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IRCT20140818018842N48 IRCT 2025-04-15 Research Institute for Oncology, Hematology and Cell Therapy The effectiveness of melatonin in reducing pain and anxiety caused by bone marrow sampling Assessing the effectiveness of melatonin compared to placebo in reducing pain and anxiety caused by bone marrow aspiration/biopsy in hematological patients: A randomized, double-blind, placebo-controlled clinical trial 2025-04-21 anticipated 146 Complete https://irct.ir/trial/80145 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Other design features: All study participants will receive the same treatments based on existing protocols. BMAB will be performed in the study participants with the same method and by a common physician and assistant. After entering the study, patients are randomly divided into drug and placebo groups. In addition to the local anesthetic, melatonin with a dose of 10 mg or placebo is administered orally to each participant 30 minutes before the start of bone marrow sampling. Each patient will be included in the study only once, even if multiple BMABs are needed, Randomization description: Melatonin and placebo in the form of completely identical oral tablets will be produced by the pharmaceutical company and will be provided to the research team (third party). Balance Blocked Randomization method and Stata software will be used for randomization. Random allocation is done using blocks of size 4. In this way, using the ralloc module (Random allocation of treatments in controlled trials) in Stata software, random samples are determined for study, Blinding description: The randomization sequence is prepared by a statistician who has no connection with the patients. Melatonin and placebo will be produced by the pharmaceutical company in completely identical appearance and will be provided to the research team (third pateint). The researchers and participants will be unaware of which tablet is the drug and which is the placebo. After confirming the entry of a new patient into the study and registering the patient code, the coordinator who is stationed at the patient registration site will place the patient in one of the study groups based on the specified randomization sequence, and the drugs that are labeled with the specified code Each patient provides them. 2-3 hematologic malignancy. Intervention 1: Intervention group: All study participants will receive the same treatments based on existing protocols. BMAB will be performed in the study participants with the same method and by a common physician and assistant. After entering the study, patients are randomly divided into drug and placebo groups. Each participant in the drug group was prescribed melatonin with a dose of 10 mg orally, 30 minutes before the start of bone marrow sampling, in addition to the local anesthetic. Each patient will be included in the study only once, even if multiple BMABs are needed. Intervention 2: Control group: ll study participants will receive the same treatments based on existing protocols. BMAB will be performed in the study participants with the same method and by a common physician and assistant. After entering the study, patients are randomly divided into drug and placebo groups. Each participant will be prescribed a placebo orally, 30 minutes before the start of bone marrow sampling, along with local anesthetic. Each patient will be included in the study only once, even if multiple BMABs are needed. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Soma Rahimi
Dr. Shariati Educational, Research and Treatment Center, opposite the Faculty of Economics, Jalal Al-Ahmad Intersection, North Kargar Street
Tehran Iran (Islamic Republic of) 1411713131 +98 21 8490 2635 somarahimidr@gmail.com Tehran University of Medical Sciences scientific Bita Shahrami
Dr. Shariati Educational, Research and Treatment Center, opposite the Faculty of Economics, Jalal Al-Ahmad Intersection, North Kargar Street
Tehran Iran (Islamic Republic of) 14117-13135 +98 21 8490 2635 bita.shahrami@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Definitive or probable diagnosis of hematological malignancy with the indication of performing BMAB Normal functional status (in the form of points 0 to 2 from ECOG) Consciously to enter the study 18 years no limit Both Known allergy to melatonin or any of the product's components History of recent daily use of melatonin (the patient has not received melatonin medicine in the 72 hours before the study) Inability to swallow oral medication Known or suspected mal absorption or gastrointestinal obstruction The presence of moderate-intensity uncontrolled pain (controlled pain is defined as no change in pain intensity or a change in the patient's pain medication in the last 48 hours) Patients treated with analgesics or anti-anxiety drugs Known patients with anxiety or psychotic disorders Patients with drug or nicotine addiction Pregnancy or breastfeeding Patient participation in another research project at the same time C96.9 Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified Treatment - Drugs Placebo Intervention group: All study participants will receive the same treatments based on existing protocols. BMAB will be performed in the study participants with the same method and by a common physician and assistant. After entering the study, patients are randomly divided into drug and placebo groups. Each participant in the drug group was prescribed melatonin with a dose of 10 mg orally, 30 minutes before the start of bone marrow sampling, in addition to the local anesthetic. Each patient will be included in the study only once, even if multiple BMABs are needed. Control group: ll study participants will receive the same treatments based on existing protocols. BMAB will be performed in the study participants with the same method and by a common physician and assistant. After entering the study, patients are randomly divided into drug and placebo groups. Each participant will be prescribed a placebo orally, 30 minutes before the start of bone marrow sampling, along with local anesthetic. Each patient will be included in the study only once, even if multiple BMABs are needed. Pain intensity in the visual analogue scale. Timepoint: Pain intensity immediately, 30 minutes, and then the day after the bone marrow biopsy. Method of measurement: By using a visual analogue scale questionnaire. Anxiety severity using the Speilberger State–Trait Anxiety Inventory questionnaire. Timepoint: Patient's anxiety level 5 minutes before BMAB. Method of measurement: by using Speilberger State–Trait Anxiety Inventory questionnaire. The amount of painkillers required to reduce pain, the total dose of painkillers (including opioids, acetaminophen, and NSAIDs) used after BMAB in each patient. Timepoint: Patients are monitored for 24 hours after the end of BMAB. Method of measurement: Patient's record. The need for sedatives to reduce anxiety. Timepoint: Patients are monitored for 24 hours after the end of BMAB. Method of measurement: By using patient record data. The time required to administer the first dose of pain medication. Timepoint: Patients are monitored for 24 hours after the end of BMAB. Method of measurement: By using patient record data. Time required to administer the first dose of a sedative. Timepoint: Patients are monitored for 24 hours after the end of BMAB. Method of measurement: By using patient record data. Patient satisfaction with the procedure. Timepoint: The morning after BMAB. Method of measurement: The patient's level of satisfaction with the procedure is evaluated with the question "Are you willing to repeat the procedure with the same amount of pain reliever/anti-anxiety medication?" (yes/no). In this regard, if the answer to the satisfaction question is yes, the patient is considered "satisfied". Satisfaction with the procedure - yes - no. Pain score on the visual analogue scale. Timepoint: One month after performing BMAB, the presence or absence of pain and then its intensity are recorded in patients. Method of measurement: By using visual analogues scale. The memory of pain a month later. Timepoint: The patient's memory of the pain experience caused by BMAB is evaluated in a telephone call after one month Community Verified icon. Method of measurement: In this regard, if the answer to any of the three questions including "dreaming about this event", "feeling like running away from thinking about this event" and "feeling overwhelmed by thinking about this event", is yes, the memory of pain The patient is considered "positive". Pain memory - yes - no. Research Institute for Oncology, Hematology and Cell Therapy Approved 2024-10-12 Research Ethics Committee of Institute of Pharmaceutical Sciences, Tehran University of Medical Scie Research Center for Pharmaceutical Sciences, Faculty of Pharmacy, Porsina Street Tehran Tehran Iran (Islamic Republic of)