Plain English Summary
Background and study aims
Pregnancy is a stressful life event, and according to Social Readjustment Rating Scale, it has been ranked 12th of the 43 most stressful life events. Pregnancy stress is common and comes from a variety of pregnancy-specific problems, including physical symptoms and changes, changes in body image, medical problems, anxiety about delivery, and concerns about birth and the baby's health. Previous studies have examined the incidence and prevalence of stress levels during pregnancy. The impact of pregnancy stress on women and fetal health can lead to adverse outcomes, including miscarriage, premature labor and birth defects. Maternal psychological stress can also be responsible for any learning and cognitive developmental delays in the child. Many researchers have used cognitive behavioral therapy (CBT) to release stress. Elements of CBT include cognitive restructuring, raising awareness about stress, relaxation training, problem-solving training, self-management and adequate social support. Cognitive behavioral stress management has been applied successfully in many physical and emotional conditions, such as cancer, depression, insomnia and heroin-dependent individuals. However, cognitive behavioral stress management has not yet been fully applied to pregnant women in reducing their pregnancy stress. Thus, this study aims to examine the effects of cognitive behavioral stress management, with cognitive intervention, relaxation techniques, problem-solving training and social support, to reduce pregnancy stress among pregnant women.
Who can participate?
Pregnant women (at early stage of pregnancy, i.e., 6 to 8 weeks of the pregnancy) aged 20-38 years, who are able to come to the hospital for antenatal examinations
What does the study involve?
Participants will be asked to join this study while they came to the hospital obstetric outpatient clinic for antenatal examination. Participants must pass the screening to ensure that they meet the inclusion criteria. Participants will be randomly assigned to either the intervention group and the control group.
The control group receive routine antenatal examination and pregnancy health education instructions (including advice on diet, fetal monitoring and daily care during pregnancy) and the intervention group receive an extra seven cognitive behavior stress management sessions between weeks 8 and 38 of their pregnancy. Participants will be asked to complete a questionnaire at the beginning and end of the study to assess the effectiveness of intervention in terms of reducing pregnancy stress levels.
What are the possible benefits and risks of participating?
The possible benefit of participating is that the intervention may help to reduce pregnancy stress, and the results may enable the improvement of the quality of antenatal care received by women in the future. There are no known risks to participants taking part in this study.
Where is the study run from?
The study is being run by Bengbu Medical College, Anhui, China and takes place in obstetrics of Obstetrics department of the First Affiliated Hospital of Bengbu Medical College, Anhui Prov, China
When is the study starting and how long is it expected to run for?
November 2015 to December 2018
Who is funding the study?
Educational Commission of Anhui Province of China (China)
Who is the main contact?
Prof. Jin zhi Li
lijinzhi@bbmc.edu.cn
Trial website
Contact information
Type
Scientific
Primary contact
Prof jinzhi li
ORCID ID
http://orcid.org/0000-0002-4372-2340
Contact details
Nursing of school
Bengbu Medical College
No. 2600
the East China Sea Road
Bengbu City
Anhui Prov
China 233030
Bengbu city
233000
China
+86 (0)552 3175212.
lijinzhi@bbmc.edu.cn
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SK2015A403
Study information
Scientific title
Effective cognitive behavioural stress management to reduce pregnancy stress among pregnant women: a randomised controlled trial
Acronym
Study hypothesis
Pregnancy is a normal physiological process, but a stressful life event. The impact of maternal psychological stress during the pregnancy could lead to adverse health outcomes for both mother and child. Effective cognitive behavior stress management can reduce pregnancy stress among pregnant women.
Ethics approval
Ethics Committee of Bengbu Medical College in China, 22/07/2015, SK2015A403
Study design
Interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Pregnancy
Intervention
All pregnant women were required to undergo 7 antenatal visits in accordance with the "Chinese Guidelines for pre-pregnancy and prenatal care" from 12 to 41 weeks of their pregnancy. 100 participants were randomly divided into the control group (N=50) and the intervention group (N=50) using a computerized random number generator.
The control group received routine antenatal care and pregnancy health education instruction (including advice on diet, fetal monitoring and daily care during pregnancy).
Participants in the intervention group underwent an extra 7 cognitive behavioural stress management sessions between weeks 8 and 38 of their pregnancy. The sessions covered information on the physiological and psychological changes in pregnancy, coping methods for pregnancy stress, relaxation techniques, and family support. Following each seminar, the facilitator invited participants to participate in group discussions to share their pregnancy experience, including their problem-solving strategies. The facilitator recorded the process but did not participate the discussion. At the end of the session the facilitator summarized the results of the group discussion and proposed strategies of reducing pregnancy stress to participants. Additionally, individual counseling was provided if the participants required this.The cognitive behavioral stress management was delivered mainly through face-to-face communication in the hospital, but in some cases, it was delivered via phone and e-mail. The whole process for each intervention lasted 40-60 minutes.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Pregnancy stress level, assessed using the Pregnancy Pressure Scale (PPS) at the baseline and after 39 weeks of pregnancy
Secondary outcome measures
N/A
Overall trial start date
01/11/2015
Overall trial end date
30/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Pregnant
2. Able to communicate and understand Chinese
3. No severe medical conditions, including heart disease, diabetes and kidney disease
4. Aged 20-38 years
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100 participants (50 in the intervention group; 50 in the control group)
Participant exclusion criteria
1. Pregnancy complications, such as incipient abortion
2. Pre-existing mental ilness, such as depression
Recruitment start date
01/04/2016
Recruitment end date
30/05/2017
Locations
Countries of recruitment
China
Trial participating centre
Department of obstetrics, The First Affiliated Hospital of Bengbu Medical College
No. 287, Changhuai Road, Bengbu City, Anhui Prov
Bengbu
233000
China
Funders
Funder type
Government
Funder name
Educational Commission of Anhui Province of China
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We expect that the study results will be published before 30/12/2019.
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available.
Intention to publish date
30/12/2019
Participant level data
Not expected to be available
Basic results (scientific)
Publication list