Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-AO1042-41 | Other Identifier | IDRCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: relational touch | Experimental | Relational touch 15 mn " relational touch", hand touch (neck, face and head) |
|
| B: relational | Active Comparator | Relational: 10 mn verbal patient's centered exchanges |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relational Touch | Other | Relational touch 15 mn " relational touch", hand touch (neck, face and head) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Global benefit questionary | Global benefit : 2 sessions per week for 4 weeks and one after the 6 sessions following the intervention (for all patients) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philippe JOSEPH-SYLVESTRE, Nurse | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital René Muret - Head of department Long Term hospital ward | Sevran | 93270 | France |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000080105 | Relational Autonomy |
| ID | Term |
|---|---|
| D026684 | Personal Autonomy |
| D028662 | Principle-Based Ethics |
| D004989 | Ethics |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Relational: | Other | Relational: 10 mn verbal patient's centered exchanges |
|
| 2 sessions per week for 4 weeks and one after the 6 sessions |
| 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 |
| 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 |
| 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 |