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Effectiveness of Relational Touch in Painful Elderly

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01837732
Acronym
EFFITOUREL
Enrollment
74
Registered
2013-04-23
Start date
2013-03-31
Completion date
2015-12-31
Last updated
2017-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Chronic pain, elderly, relational touch

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.

Interventions

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

OTHERRelational:

Relational: 10 mn verbal patient's centered exchanges

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SCALE DOLOPLUS BEHAVIORAL ASSESSMENT OF PAIN IN THE ELDERLY (DOLOPLUS pain score variations)change from baseline to 4th weekPain assessment : DOLOPLUS pain score variations at baseline and in the 4th week following the intervention (for all patients)

Secondary

MeasureTime frameDescription
Scale of Guy (Pain related symptoms)at 3th week and 4th weekPain related symptoms variation at 3th week (session 6) and 4th week (session 9)(for all patients)
Global benefit questionary2 sessions per week for 4 weeks and one after the 6 sessionsGlobal benefit : 2 sessions per week for 4 weeks and one after the 6 sessions following the intervention (for all patients)
Acceptability rate at each session2 sessions per week for 3 weeks and in 4 th weekAcceptability rate at each session and proportion of the patients completing the whole treatment (for all patients)
score variations of Verbal Rating Scale (VRS)change from baseline to 4th weekPain 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 sessionsGlobal benefit : 2 after the 6 sessions following the intervention by nurse, doctor, carer for all patients

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026