End Stage DiseaseRPASPNCT04561271
Feasability of Foot Reflexology to Alleviate Anxiety in Palliative Care Unit (RPASP)
A study testing foot reflexology and toucher massage in people with End Stage Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Disease
- What is being tested?
- foot reflexology and toucher massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2021to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Viginie Guastella
About this study
Official title: 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.
Read the 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
- Being tested
- foot reflexology, toucher massage
- Keywords
- Palliative care, Foot reflexology, Anxiety, Acceptability, Feasability
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot reflexologyOther
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 massageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: toucher massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: day 0
Secondary outcomes (6)
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study startJan 2021 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arms, one called "foot reflexology" who receive one session, the second called "toucher massage".
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie Guastella, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561271
- Sponsor's protocol ID
- RBHP 2020 GUASTELLA
- Other IDs
- 2020-A01880-39
- Acronym
- RPASP
- Status last verified
- Dec 2020
- First submitted
- 8 Sep 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasability of Foot Reflexology to Alleviate Anxiety in Palliative Care Unit : a Pilot Randomised Double Blind Study
- ClinicalTrials.gov ID
- NCT04561271
- Acronym / sponsor ID
- RPASP / RBHP 2020 GUASTELLA
- Conditions
- End Stage Disease
- Keywords
- Palliative care, Foot reflexology, Anxiety, Acceptability, Feasability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 arms, one called "foot reflexology" who receive one session, the second called "toucher massage".
| Arm | Type | Receives |
|---|---|---|
| foot reflexology | Experimental | Other: foot reflexologypatients 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 |
| toucher massage | Sham comparator | Other: toucher massagepatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- Painfull bone metastasis on the feet
- foot amputation
- foot bedsore
- peripheral distal neuropathy, trouble of foot sensibility
- agonic or pre agonic state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| foot reflexologyPatients 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. | Other | foot reflexology |
| toucher massageone 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 |
Primary outcome
acceptability of foot reflexology in palliative care unit
Time frame: day 0
the acceptability will be assessed by the number of patient who accept to participate to the study
feasibility of foot reflexology in palliative care unit
Time frame: day 0
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).
6 secondary outcomes
Effects of foot reflexology on anxiety
Time frame: Before the session (day 0) and 24 hours after
Effects of foot reflexology on pain
Time frame: Before the session (day 0) and 24 hours after
Effects of foot reflexology on sleep quality
Time frame: Before the session (day 0) and 24 hours after
Effects of foot reflexology on anxiolytic intake
Time frame: Before the session (day 0) and 24 hours after
Effects of foot reflexology on pain killers intake
Time frame: Before the session (day 0) and 24 hours after
patients' experience
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginie Guastella principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing foot reflexology and toucher massage in people with End Stage Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acceptability of foot reflexology in palliative care unit (time frame: day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.