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Completed

NCT Number: NCT01837732

Effectiveness of Relational Touch in Painful Elderly

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital René Muret - Head of department Long Term hospital ward

Sevran, 93270, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relational Touch

Other

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

Relational:

Other

Relational: 10 mn verbal patient's centered exchanges

Primary outcomes

  1. SCALE DOLOPLUS BEHAVIORAL ASSESSMENT OF PAIN IN THE ELDERLY (DOLOPLUS pain score variations)

    Time frame: 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 outcomes

  1. Scale of Guy (Pain related symptoms)

    Time frame: at 3th week and 4th week

    Pain related symptoms variation at 3th week (session 6) and 4th week (session 9)(for all patients)

  2. Global benefit questionary

    Time frame: 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)

  3. Acceptability rate at each session

    Time frame: 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)

  4. score variations of Verbal Rating Scale (VRS)

    Time frame: 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)

  5. Global benefit questionary (nurse, doctor, carer)

    Time frame: after the 6 sessions

    Global benefit : 2 after the 6 sessions following the intervention by nurse, doctor, carer for all patients

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: EFFITOUREL

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 23, 2013
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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