- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07422077
Impact of ERCS on Perceived Stress in Patients Hospitalized in the Post-resuscitation Rehabilitation Service (IRESC)
Impact of Energy Resonance by Skin Stimulation on Perceived Stress in Patients Hospitalized in the Post-resuscitation Rehabilitation Service
Surviving an intensive care unit hospitalization (ICU) can be the beginning of a long rehabilitation journey, hindered by symptoms of stress, PTSD, anxiety, and depression. In order to improve the care of these patients, it's essential to explore effective non-pharmacological approaches to reduce stress. Many non-drug techniques are being developed to alleviate the physical and psychological pain of patients.
Energy Resonance by Skin Stimulation (ERCS) is a noninvasive method of soothing and supporting the patient. This technique is based on the energetic principles of traditional Chinese medicine. It relies on a "listening contact" through the stimulation of cutaneous points to create resonance and transmit vibrational and wave messages in the tissues. ERCS has various applications, whether for the management of acute or chronic pain, emotional disorders such as fear, anxiety, and depression.
Our study aims to assess the effects of ERCS on the perceived stress of patients hospitalized in the post-ICU rehabilitation service. By demonstrating its potential impact on both physical and psychological recovery, this research could support the integration of RESC into care protocols and open new perspectives for stress management in hospital settings
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Myriam BENNANI
- Phone Number: 0413428351
- Email: m.bennani@hopital-europeen.fr
Study Locations
-
-
-
Marseille, France
- Recruiting
- Hopital Europeen Marseille
-
Contact:
- Myriam BENNANI
- Phone Number: 0413428351
- Email: m.bennani@hopital-europeen.fr
-
Principal Investigator:
- Gina BOUVIER
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged ≥ 18 years
- Hospitalized adults in a Post-Intensive Care Rehabilitation Unit (SRPR)
- Having given free and informed written consent
Exclusion Criteria:
- Pregnant or breastfeeding woman
- Persons deprived of their liberty by a judicial or administrative decision.
- Persons who are subject to a legal protection measure or who are unable to express their consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patients hospitalized in the post-ICU rehabilitation service.
|
Two ERCS sessions spaced one week apart, on Day 0 and Day 7
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Difference in the level of perceived stress by the patient before and immediately after the second RESC session (two sessions on day 0 and day 7), measured using a Visual Analog Scale (VAS).
Time Frame: Day 0 and day 7
|
Day 0 and day 7
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Daily evolution of perceived stress (VAS) between Day 0 and Day 7
Time Frame: Day 0 and day 7
|
Day 0 and day 7
|
|
Difference in pain (VAS) between, before and after each session
Time Frame: Day 0 and day 7
|
Day 0 and day 7
|
|
Measurement in clinical parameters before and after each session (respiratory rate breaths per minute/bpm; heart rate beats per minute/bpm; blood pressure millimeters of mercury, mmHg; oxygen saturation percentage, %)
Time Frame: Day 0 and day 7
|
Day 0 and day 7
|
|
Anxiety score (COVI scale) before and after each session
Time Frame: Day 0 and day 7
|
Day 0 and day 7
|
|
Measurement of the patient's physical symptoms during the session using a binary scale for each symptom at the end of each RESC session
Time Frame: Day 0 and day 7
|
Day 0 and day 7
|
|
Duration of each ERCS session
Time Frame: Day 0 and day 7
|
Day 0 and day 7
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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