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Effectiveness of Relational Touch in Painful Elderly (EFFITOUREL)

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Relational Touch
Relational:
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic pain, elderly, relational touch

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital René Muret - Head of department Long Term hospital ward

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A: relational touch

B: relational

Arm Description

Relational touch 15 mn " relational touch", hand touch (neck, face and head)

Relational: 10 mn verbal patient's centered exchanges

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Scale of Guy (Pain related symptoms)
Pain related symptoms variation at 3th week (session 6) and 4th week (session 9)(for all patients)
Global benefit questionary
Global benefit : 2 sessions per week for 4 weeks and one after the 6 sessions following the intervention (for all patients)
Acceptability rate at each session
Acceptability rate at each session and proportion of the patients completing the whole treatment (for all patients)
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)
Global benefit questionary (nurse, doctor, carer)
Global benefit : 2 after the 6 sessions following the intervention by nurse, doctor, carer for all patients

Full Information

First Posted
April 2, 2013
Last Updated
January 3, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01837732
Brief Title
Effectiveness of Relational Touch in Painful Elderly
Acronym
EFFITOUREL
Official Title
Effectiveness of Relational Touch in the Management of Chronic Pain in Institutionalized Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic pain, elderly, relational touch

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: relational touch
Arm Type
Experimental
Arm Description
Relational touch 15 mn " relational touch", hand touch (neck, face and head)
Arm Title
B: relational
Arm Type
Active Comparator
Arm Description
Relational: 10 mn verbal patient's centered exchanges
Intervention Type
Other
Intervention Name(s)
Relational Touch
Intervention Description
Relational touch 15 mn " relational touch", hand touch (neck, face and head)
Intervention Type
Other
Intervention Name(s)
Relational:
Intervention Description
Relational: 10 mn verbal patient's centered exchanges
Primary Outcome Measure Information:
Title
SCALE DOLOPLUS BEHAVIORAL ASSESSMENT OF PAIN IN THE ELDERLY (DOLOPLUS pain score variations)
Description
Pain assessment : DOLOPLUS pain score variations at baseline and in the 4th week following the intervention (for all patients)
Time Frame
change from baseline to 4th week
Secondary Outcome Measure Information:
Title
Scale of Guy (Pain related symptoms)
Description
Pain related symptoms variation at 3th week (session 6) and 4th week (session 9)(for all patients)
Time Frame
at 3th week and 4th week
Title
Global benefit questionary
Description
Global benefit : 2 sessions per week for 4 weeks and one after the 6 sessions following the intervention (for all patients)
Time Frame
2 sessions per week for 4 weeks and one after the 6 sessions
Title
Acceptability rate at each session
Description
Acceptability rate at each session and proportion of the patients completing the whole treatment (for all patients)
Time Frame
2 sessions per week for 3 weeks and in 4 th week
Title
score variations of Verbal Rating Scale (VRS)
Description
Pain variation according to VRS at baseline and in the 4th week following the intervention (for communicative patients only)
Time Frame
change from baseline to 4th week
Title
Global benefit questionary (nurse, doctor, carer)
Description
Global benefit : 2 after the 6 sessions following the intervention by nurse, doctor, carer for all patients
Time Frame
after the 6 sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe JOSEPH-SYLVESTRE, Nurse
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Hopital René Muret - Head of department Long Term hospital ward
City
Sevran
ZIP/Postal Code
93270
Country
France

12. IPD Sharing Statement

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Effectiveness of Relational Touch in Painful Elderly

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