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临床试验/NCT06936956
NCT06936956已完成不适用

The Effect of Acupressure on Polyneuropathy-related Pain and Sleep Quality in Patients With Type 2 Diabetes

Giresun University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2019年1月17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
入组人数
86
试验地点
1
主要终点
Pain Quality Assessment Scale (PQAS)

研究概览

简要总结

This study aimed to determine the effect of acupressure on polyneuropathy-related pain and sleep quality in patients with type 2 diabetes. A randomized controlled experimental design was employed in the study. The study sample consisted of 86 patients with type 2 diabetes (44 in the acupressure group and 42 in the control group) who met the inclusion criteria and agreed to participate. Participants were randomly assigned to either the experimental or control group. The experimental group received six sessions of acupressure over six consecutive days, while the control group received no intervention. Data were collected using a personal information form, the Pain Quality Assessment Scale (PQAS), and the Pittsburgh Sleep Quality Index (PSQI). Statistical analyses were conducted using SPSS for Windows 22. Acupressure was found to reduce polyneuropathy-related pain and enhance sleep quality in patients with type 2 diabetes. Therefore, acupressure may be considered an alternative nursing intervention for individuals with type 2 diabetes.

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 (Participant)

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
否

入选标准

  • •Were between the ages of 18-65 years old
  • •Resided in the city center
  • •Had no additional diseases that could cause sensory neuropathy, such as peripheral arterial disease, peripheric vein disease, nervous system diseases, benign or malign tumor, chemotherapy history, carpal tunnel syndrome, and arthritis.
  • •Had no clotting or bleeding disorders
  • •Were not undergoing dialysis treatment during the study period
  • •Had no ulcers, physical deformities or foot calluses
  • •Had no history of analgesic medication, except for medication used for DPN
  • •Had no physical diseases, cognitive deficiencies or psychiatric disease diagnosis that would prevent understanding of the questions on the scales used for data collection.

排除标准

  • 未提供

研究组 & 干预措施

Acupressure group

Experimental

Particiants in this group received acupressure application.

干预措施: Acupressure (Other)

Control group

No Intervention

Participants in this group did not receive any intervention.

结局指标

主要结局

Pain Quality Assessment Scale (PQAS)

时间窗: 6 days

This scale was originally developed by Galer et al. as the Neuropathic Pain Scale and its validity was confirmed with multiple sclerosis patients (Galer\&Jensen 1997). However, this original scale does not include allodynia and paroxysmal pain characteristics, which are common in neuropathic pain syndromes. Jensen et al. developed the Pain Quality Assessment Scale (PQAS) by adding 10 items related to the quality of neuropathic pain, and its validity was confirmed by measuring the neuropathic pain due to carpal tunnel syndrome (Cronbach's alpha 0.87-0.98) (Jense et al.,2006). Şahin et al. adapted the final version of the scale for Turkish society and reported that it is reliable to be used for the cases of diseases with neuropathic pain (Şahin et al., 2010). For the PQAS, it is recommended that no total score be calculated; rather, the three subscales are scored from 0 to 10. In this study, the Cronbach's alpha values were 0.836 for the paroxysmal pain subscale, 0.624 for the surface pa

Pittsburgh Quality of Sleep Index (PQSI)

时间窗: 6 days

This questionnaire was developed by Buysse et al. and was confirmed to have a high internal consistency (Cronbach's alpha=0.75), test-retest reliability, and validity (Buyyse et al., 1989). A study was conducted to confirm the Turkish validity and reliability of the questionnaire (Cronbach alpha=0.660) (Ağargün\&Anlar 1996). Each item of the questionnaire is scored between 0 and 3, and the total PQSI score, which ranges between 0 and 21, is obtained by adding the subscale scores. A PSQI score between 0 and 4 indicates a good quality of sleep, while a score between 5 and 21 indicates a bad quality of sleep (Ağargün\&Anlar 1996). In the present study, Cronbach's alpha value was 0.576 for the total PSQI.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Gündüz Oruç

Dr. Öğr. Üyesi

Giresun University

研究点 (1)

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