The effect of mandala staining on anxiety, Intensity of pain and dysmenorrhea symptoms in girls with dysmenorrhea
Design
Clinical trial with control and intervention groups, randomized, with a sample size of 80 people. The rand function of Excel software was used for randomization.
Settings and conduct
This study will be conducted on female students at Arak University, in the form of pre-test and post-test in two control and intervention groups, for two consecutive cycles. In the intervention group, during two days before menstruation and 3 days at the beginning of menstruation 5 days) they will color a mandala design that will be given to them by the researcher at the beginning of the month along with a pack of 6 colored pencils. It is better to color in the early morning and after waking up. Due to the higher concentration, no intervention is performed in the control group during one cycle.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Arak university students; having at least 18 years of age; Absence of known physical and mental illness
Exclusion criteria: irregular menstrual cycle, chronic pelvic disease, surgery in the last three months, Continuous use of painkillers
Intervention groups
In the intervention group, during two days before menstruation and 3 days at the beginning of menstruation (5 days in total), they will color a mandala design, which will be provided to them by the researcher at the beginning of the month along with a pack of 6 colored pencils. and this work will continue for two menstrual periods. It is better to paint in the beginning of the morning and after waking up due to higher concentration. In the control group, no intervention is done during one cycle.
Main outcome variables
anxiety; pain intensity; Symptoms of dysmenorrhea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220703055351N1
Registration date:2022-09-02, 1401/06/11
Registration timing:registered_while_recruiting
Last update:2022-09-02, 1401/06/11
Update count:0
Registration date
2022-09-02, 1401/06/11
Registrant information
Name
Mahsa Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 1221 9498
Email address
smahsahosseini99@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-05, 1401/04/14
Expected recruitment end date
2022-10-06, 1401/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Mandala staining on anxiety, Intensity of pain and dysmenorrhea symptoms in girls with dysmenorrhea
Public title
The effect of Mandala staining in girls with dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female students of Arak universities
Having at least 18 years of age
Exclusion criteria:
Presence of known physical and mental illness
Presence of known chronic pelvic disease
Surgery in the past three months
Use of contraceptive pills
The onset of menstrual pain after the age of 20
Irregular menstrual cycles
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In the first step, to create a random sequence or random sequence generation, first, each of the 80 volunteers who meet the criteria for entering the study by randomization using the random block method by statistical software and individually and assigning students in two groups of 40 Intervention and control will be based on even and odd numbers.
The second stage of concealment of randomization or Allocation concealment, in this research, according to the allocation of the drawing of the Mandela plan for one group and not doing this for the second group of participants will be studied.
In the third stage of randomization or implementation of the process, the person who created the random sequence, the person who examined the participants in terms of entry and exit criteria and enrolled them in the study, and the person who divided the participants into groups is the data allocation, the person who performs the data analysis and the researcher will not know about the group allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the third stage of randomization or implementation of the process, the person who created the random sequence, the person who examined the participants in terms of entry and exit criteria and enrolled them in the study, and the person who divided the participants into groups is the data allocation, the person who performs the data analysis and the researcher will not know about the group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3813944438
Approval date
2022-03-06, 1400/12/15
Ethics committee reference number
IR.ARAKMU.REC.1400.344
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
Anxiety
Timepoint
once before the intervention from the time people entered the study and once after the intervention by the relevant questionnaire in the control and intervention groups.
Method of measurement
Spellberger's questionnaire
2
Description
intensity of pain
Timepoint
once before the intervention from the time people entered the study and once after the intervention by the relevant questionnaire in the control and intervention groups.
Method of measurement
Numerical Pain Scale Questionnaire
3
Description
Symptoms of dysmenorrhea: In this research, symptoms of dysmenorrhea will be measured using the standard mouse menstrual questionnaire.
Timepoint
once before the intervention from the time people entered the study and once after the intervention by the relevant questionnaire in the control and intervention groups.
Method of measurement
Mouse menstrual standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, during two days before menstruation and 3 days at the beginning of menstruation (5 days in total), they will color a mandala design, which will be provided to them by the researcher at the beginning of the month along with a pack of 6 colored pencils. and this work will continue for two menstrual periods. It is better to paint in the beginning of the morning and after waking up due to higher concentration. In the control group, no intervention is done during one cycle. And in order to achieve the most accurate date of the intervention, the intervention group is asked to write down the exact date of their menstruation one cycle before the start of the intervention and fill the relevant questionnaires immediately after the end of this cycle. Mandala coloring includes circular designs that are used as a tool for meditation and psychological improvement, 10 designs are provided to each participant in the intervention group.
Category
N/A
2
Description
Control group: n the control group, no intervention is performed during one cycle.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak University of Medical Sciences
Full name of responsible person
mahsa hosseini
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
smahsahosseini99@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza kamali
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
alikamaliir@yahoo.com
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
Mahsa Hosseini
Position
Nursing student of Arak University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3503
Email
smahsahosseini99@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fereshteh Farzanazar
Position
Assistant Professor of Arak School of Nursing
Latest degree
Medical doctor
Other areas of specialty/work
Midwifery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
narenji@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahsa Hosseini
Position
Nursing student of Arak University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
Smahsahosseini99@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available