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Influence of Socio-aesthetic Care on the Quality of Life of Hemodialysis Patients (SocioAesthetic)

Primary Purpose

Chronic Kidney Insufficiencies

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
dialysis and socio-aesthetic care
dialysis
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Insufficiencies focused on measuring Quality of life, renal dialysis, socio aesthetic care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

inclusion criteria :

  • 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;
  • 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

Sites / Locations

  • Damien JOLLYRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Arm

Control arm

Arm Description

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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 )
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 )

Full Information

First Posted
August 3, 2021
Last Updated
February 22, 2023
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT05000073
Brief Title
Influence of Socio-aesthetic Care on the Quality of Life of Hemodialysis Patients
Acronym
SocioAesthetic
Official Title
Influence of Socio-aesthetic Care on the Quality of Life of Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2022 (Actual)
Primary Completion Date
September 17, 2024 (Anticipated)
Study Completion Date
October 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Insufficiencies
Keywords
Quality of life, renal dialysis, socio aesthetic care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Experimental
Arm Title
Control arm
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
dialysis and socio-aesthetic care
Intervention Description
dialysis and socio-aesthetic care
Intervention Type
Other
Intervention Name(s)
dialysis
Intervention Description
dialysis
Primary Outcome Measure Information:
Title
Scale of quality of life (KDQoL)
Description
Quality of life is assess by using KDQoL from 0 (worse quality of life) to 100 (better quality of life)
Time Frame
Day 0
Title
Scale of quality of life (KDQoL)
Description
Quality of life is assess by using KDQoL from 0 (worse quality of life) to 100 (better quality of life)
Time Frame
At Month 1
Secondary Outcome Measure Information:
Title
Scale of anxiety and depression (HADS)
Description
Anxiety and Depression are assess by using HADS scales from 0 (no anxiety or no depression) to 21 (anxiety or depression )
Time Frame
Day 0
Title
Scale of anxiety and depression (HADS)
Description
Anxiety and Depression are assess by using HADS scales from 0 (no anxiety or no depression) to 21 (anxiety or depression )
Time Frame
At Month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
inclusion criteria : 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; 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline SERNICLAY
Phone
03 26 78 86 81
Ext
0033
Email
cserniclay@chu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline SERNICLAY
Phone
03 26 78 86 81
Ext
0033
Email
cserniclay@chu-reims.fr

12. IPD Sharing Statement

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Influence of Socio-aesthetic Care on the Quality of Life of Hemodialysis Patients

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