Effectiveness of Relational Touch in Painful Elderly

NCT ID: NCT01837732

Last Updated: 2017-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A: relational touch

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

Group Type EXPERIMENTAL

Relational Touch

Intervention Type OTHER

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

B: relational

Relational: 10 mn verbal patient's centered exchanges

Group Type ACTIVE_COMPARATOR

Relational:

Intervention Type OTHER

Relational: 10 mn verbal patient's centered exchanges

Interventions

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Relational Touch

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

Intervention Type OTHER

Relational:

Relational: 10 mn verbal patient's centered exchanges

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe JOSEPH-SYLVESTRE, Nurse

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hopital René Muret - Head of department Long Term hospital ward

Sevran, , France

Site Status

Countries

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France

Other Identifiers

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2012-AO1042-41

Identifier Type: OTHER

Identifier Source: secondary_id

K110702

Identifier Type: -

Identifier Source: org_study_id

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