Protocol summary
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Study aim
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The effect of abdominal massage with olive oil compared to paraffin on infantile colic symptoms
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Design
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This study is a clinical trial with placebo, randomized, double-blind, and phase 2-3 on 80 patients. Patients are assigned into 2 groups of 40 by permuted block randomization method.
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Settings and conduct
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This study will be performed in a pediatrician's office. The diagnosis of infantile colic will be based on the Rome IV criteria. Infants are included in the study with parental consent and are randomly divided into 2 groups of 40 people. Both groups will receive colic EZ drop. In both groups, abdominal massage with oil is performed 3 times a day for 5 minutes. The duration of the intervention is 2 weeks. All mothers are given a list of nutritional instructions. All parents are also asked to complete a checklist prepared by the researcher on a daily basis. The variables will be evaluated and compared on days 0, 7 and 14.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: term infants (gestational age more than 37 weeks) at the age of 4 to 12 weeks, birth weight more than 2500 gr; good general condition,
breastfeeding.
Exclusion criteria: infantile factors: underlying disease, malnutrition, skin lesions in the abdomen, maternal factors: depression and sever stress, smoking, employment at time of study
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Intervention groups
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Intervention group: Abdominal massage with liquid paraffin 3 times a day.
Control group: Abdominal massage with olive oil 3 times a day
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Main outcome variables
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Average frequency of crying and fussing, duration of crying and fussing, duration of sleep and frequency of defecation in 24 hours, intensity of crying and fussing, ICS score
General information
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Reason for update
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Remove of the group 1 (control) and group 4 (Oral consumption of Golghand) from the study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200528047585N1
Registration date:
2020-06-12, 1399/03/23
Registration timing:
prospective
Last update:
2021-12-13, 1400/09/22
Update count:
2
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Registration date
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2020-06-12, 1399/03/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-05-25, 1400/03/04
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Expected recruitment end date
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2022-03-20, 1400/12/29
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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 effect of abdominal massage with olive oil compared to paraffin on infantile colic symptoms
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Public title
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Anointment in treatment of diseases based on traditional Persian medicine and the effect of topical olive oil application on infantile colic symptoms
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
term infants (gestational age more than 37 weeks)
birth weight more than 2500 gr
good general condition
Breastfeeding
Exclusion criteria:
Infantile underlying disease
Infant malnutrition
Skin lesions in the abdomen
Mother's depression and sever stress
Smoking by mother
Mother's employment at time of study
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Age
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From 28 days old to 84 days old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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permuted block randomization
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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By assigning code to each group, put the code in an opaque and closed envelope and likening the drug and placebo container (olive oil and liquid paraffin)
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Placebo
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Used
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Assignment
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Other
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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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2020-02-15, 1398/11/26
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Ethics committee reference number
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IR.MUMS.REC.1398.300
Health conditions studied
1
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Description of health condition studied
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infantile colic
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ICD-10 code
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R10.4
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ICD-10 code description
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Other and unspecified abdominal pain
Primary outcomes
1
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Description
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The average duration of colic crying and fussing in 24 hours
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Timepoint
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0, 7 and 14 days
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Method of measurement
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Filling daily checklists by parents
Secondary outcomes
1
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Description
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The average frequency of colic crying and fussing in 24 hours
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Timepoint
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0, 7 and 14 days
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Method of measurement
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Filling daily checklists by parents
2
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Description
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The average duration of colic crying and fussing in 24 hours
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Timepoint
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0, 7 and 14 days
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Method of measurement
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Filling daily checklists by parents
3
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Description
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The average duration of sleep in 24 hours
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Timepoint
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0, 7 and 14 days
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Method of measurement
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Filling daily checklists by parents
4
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Description
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The average frequency of defication in 24 hours
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Timepoint
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0, 7 and 14 days
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Method of measurement
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Filling daily checklists by parents
5
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Description
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ICS score
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Timepoint
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0 and 14 days
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Method of measurement
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Completion of Infantile colic scale questionnaire
6
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Description
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intensity of colic crying and fussing
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Timepoint
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0 and 14 days
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Method of measurement
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Visual analog scale
Intervention groups
1
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Description
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Control group: Abdominal massage with placebo oil (liquid paraffin) 3 times a day and each time 5 minutes, for 14 days
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Category
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Placebo
2
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Description
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Intervention group: Abdominal massage with olive oil 3 times a day and each time 5 minutes, for 14 days
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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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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Mashhad 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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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The publication program is not specified yet
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When the data will become available and for how long
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The publication program is not specified yet
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To whom data/document is available
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The publication program is not specified yet
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Under which criteria data/document could be used
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The publication program is not specified yet
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From where data/document is obtainable
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The publication program is not specified yet
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What processes are involved for a request to access data/document
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The publication program is not specified yet
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Comments
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