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

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

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.

Study Overview

• Status: Unknown
• Conditions: End Stage Disease
• Intervention / Treatment: Other: foot reflexology; Other: toucher massage

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.

• Study Type: Interventional
• Enrollment (Anticipated): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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.
Sham Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of foot reflexology on anxiety	investigator 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	Before the session (day 0) and 24 hours after
Effects of foot reflexology on pain	investigators 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	Before the session (day 0) and 24 hours after
Effects of foot reflexology on sleep quality	investigators 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.	Before the session (day 0) and 24 hours after
Effects of foot reflexology on anxiolytic intake	investigators 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	Before the session (day 0) and 24 hours after
Effects of foot reflexology on pain killers intake	investigators 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.	Before the session (day 0) and 24 hours after
patients' experience	24 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	day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Virginie Guastella, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Anxiety; Palliative care; Foot reflexology; Acceptability; Feasability
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: RBHP 2020 GUASTELLA; 2020-A01880-39 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No