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

NCT04561271 | Unknown

• 2 other identifiers: RBHP 2020 GUASTELLA2020-A01880-39
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Disease

Keywords

Palliative care; Foot reflexology; Anxiety; Acceptability; Feasability

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Effects of foot reflexology on anxiety

  Before the session (day 0) and 24 hours after

• Effects of foot reflexology on pain

  Before the session (day 0) and 24 hours after

• Effects of foot reflexology on sleep quality

  Before the session (day 0) and 24 hours after

• Effects of foot reflexology on anxiolytic intake

  Before the session (day 0) and 24 hours after

• Effects of foot reflexology on pain killers intake

  Before the session (day 0) and 24 hours after

Study Arms (2)

foot reflexology

EXPERIMENTAL

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

toucher massage

SHAM COMPARATOR

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

Interventions

foot reflexology 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.

foot reflexology

toucher massage 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.

toucher massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Virginie Guastella

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 arms, one called "foot reflexology" who receive one session, the second called "toucher massage".

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 23, 2020
• Study Start: January 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

FR (1)