Effectiveness of Relational Touch in Painful Elderly

Study Overview
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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.

Official Title
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Effectiveness of Relational Touch in the Management of Chronic Pain in Institutionalized Elderly

Conditions
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Chronic Pain

Intervention / Treatment
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* Other: Relational Touch
* Other: Relational:


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale of Guy (Pain related symptoms) | 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 | 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 | 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) | 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) | Global benefit : 2 after the 6 sessions following the intervention by nurse, doctor, carer for all patients | after the 6 sessions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, elderly, relational touch