gestation) at Avignon Hospital

Abortion is a fundamental right for women in France, where the legal time limit was extended from 14 to 16 weeks' gestation. This extension allows women, whose psychosocial determinants are poorly known, and who face various obstacles (personal, administrative, medical, or other), to access abortion. However, it may also expose them to psychological troubles and difficulties in accessing healthcare. This study aims to identify the psychosocial determinants and disruptions in the primary care pathway associated with late abortions (≥14 weeks' gestation \[WG\]) in order to propose preventive actions, particularly regarding contraception, screening, and referral, directly applicable in general practice.

Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers

The proposed two-arm randomized waitlist-controlled trial will use a mixed-methods design to investigate the effects of dyadic mindfulness on physio-psycho-spiritual outcomes in people with Parkinson's Disease (PwPD) and their family caregivers. One hundred Chinese patient-caregiver dyads will be randomized to receive eight weekly 90-minute dyadic mindfulness sessions or usual care. Outcome measures include negative emotions (primary outcome), patient-caregiver relationship, mindfulness, HRQOL, gut microbiome, PD-related symptoms, and caregiving burden. An actor-partner interdependence model will be used to explore the interactions of treatment effects within the dyads. The dyads will be assessed at baseline(T0), post-intervention(T1), and 4-months post-intervention(T2). The investigators will also invite 25 dyads to attend in-depth interviews exploring their experiences, perceived changes, and factors attributable to the effectiveness/ineffectiveness of the intervention. Generalized linear mixed-effects (GLME) with intention-to-treat analysis will be used to compare the changes in outcomes over time within and between the two arms. The findings will be triangulated to provide a comprehensive evaluation of the intervention's effectiveness. This study will generate rigorous scientific evidence to inform the application of dyadic mindfulness as a public health practice preventing the progression of psychological distress in PwPD and caregivers to clinically severe levels. Its self-help nature also enriches the primary care for this clinical cohort.

Study Protocol for a Pilot Randomized Controlled Trial of a Psychosocial Care Intervention in Intensive Care

This Pilot-RCT is part of a feasibility study that aims to learn if the IPS-psychosocial care intervention and an RCT on its efficacy are feasible in patients, relatives and staff on icu wards. The Pilot-RCT will examine outcomes, that might indicate an improvement in psychosocial safety climate and other health- and wellbeing-related measures due to the administration of the intervention that is described in the following. The main question the Pilot-RCT aims to answer is: Is there evidence that the IPS intervention improves the psychosocial safety climate and other components of psychosocial well-being in ICU teams, patients and their relatives? Researchers will compare four intervention groups (icu wards with implementation of the IPS-Intervention) with four control groups (icu wards with regular supply of psychosocial care) to see if the comparison of two groups in this RCT is feasible. The IPS-Intervention consists of a ward psychologist who works as part of the ICU team and takes care of the staff, patients and relatives in accordance to the intervention manual that was developed in a prior phase of this project.