Protocol summary
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Study aim
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Determining the effectiveness of Mandela coloring on second trimester anxiety
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Design
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Clinical trial with a control group, a blinded, randomized, on 60 patients. Random Allocation Software was used for randomization.
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Settings and conduct
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Placement of pregnant women with a gestational age of 14-28 weeks based on random block in two groups. Blinding is performed only for the data analyst.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Willingness of pregnant women to participate in the study, second trimester of pregnancy (14-28 weeks), singleton and low-risk pregnancy, reading and writing literacy, obtaining a score of 43 to 94 from the Vandenberg Antenatal Anxiety Questionnaire (1989)
Exclusion criteria:
Multiple pregnancy, suffering from a known physical and mental illness, a stressful event in the last six months such as the death of a close family member, the use of psychotropic and anti-anxiety and depression drugs, a score of less than 42 and more than 95 from the Vandenberg Pregnancy Anxiety Questionnaire
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Intervention groups
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In the intervention group, pregnant women will be provided with six Mandela designs along with colored pencils, and they will be asked to color Mandela designs for six days at least half an hour each time. At the time of coloring, be in a calm environment and concentrate. Routine pregnancy care will be performed in the control group.
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Main outcome variables
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Average pregnancy anxiety score, Average general health score
General information
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Reason for update
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The requirement time for sampling was entered mistakenly before registration date in IRCT. We started sampling after registration.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180218038783N6
Registration date:
2023-12-30, 1402/10/09
Registration timing:
prospective
Last update:
2024-05-28, 1403/03/08
Update count:
1
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Registration date
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2023-12-30, 1402/10/09
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2024-01-13, 1402/10/23
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Expected recruitment end date
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2025-12-02, 1404/09/11
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effectiveness of Mandela coloring on anxiety in the second trimester of pregnancy
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Public title
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Mandela coloring and the anxiety of the second trimester of pregnancy
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Willingness of pregnant women to participate in the study
Second trimester of pregnancy (week 14-28)
Low-risk singleton pregnancy
Reading and writing literacy
Not taking psychoactive and anti-anxiety and depression drugs
Obtaining a score of 43 to 94 from Vandenberg Pregnancy Anxiety Questionnaire (1989)
Exclusion criteria:
Multiple pregnancy
Suffering from a known physical and mental illness
Obtaining a minimum score of 42 and a maximum score of 95 from the pregnancy anxiety questionnaire
Having a stressful event in the last six months, such as the death of a first-degree family member
Taking psychoactive and anti-anxiety and depression drugs
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Age
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No age limit
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To allocate the intervention group and the control group (two groups A and B), the Block Randomization method with ten blocks will be used. Then the participants will be assigned to one of two groups 1 with a ratio of 1:1 according to the block randomization protocol (produced by Random Allocation Software), so that the researcher cannot predict which group the next person will be in
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Blinding in this study will not be possible for the researcher due to the nature of the intervention. Blinding will only be done for the data analyst.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-11-06, 1402/08/15
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Ethics committee reference number
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IR.MUBABOL.REC.1402.129
Health conditions studied
1
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Description of health condition studied
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Pregnancy anxiety
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ICD-10 code
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F41.8
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ICD-10 code description
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Other specified anxiety disorders
Primary outcomes
1
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Description
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Pregnancy anxiety
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Timepoint
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Before, immediately and one month after the end of the intervention
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Method of measurement
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Vandenberg pregnancy anxiety questionnaire (1989)
Secondary outcomes
1
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Description
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General health
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Timepoint
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Before, immediately and one month after the end of the intervention
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Method of measurement
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Goldberg General Health Questionnaire
Intervention groups
1
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Description
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Intervention group: People in the intervention group will be given six designs of Mandela along with colored pencils and they will be asked to color the designs of Mandela every day for six days and at least half an hour each time. At the time of coloring, be in a calm environment and concentrate. Routine care such as pregnancy visits, weight and blood pressure measurement, nutrition and health care training and the use of supplements during pregnancy are done.
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Category
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Other
2
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Description
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Control group: During the study period, routine pregnancy care will be performed in the control group. These cares include: pregnancy visits, weight and blood pressure measurement, nutritional and health care training and taking supplements during pregnancy.
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Category
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Other
1
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Sponsor
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Grant name
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Research projects grant
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Grant code / Reference number
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724135329
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Babol University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable