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

U

University Hospital, Clermont-Ferrand

Status

Unknown

Conditions

End Stage Disease

Treatments

Other: foot reflexology
Other: toucher massage

Study type

Interventional

Funder types

Other

Identifiers

NCT04561271
RBHP 2020 GUASTELLA
2020-A01880-39 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

43 participants in 2 patient groups

foot reflexology
Experimental group
Description:
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
Treatment:
Other: foot reflexology
toucher massage
Sham Comparator group
Description:
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.
Treatment:
Other: toucher massage

Trial contacts and locations

1

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Central trial contact

Lise LACLAUTRE

Data sourced from clinicaltrials.gov

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