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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Maintain normal treatment without any intervention | |
| Transcutaneous Electrical Nerve Stimulation (TENS) | Experimental | The transcutaneous electrical stimulation group used a transcutaneous electrical nerve stimulator daily, with electrode patches attached to the unilateral Hegu and Lieque points respectively, providing 20 minutes of 80-100 HZ TENS, 3 times a day, and the electrical stimulation was adjusted to a level that the subjects felt was comfortable. |
|
| Acupressure | Experimental | The acupressure group selected Hegu and Lieque points for the treatment, placed the acupoint stickers on the acupoints of both hands, and pressed each acupoint with the thumb and index finger for 1 minute, 3 times a day, each time for about 4 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale | 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). | Daily for up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Symptom Rating Scale | The Brief Symptom Rating Scale (BSRS-5) compiled by Professor Li Mingbin can quickly understand an individual's psychological care needs. The BSRS consists of 5 questions (measuring anxiety, anger, depression, low self-esteem and insomnia) and 1 additional question. Participants used a 5-point Likert scale (0-4 points), where 0 represented "not at all", 1 represented "mild", 2 represented "moderate", 3 represented "severe", and 4 represented "very severe", with a total score of 0-20 points. The higher the score, the more severe the psychological distress. The Cronbach's α value measured for the sample in this study was 0.829, which has a high internal consistency reliability. Participants will complete the BSRS-5 assessment once at the beginning of the program, and then complete the follow-up once a week (start day (pre-test) + 7 days, 14 days, 28 days, etc.) until they are discharged from the hospital or transferred to another ward (whichever comes first). |
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Participant inclusion criteria:
Participant exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lin Ling Li | Supervision | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Veterans General Hospital | Kaohsiung City | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11733293 | Background | Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x. | |
| 28524908 | Background | Brant JM, Eaton LH, Irwin MM. Cancer-Related Pain: Assessment and Management With Putting Evidence Into Practice Interventions . Clin J Oncol Nurs. 2017 Jun 1;21(3 Suppl):4-7. doi: 10.1188/17.CJON.S3.4-7. |
| Label | URL |
|---|---|
| Development and Applications of the WHOQOL-Taiwan Version | View source |
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The patients with head and neck cancer were randomly assigned to an intervention group or a control group using computer random numbers. The intervention group was further divided into two groups: transcutaneous electrical nerve stimulation intervention and acupoint pressing measures.
The transcutaneous electrical stimulation group used a transcutaneous electrical nerve stimulator daily, with electrode patches attached to the unilateral Hegu and Lieque points for 20 minutes of 80-100 Hz TAES stimulation, three times a day, and the electrical stimulation was adjusted to a level that the subjects felt was comfortable. The acupressure group also selected Hegu and Lieque points for the treatment, placed the acupoint stickers on the acupoints of both hands, and pressed each acupoint with the thumb and index finger for 1 minute, 3 times a day, each time for about 4 minutes.
The control group took the original analgesics and did not receive any acupoint stimulation.
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| Acupressure | Behavioral | 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. |
|
| 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 | The World Health Organization Quality of Life Questionnaire (WHOQOL BREF) developed by Yao Qizhi was used to measure the overall quality of life, general health status and 24 aspects of quality of life, which are divided into four categories: "physical health (covering the original physical and independence categories), psychological (covering the original psychological and spiritual/religious/personal belief categories), social relationships and environment". The scale consists of 28 questions, each with a score range of 1-5 points, and a total score of 28-140 points. The higher the score, the better the quality of life. Participants will complete the World Health Organization Quality of Life Questionnaire Taiwan Version (pre-test) once after the start of the program, and then complete it once a week (starting day + 7 days, 14 days, 28 days, etc.) until they were discharged or transferred to other wards whichever came first. | Baseline, Day 7, and Day 14 or until discharge/transfer, whichever occurred first. |
| 35528798 | Background | Chou YH, Yeh ML, Huang TS, Hsu H. Acupoint stimulation improves pain and quality of life in head and neck cancer patients with chemoradiotherapy: A randomized controlled trial. Asia Pac J Oncol Nurs. 2021 Dec 25;9(1):61-68. doi: 10.1016/j.apjon.2021.11.002. eCollection 2022 Jan. |
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| 31855257 | Background | He Y, Guo X, May BH, Zhang AL, Liu Y, Lu C, Mao JJ, Xue CC, Zhang H. Clinical Evidence for Association of Acupuncture and Acupressure With Improved Cancer Pain: A Systematic Review and Meta-Analysis. JAMA Oncol. 2020 Feb 1;6(2):271-278. doi: 10.1001/jamaoncol.2019.5233. |
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| Pain mechanisms: A new theory: A gate control system modulates sensory input from the skin before it evokes pain perception and response | View source |
| Cancer Facts \& Figures 2018 | View source |
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| The incidence of the top ten cancers | View source |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D019050 | Acupressure |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
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