Effect of Hand Massage on Chronic Kidney Disease Associated Pruritus in Patients Receiving Hemodialysis: a Mixed Methods Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Itch severity
研究概览
简要总结
Chronic Kidney Disease-Associated Pruritus (CKD-aP) affects about 25% of Swiss hemodialysis patients, most with moderate to severe itching. It negatively impacts sleep, quality of life, and survival. This mixed-methods study will investigate the effect hand massage delivered by nurses on the itch severity, health-related quality of life and sleep compared to usual care in patients on hemodialysis. Fifty-four patients will be randomized to receive either hand massage or verbal attention over three months. Quantitative data (NRS, 5D Itch Scale, KDQOL-SFv1.2) will be collected at baseline, one, and three months. Qualitative interviews with 12 participants who received the hand massage intervention, will explore their experiences. The intervention is safe, non-invasive, and may offer valuable insights into CKD-aP management and pathogenesis.
详细描述
Chronic Kidney Disease Associated Pruritus (CKD-aP) represents a distressing skin itch symptom that affects 20-42% of adults on dialysis. We recently conducted the first CKD-aP prevalence study in Switzerland. Results showed that 25% of individuals on hemodialysis experience CKD-aP with 80% suffering from moderate to severe itching. CKD-aP is associated with sleep disturbances, compromised quality of life, social isolation and increased risk of hospitalization and death. CKD-aP may be related to increased uremic toxins, endogenous opioid or immune system dysregulation, peripheral neuropathy with abnormal cutaneous innervation and nerve conduction. In this context, the effect of non-pharmacological management approaches like hand massage on nerve conduction, autonomic stress responses and skin inflammation deserve more attention. Few studies have evaluated the effect of short-term massage (3-4 weeks) on CKD-aP and showed improvement on outcomes evaluated 48 hours after the intervention. The study will be offered to all eligible CKD-aP patients; however, a balanced sex distribution is unlikely due to the male predominance in this population.
This study does not present any risks related to physical or psychological harm to participants. Participants will benefit from a promising non-invasive complementary therapy. Additionally, this study may contribute to a better understanding of the CKD-aP pathogenesis.
The primary objective of this study is to determine whether hand-massage by nurses has an effect on itch severity, Health Related Quality of Life (HRQoL) and sleep in hemodialysis patients with CKD-aP, at one and three months, as compared to usual care, and to explore the lived experience of patients receiving the hand-massage intervention.
A sequential multicenter Explanatory Mixed Methods design will be used. A randomized controlled trial design with two study arms will be conducted first (phase 1), followed by descriptive qualitative research (phase 2).
Phase 1: A total sample size of 54 participants (intervention group n=27; control group n= 27) will be recruted for the RCT. Phase 2: 12 participants from the intervention group who completed the intervention will be recruited to participate in the individual semi-structured interviews.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years
- •on hemodialysis ≥ three months
- •able to communicate in French
- •diagnosed with CKD-aP based on VAS
- •signed informed consent
排除标准
- •Participants with cognitive impairment -
- •participants who have been prescribed CKD-aP medications after enrollment in study.
研究组 & 干预措施
Hand-massage
Participants randomized to the intervention group (n=27) will receive hand-massage that consists of 10 min hand-massage, two times/week for the first month, then once/week for the two consecutive months, at any time during the hemodialysis session.
干预措施: Hand-massage (Other)
Control
Participants assigned to the control group (n=27) will receive uninterrupted attention from the nurse via a conversation without use of physical touch for 10 min, two times /week for the first month, then once/month for the two consecutive months, at any time during the hemodialysis session
结局指标
主要结局
Itch severity
时间窗: at baseline, 1 month, 3 months
The NRS will also be used to measure CKD-aP severity. It includes two questions. The first refers to the average itch intensity during the last 24h and the second refers to the WI-NRS and addresses the worst itch intensity experienced during the last 24h. VAS score ranges from 0 (not itchy) to 10 (extremely itchy); severity can be classified into five categories: 1) 0 =no itch, 2) 0.1-2.9 points =mild itch, 3) 3.0-6.9 points =moderate itch, 4) 7.0-8.9 points =severe itch, and 5) 9.0-10.0 points =very severe itch
Itch severity and itch related quality of life
时间窗: at baseline, 1 month, 3 months
5D itch scale consists of 5-domains (Disability, Distribution, Duration, Degree, and Direction), 5 point-Likert scale designed to measure itch severity and itch-related QoL with an overall score range from 5 to 25. Lower scores indicate less itch severity and a better QoL.
Health related quality of life (HRQoL)
时间窗: at baseline, 1 month, 3 months
The Kidney Disease Quality of Life Short Form (KDQOL-SF)™v1.2 questionnaire, a SF-36 derived short-form will be used to measure HRQoL. It is a self-administered 12-question survey assessing eight domains of physical (limitations in physical activities because of health problems, in social activities because of physical or emotional problems, in usual role activities because of physical health problems, bodily pain), and mental health (psychological distress and well-being, limitations in usual role activities because of emotional problems, vitality, and general health perceptions. Scores range between 0-100 and higher scores indicate better HRQoL.
Sleep quality
时间窗: at baseline, 1 month, 3 months
Sleep quality will be assessed using the Kidney Disease Quality of Life Short form (KDQOL-SF)™v1.2 Sleep Subscale, composed of four items evaluating sleep quality, difficulty falling asleep, waking up during the night, and feeling rested upon waking. Scores for each item are transformed to a 0-100 scale, with higher scores indicating better sleep quality.
次要结局
未报告次要终点
研究者
Nancy Helou
Full Professour UAS
University of Applied Sciences of Western Switzerland