Back to resultsMaternal Exercise and Antenatal Anxiety
Primary Purpose
Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
maternal exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety focused on measuring anxiety, pregnancy, exercise
Eligibility Criteria
Inclusion Criteria:
- Pregnant women who are over 18 years old and confirmed to be pregnant in Shenzhen Dapeng New District.
Exclusion Criteria:
- 1.pregnant women who have accepted maternal exercise training (at least twice a week in last month);2.pregnant women who have orthopedics, cardiovascular or mental diseases; 3.pregnant women who have or had any condition as follows:miscarriage more than two times,premature delivery,placenta previa,fetal dysplasia, low weight before pregnancy (BMI <17.5),polycyesis,preeclampsia,premature rupture of membranes,Uterine growth retardation,cervical/ligation,repeated vaginal bleeding,anemia or diabetes; 4.the gestational age is less than 12 weeks or more than 16 weeks;5.received psychotherapy or psychotropic medication within 6 months before the study;6.can not participate in regular inspections.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
maternal exercise training group
antenatal care group
Arm Description
Pregnant women in experimental group are invited to participate in 16 exercise weekly classes for 40 min including 15 min aerobic exercise，10 min relaxation exercise, and 15 min aerobic exercise, from week 16 to week 32 of gestation, and receive antenatal care and examination regularly.
Pregnant women in antenatal care group receive antenatal care and examination regularly.
Outcomes
Primary Outcome Measures
Change from Baseline of State Anxiety at 32 Weeks of Gestation
We use state anxiety subscale of State-Trait Anxiety Inventory (STAI) as the measure of anxiety severity. The STAI comprises two-self report scales for measuring two distinct anxiety concepts, the State anxiety and Trait anxiety. Both scales contain 20 statements that ask the respondent to describe how she feels at a particular moment (state anxiety) or how she generally feels (trait anxiety). State anxiety is conceptualized as a transitory emotional state, where as trait anxiety refers to relatively stable individual differences in proneness to anxiety. The respondents are required to rate themselves on a four point likert scale 'not at all' to 'very much so on' various anxiety related symptoms which they experience in the past weeks for the state scale or how they generally feel for the trait scale. STAI is widely used and has been shown to have high reliability and validity with a Cronbach's alpha of 0.88 and 0.83 for state (STAI-I) and trait anxiety (STAI-II) respectively.
Secondary Outcome Measures
Change from Baseline of Depressive Symptom at 32 Weeks of Gestation
We use Beck Depression Inventory second edition (BDI-Ⅱ) as the measure of depressive symptom severity. The BDI-II is a 21-item self-report measure of common depressive symptoms. Each item has four possible responses, and higher total scores are indicative of a greater number and severity of depressive symptoms. Scores ranging from 0 to 13 indicate minimal/no symptoms, 14-19 indicate mild depression, 20-28 indicate moderate depression, and 29-63 indicate severe depression.
Change from Baseline of Pain at 32 Weeks of Gestation
We use Brief Pain Inventory (BPI) as the measure of the severity of pain. The pain intensity section of the BPI is composed by four items that are scored from 0 (no pain) to 10 (worst pain), while the functional interference section is composed by seven items that are scored from 1 (no interference with activities of daily living) to 10 (total interference). The severity index is calculated on the basis of the mean of the four pain intensity items, and interference index is calculated from the mean of the seven pain interference items.
Full Information
NCT ID
NCT04624802
First Posted
October 11, 2020
Last Updated
November 5, 2020
Sponsor
Shenzhen Second People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04624802
Brief Title
Maternal Exercise and Antenatal Anxiety
Official Title
The Effect of Maternal Exercise on Anxiety During Normal Pregnancy：a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2020 (Anticipated)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Second People'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
Yes
5. Study Description
Brief Summary
This is a randomized controlled trial study. We evaluate effectiveness of maternal exercise on anxiety during normal pregnancy compared to those who receive antenatal care regularly. We plan to recruit 220 healthy pregnant women over the age of 18 in Shenzhen and to use a standard maternal exercise from Korea as intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
anxiety, pregnancy, exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
maternal exercise training group
Arm Type
Experimental
Arm Description
Pregnant women in experimental group are invited to participate in 16 exercise weekly classes for 40 min including 15 min aerobic exercise，10 min relaxation exercise, and 15 min aerobic exercise, from week 16 to week 32 of gestation, and receive antenatal care and examination regularly.
