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

NCT05000073 | Completed

• 1 other identifier: PP21064
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Insufficiencies

Keywords

Quality of life; renal dialysis; socio aesthetic care

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  At Month 1

Secondary Outcomes (2)

• Scale of anxiety and depression (HADS)

  Day 0

• Scale of anxiety and depression (HADS)

  At Month 1

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Other: dialysis and socio-aesthetic care

Control arm

ACTIVE COMPARATOR

Other: dialysis

Interventions

dialysis and socio-aesthetic care OTHER

dialysis and socio-aesthetic care

Experimental Arm

dialysis OTHER

dialysis

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 11, 2021
• Study Start: January 17, 2022
• Primary Completion: June 25, 2024
• Study Completion: July 25, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

FR (1)