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临床试验/NCT06920082
NCT06920082进行中(未招募)不适用

Effects of Progressive Muscle Relaxation Exercises on Sleep, Fatigue and Pain in Pancreatic and Colon Cancer Patients Receiving Chemotherapy

Istanbul Sabahattin Zaim University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
The Piper Fatigue Scale

研究概览

简要总结

With regular practice, relaxation has been found to have many benefits such as reducing sensitivity to pain and fatigue, facilitating the transition to sleep, and improving quality of life. Therefore, this study was planned to examine the effects of progressive muscle relaxation exercises applied to pancreatic and colon cancer patients receiving chemotherapy on sleep, fatigue, and pain.

详细描述

A total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks.

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
Single (Participant)

入排标准

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

入选标准

  • •Being over 18 years of age
  • •Being able to communicate adequately
  • •Not having a psychiatric problem
  • •Those who are determined by a physician to have no physical obstacle to exercise
  • •Individuals who can use technological devices
  • •Patients who have had at least 3 cycles

排除标准

  • •Those with communication problems
  • •Those with psychiatric problems
  • •Patients doing any exercise
  • •Individuals with phones that do not have a voice recording feature
  • •Individuals with phones that do not have a WhatsApp feature

研究组 & 干预措施

Progressive muscle relaxation exercises

Experimental

A total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks

干预措施: Progressive muscle relaxation exercises (Other)

Control group

No Intervention

Routine maintenance will be applied

结局指标

主要结局

The Piper Fatigue Scale

时间窗: After the intervention (After progressive muscle relaxation exercises applied in week 6)

It is a 22-item scale that measures four subscales: behavior (6 items), affect (5 items), sensory (5 items), and cognition/mood (6 items). Each item has 11 response categories on a 0-10 metric with verbal descriptors anchoring the endpoints. Each subscale is scored individually and then aggregated together for an overall score, with higher scores reflecting more fatigue.

Visual Analog Scale

时间窗: After the intervention (After progressive muscle relaxation exercises applied in week 6)

The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.

Visual Analog Scale

时间窗: Baseline, pre-intervention (Before progressive muscle relaxation exercises applied)

The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.

The Piper Fatigue Scale

时间窗: Baseline, pre-intervention (Before progressive muscle relaxation exercises applied)

It is a 22-item scale that measures four subscales: behavior (6 items), affect (5 items), sensory (5 items), and cognition/mood (6 items). Each item has 11 response categories on a 0-10 metric with verbal descriptors anchoring the endpoints. Each subscale is scored individually and then aggregated together for an overall score, with higher scores reflecting more fatigue.

次要结局

  • Pittsburgh Sleep Quality Index (PSQI)(After the intervention (After progressive muscle relaxation exercises applied in week 6))
  • Pittsburgh Sleep Quality Index (PSQI)(Baseline, pre-intervention (Before progressive muscle relaxation exercises applied))

研究者

发起方
Istanbul Sabahattin Zaim University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zülfünaz ÖZER

Principal Investigator

Istanbul Sabahattin Zaim University

研究点 (1)

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