Effectiveness of Relational Touch in Painful Elderly

NCT01837732 | Completed

• 2 other identifiers: K1107022012-AO1042-41
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Chronic pain; elderly; relational touch

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Scale of Guy (Pain related symptoms)

  at 3th week and 4th week

• Global benefit questionary

  2 sessions per week for 4 weeks and one after the 6 sessions

• Acceptability rate at each session

  2 sessions per week for 3 weeks and in 4 th week

• score variations of Verbal Rating Scale (VRS)

  change from baseline to 4th week

• Global benefit questionary (nurse, doctor, carer)

  after the 6 sessions

Study Arms (2)

A: relational touch

EXPERIMENTAL

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

Other: Relational Touch

B: relational

ACTIVE COMPARATOR

Relational: 10 mn verbal patient's centered exchanges

Other: Relational:

Interventions

Relational Touch OTHER

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

A: relational touch

Relational: OTHER

Relational: 10 mn verbal patient's centered exchanges

B: relational

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• acute pain
• unstable clinical status

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital René Muret - Head of department Long Term hospital ward

Sevran, 93270, France

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Relational Autonomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Personal Autonomy; Principle-Based Ethics; Ethics; Health Care Quality, Access, and Evaluation

Study Officials

• Philippe JOSEPH-SYLVESTRE, Nurse

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 23, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 4, 2017

Record last verified: 2016-12

Locations

FR (1)