Chronic PainEFFITOURELNCT01837732

Effectiveness of Relational Touch in Painful Elderly

A study testing Relational Touch and Relational: in people with Chronic Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 65 years and older
Conditions the study is for: Chronic Pain
What is being tested?: Relational Touch and Relational:
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 1 siteFrance
Study dates: Mar 2013to Dec 2015
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 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Age >65 y
Chronic pain > 3 months
Follow up 4 weeks
Patient's speak french
Patient's or representative's agreement to participate and to the informatics treatment of the data

Who cannot join

acute pain
unstable clinical status

Trial locations and contacts

1 site in 1 country.

France1 site

Hopital René Muret - Head of department Long Term hospital ward
Sevran, 93270

Other trials in France

About this study

Official title: Effectiveness of Relational Touch in the Management of Chronic Pain in Institutionalized Elderly

The aim is to investigate the feasibility and efficacy of a relational touch / relational intervention on persistent pain in a long term geriatric hospital care ward population. The main issue is the pain reduction. The hypothesis is that this type of intervention is very useful on pain reduction in old people even with physical or mental disability.

Read the detailed description

The first 74 patients wanting to participate are randomly assigned to 2 groups: relational- touch or relational. Inclusion criteria are : patients with chronic pain; age >65y and informed consent. Where patients had mental impairment the family's agreement is solicited. The regional Ethics Committee agreement was granted. The intervention consists of 6 Relational versus Relational- Touch sessions (twice a week) .Evaluation takes place after the second, 4th and 6th sessions and in the 4th week following the intervention. The main outcome is the pain reduction.

The primary outcome measure is the pain reduction according to the DOLOPLUS scale and the VRS; the secondary outcomes measures are : patient's participation rate; pain related symptoms variation; overall benefit.

Conditions: Chronic Pain
Being tested: Relational Touch, Relational:
Keywords: Chronic pain, elderly, relational touch
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Relational TouchOther
Relational touch 15 mn " relational touch", hand touch (neck, face and head)
Relational:Other
Relational: 10 mn verbal patient's centered exchanges

Study groups in NCT01837732
Study group	Role	What they receive
A: relational touch	Experimental	Relational touch 15 mn " relational touch", hand touch (neck, face and head) Receives: Other: Relational Touch
B: relational	Active comparator	Relational: 10 mn verbal patient's centered exchanges Receives: Other: Relational:

What is being measured

The primary outcome is the main question the study is designed to answer.

SCALE DOLOPLUS BEHAVIORAL ASSESSMENT OF PAIN IN THE ELDERLY (DOLOPLUS pain score variations)
Pain assessment : DOLOPLUS pain score variations at baseline and in the 4th week following the intervention (for all patients)
Measured: change from baseline to 4th week

Secondary outcomes (5)

Scale of Guy (Pain related symptoms)
Pain related symptoms variation at 3th week (session 6) and 4th week (session 9)(for all patients)
Measured: at 3th week and 4th week
Global benefit questionary
Global benefit : 2 sessions per week for 4 weeks and one after the 6 sessions following the intervention (for all patients)
Measured: 2 sessions per week for 4 weeks and one after the 6 sessions
Acceptability rate at each session
Acceptability rate at each session and proportion of the patients completing the whole treatment (for all patients)
Measured: 2 sessions per week for 3 weeks and in 4 th week
score variations of Verbal Rating Scale (VRS)
Pain variation according to VRS at baseline and in the 4th week following the intervention (for communicative patients only)
Measured: change from baseline to 4th week
Global benefit questionary (nurse, doctor, carer)
Global benefit : 2 after the 6 sessions following the intervention by nurse, doctor, carer for all patients
Measured: after the 6 sessions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Dec 2015

First posted23 Apr 2013 (estimated)
Study startMar 2013
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by Assistance Publique - Hôpitaux de ParisThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01837732
Sponsor's protocol ID: K110702
Other IDs: 2012-AO1042-41
Acronym: EFFITOUREL
Status last verified: Dec 2016
First submitted: 2 Apr 2013
Last updated: 4 Jan 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Relational Touch in the Management of Chronic Pain in Institutionalized Elderly
ClinicalTrials.gov ID: NCT01837732
Acronym / sponsor ID: EFFITOUREL / K110702
Conditions: Chronic Pain
Keywords: Chronic pain, elderly, relational touch
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
Study start: Mar 2013
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 23 Apr 2013 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A: relational touch	Experimental	Other: Relational TouchRelational touch 15 mn " relational touch", hand touch (neck, face and head)
B: relational	Active comparator	Other: Relational:Relational: 10 mn verbal patient's centered exchanges

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

Age >65 y
Chronic pain > 3 months
Follow up 4 weeks
Patient's speak french
Patient's or representative's agreement to participate and to the informatics treatment of the data

Key exclusion criteria (2 listed)

acute pain
unstable clinical status

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 TouchRelational touch 15 mn " relational touch", hand touch (neck, face and head)	Other	A: relational touch
Relational:Relational: 10 mn verbal patient's centered exchanges	Other	B: relational

Primary outcome

SCALE DOLOPLUS BEHAVIORAL ASSESSMENT OF PAIN IN THE ELDERLY (DOLOPLUS pain score variations)
Time frame: change from baseline to 4th week
Pain assessment : DOLOPLUS pain score variations at baseline and in the 4th week following the intervention (for all patients)

5 secondary outcomes

Scale of Guy (Pain related symptoms)
Time frame: at 3th week and 4th week
Global benefit questionary
Time frame: 2 sessions per week for 4 weeks and one after the 6 sessions
Acceptability rate at each session
Time frame: 2 sessions per week for 3 weeks and in 4 th week
score variations of Verbal Rating Scale (VRS)
Time frame: change from baseline to 4th week
Global benefit questionary (nurse, doctor, carer)
Time frame: after the 6 sessions

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 4 Jan 2017.

Related trials for Chronic Pain

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

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.

Philippe JOSEPH-SYLVESTRE, Nurse study director

Assistance Publique - Hôpitaux de Paris

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Relational Touch and Relational: in people with Chronic Pain, run by Assistance Publique - Hôpitaux de Paris 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 2 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 4 Jan 2017. 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?

SCALE DOLOPLUS BEHAVIORAL ASSESSMENT OF PAIN IN THE ELDERLY (DOLOPLUS pain score variations) (time frame: change from baseline to 4th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01837732.

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 4 Jan 2017.