Clinical trial NCT06913582: The Effectiveness of Distance Yoga Learning in Improving Ma-ternal Pandemic-related Depression and Stress During Pregnancy
Official title: Chang Gung Medical Foundation Institutional Review Board
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: distance yoga
pandemic
depression and stress
pregnancy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 76
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: quasi-experimental design with experimental and control group.
Primary purpose: PREVENTION

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. 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.

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 .

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:Exclusion conditions (any one)

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

Primary outcomes:
measure: demographic data and exercise history of two groups
timeFrame: 12 months
measure: The change of depression status of two groups
timeFrame: 12 months
measure: Stress during pregnancy of two groups
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
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