This study will be conducted with the aim of investigating the effect of mandala coloring on anxiety and pain in patients who are candidates for bone marrow sampling.
Design
A clinical trial that includes intervention and control groups and based on block selection, which is conducted on 80 patients randomly.
Settings and conduct
All patients who are candidates for bone marrow sampling in Arak city in Khansari Hospital, which is performed before sampling, the level of pain and anxiety is measured from the Spielberger questionnaire and using a numerical pain rating scale. A code will be given to the control and intervention groups to prevent the statistical analyst from knowing the type of groups and to prevent bias in the data analysis by the statistical analyst.
Participants/Inclusion and exclusion criteria
Entry requirements:
Willingness to participate in research.
Be in the age range of 18 to 45 years.
To undergo bone marrow sampling for the first time.
According to the Spielberger anxiety questionnaire, the research unit has mild or moderate anxiety.
To treat pain and anxiety, they have not taken medicine or are not undergoing therapeutic intervention.
Bone marrow sampling of the research units should be performed by a single physician.
Sampling is done from the iliac region.
Exit conditions:
Failure to complete the procedure or repeating the procedure on the patient for any reason
Unwillingness to continue participating in the intervention
Taking painkillers and anti-anxiety drugs with the doctor's opinion during the procedure
Failure to answer all questionnaire questions
Intervention groups
All candidate patients for bone marrow sampling in Arak city
The intervention performed in the intervention group is mandala coloring.
There is no intervention in the control group.
Main outcome variables
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231126060181N1
Registration date:2024-02-03, 1402/11/14
Registration timing:registered_while_recruiting
Last update:2024-02-03, 1402/11/14
Update count:0
Registration date
2024-02-03, 1402/11/14
Registrant information
Name
Fatemeh Hasani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3477 2242
Email address
f.hasani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-05, 1402/10/15
Expected recruitment end date
2024-02-04, 1402/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mandala coloring on anxiety and pain in patients undergoing bone marrow biopsy
Public title
The effect of Manda staining on biopsy pain and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in research.
Be in the age range of 18 to 45 years.
To undergo bone marrow sampling for the first time.
Based on the Spielberger anxiety questionnaire, the research unit has mild or moderate anxiety.
To treat pain and anxiety, they have not taken medicine or are not undergoing therapeutic intervention.
Bone marrow sampling of the research units should be performed by a single physician.
Sampling is done from the iliac region.
Exclusion criteria:
Unwillingness to participating in the intervention
Receiving painkillers and anti-anxiety drugs
Being under 18 years old or over 45 years old
Lack of mental health
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method is used to make sure that exactly equal number of participants enter the intervention and control groups in consecutive time intervals. The process of randomly dividing participants into different groups is called block randomization. Randomization gives every participant an equal chance to be placed in each of the groups. 4 blocks including 2 participants in the intervention group (B) and 2 participants in the control group (A) have been used, based on the sequence of entry and according to the block pattern that is randomly selected among the blocks AABB, ABBA, ABAB, BABA, BAAB are selected and assigned to intervention and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, people are divided into control and intervention groups, in the intervention group, people receive a type of intervention, and at the end, the control and intervention groups will be compared.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of arak University of Medical Sciences
Street address
Yas Alley، Jahangiri Street ،Imam Street
City
arak
Province
Markazi
Postal code
3816637677
Approval date
2023-12-03, 1402/09/12
Ethics committee reference number
IR.ARAKMU.REC.1402.188
Health conditions studied
1
Description of health condition studied
Pain and anxiety
ICD-10 code
F45.4
ICD-10 code description
Persistent somatoform pain disorder
Primary outcomes
1
Description
The anxiety score of the people is from the Spielberger questionnaire, which will be measured before the intervention, after the intervention, and after sampling.
Timepoint
Before intervention and ten minutes after sampling
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
1
Description
Pain score of patients
Timepoint
بعد از نمونه برداری مغز استخوان
Method of measurement
Numerical pain rating scale
Intervention groups
1
Description
Intervention group: The only intervention performed in this group consists of coloring the same pattern copied in patients undergoing bone marrow sampling with 6-color ink made in Iran, for 30 minutes before the start of bone marrow sampling.
Category
N/A
2
Description
"Control group:" No intervention is done in this group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Khansari Hospital
Full name of responsible person
Fatemeh Hasani
Street address
Yas Alley, Jahangiri St., Imam St
City
Arak
Province
Markazi
Postal code
3816637677
Phone
+98 86 3477 2242
Email
f.hasani@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davood Hekmatpo
Street address
Arak University of Medical Sciences ,Basij Square, Arak Town
City
Arak
Province
Markazi
Postal code
3818146851
Phone
+98 86 3368 6443
Email
rehab@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
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
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Hasani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Yas Alley ,Jahangiri Street ,Imam Street
City
Arak
Province
Markazi
Postal code
3816637677
Phone
009886344772242
Email
f.hasani@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Hasani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Yas Alley , Jahangiri Street ,Imam Street
City
Arak
Province
Markazi
Postal code
3816637677
Phone
+98 86 3477 2242
Email
f.hasani@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Hasani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Yas Alley , Jahangiri Street ,Imam Street
City
Arak
Province
Markazi
Postal code
3816637677
Phone
+98 86 3477 2242
Email
f.hasani@arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can potentially be shared after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The data is accessible to all researchers.
Under which criteria data/document could be used
There are no conditions for using the data.
From where data/document is obtainable
To the researcher named Fatemeh Hasani with email address
f.hasani@arakmu.ac.ir
What processes are involved for a request to access data/document