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IRCT20250311065043N1 IRCT 2025-04-14 Mashhad University of Medical Sciences Comparing the Effects of Acupressure and TENS on Fatigue Improvement in Patients Undergoing Chemotherapy Comparing the effect of transcutaneous electrical nerve stimulation with acupressure on the fatigue of colorectal cancer patients Undergoing chemotherapy 2025-04-19 anticipated 60 Complete https://irct.ir/trial/82613 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are randomly assigned to two groups using block randomization via the Sealed Envelope website, with mixed block sizes of 2 and 4. The groups are sequentially labeled A and B, where A represents the TENS group and B represents the Acupressure group (e.g., ABBABBA…). After allocation, the sequence is numbered, and the letters are placed inside sealed envelopes. The envelopes are numbered, and individuals randomly select envelopes until the final sample size is reached. N/A Colorectal cancer. Intervention 1: Intervention Group 1: Transcutaneous Electrical Nerve Stimulation (TENS) group. The TENS intervention will be performed by the researcher and research assistant (female patients) to electrically stimulate sensory nerves in the lower back and back of the legs using a Berjis ST90 device. The current intensity will be tolerable for the patient, and the frequency will be 100 Hz. This will be conducted for 30 to 45 minutes in 4 sessions. Two sessions will be held on 2 consecutive days during one chemotherapy cycle, and the subsequent 2 sessions will be held on 2 days during the next chemotherapy cycle, which is scheduled every other week. Intervention 2: Intervention Group 2: Acupressure group. Pressure will be applied to the points ST-36, LR-3, GB-20, TW-5 until the patient experiences pain, then the pressure will be slightly reduced. This will be done for 2 to 5 minutes at each point for 2 weeks (14 sessions) daily, during the intervals of 2 consecutive chemotherapy cycles, which are scheduled every other week. The patient will be trained by the researcher and research assistant (female patients) who have completed relevant training under the supervision of a Traditional Chinese Medicine specialist in the first 2 sessions. The remaining acupressure sessions (12 sessions) will be performed by the patient and followed up via telephone. Yes - There is a plan to make this available What will be shared: All data obtained from the collected questionnaires will be shared. When: Access period starts 6 months after results are published. To whom: Researchers working in academic and scientific institutions Conditions: Using data to reduce disease complications Using data to improve patient outcomes Using data to advance science Where to obtain: Matin Abdollahi Tel. No. 00989154231632 Email matin09307@gmail.com How to obtain: The email will be responded to within a maximum of one month regarding the terms of use of the data. The summary of the plan must be provided to the responsible person in an academic format. Comments:
public Matin Abdollahi
Number 7, Bozorgmehr Alley, Molana Sharghi Street,Taybad town
Mashhad Iran (Islamic Republic of) 9591784691 +98 915 423 1632 matin09307@gmail.com Mashhad University of Medical Sciences scientific Matin Abdollahi
No. 7, Bozorgmehr Alley, Molana Sharghi Street, Taybad Town
Taybad Iran (Islamic Republic of) 9591784691 +98 915 423 1632 matin09307@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Undergoing chemotherapy for colorectal cancer. No metastatic cancer (documented in the record) Chemotherapy appointment requires at least 48 hours' notice. Attendance for chemotherapy to be performed in 2 consecutive cycles, back-to-back. Has not used other treatments such as cryotherapy, thermotherapy, and radiotherapy concurrently. No metallic objects in the body. 18 years 60 years Both Having metastatic cancer History of hospitalization due to mental health issues Having platinum or a foreign metal object in the body Simultaneous use of therapeutic methods to improve fatigue Being hospitalized for just one course of chemotherapy C26.9 Malignant neoplasm of ill-defined sites within the digestive system Treatment - Devices Treatment - Devices Intervention Group 1: Transcutaneous Electrical Nerve Stimulation (TENS) group. The TENS intervention will be performed by the researcher and research assistant (female patients) to electrically stimulate sensory nerves in the lower back and back of the legs using a Berjis ST90 device. The current intensity will be tolerable for the patient, and the frequency will be 100 Hz. This will be conducted for 30 to 45 minutes in 4 sessions. Two sessions will be held on 2 consecutive days during one chemotherapy cycle, and the subsequent 2 sessions will be held on 2 days during the next chemotherapy cycle, which is scheduled every other week. Intervention Group 2: Acupressure group. Pressure will be applied to the points ST-36, LR-3, GB-20, TW-5 until the patient experiences pain, then the pressure will be slightly reduced. This will be done for 2 to 5 minutes at each point for 2 weeks (14 sessions) daily, during the intervals of 2 consecutive chemotherapy cycles, which are scheduled every other week. The patient will be trained by the researcher and research assistant (female patients) who have completed relevant training under the supervision of a Traditional Chinese Medicine specialist in the first 2 sessions. The remaining acupressure sessions (12 sessions) will be performed by the patient and followed up via telephone. Fatigue score on the cancer fatigue scale. Timepoint: Fatigue measurement at baseline (pre-intervention) and endpoint (post-intervention, after the last intervention session). Method of measurement: Cancer fatigue scale Questionnaire. Mashhad University of Medical Sciences Approved 2025-03-12 Ethics committee, School of nursing and midwifery, Mashhad University of Medical Sciences Mashhad University of Medical Sciences, Bahonar Street, Mashhad, Razavi Khorasan Province Mashhad Razavi Khorasan Iran (Islamic Republic of)