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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Procedure: relational touch

• Registration Number: NCT02684149
• Lead Sponsor: University Hospital, Angers

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-21
• Study Start: 2015-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-17
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-17
• Last Update Posted: 2016-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	relational touch	Relational touch before the first arterial puncture and the second arterial puncture without relational touch
B	relational touch	First arterial puncture without relational touch and relational touch before the second arterial puncture

Primary Outcome Measures

Name	Time	Method
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.	1 day	At the first and second arterial puncture

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University Hospital; 🇫🇷 Angers, France

University Hospital TOURS; 🇫🇷 Tours, France