Pain Impact Assessment of the Relational Touch During Arterial Puncture in ICU (TORREA) (ToRRéa)

Pain Impact Assessment of the Relational Touch During Arterial Puncture in ICU - TORREA

Study objective is to assess the interest of the relational touch before an arterial puncture to reduce pain on patient in intensive care unit.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Procedure: relational touch

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • University Hospital
  • Tours, France, 37044
    • university hospital Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Admission in Intensive Care Unit
• Communicating patient (able to rate their pain on a numerical scale)
• Need for a radial arterial puncture for conducting blood tests, apart for the emergency
• Non-opposition of the patient

Exclusion Criteria:

• Age under 18
• Tetraplegic patient or having a sensitivity disorder on the limb to be punctured
• No radial pulse perception

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Relational touch before the first arterial puncture and the second arterial puncture without relational touch	Procedure: relational touch
Experimental: B; First arterial puncture without relational touch and relational touch before the second arterial puncture	Procedure: relational touch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint is the variation in pain score (evaluation on a numerical scale 0 to 10) between the measurement made before the arterial puncture and during the arterial puncture.	At the first and second arterial puncture	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in consumption of analgesics and hypnotics	At the first and second arterial puncture	1 day
Blood pressure and heart rate variation	At the first and second arterial puncture	1 day
Patient satisfaction score	At the first and second arterial puncture	1 day
Number of arterial punctures needed before success	At the first and second arterial puncture	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Régine MONCHO, Nurse, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: January 21, 2015
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 17, 2016

Study Record Updates

• Last Update Posted (Estimate): June 20, 2016
• Last Update Submitted That Met QC Criteria: June 17, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Pain; Intensive care; Cross-over; Arterial puncture; Relational touch
• Other Study ID Numbers: 2014-A01607-40