Clinical trial NCT04561271: Feasability of Foot Reflexology to Alleviate Anxiety in Palliative Care Unit (RPASP)
Official title: Feasability of Foot Reflexology to Alleviate Anxiety in Palliative Care Unit : a Pilot Randomised Double Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Disease
Keywords: Palliative care
Foot reflexology
Anxiety
Acceptability
Feasability
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arms, one called "foot reflexology" who receive one session, the second called "toucher massage".
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: acceptability of foot reflexology in palliative care unit
timeFrame: day 0
measure: feasibility of foot reflexology in palliative care unit
timeFrame: day 0
Secondary outcomes:
measure: Effects of foot reflexology on anxiety
timeFrame: Before the session (day 0) and 24 hours after
measure: Effects of foot reflexology on pain
timeFrame: Before the session (day 0) and 24 hours after
measure: Effects of foot reflexology on sleep quality
timeFrame: Before the session (day 0) and 24 hours after
measure: Effects of foot reflexology on anxiolytic intake
timeFrame: Before the session (day 0) and 24 hours after
measure: Effects of foot reflexology on pain killers intake
timeFrame: Before the session (day 0) and 24 hours after
measure: patients' experience
timeFrame: day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Virginie Guastella
role: PRINCIPAL_INVESTIGATOR
References: