hematologic malignancy. Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified
Conditions
Interventions
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
Sponsors
Research Institute for Oncology, Hematology and Cell Therapy
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSoma Rahimi
Tehran University of Medical Sciences
Outcome results
None listed