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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04561271
Acronym
RPASP
Enrollment
43
Registered
2020-09-23
Start date
2021-01-31
Completion date
2021-07-31
Last updated
2020-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Disease

Keywords

Palliative care, Foot reflexology, Anxiety, Acceptability, Feasability

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.

Interventions

OTHERfoot reflexology

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.

OTHERtoucher massage

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.

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

2 arms, one called foot reflexology who receive one session, the second called toucher massage.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
acceptability of foot reflexology in palliative care unitday 0the acceptability will be assessed by the number of patient who accept to participate to the study
feasibility of foot reflexology in palliative care unitday 0The 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).

Secondary

MeasureTime frameDescription
Effects of foot reflexology on sleep qualityBefore the session (day 0) and 24 hours afterinvestigators 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.
Effects of foot reflexology on anxiolytic intakeBefore the session (day 0) and 24 hours afterinvestigators 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
Effects of foot reflexology on anxietyBefore the session (day 0) and 24 hours afterinvestigator 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
patients' experienceday 124 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
Effects of foot reflexology on pain killers intakeBefore the session (day 0) and 24 hours afterinvestigators 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.
Effects of foot reflexology on painBefore the session (day 0) and 24 hours afterinvestigators 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

Countries

France

Contacts

Primary ContactLise LACLAUTRE
promo_interne_drci@chu-clermontferrand.fr+33473754963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026