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

NCT ID: NCT04561271

Last Updated: 2020-12-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2021-07-31

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.

Conditions

End Stage Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

foot 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. 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

Group Type: EXPERIMENTAL

foot reflexology

Intervention Type: OTHER

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.

toucher massage

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.

Group Type: SHAM_COMPARATOR

toucher massage

Intervention Type: OTHER

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.

Interventions

foot 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.

Intervention Type: OTHER

toucher 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Virginie Guastella

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Central Contacts

Lise LACLAUTRE

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Facility Contacts

Lise Laclautre

Role: primary

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Other Identifiers

2020-A01880-39

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2020 GUASTELLA

Identifier Type: -

Identifier Source: org_study_id