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临床试验/NCT07518628
NCT07518628已完成不适用

THE EFFECT OF REFLEXOLOGY AND SLEEP HYGIENE EDUCATION ON SLEEP QUALITY AND COMFORT LEVEL IN HEMODIALYSIS TREATMENT (HD)

Kibrıs Aydin Üniversitesi2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
The Effect of Reflexology and Sleep Hygiene Training on Sleep Quality and Comfort Level in Patients Undergoing Hemodialysis Treatment

研究概览

简要总结

Sleep problems are common in people undergoing dialysis treatment due to kidney failure. Methods other than medication can be used to improve this condition. For example, reflexology, a foot massage technique, and sleep training can be helpful.

This study investigated the effects of reflexology and sleep training on sleep quality and comfort in dialysis patients in Cyprus.

The results showed that both reflexology and sleep training improved patients' sleep and overall comfort. However, reflexology was found to be more effective than the other methods.

Objective:

To improve sleep quality and comfort in dialysis patients.

Method:

Reflexology (foot massage) and sleep training were applied.

Findings:

Both methods improved sleep and comfort.

Conclusion:

Reflexology was found to be more effective than sleep training.

详细描述

Study Design:

This study was designed as a pre-test-post-test controlled experimental clinical trial.

Objective:

To evaluate the effects of reflexology and sleep hygiene training on sleep quality and comfort level in patients undergoing hemodialysis treatment.

Participants:

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

盲法说明

Blinding was not possible in this study because participants could tell which intervention they received (reflexology, sleep hygiene training, or routine care). However, efforts were made to assess the outcomes in an objective and standardized way.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing hemodialysis for at least 6 months
  • Voluntary participation in the study
  • Aged between 18 and 65 years
  • No communication problems
  • No active infectious disease

排除标准

  • Presence of an open foot ulcer
  • Suspected fracture or burn in the foot area
  • Thrombocytopenia
  • Diagnosed deep vein thrombosis 5.Diagnosed peripheral neuropathy

研究组 & 干预措施

Arm 1: Reflexology Group

Experimental

Participant in this group receive reflexology intervention in addition to routine hemodialysis care.Reflexology is applied regularly during the study period according to a standardized protocol.

干预措施: Reflexology (Behavioral)

Arm 2: Sleep Hygİene Training Group

Experimental

Participants in this group receive sleep hygiene education along with routine care.The education includes structured information and recommendation aimed at improving sleep habits and sleep quality.

干预措施: Reflexology (Behavioral)

Arm 3: Control Group

Other

Participants received routine hemodialysis care without additional intervention.

干预措施: Reflexology (Behavioral)

结局指标

主要结局

The Effect of Reflexology and Sleep Hygiene Training on Sleep Quality and Comfort Level in Patients Undergoing Hemodialysis Treatment

时间窗: Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI) before (baseline) the intervention and after an 8-week challenge period.

Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)

Sleep Quality

时间窗: Baseline and 8 weeks

Sleep Quality will be assessed Pittsburgh Sleep Quality Index - PSQI

Pittsburgh Sleep Quality Index (PSQI).

时间窗: Baseline and 8 weeks

The Pittsburgh Sleep Quality Index (PSQI) was developed by Daniel J. Buysse et al. in 1989. The Turkish validity and reliability study of the scale was conducted by Mehmet Yavuz Ağargün et al. The PSQI is a widely used instrument that evaluates individuals' sleep quality and distinguishes between "good sleepers" and "poor sleepers." The PSQI consists of 18 items and seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored on a 0-3 scale, and the sum of the component scores yields a total score ranging from 0 to 21. A total score of ≥5 indicates poor sleep quality.

次要结局

  • The Effect Of Reflexology And Sleep Hygiene Education Applied To Patients Undergoing Hemodialysis Treatment On Sleep Quality And Comfort Level(Comfort level was measured using the Hemodialysis Comfort Scale at baseline and after the 8-week intervention period.)
  • Patient Comfort(Baseline and 8 weeks)
  • Hemodialysis Comfort Scale II (HCS-II)(Baseline and 8 weeks)

研究者

发起方
Kibrıs Aydin Üniversitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ulfet Kral

Postgraduate

Kibrıs Aydin Üniversitesi

研究点 (2)

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