Effectiveness of Relational Touch in Painful Elderly (EFFITOUREL)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Chronic Pain

Treatments: Other: Relational:; Other: Relational Touch

Study type: Interventional

Funder types: Other

Identifiers

NCT01837732

2012-AO1042-41 (Other Identifier)

K110702

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

A: relational touch

Experimental group

Description:

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

Treatment:

Other: Relational Touch

B: relational

Active Comparator group

Description:

Relational: 10 mn verbal patient's centered exchanges

Treatment:

Other: Relational: