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Tutorial of Clinical Trial Registration (CTREG)

Primary Purpose

Behavior, Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
psychotherapy
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behavior focused on measuring anxiety, regulation of states, NBO, HAMA

Eligibility Criteria

undefined - 2 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • mother aged 18-40 years;
  • first-time mother, full-term and singleton pregnancy;
  • the Hamilton Anxiety Scale(HAMA) score ≥14;
  • the birth with no intrapartum complications;
  • Apgar score > 8 at the first, fifth, and tenth minutes after birth.

Exclusion Criteria:

  • 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);
  • multiple births;
  • infants with congenital anomalies, signs of illness, or high-risk factors.

Sites / Locations

  • First Affiliated Hospital of Xi'an Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

psychotherapy intervention group

control group

Arm Description

NBO behavioral intervention would be used to improve mother-infant dyad interaction and infants' disorders of regulation of states.

No behavioral intervention would be used.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 30, 2017
Last Updated
April 2, 2018
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Xian Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03481452
Brief Title
Tutorial of Clinical Trial Registration
Acronym
CTREG
Official Title
NBO Ameliorates Disorders of Regulation of States in Little Infants From Perinatal Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Anticipated)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Xian Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior, Anxiety
Keywords
anxiety, regulation of states, NBO, HAMA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
psychotherapy intervention group
Arm Type
Experimental
Arm Description
NBO behavioral intervention would be used to improve mother-infant dyad interaction and infants' disorders of regulation of states.
Arm Title
control group
Arm Type
No Intervention
Arm Description
No behavioral intervention would be used.
Intervention Type
Behavioral
Intervention Name(s)
psychotherapy
Other Intervention Name(s)
Neonatal Behavioral Observation (NBO)
Intervention Description
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.
Primary Outcome Measure Information:
Title
NBO ameliorates disorders of regulation of states in little infants from perinatal anxiety
Description
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: mother aged 18-40 years; first-time mother, full-term and singleton pregnancy; the Hamilton Anxiety Scale(HAMA) score ≥14; the birth with no intrapartum complications; Apgar score > 8 at the first, fifth, and tenth minutes after birth. Exclusion Criteria: 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); multiple births; infants with congenital anomalies, signs of illness, or high-risk factors.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Li, PhD, MD
Phone
+86 18991232133
Email
huili@mail.xjtu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
zhongliang Zhu, PhD
Phone
+86 13991289992
Email
zlzhu@mail.xjtu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Li, PhD, MD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Li, PhD, MD
Phone
+86 18991232133
Email
huili@mail.xjtu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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