Comparison of the Effects of Mandala Coloring and Music Therapy on the Consumption of Primiparous Women
Design
This research is a clinical trial with a control group, with parallel groups, with a sample size of 150 people who are divided into three color therapy, music therapy and control groups by simple random assignment.
Settings and conduct
This research will be done in the health clinics of Zabul city. The researcher identified pregnant women eligible to enter the study, and after obtaining informed consent, they were asked to complete the demographic and obstetric information checklist and the Spielberger anxiety questionnaire.In the color therapy group, people will be given a box of 6 colored pencils and a coloring book with mandala designs. became.
Participants/Inclusion and exclusion criteria
First Pregnancy, Singleton and Desire
Gestational age 20-28 Pregnancy
Age 18-35 years
Absence of Fetal abnormalities
No History of Depression and Anxiety Before Pregnancy
No History of Infertility
Absence of Acute and Chronic illness of the Mother
Have not Had an Accident in the Past 9 Months
Not Having a High-Risk Pregnancy
Intervention groups
The present study includes two intervention groups. The participants will be divided into two groups: color therapy and music therapy. In the color therapy group, people will be given a box of 6 colors and a coloring book with mandala designs. In the music therapy group, a CD containing soothing wordless music with a slow rhythm will be given to the participants.
Main outcome variables
Anxiety of primiparous women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241202063915N1
Registration date:2024-12-22, 1403/10/02
Registration timing:prospective
Last update:2024-12-22, 1403/10/02
Update count:0
Registration date
2024-12-22, 1403/10/02
Registrant information
Name
Zeynab Sheikh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3328 0551
Email address
zeinab.sh@zbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-12-30, 1403/10/10
Expected recruitment end date
2025-05-22, 1404/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Mandela Coloring and Music Therapy on the Anxiety of Primiparous Women
Public title
Comparison of the Effects of Mandela Coloring and Music Therapy on the Anxiety of Primiparous Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
First Pregnancy, Singleton and Desire
Gestational age 20-28 Pregnancy
Age 18-35 years
Absence of Fetal abnormalities
No History of Depression and Anxiety Before Pregnancy
No History of Infertility
Absence of Acute and Chronic illness of the Mother
Have not Had an Accident in the Past 9 Months
Not Having a High-Risk Pregnancy
Exclusion criteria:
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done with a purpose-based method. For this purpose, all referring pregnant mothers who meet the study entry criteria will be selected as a sample and this work will continue until the final sample size is reached.People who meet the criteria for entering the research will be selected and then randomly assigned using the list prepared by random assignment software, will be divided into one of two groups: coloring and music therapy. The samples are placed in the designated group in the order of entry into the study based on the prepared list.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zabol University of Medical Sciences
Street address
Zabol University of Medical Sciences Headquarters, Shahid Bagheri St, Jihad Square, Zabol
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Approval date
2024-11-23, 1403/09/03
Ethics committee reference number
IR.ZBMU.REC.1403.903
Health conditions studied
1
Description of health condition studied
Anxiety of Primiparous Women
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
َAnxiety
Timepoint
Before and After the Intervention
Method of measurement
Demographic and Midwifery Information Questionnaire and Spielberger
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First intervention group: In the color therapy group, people will be given a box of 6 colors and a coloring book with mandala designs. The designs used will be provided to the research units for 20 minutes during 8 consecutive weeks (2 sessions per week) after the approval of the counseling and guidance professors and a psychologist.
Category
Other
2
Description
Intervention group: The second intervention group: In the music therapy group, a CD containing relaxing music without words with a slow rhythm (60 to 75 beats per minute measured with a metronome) will be provided to the participants. In the current study, the participants will be asked to listen to the iguana piece of music that has a uniform, gentle theme and away from any kind of music for 8 weeks (twice a week) for 20 minutes in a quiet and dimly lit environment and in a comfortable position. The emotions are melodic and rhythmic and the rhythm is less than 80 beats per second. Listen using the device. Participants are advised not to use hands-free and the volume should be in the range of 65-70 dB.
Category
Other
3
Description
Control group: prenatal care during pregnancy is performed routinely for the participants.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Health Center
Full name of responsible person
Zeynab sheikh
Street address
Imam Khomeini 68, Imam Khomeini st, Zabol
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3222 1744
Email
zynbshykh77@gmail.com
2
Recruitment center
Name of recruitment center
Hazrat Ali (AS) Health Center
Full name of responsible person
zeynab sheikh
Street address
next to Mosli Al-Mohdi (AJ), Shahid Sargolzaei St, zabol
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3224 1083
Email
zynbshykh77@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Zeynab sheikh
Street address
Zabol University of Medical Sciences Headquarters, Shahid Bagheri St, Jihad Square, Zabol
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3222 5402
Email
zynbshykh77@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol 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
Zabol University of Medical Sciences
Full name of responsible person
Zeynab sheikh
Position
Midwifery undergraduate student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
mamai Nursing school.,next to civil Registry office.,East ferdowsi St.,Zabol
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 1271
Email
zynbshykh77@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Zeynab sheikh
Position
Midwifery undergraduate student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
mamai Nursing school.,next to civil Registry office.,East ferdowsi St.,Zabol
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 1271
Email
zynbshykh77@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Zeynab sheikh
Position
Midwifery undergraduate student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
mamai Nursing school.,next to civil Registry office.,East ferdowsi St.,Zabol
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 1271
Email
zynbshykh77@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