AnxietyNCT04624802
Maternal Exercise and Antenatal Anxiety
A study testing maternal exercise in people with Anxiety, run by Shenzhen Second People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- maternal exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2020to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women who are over 18 years old and confirmed to be pregnant in Shenzhen Dapeng New District.
Who cannot join
- 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.
About this study
Official title: The Effect of Maternal Exercise on Anxiety During Normal Pregnancy：a Randomized Controlled Trial
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.
- Conditions
- Anxiety
- Being tested
- maternal exercise
- Keywords
- anxiety, pregnancy, exercise
- Medical subject headings
- Anxiety Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maternal exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| maternal exercise training group | Experimental | 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. Receives: Behavioral: maternal exercise |
| antenatal care group | No intervention | Pregnant women in antenatal care group receive antenatal care and examination regularly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The participants are examined between 12 and 16 weeks of gestation (baseline visit) and at gestation week 32 (after the intervention).
Secondary outcomes (2)
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.
Measured: The participants are examined between 12 and 16 weeks of gestation (baseline visit) and at gestation week 32 (after the intervention).
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.
Measured: The participants are examined between 12 and 16 weeks of gestation (baseline visit) and at gestation week 32 (after the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start10 Nov 2020 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624802
- Sponsor's protocol ID
- 20200601031-FS01
- Status last verified
- Nov 2020
- First submitted
- 11 Oct 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Maternal Exercise on Anxiety During Normal Pregnancy：a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04624802
- Acronym / sponsor ID
- 20200601031-FS01
- Conditions
- Anxiety
- Keywords
- anxiety, pregnancy, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 10 Nov 2020 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| maternal exercise training group | Experimental | Behavioral: maternal exercisePregnant 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. |
| antenatal care group | No intervention | –Pregnant women in antenatal care group receive antenatal care and examination regularly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women who are over 18 years old and confirmed to be pregnant in Shenzhen Dapeng New District.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maternal exerciseThe 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. | Behavioural | maternal exercise training group |
Primary outcome
Change from Baseline of State Anxiety at 32 Weeks of Gestation
Time frame: The participants are examined between 12 and 16 weeks of gestation (baseline visit) and at gestation week 32 (after the intervention).
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.
2 secondary outcomes
Change from Baseline of Depressive Symptom at 32 Weeks of Gestation
Time frame: The participants are examined between 12 and 16 weeks of gestation (baseline visit) and at gestation week 32 (after the intervention).
Change from Baseline of Pain at 32 Weeks of Gestation
Time frame: The participants are examined between 12 and 16 weeks of gestation (baseline visit) and at gestation week 32 (after the intervention).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing maternal exercise in people with Anxiety, run by Shenzhen Second People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline of State Anxiety at 32 Weeks of Gestation (time frame: The participants are examined between 12 and 16 weeks of gestation (baseline visit) and at gestation week 32 (after the intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.