AnxietyREaLAXNCT03030482
Evaluation of Touch Massage on Anxiety in Critically Ill Patients
A study testing touch massage in people with Anxiety, run by Versailles Hospital at 1 site in France.
Trial summary
Anxiety is a common problem encountered in a about 43 % of critically ill patients. Its occurrence can be related to several causes, mainly dominated by invasive procedures. anxiety management is typically based on a combination of prevention, evaluation, and therapeutic agents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- touch massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2017to 30 Apr 2020
- 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
- All adult patients (age≥18 years) hospitalized in Intensive Care Unit > 24 h
- Requiring mechanical ventilation or not
- Securité Sociale affiliated
- Patient with accessible zone for touch massage (head-face, arms-hands, feet, legs and back)
- No significant event (invasive procedure, diagnostic ad, CAT,MRI) before enrollment
Who cannot join
- Pregnant
- Legal guardianship
- Neurological failure : stroke ischemic or hemorrhagic, meningitis, status epilepticus,polytrauma( including head trauma),meningo encephalitis, meningism,
- Patient with upper limbs neuromuscular disorders
- Cutaneous lesion (zone of touch massage)
- Temperature ≥ 38,5°C
- A positive score of CAM ICU scale
- Patient refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Touch Massage on Anxiety in Critically Ill Patients : a Randomised Controlled Trial Study (REaLAX)
Anxiety is a common problem encountered in a about 43 % of critically ill patients. Its occurrence can be related to several causes, mainly dominated by invasive procedures.
anxiety management is typically based on a combination of prevention, evaluation, and therapeutic agents. However, it appears important to develop adjuvant approaches. Touch massage is one of them and that has been evaluated in various medical conditions.
The aim of our study is to evaluate the anxiolytic effect of touch massage in critically ill patients during potentially painful nursing procedures.
- Conditions
- Anxiety
- Being tested
- touch massage
- Keywords
- Anxiety, intensive care, mechanical ventilation, touch massage
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
touch massageProcedure or surgery
Patients will have a touch massage session during 30 minutes the intervention will take place remotely (1 h) of all events that can generate anxiety
| Study group | Role | What they receive |
|---|---|---|
| Touch massage | Experimental | Patients will have a touch massage session during 30 minutes the intervention will take place remotely (1 h) of all events that can generate anxiety Receives: Procedure: touch massage |
| control | No intervention | standard care ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the anxiolytic value of touch massage to critically ill patient, awake, communicating
Total score variation of the Spielberger STAI Y-A anxiety scale (short form) before and after the touch massage session (score 6-24) or standard care ICU.
Measured: 60 minutes
Secondary outcomes (2)
Measure the correlation between the Spielberger STAI Y-A (short form) anxiety scale and the Anxiety Visual Anxiety Scale (EVA-A).
Patient anxiety will be evaluated by the score of anxiety measured in millimeters from 0 to 100 using a Visual analogue scale of anxiety (EVA - A) before and after touch massage session or standard care ICU.
Measured: 60 minutes
Measure the analgesic effect of touch massage to critically ill patient awake, communicating
Pain will be evaluated by the pain score measured in millimeters of 0 and 100 with scale visual analog pain (EVA) before and touch massage session or standard care ICU.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start20 Apr 2017
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melot Karine, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030482
- Sponsor's protocol ID
- P14/10_REaLAX
- Acronym
- REaLAX
- Status last verified
- Feb 2021
- First submitted
- 21 Jan 2017
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Touch Massage on Anxiety in Critically Ill Patients : a Randomised Controlled Trial Study (REaLAX)
- ClinicalTrials.gov ID
- NCT03030482
- Acronym / sponsor ID
- REaLAX / P14/10_REaLAX
- Conditions
- Anxiety
- Keywords
- Anxiety, intensive care, mechanical ventilation, touch massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 25 Jan 2017 (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.
Anxiety is a common problem encountered in a about 43 % of critically ill patients. Its occurrence can be related to several causes, mainly dominated by invasive procedures.
anxiety management is typically based on a combination of prevention, evaluation, and therapeutic agents. However, it appears important to develop adjuvant approaches. Touch massage is one of them and that has been evaluated in various medical conditions.
The aim of our study is to evaluate the anxiolytic effect of touch massage in critically ill patients during potentially painful nursing procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Touch massage | Experimental | Procedure: touch massagePatients will have a touch massage session during 30 minutes the intervention will take place remotely (1 h) of all events that can generate anxiety |
| control | No intervention | –standard care ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All adult patients (age≥18 years) hospitalized in Intensive Care Unit > 24 h
- Requiring mechanical ventilation or not
- Securité Sociale affiliated
- Patient with accessible zone for touch massage (head-face, arms-hands, feet, legs and back)
- No significant event (invasive procedure, diagnostic ad, CAT,MRI) before enrollment
Key exclusion criteria (8 listed)
- Pregnant
- Legal guardianship
- Neurological failure : stroke ischemic or hemorrhagic, meningitis, status epilepticus,polytrauma( including head trauma),meningo encephalitis, meningism,
- Patient with upper limbs neuromuscular disorders
- Cutaneous lesion (zone of touch massage)
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 |
|---|---|---|
| touch massagePatients will have a touch massage session during 30 minutes the intervention will take place remotely (1 h) of all events that can generate anxiety | Procedure or surgery | Touch massage |
Primary outcome
Measure the anxiolytic value of touch massage to critically ill patient, awake, communicating
Time frame: 60 minutes
Total score variation of the Spielberger STAI Y-A anxiety scale (short form) before and after the touch massage session (score 6-24) or standard care ICU.
2 secondary outcomes
Measure the correlation between the Spielberger STAI Y-A (short form) anxiety scale and the Anxiety Visual Anxiety Scale (EVA-A).
Time frame: 60 minutes
Measure the analgesic effect of touch massage to critically ill patient awake, communicating
Time frame: 60 minutes
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 12 Feb 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing touch massage in people with Anxiety, run by Versailles Hospital at 1 site 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 5 inclusion and 8 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 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Measure the anxiolytic value of touch massage to critically ill patient, awake, communicating (time frame: 60 minutes). 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 12 Feb 2021.