Determining the effect of behavioral counseling on infants' colic in anxious mothers
Design
Randomized trial with control group and parallel groups, on 46 subjects who will be randomly divided into control and intervention groups by random.org site and random blocking method with 4 and 6 block sizes and 1: 1 allocation ratio.
Settings and conduct
This study will be performed in the pediatric clinics of Tabriz, and 46 anxious mothers whose infants have colic will be easily selected. Then, questionnaires of postpartum anxiety, demographic characteristics, infant colic and mother-infant attachment will be completed. Participants will be randomly assigned to the control and intervention groups, the intervention group will receive 8 counseling sessions and the control group will receive routine care. Two weeks after the intervention, post-test questionnaires will be completed again for both groups.
Participants/Inclusion and exclusion criteria
Mothers whose infants 2 to 6 weeks old had colic according to Wessel criteria and pediatrician diagnosis and scored 112 or higher on the Postnatal Specific Anxiety Questionnaire.
Intervention groups
For the intervention group mothers, according to the behavioral psychology approach , 8 counseling sessions will be held two days a week for 4 consecutive weeks, with some sessions to teach relaxation as well as the ordering of stress triggers. Training on breastfeeding, taking extra baby gastric air, and nutritional counseling will be conducted in groups and individually.The control group will only be offered breastfeeding training, extra gastric air intake and nutritional counseling.
The effect of counseling with behavioral approach on the infant’s Colic of anxious mothers : a randomized controlled trial
Public title
The effect of counseling on the infant’s Colic of anxious mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women with 2 to 6 weeks infants
Anxiety Based on Postpartum Anxiety Questionnaire (PSAS)
Diagnosis of infant colic based on Wessel criteria and approved by pediatrician
Having at least intermediate Education
Exclusive Breastfeeding
Healthy term infant weighing at least 2500 grams and normal weight gain
Exclusion criteria:
Twin
Use of all kinds of chemical and herbal remedies such as anti-flatulence to treat infant colic.
Congenital autoimmune disease or infant nutritional problems.
A history of mental illness requiring medication, including postpartum depression in previous deliveries (according to the individual).
The mother's anxiety as much as she needs medication.
Existence of mothers' drug abuse during pregnancy and in the postpartum period (according to the individual).
Mother's education in research topic from other sources.
Maternal formal education / training to reduce anxiety.
Mother's uncertainty about attending all counseling sessions.
Adverse events such as the death of loved ones or divorce and ... for the mother in the last 2 months.
Mother's use of antibiotics.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Participants would be allocated into two groups (receiving counseling and control), using a randomized block method with a block size of four and six, and the allocation ratio of 1: 1.
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 Tabriz University of Medical Sciences
Street address
South Shariati Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Approval date
2020-01-07, 1398/10/17
Ethics committee reference number
IR.TBZMED.REC.1398.1083
Health conditions studied
1
Description of health condition studied
Infantile Colic
ICD-10 code
R10.83
ICD-10 code description
Colic
2
Description of health condition studied
maternal anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
infantile colic
Timepoint
Measurement of infant colic score before the intervention and 2 weeks after the intervention.
Method of measurement
Infantile Colic scale (ICS)
2
Description
maternal anxiety
Timepoint
Measurement of maternal anxiety score before the intervention and 2 weeks after intervention.
Method of measurement
Postpartum Specific Anxiety scale (PSAS)
Secondary outcomes
1
Description
Maternal Postnatal Attachment
Timepoint
Measuring mother-infant attachment score before and two weeks after intervention
Method of measurement
Maternal Postnatal Attachment scale (MPAs)
Intervention groups
1
Description
Intervention group: For intervention group mothers, according to the behavioral psychology approach and regular desensitization technique, 8 counseling sessions will be held two days a week for 4 consecutive weeks.The intervention protocol is as follows: Session 1: Teaching how to breastfeed and get extra air in the baby's stomach and training relaxation for mothers with infants with colic, Session 2: Continuation of relaxation training for mothers with colic, Session 3: Identifying the anxiety hierarchy of mothers with infants with colic (from severe to mild), Session 4: Initiation of desensitization: clients will sit relaxed or lying down and will begin to visualize and deal with anxiety (from the least anxious to the most). The fifth, sixth, seventh and eighth sessions of desensitization continue until the person Minimize anxiety in the cases listed. Probiotic drops will be prescribed for both groups infants. Two weeks after the intervention, infants' colic questionnaires, postpartum anxiety and mother-infant attachment questionnaires will be completed again.
Category
Other
2
Description
Control group: The control group will be taught how to breastfeed and get extra air in the baby's stomach individually, and their babies will also receive probiotic drops.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Alzahra Hospital
Full name of responsible person
dr Shirin Hasanpoor
Street address
South Artesh Street
City
Tabriz
Province
East Azarbaijan
Postal code
05138665793
Phone
+98 41 3553 9161
Email
info@ahzahrahosp.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Samiei
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Reyhaneh Montazeri
Position
Ms.c student of counseling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of NURSING and Midwifery, South Shariaty Street
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Phone
+98 41 3479 6770
Email
Midr.Montazeri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Hasanpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Phone
+98 41 3479 6770
Email
shirinhasanpoor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reyhaneh Montazeri
Position
Ms.c student of counselling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Phone
+98 41 3479 6770
Email
Midr.montazeri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD