Chronic Kidney InsufficienciesSocioAestheticNCT05000073
Influence of Socio-aesthetic Care on the Quality of Life of Hemodialysis Patients
A study testing dialysis and socio-aesthetic care and dialysis in people with Chronic Kidney Insufficiencies, run by CHU de Reims at 1 site in France.
Trial summary
The report of the Epidemiological and Information Network in Nephrology counted 44,978 hemodialysis patients in France in 2017, with more than 93% of them attending 3 sessions per week. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Insufficiencies
- What is being tested?
- dialysis and socio-aesthetic care and dialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2022to 25 Jul 2024
- 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
- 18 years of age or older;
- Suffering from chronic kidney failure
- On hemodialysis for 1 month
- Dialysed 3 times a week
- In heavy center ;
- fluent in French;
Show all 13Show fewer
- Benefiting from a social security system;
- Agreeing to participate in the study exclusion criteria :
- Having cognitive problems hindering the comprehension of the tool.
- Under protection of justice (guardianship or curatorship).
- Patients allergic to the care products used
- Patients with additional precautions related to a high risk of cross-transmission such as emerging highly resistant bacteria, scabies, clostridium difficile, pulmonary tuberculosis.
- Patients in withdrawal from other dialysis centers
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The report of the Epidemiological and Information Network in Nephrology counted 44,978 hemodialysis patients in France in 2017, with more than 93% of them attending 3 sessions per week.
This multi-weekly recourse to the healthcare system in the context of substitution treatment constantly reminds patients of their disease and has a strong impact on their quality of life.
Read more
The 2011 REIN quality of life report showed that the quality of life of patients with renal failure, particularly dialysis patients, is impaired, particularly in its physical and mental components. A recent comparative study (van Sandwijk et al., 2019) comparing hemodialysis patients with hematological cancer patients under chemotherapy supports these data.
The June 2013 report of the "Etats généraux du rein", an initiative of patient associations, called for the improvement of quality of life to be made a priority and for the possibility of using supportive care and complementary non-drug techniques to be proposed.
Socio-aesthetic care, defined "as the practice of aesthetic care for people who are suffering or vulnerable", has found its place in hospitals as a complementary discipline to medical care, particularly in oncology.
We believe that in order to improve the overall quality of life of hemodialysis patients, the quality of the experience of each session must be improved. In this perspective, the repetition of socio-aesthetic care performed during dialysis sessions could contribute to the overall improvement of the quality of life.
A national survey (Saghatchian et al., 2018) on the impact of socio-aesthetic care in oncology confirms the positive perception of this care among cancer patients. Two studies carried out in hemodialysis (Bullen et al., 2018; Unal \& Balci Akpinar, 2016) using complementary techniques, such as acupuncture, massage, or foot reflexology, highlight an impact on sleep, fatigue and quality of life.
The experience of implementing socio-aesthetic care in our hemodialysis unit also leads us to believe that they positively influence the perception of the session, and therefore perhaps the quality of life measured with a validated scale, the KDQOL (Kidney Disease Quality Of Life).
Our research therefore focuses on the effectiveness of social and aesthetic care during hemodialysis sessions to improve the quality of life of the hemodialysis patient.
Read the detailed description
Many studies have been conducted on the overall quality of life of hemodialysis patients, but our original approach is to hypothesize that the course of each dialysis session, taken individually, can influence the overall quality of life of patients.
We hypothesize that the repetition of socio-aesthetic care as supportive care during the dialysis session would be a non-drug means to improve the quality of life of hemodialysis patients and to improve the experience of the dialysis session, the overall satisfaction of the session.
This is a randomized open clinical trial, monocentric, with two parallel arms, comparing a social and esthetic care procedure performed during a session by two certified aesthetics at the usual treatment.
The target population for this study will be individuals suffering from chronic renal failure who have been undergoing hemodialysis in the Reims University Hospital for at least one month and who will be randomly assigned to one of the two groups:
- Experimental group with socio-aesthetic care: choice of the type of care (facial modeling, hand modeling or manicure) by the patient at the rate of one session per week for 4 weeks.
