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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

Protocol summary

Study aim
Determining the effectiveness of melatonin on pain and anxiety in hematological patients undergoing bone marrow aspiration/ biopsy (BMAB)
Design
This study is a single-center, randomized, placebo-controlled clinical trial, which is conducted on 146 patients in two groups, placebo and melatonin drug group. Balance Blocked Randomization method and Stata software will be used for randomization.
Settings and conduct
The research team, including researchers, doctors, nurses, patients and statistical analysts, are not aware of the type of medicine received. Half an hour after receiving the drug and placebo, the patients will undergo BMAB and the patients will be evaluated for vital signs, occurrence of side effects, level of anxiety, intensity of the patient's pain, remaining pain level one month later, patient's memory and patient consent.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years;Definite or possible diagnosis of hematologic malignancy with indication for performing BMAB; Normal functional status (in the form of points 0 to 2 from ECOG). Exclusion criteria: Known allergy to melatonin or any of the product's components; the patient has not received melatonin medicine in the; Patients treated with analgesics or anti-anxiety drugs; Known patients with anxiety or psychotic disorders
Intervention groups
In the intervention group, each participant was administered melatonin at a dose of 10 mg orally, in addition to local anesthetic, 30 minutes before the start of the bone marrow biopsy. In the control group, each participant was administered placebo at a dose of 10 mg orally, in addition to local anesthetic, 30 minutes before the start of the bone marrow biopsy.
Main outcome variables
Intensity of pain; anxiety intensity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140818018842N48
Registration date: 2025-04-15, 1404/01/26
Registration timing: prospective

Last update: 2025-04-15, 1404/01/26
Update count: 0
Registration date
2025-04-15, 1404/01/26
Registrant information
Name
Leyla Sharifi Aliabadi
Name of organization / entity
Research Institute for Hematology, Oncology and Stem Cell Transplantation,Tehran University of Medic
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 3691
Email address
ctu@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-21, 1404/02/01
Expected recruitment end date
2026-03-21, 1405/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effectiveness of melatonin in reducing pain and anxiety caused by bone marrow sampling
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 146
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Other
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Institute of Pharmaceutical Sciences, Tehran University of Medical Scie
Street address
Research Center for Pharmaceutical Sciences, Faculty of Pharmacy, Porsina Street
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2024-10-12, 1403/07/21
Ethics committee reference number
IR.TUMS.TIPS.REC.1403.128

Health conditions studied

1

Description of health condition studied
hematologic malignancy
ICD-10 code
C96.9
ICD-10 code description
Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified

Primary outcomes

1

Description
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

2

Description
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 outcomes

1

Description
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

2

Description
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

3

Description
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

4

Description
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

5

Description
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

6

Description
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

7

Description
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

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Hematology and Oncology
Full name of responsible person
Bita Shahrami
Street address
Dr. Shariati Educational, Research and Treatment Center, opposite the Faculty of Economics, Jalal Al-Ahmad Intersection, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
shariatihosp@tums.ac.ir
Web page address
https://shariati.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Institute for Oncology, Hematology and Cell Therapy
Full name of responsible person
Mohammad Vaezi
Street address
Dr. Shariati Educational, Research and Treatment Center, opposite the Faculty of Economics, Jalal Al-Ahmad Intersection, North Kargar Street
City
Tehran
Province
Tehran
Postal code
14117-13135
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
horcbmt@tums.ac.ir
Web page address
https://www.riohct.ir/RIOHCT/en/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Oncology, Hematology and Cell Therapy
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soma Rahimi
Position
Resident of Pharmacotherapy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Dr. Shariati Educational, Research and Treatment Center, opposite the Faculty of Economics, Jalal Al-Ahmad Intersection, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1411713131
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
somarahimidr@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bita Shahrami
Position
Assistant Professor of Critical Care Pharmarcotherapy
Latest degree
Subspecialist
Other areas of specialty/work
Medical Pharmacy
Street address
Dr. Shariati Educational, Research and Treatment Center, opposite the Faculty of Economics, Jalal Al-Ahmad Intersection, North Kargar Street
City
Tehran
Province
Tehran
Postal code
14117-13135
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
bita.shahrami@gmail.com
Web page address
https://www.riohct.ir/RIOHCT/en/

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leyla Sharifi Aliabadi
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Shariati Educational, Research and Treatment Center, opposite the Faculty of Economics, Jalal Al-Ahmad Intersection, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1411713131
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
l-sharifi@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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