PainToRRéaNCT02684149
Pain Impact Assessment of the Relational Touch During Arterial Puncture in ICU (TORREA)
A study testing relational touch in people with Pain, run by University Hospital, Angers at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- relational touch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age under 18
- Tetraplegic patient or having a sensitivity disorder on the limb to be punctured
- No radial pulse perception
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital
Angers, 49933
University Hospital TOURS
Tours, 37044
About this study
Official title: 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.
- Conditions
- Pain
- Being tested
- relational touch
- Keywords
- Intensive care, Arterial puncture, Cross-over, Relational touch, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relational touchProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Relational touch before the first arterial puncture and the second arterial puncture without relational touch Receives: Procedure: relational touch |
| B | Experimental | First arterial puncture without relational touch and relational touch before the second arterial puncture Receives: Procedure: relational touch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (4)
The change in consumption of analgesics and hypnotics
At the first and second arterial puncture
Measured: 1 day
Blood pressure and heart rate variation
At the first and second arterial puncture
Measured: 1 day
Patient satisfaction score
At the first and second arterial puncture
Measured: 1 day
Number of arterial punctures needed before success
At the first and second arterial puncture
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Régine MONCHO, Nurse, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684149
- Sponsor's protocol ID
- 2014-A01607-40
- Acronym
- ToRRéa
- Status last verified
- Jun 2016
- First submitted
- 21 Jan 2015
- Last updated
- 20 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Impact Assessment of the Relational Touch During Arterial Puncture in ICU - TORREA
- ClinicalTrials.gov ID
- NCT02684149
- Acronym / sponsor ID
- ToRRéa / 2014-A01607-40
- Conditions
- Pain
- Keywords
- Intensive care, Arterial puncture, Cross-over, Relational touch, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: relational touchRelational touch before the first arterial puncture and the second arterial puncture without relational touch |
| B | Experimental | Procedure: relational touchFirst arterial puncture without relational touch and relational touch before the second arterial puncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Age under 18
- Tetraplegic patient or having a sensitivity disorder on the limb to be punctured
- No radial pulse perception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| relational touch | Procedure or surgery | A, B |
Primary outcome
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.
Time frame: 1 day
At the first and second arterial puncture
4 secondary outcomes
The change in consumption of analgesics and hypnotics
Time frame: 1 day
Blood pressure and heart rate variation
Time frame: 1 day
Patient satisfaction score
Time frame: 1 day
Number of arterial punctures needed before success
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Régine MONCHO, Nurse principal investigator
University Hospital, Angers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing relational touch in people with Pain, run by University Hospital, Angers at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2016.