Effectiveness of Relational Touch in Painful Elderly

Chronic Pain Clinical Trial

— EFFITOUREL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837732
• Other study ID #: K110702
• Secondary ID: 2012-AO1042-41
• Status: Completed
• Phase: N/A
• First received: April 2, 2013
• Last updated: January 3, 2017
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Relational Touch
Relational touch 15 mn " relational touch", hand touch (neck, face and head)
• Relational:
Relational: 10 mn verbal patient's centered exchanges

Locations

Country	Name	City	State
France	Hopital René Muret - Head of department Long Term hospital ward	Sevran

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No