An interventional study of psychotherapy in Behavior and Anxiety, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to participants aged Up to 2 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-03.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Treatment
The present study aimed to determine whether infants disorders of regulation of states are associated with perinatal anxiety, and further to explore the efficacy of the behavioral intervention in enhancing positive interactions between mothers and their infants and thus ameliorating infants' disorders of regulation of states.
The subjects were recruited from the hospitalized pregnant women waiting for delivery from the department of gynecology and obstetrics of the first affiliated hospital of Xi'an Jiaotong university. A total of 200 perinatal anxiety women were divided to two group(behavioral intervention group and control group) according to mental health assessment. Inclusion criteria were applied: 1. mother aged 18-40 years; 2. First-time mother, full-term and singleton pregnancy; 3.the Hamilton Anxiety Scale(HAMA) score ≥14; 4.birth with no intrapartum complications; and 5. Apgar score > 8 at the first, fifth, and tenth minutes after birth. Exclusion criteria were as follows: any mental illness besides anxiety, maternal medical illness, hypertension, advanced liver disease, renal failure, cancer, valvular heart disease, heart failure, stroke,atrial fibrillation, peripheral arterial disease, and other severe diseases.Preterm infants (\< 37 weeks gestation) and multiple births were excluded from the current analysis. All the subjects completed the infants behavior and regulation of states assessment by the NBAS and were followed to 8 weeks postpartum. Mother-newborn pairs were randomly divided into NBO intervention group and control group. NBO intervention was performed once a week until 2 months. 2 ml peripheral blood was collected in the pregnant woman before delivery and in the newborns within 3 days postpartum.The serum fraction was removed after centrifugation and stored at -20°C. Levels of serum cortisol in mothers and newborns were determined using Chemiluminescence analysis (CLIA) and a radio immunoassay. All sample analyses were performed by the first affiliated hospital of Xi'an Jiaotong university chemistry laboratory. Laboratory personnel were blinded to mother and infant outcomes.
1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.
This study's planned enrollment of 200 is above the median of 120 across 1,197 interventional studies indexed under Behavior.
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Exclusion Criteria:
NBO behavioral intervention would be used to improve mother-infant dyad interaction and infants' disorders of regulation of states.
Behavioral: psychotherapy
No behavioral intervention would be used.
NBO is an infant-focused, family relationship-based intervention measure, which aims to exhibit to parents infants' surprised ability, understand infants' strength and aspects needed to be improved, strength parents' parenting confidence, and promote sound development of infant-mother relationship.
Also known as: Neonatal Behavioral Observation (NBO)
NBO ameliorates disorders of regulation of states in little infants from perinatal anxiety
The Hamilton Anxiety Scale(HAMA) was used to assess mothers anxiety state and whose score ≥14 were included. Meanwhile, Neonatal Behavioral Assessment Scale (NBAS) was used to assess infants neurobehavioral development and regulation of states from birth to 2 months. Regulation of states in the NBAS including four parts: cuddliness、consolability 、self-quieting and hand-to-mouth. Every part scores from 1 to 9, and the 1 represents worst and 9 for best. Higher scores of NBAS is associated with better regulation of states. Newborn Behavioral Observations (NBO) would be used to improve mother-infant dyad interaction and ameliorates infants disorders of regulation of states. Mother-newborn pairs were randomly divided into NBO intervention group and control group. NBO intervention was performed once a week until 2 months. Mother-newborn pairs serum would be collected to measure cortisol.
Time frame: up to 2 months
Plan to share: Undecided
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This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital Xi'an Jiaotong University →