NCT06913582

Brief 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. 1.hypothesis1 - Distance yoga learning can decrease depression during pregnancy.
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

12 months

First QC Date

March 12, 2025

Last Update Submit

March 30, 2025

Conditions

Keywords

distance yogapandemicdepression and stresspregnancy

Outcome Measures

Primary Outcomes (3)

  • 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.

    12 months

  • 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.

    12 months

  • 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).

    12 months

Study Arms (1)

experiment

EXPERIMENTAL

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.

Behavioral: Yoga

Interventions

YogaBEHAVIORAL

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.

experiment

Eligibility Criteria

Age22 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • Able to move normally.
  • Able to listen, speak, read and write Chinese.
  • Able to participate in the research and cooperate in completing the questionnaire.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Related Publications (20)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Ghimire U, Papabathini SS, Kawuki J, Obore N, Musa TH. Depression during pregnancy and the risk of low birth weight, preterm birth and intrauterine growth restriction- an updated meta-analysis. Early Hum Dev. 2021 Jan;152:105243. doi: 10.1016/j.earlhumdev.2020.105243. Epub 2020 Oct 24.

  • Brinsley J, Schuch F, Lederman O, Girard D, Smout M, Immink MA, Stubbs B, Firth J, Davison K, Rosenbaum S. Effects of yoga on depressive symptoms in people with mental disorders: a systematic review and meta-analysis. Br J Sports Med. 2021 Sep;55(17):992-1000. doi: 10.1136/bjsports-2019-101242. Epub 2020 May 18.

  • Ceulemans D, Thijs I, Schreurs A, Vercammen J, Lannoo L, Deprest J, Richter J, De Catte L, Devlieger R. Screening for COVID-19 at childbirth: is it effective? Ultrasound Obstet Gynecol. 2020 Jul;56(1):113-114. doi: 10.1002/uog.22099. No abstract available.

  • Davis K, Goodman SH, Leiferman J, Taylor M, Dimidjian S. A randomized controlled trial of yoga for pregnant women with symptoms of depression and anxiety. Complement Ther Clin Pract. 2015 Aug;21(3):166-72. doi: 10.1016/j.ctcp.2015.06.005. Epub 2015 Jun 9.

  • Duchette C, Tolusso DV, Stone WJ, Blankenship MM, Tinius RA. Prenatal Yoga and Mental Health During the COVID-19 Pandemic: A Randomized-Control Trial. OBM Integr Compliment Med. 2021;6(4):10.21926/obm.icm.2104051. doi: 10.21926/obm.icm.2104051. Epub 2021 Nov 25.

Related Links

MeSH Terms

Conditions

Depression

Interventions

Yoga

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
First-time mothers between 20 and 26 weeks of pregnancy
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: quasi-experimental design with experimental and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Nurse

Study Record Dates

First Submitted

March 12, 2025

First Posted

April 6, 2025

Study Start

June 22, 2022

Primary Completion

June 21, 2023

Study Completion

June 21, 2023

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations