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临床试验/NCT05000073
NCT05000073已完成不适用

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

CHU de Reims1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2022年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
161
试验地点
1
主要终点
Scale of quality of life (KDQoL)

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Scale of quality of life (KDQoL)

时间窗: At Month 1

Quality of life is assess by using KDQoL from 0 (worse quality of life) to 100 (better quality of life)

次要结局

  • Scale of anxiety and depression (HADS)(At Month 1)

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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