Determination of an educational- supportive- following program’s effect on burden of parental ’ care with infantile colic
Design
The clinical trial, parents of infants colic divided randomly into two groups of 32 peoples, intervention and control groups.
Settings and conduct
This research was done in Amin and Emam Hossein clinical centers of Isfahan. The test group received a three-cycle program during 2 weeks in 4 sessions. Both groups answered the caregiver’s burden questionnaire before, immediately and one month after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Parents of infant (Mother or Father); Wishing to participate in the study; Be able to communicate and Persian language; With no drug addiction; No history of taking any psychiatric drug; Have colicky baby in the age range from 2 weeks to 3 months old; Have a physical and mental ability to take care of colicky infants who had not previously participated in family education sessions (any other research project in the field).
Intervention groups
The experimental group received an intervention called a three-cycle program as an educational- supportive- following program during two weeks in 4 sessions while the control group received routine infant care.
Main outcome variables
Propose a three-cycle educational- supportive- following program to children's treatment centers to improve the parental care burden of colic infants.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190312043031N1
Registration date:2019-04-24, 1398/02/04
Registration timing:retrospective
Last update:2019-04-24, 1398/02/04
Update count:0
Registration date
2019-04-24, 1398/02/04
Registrant information
Name
Zahra Alikhalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3228 5266
Email address
z.alikhalili@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-02-22, 1396/12/03
Trial completion date
2018-02-22, 1396/12/03
Scientific title
Effect of an educational- supportive- following program on burden of parental ’ care with infantile colic
Public title
Effect of an educational- supportive- following program on burden of parental ’ care with infantile colic
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Parents of infant (Mother or Father) to be considered as primary caregiver and all have to assume his or her responsibilities
Have a mental and physical ability to take care of colicky baby
Wishing to participate in the study
Be able to communicate and follow the rules of the training session
Be able to speak, read and write in Persian language
Must not be drug-addicted and not to be treated with psychiatric drug
In family training sessions (any other research project in the field) have not participated in the past
Parents for colicky baby who range in age from 2 weeks to 3 months
Exclusion criteria:
Parents are reluctant to continue cooperation in the training sessions
There is any problem, so parents can not continue to participate in the study
look out for a maximum of two sessions of the training sessions absence
The physical and psychological problems in parents who can not presence in the meetings
Parents have to take care of another patient in the family
Infants have a diagnosis other than colic at the time of referral
Age
From 14 days old to 3 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Actual sample size reached:
55
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation of samples was done in two groups of test and control by simple random method and using the envelope in a package containing 32 cards with number one and 32 cards with number two. On the day of random allocation of the research units, parents were asked to choose a card. In this way, the parents who assigned the number one in the experimental group and those who were assigned number two were placed in the control group.
.
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 Isfahan University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-07-02, 1396/04/11
Ethics committee reference number
IR.MUI.REC.1396.3.224
Health conditions studied
1
Description of health condition studied
Colic in infants
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal pain
Primary outcomes
1
Description
Caregiver burden for parents
Timepoint
Before the intervention, immediately after the intervention and one month after the intervention
Method of measurement
Zarit caregiver burden questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In this study, for patients in the test group, educational- supportive- following program was held for 4 sessions, 30-45 minutes, during 2 weeks.