Arm Title
antenatal care group
Arm Type
No Intervention
Arm Description
Pregnant women in antenatal care group receive antenatal care and examination regularly.
Intervention Type
Behavioral
Intervention Name(s)
maternal exercise
Intervention Description
The maternal exercise is broadly practiced by pregnant women in China. It is designed by a team led by Shen Shanmei, a professor of Maternity Exercises at Department of Obstetrics and Gynecology of First Hospital in Korea.
Primary Outcome Measure Information:
Title
Change from Baseline of State Anxiety at 32 Weeks of Gestation
Description
We use state anxiety subscale of State-Trait Anxiety Inventory (STAI) as the measure of anxiety severity. The STAI comprises two-self report scales for measuring two distinct anxiety concepts, the State anxiety and Trait anxiety. Both scales contain 20 statements that ask the respondent to describe how she feels at a particular moment (state anxiety) or how she generally feels (trait anxiety). State anxiety is conceptualized as a transitory emotional state, where as trait anxiety refers to relatively stable individual differences in proneness to anxiety. The respondents are required to rate themselves on a four point likert scale 'not at all' to 'very much so on' various anxiety related symptoms which they experience in the past weeks for the state scale or how they generally feel for the trait scale. STAI is widely used and has been shown to have high reliability and validity with a Cronbach's alpha of 0.88 and 0.83 for state (STAI-I) and trait anxiety (STAI-II) respectively.
Time Frame
The participants are examined between 12 and 16 weeks of gestation (baseline visit) and at gestation week 32 (after the intervention).
Secondary Outcome Measure Information:
Title
Change from Baseline of Depressive Symptom at 32 Weeks of Gestation
Description
We use Beck Depression Inventory second edition (BDI-Ⅱ) as the measure of depressive symptom severity. The BDI-II is a 21-item self-report measure of common depressive symptoms. Each item has four possible responses, and higher total scores are indicative of a greater number and severity of depressive symptoms. Scores ranging from 0 to 13 indicate minimal/no symptoms, 14-19 indicate mild depression, 20-28 indicate moderate depression, and 29-63 indicate severe depression.
Time Frame
The participants are examined between 12 and 16 weeks of gestation (baseline visit) and at gestation week 32 (after the intervention).
Title
Change from Baseline of Pain at 32 Weeks of Gestation
Description
We use Brief Pain Inventory (BPI) as the measure of the severity of pain. The pain intensity section of the BPI is composed by four items that are scored from 0 (no pain) to 10 (worst pain), while the functional interference section is composed by seven items that are scored from 1 (no interference with activities of daily living) to 10 (total interference). The severity index is calculated on the basis of the mean of the four pain intensity items, and interference index is calculated from the mean of the seven pain interference items.
Time Frame
The participants are examined between 12 and 16 weeks of gestation (baseline visit) and at gestation week 32 (after the intervention).
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women who are over 18 years old and confirmed to be pregnant in Shenzhen Dapeng New District.
Exclusion Criteria:
1.pregnant women who have accepted maternal exercise training (at least twice a week in last month);2.pregnant women who have orthopedics, cardiovascular or mental diseases; 3.pregnant women who have or had any condition as follows:miscarriage more than two times,premature delivery,placenta previa,fetal dysplasia, low weight before pregnancy (BMI <17.5),polycyesis,preeclampsia,premature rupture of membranes,Uterine growth retardation,cervical/ligation,repeated vaginal bleeding,anemia or diabetes; 4.the gestational age is less than 12 weeks or more than 16 weeks;5.received psychotherapy or psychotropic medication within 6 months before the study;6.can not participate in regular inspections.
12. IPD Sharing Statement
Learn more about this trial
Maternal Exercise and Antenatal Anxiety
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