Condition category
Pregnancy and Childbirth
Date applied
07/10/2018
Date assigned
17/10/2018
Last edited
24/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

Sponsor information

Organisation

Educational Commission of Anhui Province of China

Sponsor details

No. 321
the Jin ZHai Road
Hefei City
Anhui Prov
China 0061
Hefei
230061
China

Sponsor type

Government

Website

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

Publication citations

Additional files

Editorial Notes

24/10/2018: Internal review.