Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05573009 |
| Other study ID # |
IstanbulU-NKALYONCU-001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
July 31, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Istanbul University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Introduction Pregnancy and giving birth to an infant is a physiological process as well as it
is also a transition of life, and a stressful period of time with a significance in the life
of woman. This period is evaluated as a developmental crisis for the woman, and for her
family.
High-risk pregnant women are at the forefront of the individuals who need to be supported the
most during the transition to motherhood.The presence of a physiological, emotional and
psychosocial condition that endanger the health and life of the pregnant and/or fetus and
increases the risk of illness and death is defined as "high-risk pregnancy". Exposure to
obstetric complications is known to be associated with the later development of psychiatric
disorders.
In the literature review, it is seen that there are few studies in which CBT and
mindfulness-based interventions are applied to reduce stress, anxiety and depression in risky
or risk-free pregnant women. However, no CBT-based stress reduction program applied to
high-risk pregnant women has been found in our country. A stress reduction program based on
cognitive behavioral interventions during the transition to motherhood can contribute to the
protection of maternal mental health and psychological well-being in pregnant women, and may
help for healthy pregnancy and birth outcomes.
Research Aim This study was planned to examine the effect of cognitive behavioral
approach-based stress reduction program on pregnancy process and maternal mental health to be
applied to high-risk pregnant women.
Research Type The study was planned as an experimental study with a randomized control group
including pre-test, post-test and follow-up measurements to examine the effect of "stress
reduction program based on cognitive behavioral approach" on the maternal mental health,
pregnancy, and childbirth process of the high risk pregnant women.
Description:
Introduction Pregnancy and giving birth to an infant is a physiological process as well as it
is also a transition of life, and a stressful period of time with a significance in the life
of woman. This period is evaluated as a developmental crisis for the woman, and for her
family.
High-risk pregnant women are at the forefront of the individuals who need to be supported the
most during the transition to motherhood.The presence of a physiological, emotional and
psychosocial condition that endanger the health and life of the pregnant and/or fetus and
increases the risk of illness and death is defined as "high-risk pregnancy" Exposure to
obstetric complications is known to be associated with the later development of psychiatric
disorders.
A woman diagnosed with a high-risk pregnancy is experiencing the excitement of becoming a
mother despite all the uncertainty, while on the other hand she is trying to cope with
important complications such as premature birth risk and infection. During this period, the
pregnant woman needs biopsychosocial support. However, in the care management of a high-risk
pregnant in hospitals, only the physiological elements can be focused and social,
psychological and spiritual care can be ignored.The pregnant woman who cannot meet these
requirements, in the postpartum period, it is possible to experience inability to adapt to
the maternal role, posttraumatic stress syndrome, postpartum blues or postpartum depression
(PPD).
The researchers stated that if the prenatal stress level decreases in depressed women with
high-risk pregnancies, the depression indicators will also tend to decrease, and they stated
that new psychosocial approaches are needed. Psychotherapeutic interventions are highly
effective methods for peripartum depression, anxiety and stress; includes cognitive
behavioral therapy (CBT), mindfulness therapy, problem-solving therapy, stress reduction
therapy, psychoeducational intervention, or a combination of these.
In the literature review, it is seen that there are few studies in which CBT and
mindfulness-based interventions are applied to reduce stress, anxiety and depression in risky
or risk-free pregnant women.However, no CBT-based stress reduction program applied to
high-risk pregnant women has been found in our country. A stress reduction program based on
cognitive behavioral interventions during the transition to motherhood can contribute to the
protection of maternal mental health and psychological well-being in pregnant women, and may
help for healthy pregnancy and birth outcomes.
Research Aim This study was planned to examine the effect of cognitive behavioral
approach-based stress reduction program on pregnancy process and maternal mental health to be
applied to high-risk pregnant women.
Research Type The study was planned as an experimental study with a randomized control group
including pre-test, post-test and follow-up measurements to examine the effect of "stress
reduction program based on cognitive behavioral approach" on the maternal mental health,
pregnancy, and childbirth process of the high risk pregnant women.
The target population and sample of the research:
The target population of the research consists of pregnant women hospitalized in the
high-risk pregnancy service of a university hospital. The sample of the study was calculated
by power analysis using the GPower 3.1.9.7 program. The detected number of the sample was
found as 46 including minimum 23 for each group for power: 0.95 when the effect size was
taken as 1.25 for identifying the differentiation of score change by the time as a result of
the power analysis performed based on a similar study for the research to be designed as one
intervention and one control group. Considering the losses that may be experienced during the
practice, as many as 50% of the sample group will be included in the study. The experimental
group is predicted to include 40 people, and the control group is predicted to include 40
people.
Research Protocol The research will be conducted between March 2022, and March 2023, and will
last in a total of 12 months. The research will be conducted in a single center in Istanbul
University Istanbul Faculty of Medicine High-Risk Pregnancies (Perinatology) service of the
Department of Obstetrics and Gynecology. The detailed study plan is given below.
The study plan:
1. Details of the cognitive behavioral based(CBB) stress reduction program will be created,
and expert opinions will be taken.
2. The pilot study and revision of the developed program will be carried out.
3. Pregnant women who meet the research criteria and agree to participate in the study will
be assigned to the experimental, and control groups using the randomization method.
Randomization of the groups will be performed on a simple random basis using the site
www.random.org. Women with high-risk pregnancies will be placed in the experimental and
control groups by applying randomization using a simple random number table according to
the order of hospitalization in Istanbul University Istanbul Faculty of Medicine.
4. Preliminary interviews will be conducted with the experimental and control groups and
the first measurements and data (Information Form, Uncertainty Intolerance Scale,
Depression, Anxiety and Stress Scale and Psychological Well-Being Scale) will be
collected.
5. Five days lasting stress reduction program based on cognitive behavioral approach(each
session will be an average of 60 minutes) will be initiated in the third day of
hospitalisation to the intervention group whereas routine nursing care will be provided
to the control group along with a stress management manual.
6. At least 3-days of the cognitive behavioral approach-based stress reduction program will
be given as face to face interviews to the intervention group during hospitalisation,
and the remaining sessions will be given at the bedside as long as the hospitalization
continues. If the patient is discharged, the remaining 2 sessions will be completed
online.
7. After the intervention program is completed (7th day of hospitalisation), scales will be
applied to the intervention and control groups for post-intervention measurements
(Uncertainty Intolerance Scale, Depression, Anxiety and Stress Scale and Psychological
Well-Being Scale). In addition to the scales, Program Evaluation and Satisfaction
Questionnaire will be performed only for the intervention group.
8. After the completion of the program, supportive interviews will be conducted weekly
until the childbirth as well as the hospitalisation continues so that the patient can
practice the learned data, and once in two weeks on the phone if the patient is
discharged from hospital.
9. The week of birth, mode of birth, birth weight, and APGAR scores of the experimental and
control group will be recorded from the hospital records.
10. Follow-up measurements will be applied to the intervention and control groups at 4-6
weeks of the postpartum period, and at the end of the third month (Uncertainty
Intolerance Scale, Depression, Anxiety and Stress Scale and Psychological Well-Being
Scale, Edinburgh Postpartum Depression Scale). After the program is completed,
cognitive-behavioral approach based stress reduction program will be implemented to the
individuals from the control group who are willing to have the program.
Randomization Step 1: Randomization Method The names of the pregnant women admitted to the
high-risk pregnancy service are written by the service nurse to the patient's hospitalization
list according to the hospitalization dates. In order to differentiate the experimental and
control groups, a notebook with the order of hospitalization from 1 to 80 was prepared by the
researcher considering that there may be losses. The differentiation of the experimental and
control groups was carried out by a simple random sampling method. The numbers that will be
entered into the sample were determined by generate number www.random.org. Then, the women
who met the criteria for inclusion in the sample were recorded in the notebook according to
the order of hospitalization by the nurse in charge of in the high-risk pregnancy service.
The numbers determined according to randomized numbers in the hospitalization book were
adjusted to be the order of hospitalization. The experimental, and control groups were
determined according to the order of hospitalization.
The numbers that make up the experimental, and control group are as follows; Experimental
group: 1, 2, 3,4, 7, 8, 9, 11, 14, 21, 22, 24, 25, 26, 27, 29, 31, 37, 39, 41, 42, 45, 46,
48, 51, 52, 53, 54, 56, 57, 59, 60, 62, 65, 67, 68, 70,71, 74, 79 Control group: 5, 6, 10,
12, 13, 15, 16, 17, 18, 19, 20, 23, 28, 30, 32, 33, 34, 35, 36, 38, 40, 43, 44, 47, 49, 50,
55, 58, 61, 63, 64, 66, 69, 72, 73, 75, 76, 77, 78, 80 Step 2: Concealing the randomization
data The separation of the experimental and control group was carried out by a third person
as the nurse in charge of the service who had no association with the research. The service
nurse in charge wrote the names of the hospitalized women in a notebook prepared by the
researcher in accordance with the order of hospitalization. The notebook included no data
about the numbers which belong to the experimental or control groups. The woman involved in
the study was directed to the researcher by the nurse in charge with the envelope involving
the number of the women.
Step 3: Practice The researcher found out the number of the patient after opening the
envelope. From the numbers previously determined for the experimental and control group, the
researcher included the women to the experimental or control group.
Step 4: Masking (Blinding) The women included in the sample of the study do not know which
group they are involved in. The data of the experimental and control group was also hidden
from the staff of the clinic. One by one interviews were performed in order to prevent the
women from contacting each other in the experimental, and control groups.
