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

Pain Clinical Trial

— ToRRéa  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684149
• Other study ID #: 2014-A01607-40
• Status: Completed
• Phase: N/A
• First received: January 21, 2015
• Last updated: June 17, 2016
• Start date: February 2015
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• relational touch

Locations

Country	Name	City	State
France	University Hospital	Angers
France	University Hospital TOURS	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The change in consumption of analgesics and hypnotics	At the first and second arterial puncture	1 day	No
Secondary	Blood pressure and heart rate variation	At the first and second arterial puncture	1 day	No
Secondary	Patient satisfaction score	At the first and second arterial puncture	1 day	No
Secondary	Number of arterial punctures needed before success	At the first and second arterial puncture	1 day	No