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Effectiveness of Relational Touch in Painful Elderly (EFFITOUREL)

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ClinicalTrials.gov Identifier: NCT01837732
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Other: Relational Touch Other: Relational: Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Relational Touch in the Management of Chronic Pain in Institutionalized Elderly
Study Start Date : March 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: A: relational touch
Relational touch 15 mn " relational touch", hand touch (neck, face and head)
Other: Relational Touch
Relational touch 15 mn " relational touch", hand touch (neck, face and head)

Active Comparator: B: relational
Relational: 10 mn verbal patient's centered exchanges
Other: Relational:
Relational: 10 mn verbal patient's centered exchanges




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837732


Locations
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France
Hopital René Muret - Head of department Long Term hospital ward
Sevran, France, 93270
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Philippe JOSEPH-SYLVESTRE, Nurse Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01837732    
Other Study ID Numbers: K110702
2012-AO1042-41 ( Other Identifier: IDRCB )
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: December 2016
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Chronic pain
elderly
relational touch
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms