Effectiveness of Relational Touch in Painful Elderly

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Other: Relational Touch

• Registration Number: NCT01837732
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-02
• Study First Submitted QC: 2013-04-18
• Study First Posted: 2013-04-23
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-12
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: relational touch	Relational Touch	Relational touch 15 mn " relational touch", hand touch (neck, face and head)

Primary Outcome Measures

Name	Time	Method
SCALE DOLOPLUS BEHAVIORAL ASSESSMENT OF PAIN IN THE ELDERLY (DOLOPLUS pain score variations)	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)

Secondary Outcome Measures

Name	Time	Method
Scale of Guy (Pain related symptoms)	at 3th week and 4th week	Pain related symptoms variation at 3th week (session 6) and 4th week (session 9)(for all patients)
Acceptability rate at each session	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)
Global benefit questionary	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)
score variations of Verbal Rating Scale (VRS)	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)
Global benefit questionary (nurse, doctor, carer)	after the 6 sessions	Global benefit : 2 after the 6 sessions following the intervention by nurse, doctor, carer for all patients

Trial Locations

Locations (1)

Hopital René Muret - Head of department Long Term hospital ward; 🇫🇷 Sevran, France