NCT02684149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

January 21, 2015

Last Update Submit

June 17, 2016

Conditions

Pain

Keywords

Intensive careArterial punctureCross-overRelational touchPain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • The change in consumption of analgesics and hypnotics

    1 day

  • Blood pressure and heart rate variation

    1 day

  • Patient satisfaction score

    1 day

  • Number of arterial punctures needed before success

    1 day

Study Arms (2)

A

EXPERIMENTAL

Relational touch before the first arterial puncture and the second arterial puncture without relational touch

Procedure: relational touch

B

EXPERIMENTAL

First arterial puncture without relational touch and relational touch before the second arterial puncture

Procedure: relational touch

Interventions

relational touchPROCEDURE
AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital

Angers, 49933, France

Location

University Hospital TOURS

Tours, 37044, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Régine MONCHO, Nurse

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2015

First Posted

February 17, 2016

Study Start

February 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

June 20, 2016

Record last verified: 2016-06

Locations

FR(2)