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

February 22, 2023 updated by: CHU de Reims

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 :

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Arm
Other: dialysis and socio-aesthetic care
dialysis and socio-aesthetic care
Active Comparator: Control arm
Other: dialysis
dialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Day 0
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)
At Month 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scale of anxiety and depression (HADS)
Time Frame: Day 0
Anxiety and Depression are assess by using HADS scales from 0 (no anxiety or no depression) to 21 (anxiety or depression )
Day 0
Scale of anxiety and depression (HADS)
Time Frame: At Month 1
Anxiety and Depression are assess by using HADS scales from 0 (no anxiety or no depression) to 21 (anxiety or depression )
At Month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2022

Primary Completion (Anticipated)

September 17, 2024

Study Completion (Anticipated)

October 17, 2024

Study Registration Dates

First Submitted

August 3, 2021

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 11, 2021

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PP21064

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Kidney Insufficiencies

Clinical Trials on dialysis and socio-aesthetic care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe