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Search / Trial NCT05903378

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

Ventilation Therapy Icu Relational Touch

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.

Locations

Boulogne Billancourt, , France

Patients applied

0 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