The effect of educational-supportive program-maternal care, pain and crying rate due to colic pain in infants aged 1-5 months.
Design
In this study, all infants admitted to the Gonabadi hospital Dr. Derafshi clinic who have colic disease that is confirmed by doctor and then justify parental consent will be invited to study.
A total of 88 infants with colic were randomly selected and randomly divided into case and control groups
Settings and conduct
In this study, all infants admitted to the GONABADI hospital clinic and doctor Derafshi clinic who have colic and colic disease is confirmed by doctor.
Participants/Inclusion and exclusion criteria
Collic disease must be approved by the physician according to the Wessel standard.
Intervention groups
A care support program will be conducted on interventional colic pain for 3 weeks in the intervention group and compared to the control group.
Main outcome variables
The amount of colic pain, infant crying, the frequency of crying, the duration of infancy and the severity of infant crying.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171102037187N2
Registration date:2018-02-23, 1396/12/04
Registration timing:registered_while_recruiting
Last update:2018-02-23, 1396/12/04
Update count:0
Registration date
2018-02-23, 1396/12/04
Registrant information
Name
Maryam Khajeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 1886
Email address
khajehm941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-29, 1396/11/09
Expected recruitment end date
2019-01-12, 1397/10/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a maternal, educational, supportive and care program on sleeping, pain and crying rate due to colic in 1-5 months infants
Public title
The effect of a maternal, educational, supportive and care program on treatment of infantile colic pain
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have exclusive breastfeeding.
Between 1 and 5 months.
The infant has no autoimmune congenital or nutritional problem.
At birth, the term of birth is more than 2500 grams.
Appropriate weighing of the infant at that age is based on the percentile in the normal range.
No skin lesions in breastfeeding and maternity.
Exclusion criteria:
Good poor feeding.
Use of chemical drugs such as anti-pneumonia and ... at the time of the intervention.
The child has a history of surgery and swelling.
Exclusion of exclusive breastfeeding.
The child now has an acute illness, such as a cold, etc.
Age
From 30 days old to 5 months old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
All referrers who come to the colic during the winter to spring are invited to study using available samples. Examples that appear on odd days are part of the control group. Examples that go on even days are part of the intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, all participants are informed on the basis of informed consent and are unaware of the allocation of the groups. And the main seeker who seeks to respond to the research hypothesis is unaware of the outcome of the study.
Placebo
Not used
Assignment
Parallel
Other design features
At the start of the intervention and in a briefing session, a case study and one-person-care counseling program will be provided to the case group and a training booklet will be provided.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee
Street address
Faculty of Nursing and Midwifery, Ibn Sina Avenue, Ph.D., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-01-12, 1396/10/22
Ethics committee reference number
IR.MUMS.REC.1396.345
Health conditions studied
1
Description of health condition studied
infants colic
ICD-10 code
R10.4
ICD-10 code description
R10.4 Other and unspecified abdominal pain. Abdominal tenderness NOS Colic: NOS infantile
Primary outcomes
1
Description
Pain colic in infants
Timepoint
The severity of colic symptoms in infants before and after intervention in each group is calculated on the third and seventh day of treatment, and each group will be compared on the third and the third day of treatment separately from before intervention (due to taking the third day of treatment, the mean of the treatment for the infant and the day Seventh is the end of intervention treatment).
Method of measurement
In both groups, mothers will complete the checklist based on the criteria for pain relief for severity of crying and hours for infant.The questionnaire includes a tool for evaluating colic pain, Visual Analogue Scale.
Secondary outcomes
1
Description
The amount of colic pain, infant crying, the frequency of crying, the duration of infancy and the severity of infant crying.
Timepoint
Weekly (as the basal stage) record the infant's cry and sleep at night. In the second stage (as an intervention stage), mothers will be advised to run an educational-support-care program for a period of 8 days.
Method of measurement
A researcher-made instrument that has four parts: maternal and infant characteristics, and breastfeeding pattern, maternal nutritional instrument, incubation colic assay (the main tool for the dependent variables), Visual Analogue Scale, including the duration of crying and its frequency in 24 Hours is.
Intervention groups
1
Description
In the case of infants who suffer from colic and have their colic approved by the doctor and are among the criteria for entering the study, parents are informed by written consent.
Category
Prevention
2
Description
Control group:In the control group, probiotic drops are prescribed by the doctor, and the doctor will instruct the doctor how to give it to the infant by the researcher. Telling mothers about how to complete the registration (length of crying, infant crying, 24-hour sleep, and lactating sleep), as well as the breastfeeding model, maternal and infant's demographic information, and maternal nutritional information, by the researcher upon entering the study Is taught. For 8 days, complete the checklist based on the criteria for the pain cache for the severity of the cry and the hours for the infant. On the eighth day after the referral to the clinic, the checklist is delivered to the researcher.
Category
Treatment - Drugs
3
Description
Intervention group: In the intervention group, at a briefing session, a tutorial-support-care program for 30 minutes in person and one-to-one and giving a training booklet and giving the drops of probiotics prescribed by the doctor and how to give it to the infant. Telling mothers about how to complete the registration (length of crying, infant crying, 24-hour sleep, and lactating sleep), as well as the breastfeeding model, maternal and infant's demographic information, and maternal nutritional information, by the researcher upon entering the study Will be taught. For 8 days, they will run an educational-support-care program and within these 8 days, mothers will complete their checklist based on the criteria for pain relief for severity of crying and hours for infancy. On the eighth day after the referral to the clinic, the checklist is delivered to the researcher.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Bhlol Hospital, Gonabadi and derafshi Doctor's office
Full name of responsible person
Maryam khajeh
Street address
Razavi Khorasan, Gonabad, Saadi St., Vahd Blvd, Allameh Bhlol Gonabadi, Research & Treatment Center
City
Gonabad
Province
Razavi Khorasan
Postal code
info@gmu.ac.ir
Phone
+98 51 5723 6833
Fax
+98 51 5723 6160
Email
Bohlool@gmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tappaghdi
Street address
Faculty of Nursing and Midwifery, Ibn Sina Avenue, Ph.D., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
khajehm941@mums.ac.ir
Web page address
Grant name
Grant code / Reference number
960998
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Tahereh Sadeghi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
Faculty of Nursing and Midwifery, Ibn Sina Avenue, Ph.D., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
SadeghiT@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tahereh Sadeghi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
Faculty of Nursing and Midwifery, Ibn Sina Avenue, Ph.D., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
SadeghiT@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tahereh Sadeghi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
Faculty of Nursing and Midwifery, Ibn Sina Avenue, Ph.D., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
SadeghiT@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
Only part of the data, such as the information on the main outcome, can be shared.
When the data will become available and for how long
"Starting the access period from 1397"
To whom data/document is available
It will be available to researchers working in academic and scientific institutions and industry professionals.
Under which criteria data/document could be used
Based on the diagnostic criteria of Wessel, crying healthy infants for more than 3 hours a day, for 3 days a week, and in 3 consecutive weeks, they are called colic of infancy.
From where data/document is obtainable
This study is a clinical trial study with 5% lower weight in the intervention group. Infants whose crying hours dropped between 1-2 hours a day would decrease as more than 2 hours as relative responders as full responders, and those whose crying hours are unaltered as non-response.
What processes are involved for a request to access data/document
2 months approval of the design and approval of the Ethics Committee, 3 months of sampling and intervention, writing of the first and third seasons, 1 month of data recording and statistical analysis, 2 months arranging and finalizing the fourth and fifth chapters, typing and replicating, preparing and accepting the article.