Feasability of Foot Reflexology to Alleviate Anxiety in Palliative Care Unit (RPASP)

Study Overview
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Brief Summary
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The primary purpose of the study is to know if foot reflexology can be accepted by patients hospitalized in palliative unit care (assessed by the number of patient who accept to participate), and if it is feasible (assessed by the realization of one session in normal condition : duration of 15-20 min, in supine position/seated or half-seated position).The investigators make the hypothesis that patients will accept to receive foot reflexology, and maybe feel less anxious after one session.

Detailed Description
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The patients will receive an informative content about the study and will have 24 hours of reflexion. If they accept to participate to the study, they will be randomised in one of the two groups : foot reflexology or toucher massage (for those randomised in the toucher massage group, a session of foot reflexology will be proposed in a second time). The investigators will assess the level of anxiety, the quality of the sleep and the pain using the ESAS scale, before and after the session. 24 hours after the session, they will be interviewed about what they felt with the session. The investigators will also have a look on the anxiolytic and antagic medication they consume before and after the session.

Official Title
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Feasability of Foot Reflexology to Alleviate Anxiety in Palliative Care Unit : a Pilot Randomised Double Blind Study

Conditions
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End Stage Disease

Intervention / Treatment
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* Other: foot reflexology
* Other: toucher massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult able to give consent, man or woman, hospitalized in palliative care unit, with vigilance criteria from +1 to -3 on the Richmond scale. Affiliated to Social Security Exclusion Criteria: Painfull bone metastasis on the feet foot amputation foot bedsore peripheral distal neuropathy, trouble of foot sensibility agonic or pre agonic state Patients under juridical protection Refusal to participate to the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 arms, one called foot reflexology who receive one session, the second called toucher massage.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: foot reflexology<br>patients will receive one session of foot reflexology with a nurse who received a specific formation. The session lasts 15 to 20 minutes, patients seated, half seated or in supine position. The technique consists in stimulating reflex zones of foot, each zone corresponding to a specific organ. Almond oil will be used. The session is accompanied by relaxing music | Other: foot reflexology<br>* Patients will receive one session of foot reflexology with a nurse who received a specific formation. The session lasts 15 to 20 minutes, patients seated, half seated or in supine position. A neutral oil will be used. The technique associates specific movements of foot reflexology. The session is accompanied by relaxing music.<br>|
| Sham Comparator: toucher massage<br>patients will receive one session of toucher massage with a nurse (this technique is taught during the formation of every nurse in palliative care units). The session lasts 15 to 20 minutes, patients seated, half seated or in supine position. It consists in a simple massage and effleurage, with fluid and progressive movements. Almond oil will be used. The session is accompanied by relaxing music. | Other: toucher massage<br>* one session of toucher massage with a nurse (this technique is taught during the formation of every nurse in palliative care units). The session lasts 15 to 20 minutes, patients seated, half seated or in supine position. It consists in a simple massage and effleurage, with fluid and progressive movements. Almond oil will be used. The session is accompanied by relaxing music.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acceptability of foot reflexology in palliative care unit | the acceptability will be assessed by the number of patient who accept to participate to the study | day 0 | 
| feasibility of foot reflexology in palliative care unit | The feasibility will be assessed by the conditions of realization of one session : for the study, the normal conditions will be : duration (15-20 min) and possibility for the patient to remain in the good position (supine position/seated or half-seated position). | day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of foot reflexology on anxiety | investigator will assess the anxiety, using the Edmonton Symptom Assessment System (ESAS scale), before and after the session. This scale permits the patient to choose a number from 0 to 10, 0 corresponding to the lowest level of anxiety, and 10 corresponding to the highest level of anxiety | Before the session (day 0) and 24 hours after | 
| Effects of foot reflexology on pain | investigators will assess the pain using the Edmonton Symptom Assessment System (ESAS scale), before and after the session. This scale permits the patient to choose a number from 0 to 10, 0 corresponding to the lowest level of pain, and 10 corresponding to the highest level of pain | Before the session (day 0) and 24 hours after | 
| Effects of foot reflexology on sleep quality | investigators will assess the sleep quality using the Edmonton Symptom Assessment System (ESAS scale), before and after the session. This scale permits the patient to choose a number from 0 to 10, 0 corresponding to the lowest level of tiredness, and 10 corresponding to the highest level of tiredness. | Before the session (day 0) and 24 hours after | 
| Effects of foot reflexology on anxiolytic intake | investigators will write down the anxiolytic intake before the session, and until 24 hours after the session, using redcap software. There will be a yes/no question for benzodiazepine and neuroleptic. If yes is chosen, there will be a free text box to be more specific | Before the session (day 0) and 24 hours after | 
| Effects of foot reflexology on pain killers intake | investigators will write down the pain killer intake before the session, and until 24 hours after the session, using redcap software. There will be a yes/no question for paracetamol, weak opioids, strong opioids and co-analgesics. If yes is chosen, there will be a free text box to be more specific. | Before the session (day 0) and 24 hours after | 
| patients' experience | 24 hours after the session, investigators will collect patients' experience and feeling about the session they undergone. Key words and verbatims will be reported on a free text box with redcap | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative care, Foot reflexology, Anxiety, Acceptability, Feasability