Effect of Transcutaneous Electrical Nerve Stimulation or Acupressure on Pain in Patients With Head and Neck Cancer

Официальное название

Effect of Transcutaneous Electrical Nerve Stimulation (TENS) or Acupressure on Pain in Patients With Head and Neck Cancer

Обзор

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.

Подробное описание

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).

Possible side effects and how to cope with them:

• TENS or acupressure: Participants may experience soreness, tingling, pressure, or mild pain when using TENS or acupressure to treat the Hegu (LI4) and Lieque (LU7) points. These are normal reactions and are generally well tolerated. No studies have shown any harmful side effects from stimulating these points. If discomfort is too great, the intensity of stimulation can be adjusted.

• Risks to participants: Participants can stop at any time if they feel discomfort during the study. Participants can also contact the study's emergency contact for assistance.

Expected benefits:

Previous research and traditional practices have shown that acupressure on the Hegu (LI4) and Lieque (LU7) points may help regulate the flow of Qi and blood, enhance lung function, improve blood circulation, and relieve pain and discomfort. While researchers cannot guarantee that this study will benefit participants, acupressure may help healthcare professionals better understand how to support clinical inpatients (non-participants) and may benefit others in the future.

Participant privacy is protected: Researchers will only collect information necessary for this study. All participant personal information and questionnaire responses will remain confidential. Participants' names and personal identifying information will not be used; instead, researchers will assign participants a code to ensure that the participant's identity remains anonymous in all records.

Вмешательства

• Поведенческое Transcutaneous Electrical Nerve Stimulation (TENS)
  Participants received TENS therapy at two specific acupoints - Hegu (LI4) and Lieque (LU7). Surface electrodes were placed over the acupoints, and stimulation was delivered using a standard TENS device.
• Поведенческое Acupressure
  The acupressure group placed the acupoint patches on the Hegu and Lieque points on both hands and pressed each acupoint with the index finger and thumb for 1 minute, 3 times a day, each time for about 4 minutes.

Первичные конечные точки

• Numerical Rating Scale [Срок оценки: Daily for up to 14 days]

Вторичные конечные точки (2)

• Brief Symptom Rating Scale [Срок оценки: 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 [Срок оценки: Baseline, Day 7, and Day 14 or until discharge/transfer, whichever occurred first.]

Критерии участия

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 exclusion criteria:

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Тайвань · 1 центр

• Kaohsiung Veterans General Hospital — Kaohsiung City

Публикации

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Идентификаторы

NCT: NCT07051265 · KSVGH25-CT4-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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