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

End Stage Disease Clinical Trial

— RPASP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04561271
• Other study ID #: RBHP 2020 GUASTELLA
• Secondary ID: 2020-A01880-39
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: July 2021

Study information

• Verified date: December 2020
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 43
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• End Stage Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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