AzTrials
AzTrials

Pregnancy RelatedNCT06913582

The Effectiveness of Distance Yoga Learning in Improving Ma-ternal Pandemic-related Depression and Stress During Pregnancy

A study testing Yoga in people with Pregnancy Related, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this quasi-experimental study design is to explore the effects of distance yoga learning in improving depression and pregnancy stress in pregnant women during the pandemic disease. The main questions which aim to answer are: 1. hypothesis1 - Distance yoga learning can decrease depression during pregnancy. Read more about this study

Who is it for?
Ages 22 to 43 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Related
What is being tested?
Yoga
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteTaiwan
Study dates
22 Jun 2022to 21 Jun 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 22 to 43 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • First-time mothers between 20 and 26 weeks of pregnancy.
  • normal fetus with a singleton.
  • no history of smoking, drinking, or drug abuse.
  • no bleeding during pregnancy.
  • no related high-risk complications during pregnancy (such as high blood pressure, preeclampsia, gestational diabetes, heart dis-ease, etc.).
  • no early abortion symptoms.
Show all 9Show fewer
  • Able to move normally.
  • Able to listen, speak, read and write Chinese.
  • Able to participate in the research and cooperate in completing the questionnaire.

Who cannot join

  • Multiparous women.
  • First-time mothers with pregnancy >26 weeks.
  • Multiple births.
  • Symptoms of bleeding or early miscarriage.
  • Related high-risk pregnancy complications.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: Chang Gung Medical Foundation Institutional Review Board

The goal of this quasi-experimental study design is to explore the effects of distance yoga learning in improving depression and pregnancy stress in pregnant women during the pandemic disease. The main questions which aim to answer are:

  1. hypothesis1 - Distance yoga learning can decrease depression during pregnancy.
  2. hypothesis2 -Distance yoga learning can decrease pregnancy stress. The experimental group received a 12-week pregnancy yoga program, including one weekly 60-minute distance yoga class and followed by 2 times of DVD yoga exercise at home while the control group received only routine nursing care.
Read the detailed description

This is a quasi-experimental study design for primiparous women in the obstetrics and gynecology department of a regional hospital as the research subjects. This study received ethical approval from the hospital and all participants provided written informed consent. After the researcher took convenience samples and explained the research purpose in the prenatal parent classroom, they were assigned to the experimental group and the control group according to the wishes of the cases. Pregnant women in the experimental group received routine prenatal care guidance and yoga exercises three times a week, while the control group only received routine pre-natal guidance and the differences between the two groups were compared.

The sample size was estimated using G-power 3.1.9.2 software. The sample size was estimated to be 52 participants. Assuming the attrition rate was 20%, there were 32 people in the experimental group and the control group making a total of 64 participants.

During the study, one participant in the experimental group had premature delivery due to early water rupture, and the other one was hospitalized for tocolysis due to frequent uterine contractions and therefore withdrew from the experiment, resulting in a loss of 2 samples. For control group, one participant was admitted to the hospital for tocolysis due to prepartum hemorrhage and was withdrew from the study. Therefore, a total of 61 participants completed the study .

Being tested
Yoga
Keywords
distance yoga, pandemic, depression and stress, pregnancy
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YogaBehavioural

    A 12-week pregnancy yoga program was delivered to experimental group (n=30) including one weekly 60-minute remote online yoga class and followed by 2 times of DVD yoga exercise.

Study groups in NCT06913582
Study groupRoleWhat they receive
experimentExperimentalA 12-week pregnancy yoga program was delivered to experimental group (n=30) including one weekly 60-minute remote online yoga class and followed by 2 times of DVD yoga exercise.
Receives: Behavioral: Yoga

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. demographic data and exercise history of two groups

    Basic characteristics: Basic personal information included age, height, religious beliefs, marital status, education, daily activities, past medical history, etc. Obstetric variable information included weeks of pregnancy, pre-pregnancy weight, weight gained during pregnancy, and exercise before and during pregnancy, etc.

    Measured: 12 months

  2. The change of depression status of two groups

    Edinburgh Postnatal Depression Scale(EPDS): The Edinburgh Postnatal Depression Scale is used to measure prenatal and postpartum depressed mood. There are 10 questions in total, each question is scored on a 4-point scale. According to the order of each option, the first, second and fourth items are scored from 0 to 3 points, the other items are scored from 3 to 0 points, and the total score is from 0 to 30 points. The levels of scale were as follows: 0-9 points: low risk, usually no further psychological intervention is needed; 10-12 points: medium risk, further evaluation and observation are recom-mended; 13 points and above: high risk, comprehensive psychological evaluation and possible intervention measures should be carried out. The higher the score of pregnant women, the more severe the prenatal depression is.

    Measured: 12 months

  3. Stress during pregnancy of two groups

    Pregnancy Stress Rating Scale (PSRS): The "Pregnancy Stress Scale" developed by Chen, Huang, and Ka in 1991 and revised it into a new version of the "Pregnancy Stress Scale" by Chen was used in this study. The scale has five factors; it mainly measures the psychological stress experienced by women during pregnancy. There are 36 questions in total with the Likert five-point scoring method totaling score of 180 points. The higher the score, the greater the stress during pregnancy. The new version of the "Pregnancy Stress Scale" has good internal consistency (α=.92) and 2-week test-retest reliability (α=.82).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2025
  2. Study start22 Jun 2022
  3. Primary completion21 Jun 2023
  4. Study completion21 Jun 2023

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
quasi-experimental design with experimental and control group.
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06913582
Sponsor's protocol ID
Kate65.0220
Status last verified
Mar 2025
First submitted
12 Mar 2025
Last updated
6 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nazzari S, Pili MP, Gunay Y, Provenzi L. Pandemic babies: A systematic review of the association between maternal pandemic-related stress during pregnancy and infant development. Neurosci Biobehav Rev. 2024 Jul;162:105723. doi: 10.1016/j.neubiorev.2024.105723. Epub 2024 May 16.

    PubMed 38762129

  • Lokken EM, Huebner EM, Taylor GG, Hendrickson S, Vanderhoeven J, Kachikis A, Coler B, Walker CL, Sheng JS, Al-Haddad BJS, McCartney SA, Kretzer NM, Resnick R, Barnhart N, Schulte V, Bergam B, Ma KK, Albright C, Larios V, Kelley L, Larios V, Emhoff S, Rah J, Retzlaff K, Thomas C, Paek BW, Hsu RJ, Erickson A, Chang A, Mitchell T, Hwang JK, Erickson S, Delaney S, Archabald K, Kline CR, LaCourse SM, Adams Waldorf KM; Washington State COVID-19 in Pregnancy Collaborative. Disease severity, pregnancy outcomes, and maternal deaths among pregnant patients with severe acute respiratory syndrome coronavirus 2 infection in Washington State. Am J Obstet Gynecol. 2021 Jul;225(1):77.e1-77.e14. doi: 10.1016/j.ajog.2020.12.1221. Epub 2021 Jan 27.

    PubMed 33515516

  • Zambrano LD, Ellington S, Strid P, Galang RR, Oduyebo T, Tong VT, Woodworth KR, Nahabedian JF 3rd, Azziz-Baumgartner E, Gilboa SM, Meaney-Delman D; CDC COVID-19 Response Pregnancy and Infant Linked Outcomes Team. Update: Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status - United States, January 22-October 3, 2020. MMWR Morb Mortal Wkly Rep. 2020 Nov 6;69(44):1641-1647. doi: 10.15585/mmwr.mm6944e3.

