Chang Gung Medical Foundation Institutional Review Board
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 76
- Locations
- 2
- Primary Endpoint
- demographic data and exercise history of two groups
Study Overview
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:
- hypothesis1 - Distance yoga learning can decrease depression during pregnancy.
- 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 .
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
First-time mothers between 20 and 26 weeks of pregnancy
Eligibility Criteria
- Ages
- 22 Years to 43 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
demographic data and exercise history of two groups
Time Frame: 12 months
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.
The change of depression status of two groups
Time Frame: 12 months
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.
Stress during pregnancy of two groups
Time Frame: 12 months
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Wen-Ping Lee
Head Nurse
Chang Gung Memorial Hospital