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Clinical Trials/IRCT20111219008459N14
IRCT20111219008459N14
Not Yet Recruiting
N/A

The effect of counseling with behavioral approach on the infant’s Colic of anxious mothers : a randomized controlled trial

Tabriz University of Medical Sciences0 sites46 target enrollmentTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
Condition 1: Infantile Colic. Condition 2: maternal anxiety.
Sponsor
Tabriz University of Medical Sciences
Enrollment
46
Status
Not Yet Recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional
Sex
Female

Investigators

Eligibility 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

  • 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.

Outcomes

Primary Outcomes

Not specified

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