    PubMed 33151921

  • Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

    PubMed 32109013

  • Marchand G, Patil AS, Masoud AT, Ware K, King A, Ruther S, Brazil G, Calteux N, Ulibarri H, Parise J, Arroyo A, Coriell C, Cook C, Ruuska A, Nourelden AZ, Sainz K. Systematic review and meta-analysis of COVID-19 maternal and neonatal clinical features and pregnancy outcomes up to June 3, 2021. AJOG Glob Rep. 2022 Feb;2(1):100049. doi: 10.1016/j.xagr.2021.100049. Epub 2022 Jan 3.

    PubMed 35005663

  • Berthelot N, Lemieux R, Garon-Bissonnette J, Drouin-Maziade C, Martel E, Maziade M. Uptrend in distress and psychiatric symptomatology in pregnant women during the coronavirus disease 2019 pandemic. Acta Obstet Gynecol Scand. 2020 Jul;99(7):848-855. doi: 10.1111/aogs.13925. Epub 2020 Jun 3.

    PubMed 32449178

  • Davenport MH, Meyer S, Meah VL, Strynadka MC, Khurana R. Moms Are Not OK: COVID-19 and Maternal Mental Health. Front Glob Womens Health. 2020 Jun 19;1:1. doi: 10.3389/fgwh.2020.00001. eCollection 2020.

    PubMed 34816146

  • Lee CF, Hwang FM, Lin HM, Chi LK, Chien LY. The Physical Activity Patterns of Pregnant Taiwanese Women. J Nurs Res. 2016 Dec;24(4):291-299. doi: 10.1097/JNR.0000000000000158.

    PubMed 27846101

  • van Mulken MR, McAllister M, Lowe JB. The stigmatisation of pregnancy: societal influences on pregnant women's physical activity Behaviour. Cult Health Sex. 2016 Aug;18(8):921-35. doi: 10.1080/13691058.2016.1148199. Epub 2016 Mar 11.

    PubMed 26967357

  • Walasik I, Kwiatkowska K, Kosinska Kaczynska K, Szymusik I. Physical Activity Patterns among 9000 Pregnant Women in Poland: A Cross-Sectional Study. Int J Environ Res Public Health. 2020 Mar 9;17(5):1771. doi: 10.3390/ijerph17051771.

    PubMed 32182850

  • Gawrysiak MJ, Leong SH, Grassetti SN, Wai M, Shorey RC, Baime MJ. Dimensions of distress tolerance and the moderating effects on mindfulness-based stress reduction. Anxiety Stress Coping. 2016 Sep;29(5):552-60. doi: 10.1080/10615806.2015.1085513. Epub 2015 Sep 15.

    PubMed 26293679

  • Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.

    PubMed 24395196

  • Mottola MF, Davenport MH, Ruchat SM, Davies GA, Poitras VJ, Gray CE, Jaramillo Garcia A, Barrowman N, Adamo KB, Duggan M, Barakat R, Chilibeck P, Fleming K, Forte M, Korolnek J, Nagpal T, Slater LG, Stirling D, Zehr L. 2019 Canadian guideline for physical activity throughout pregnancy. Br J Sports Med. 2018 Nov;52(21):1339-1346. doi: 10.1136/bjsports-2018-100056.

    PubMed 30337460

  • Farrell T, Reagu S, Mohan S, Elmidany R, Qaddoura F, Ahmed EE, Corbett G, Lindow S, Abuyaqoub SM, Alabdulla MA. The impact of the COVID-19 pandemic on the perinatal mental health of women. J Perinat Med. 2020 Nov 26;48(9):971-976. doi: 10.1515/jpm-2020-0415.

    PubMed 32975206

  • Arzamani N, Soraya S, Hadi F, Nooraeen S, Saeidi M. The COVID-19 pandemic and mental health in pregnant women: A review article. Front Psychiatry. 2022 Sep 20;13:949239. doi: 10.3389/fpsyt.2022.949239. eCollection 2022.

    PubMed 36203829

Questions about this trial

What is this clinical trial studying?

A study testing Yoga in people with Pregnancy Related, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

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 9 inclusion and 5 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: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

demographic data and exercise history of two groups (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06913582, which also lists 20 linked publications.

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 6 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in