- Control unit with standard support we use several validated scales:
- Assessment of the quality of life with the KDQOL
- Assessment of anxiety and depression with the HADS anxiety and HADS depression scale
- Analogous visual evaluation of overall satisfaction with the session
- Conditions
- Chronic Kidney Insufficiencies
- Being tested
- dialysis and socio-aesthetic care, dialysis
- Keywords
- Quality of life, renal dialysis, socio aesthetic care
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dialysis and socio-aesthetic careOther
dialysis and socio-aesthetic care
dialysisOther
dialysis
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Other: dialysis and socio-aesthetic care |
| Control arm | Active comparator | Not described Receives: Other: dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale of quality of life (KDQoL)
Quality of life is assess by using KDQoL from 0 (worse quality of life) to 100 (better quality of life)
Measured: Day 0
Scale of quality of life (KDQoL)
Quality of life is assess by using KDQoL from 0 (worse quality of life) to 100 (better quality of life)
Measured: At Month 1
Secondary outcomes (2)
Scale of anxiety and depression (HADS)
Anxiety and Depression are assess by using HADS scales from 0 (no anxiety or no depression) to 21 (anxiety or depression )
Measured: Day 0
Scale of anxiety and depression (HADS)
Anxiety and Depression are assess by using HADS scales from 0 (no anxiety or no depression) to 21 (anxiety or depression )
Measured: At Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start17 Jan 2022
- Primary completion25 Jun 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney InsufficienciesStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000073
- Sponsor's protocol ID
- PP21064
- Acronym
- SocioAesthetic
- Status last verified
- Feb 2025
- First submitted
- 3 Aug 2021
- Last updated
- 10 Feb 2025
- 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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Socio-aesthetic Care on the Quality of Life of Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05000073
- Acronym / sponsor ID
- SocioAesthetic / PP21064
- Conditions
- Chronic Kidney Insufficiencies
- Keywords
- Quality of life, renal dialysis, socio aesthetic care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 11 Aug 2021 (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 report of the Epidemiological and Information Network in Nephrology counted 44,978 hemodialysis patients in France in 2017, with more than 93% of them attending 3 sessions per week.
This multi-weekly recourse to the healthcare system in the context of substitution treatment constantly reminds patients of their disease and has a strong impact on their quality of life.
The 2011 REIN quality of life report showed that the quality of life of patients with renal failure, particularly dialysis patients, is impaired, particularly in its physical and mental components. A recent comparative study (van Sandwijk et al., 2019) comparing hemodialysis patients with hematological cancer patients under chemotherapy supports these data.
The June 2013 report of the "Etats généraux du rein", an initiative of patient associations, called for the improvement of quality of life to be made a priority and for the possibility of using supportive care and complementary non-drug techniques to be proposed.
Socio-aesthetic care, defined "as the practice of aesthetic care for people who are suffering or vulnerable", has found its place in hospitals as a complementary discipline to medical care, particularly in oncology.
We believe that in order to improve the overall quality of life of hemodialysis patients, the quality of the experience of each session must be improved. In this perspective, the repetition of socio-aesthetic care performed during dialysis sessions could contribute to the overall improvement of the quality of life.
A national survey (Saghatchian et al., 2018) on the impact of socio-aesthetic care in oncology confirms the positive perception of this care among cancer patients. Two studies carried out in hemodialysis (Bullen et al., 2018; Unal \& Balci Akpinar, 2016) using complementary techniques, such as acupuncture, massage, or foot reflexology, highlight an impact on sleep, fatigue and quality of life.
The experience of implementing socio-aesthetic care in our hemodialysis unit also leads us to believe that they positively influence the perception of the session, and therefore perhaps the quality of life measured with a validated scale, the KDQOL (Kidney Disease Quality Of Life).
Our research therefore focuses on the effectiveness of social and aesthetic care during hemodialysis sessions to improve the quality of life of the hemodialysis patient.
Detailed description
Many studies have been conducted on the overall quality of life of hemodialysis patients, but our original approach is to hypothesize that the course of each dialysis session, taken individually, can influence the overall quality of life of patients.
We hypothesize that the repetition of socio-aesthetic care as supportive care during the dialysis session would be a non-drug means to improve the quality of life of hemodialysis patients and to improve the experience of the dialysis session, the overall satisfaction of the session.
This is a randomized open clinical trial, monocentric, with two parallel arms, comparing a social and esthetic care procedure performed during a session by two certified aesthetics at the usual treatment.
The target population for this study will be individuals suffering from chronic renal failure who have been undergoing hemodialysis in the Reims University Hospital for at least one month and who will be randomly assigned to one of the two groups:
- Experimental group with socio-aesthetic care: choice of the type of care (facial modeling, hand modeling or manicure) by the patient at the rate of one session per week for 4 weeks.
- Control unit with standard support we use several validated scales:
- Assessment of the quality of life with the KDQOL
- Assessment of anxiety and depression with the HADS anxiety and HADS depression scale
- Analogous visual evaluation of overall satisfaction with the session
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Other: dialysis and socio-aesthetic care |
| Control arm | Active comparator | Other: dialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 years of age or older;
- Suffering from chronic kidney failure
- On hemodialysis for 1 month
- Dialysed 3 times a week
- In heavy center ;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| dialysis and socio-aesthetic caredialysis and socio-aesthetic care | Other | Experimental Arm |
| dialysisdialysis | Other | Control arm |
Primary outcome
Scale of quality of life (KDQoL)
Time frame: Day 0
Quality of life is assess by using KDQoL from 0 (worse quality of life) to 100 (better quality of life)
Scale of quality of life (KDQoL)
Time frame: At Month 1
Quality of life is assess by using KDQoL from 0 (worse quality of life) to 100 (better quality of life)
2 secondary outcomes
Scale of anxiety and depression (HADS)
Time frame: Day 0
Scale of anxiety and depression (HADS)
Time frame: At Month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dialysis and socio-aesthetic care and dialysis in people with Chronic Kidney Insufficiencies, run by CHU de Reims 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 13 inclusion and 0 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: finished, as of the sponsor's last update on 10 Feb 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale of quality of life (KDQoL) (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 10 Feb 2025.