Early Mobilisation and Relational Touch Practice on Intubated Patients of Intensive Care Unit
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jun 6, 2023
Trial Information
Current as of August 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how a technique called "relational touch" might help reduce anxiety in patients who are on a ventilator in the intensive care unit (ICU). Many patients feel anxious during their treatment, especially when they are waking up from sedation and still need help breathing. The researchers want to see if providing gentle touch during early mobilization—moving patients soon after they wake up—can make their experience more comfortable compared to standard care, which does not include this touch. They will also look at various health indicators, like pain levels, blood pressure, and the need for medications to manage anxiety.
To participate in this study, patients need to be adults who have been on a ventilator for at least 48 hours and are awake enough to communicate (with a specific level of awareness). However, patients with certain conditions, like severe obesity, unstable fractures, or those who are pregnant, cannot participate. If eligible, participants can expect to receive either the relational touch technique or standard care during their bedside sessions, and the researchers will monitor how this affects their anxiety and overall recovery. This study aims to improve patients' experiences and potentially shorten their time on the ventilator, leading to better outcomes while in the ICU.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult patient ventilated invasively for at least 48 hours, RASS between 0 and -1 with early mobilization prescribed but not performed.
- Exclusion Criteria:
- • Patient needing help from another person to mobilizing
- • Patient with an unstable fracture
- • Patient with a recent laparotomy (less than 10 days)
- • Patient under judicial protection measures
- • Patient on catecholamines
- • Pregnant or breastfeeding woman
- • Non-communicating patient due to neuropsychiatric pathology
- • Patient benefiting from a process of palliative care or moribund patient whose estimated life expectancy is less than 30 days
- • Strict bed rest order
- • Fraction inspired oxygen (FIO2) \>50%
- • Body mass index \> 40 Kg/m2
- • Patient having an epidural with motor impairment.
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boulogne Billancourt, , France
Patients applied
Trial Officials
Katia Nadaud, degree of nurse
Principal Investigator
ICU, Ambroise Paré Hospital - APHP
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported