Effectiveness of Relational Touch in Painful Elderly (EFFITOUREL)

January 3, 2017 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • acute pain
  • unstable clinical status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A: relational touch
Relational touch 15 mn " relational touch", hand touch (neck, face and head)
Other: Relational Touch
Relational touch 15 mn " relational touch", hand touch (neck, face and head)
Active Comparator: B: relational
Relational: 10 mn verbal patient's centered exchanges
Other: Relational:
Relational: 10 mn verbal patient's centered exchanges

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
change from baseline to 4th week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Director: Philippe JOSEPH-SYLVESTRE, Nurse, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 18, 2013

First Posted (Estimate)

April 23, 2013

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K110702
  • 2012-AO1042-41 (Other Identifier: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Clinical Trials on Relational Touch

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe