Progressive Muscle Relaxation for Pain and Quality of Life in Thyroid Cancer (PMRT-ThyCa)
2026年6月1日 更新者：Dr. Marium Zafar、University of Faisalabad
Effectiveness of Progressive Muscle Relaxation Technique on Pain and Quality of Life in Thyroid Cancer Patients: A Randomized Controlled Trial
Thyroid cancer patients often experience pain and reduced quality of life during chemotherapy.
This randomized controlled trial will evaluate whether Progressive Muscle Relaxation (PMR) exercises, added to routine range-of-motion exercises, reduce pain and improve quality of life compared to range-of-motion exercises alone.
Thirty-two thyroid cancer patients randomly assigned to either the PMR group or the control group.
Pain measured by using the Numeric Pain Rating Scale (NPRS) and quality of life using the FACT-G questionnaire before and after a 4-5 day intervention.
The study compared changes between groups.
研究概览
地位
完全的
条件
详细说明
This is a single-center, parallel-group, randomized controlled trial to be conducted at PINUM Cancer Hospital, Faisalabad, Pakistan.
A total of 32 patients with histologically confirmed thyroid cancer (Stage I-III) undergoing chemotherapy (1-3 sessions) will be enrolled.
Inclusion criteria: age 30-50 years, moderate pain (NPRS 3-7), baseline FACT-G score ≥80%, history of lobectomy or thyroidectomy.
Exclusion criteria: comorbidities (cardiomyopathy, respiratory disorders, severe mental illness), recent fractures or surgeries, inability to follow instructions, current practice of relaxation therapies.
Participants will be randomly allocated 1:1 using an online random number generator into two groups.
Experimental group (n=16): Progressive Muscle Relaxation Technique (PMRT) once daily for 4-5 consecutive days, each session 20-40 minutes, targeting head/neck, shoulders, arms/hands, lower back/hips, calves/thighs, and feet/toes.
Each movement involves deep inhalation, tensing for 10-20 seconds, then exhalation with relaxation.
Control group (n=16): gentle range-of-motion and stretching exercises of same frequency and duration.
Outcomes: pain (NPRS, 0-10) and quality of life (FACT-G, 4 subscales) measured at baseline and post-intervention.
Normality of data assessed by using Shapiro-Wilk test.
Between-group comparisons is performed by using Mann-Whitney U test, and within-group pre-post comparisons using Wilcoxon signed-rank test.
No adverse events are anticipated.
After study completion, results will be submitted separately in the Results Module.
研究类型
介入性
注册 (实际的)
32
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Punjab Province
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Faisalābad、Punjab Province、巴基斯坦、3800
- The University of Faisalabad
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- Histologically confirmed thyroid cancer (Stage I-III)
- Age 30-50 years
- Moderate pain (NPRS score 3-7)
- Baseline FACT-G score ≥80%
- Undergoing chemotherapy (1-3 sessions completed)
- History of lobectomy or thyroidectomy
- Provided written informed consent
Exclusion Criteria:
- Comorbidities (cardiomyopathy, respiratory disorders, severe mental illness)
- Recent fractures or surgeries
- Unable to comprehend or follow instructions
- Currently practicing PMR or any other relaxation therapy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：PMR + ROM
Participants received once-daily Progressive Muscle Relaxation Technique (PMRT) plus range-of-motion (ROM) exercises for 4-5 consecutive days, 20-40 minutes per session.
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Participants were guided through sequential tensing and relaxing of six muscle groups: head/neck, shoulders/upper back, arms/hands, lower back/hips, calves/thighs, and feet/toes.
For each group, they inhaled deeply and tensed muscles for 10-20 seconds, then exhaled slowly while relaxing completely.
Each session lasted 20-40 minutes, once daily for 4-5 consecutive days.
Sessions were conducted by a trained physiotherapist in a quiet hospital room.
Participants performed gentle range-of-motion (ROM) and stretching exercises for the same muscle groups (head/neck, shoulders, arms, lower back, legs, feet), without the tensing-relaxation component of PMR.
Each session lasted 20-40 minutes, once daily for 4-5 consecutive days, supervised by the same physiotherapist.
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有源比较器：ROM
Participants received only gentle range-of-motion (ROM) and stretching exercises, once daily for 4-5 consecutive days, 20-40 minutes per session.
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Participants performed gentle range-of-motion (ROM) and stretching exercises for the same muscle groups (head/neck, shoulders, arms, lower back, legs, feet), without the tensing-relaxation component of PMR.
Each session lasted 20-40 minutes, once daily for 4-5 consecutive days, supervised by the same physiotherapist.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Pain Intensity
大体时间：Baseline (day 1) and post-intervention (day 4-5)
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Pain intensity measured using the Numeric Pain Rating Scale (NPRS), an 11-point scale from 0 (no pain) to 10 (worst possible pain).
Higher scores indicate worse pain.
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Baseline (day 1) and post-intervention (day 4-5)
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Change in Quality of Life
大体时间：Baseline (day 1) and post-intervention (day 4-5)
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Quality of life measured using the Functional Assessment of Cancer Therapy - General (FACT-G), a 27-item questionnaire covering physical, social/family, emotional, and functional well-being.
Higher scores indicate better quality of life.
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Baseline (day 1) and post-intervention (day 4-5)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年1月1日
初级完成 (实际的)
2026年4月1日
研究完成 (实际的)
2026年5月15日
研究注册日期
首次提交
2026年5月23日
首先提交符合 QC 标准的
2026年6月1日
首次发布 (实际的)
2026年6月3日
研究记录更新
最后更新发布 (实际的)
2026年6月3日
上次提交的符合 QC 标准的更新
2026年6月1日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.