Effect of Transcutaneous Electrical Nerve Stimulation (TENS) or Acupressure on Pain in Patients With Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Numerical Rating Scale
研究概览
简要总结
This clinical trial aims to evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS), acupressure intervention, or standard care (control group) for pain management in participants hospitalized with head and neck cancer. This study aims to answer the following questions:
- Is TENS or acupressure intervention effective in reducing pain in participants hospitalized with head and neck cancer compared with the control group?
- Does TENS or acupressure intervention improve psychological distress (measured by the Brief Health Inventory (BMI)) in these participants?
- Does TENS or acupressure intervention improve the quality of life of participants hospitalized with head and neck cancer? Researchers will compare the effects of TENS, acupressure, and standard care to assess the effects of each group on pain, psychological distress (measured by the Brief Health Inventory (BMI)), and quality of life.
详细描述
Study Procedure:
A. If the participant agrees to participate in the study and signs the informed consent form, the researcher will ask them to complete a questionnaire. The questionnaire includes basic demographic information, pain level, emotional distress (Brief Symptom Rating Scale), and quality of life survey. It takes about 10 minutes to complete the questionnaire.
B. Participants will be randomly assigned to one of the following three groups:
- Transcutaneous electrical nerve stimulation (TENS) combined with standard treatment
- Acupressure combined with standard treatment
- Standard treatment (control group) C. Before and after daily intervention, all three groups of participants will complete a numerical rating scale (0-10 points) to assess pain intensity, and their vital signs will be recorded.
D. After one week of intervention, every week thereafter, and before discharge, participants will complete a numerical rating scale (0-10 points), the Brief Symptom Rating Scale (BSRS), and the World Health Organization Quality of Life Brief Form (WHOQOL-BREF).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant inclusion criteria:
- •Age ≥ 20 years old
- •Inpatients diagnosed with head and neck cancer
- •Conscious and able to communicate in Mandarin and Taiwanese
- •Suffering from pain problems and requiring pain medication
- •Participants agree to participate in this study.
- •Participant
排除标准
- •Those with nerve conduction disorders
- •Pregnant women
- •Those whose pain is not caused by tumors
- •Those with a history of epilepsy
- •Those with skin infections
- •Those who are allergic to the patch
- •Those with implanted devices such as pacemakers
- •Those who still disagree with the study content and are unable to cooperate with the researchers after the researchers' explanation.
结局指标
主要结局
Numerical Rating Scale
时间窗: Daily for up to 14 days
A self-reporting tool to assess subjective experience (such as symptoms, feelings and attitudes). On a 10 mm straight line (0-10 points from left to right), the far left side represents no pain (0 points) and the far right side represents extreme pain (10 points). The higher the pain score, the more severe the pain. The subjects were asked to describe the pain intensity themselves. This method has a good intraclass correlation coefficient for pain assessment (ICC=0.99). After the subjects started the trial, they were required to fill in the numerical scale three times a day (9 am, 12 pm and 4 pm). Each filling was divided into before the intervention (pretest) and after the intervention (posttest). Therefore, the pain index will be recorded 6 times a day. The numerical scale will be filled in until they are discharged from the hospital or transferred to another ward (whichever comes first).
次要结局
- Brief Symptom Rating Scale(Baseline, Day 7, and Day 14 or until discharge/transfer, whichever occurred first.)
- The Taiwanese version of the World Health Organization Quality of Life Questionnaire(Baseline, Day 7, and Day 14 or until discharge/transfer, whichever occurred first.)
研究者
Li-Ying Lin
Nursing Department Supervisor
Kaohsiung Veterans General Hospital.