The Effect of Stress Reduction Program Based on Cognitive Behavioral Approach on Pregnancy Process and Mental Health in High Risk Pregnant Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istanbul University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Information Form
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Care Provider)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Pregnants >24 weeks <34 weeks hospitalized in the high-risk pregnancy service of the relevant hospital,
- •Speaking Turkish,
- •Being literate,
- •Be over 18 years old
- •Being primigravida,
- •At least 2 days have passed since admission to the service
Exclusion Criteria
- •Pregnants <24 weeks >34 weeks hospitalized in the high-risk pregnancy service of the relevant hospital,
- •Not being willing to participate in the study,
- •Having a diagnosed psychiatric illness.
Arms & Interventions
Training Group
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.
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.
Intervention: cognitive behavioral approach-based stress reduction program (Behavioral)
Control Group
Routine nursing care will be provided to the control group along with a stress management manual.
Outcomes
Primary Outcomes
Information Form
Time Frame: To both group at baseline ( before intervention)
In the form prepared by the researcher in line with the literature review, ıt is a structured form consisting of closed-ended questions in order to determine individual characteristics such as, the age of the pregnant women, the number of pregnancies, the number of living children, social support resources, concomitant medical and psychiatric diseases, etc.
Intolerance of uncertainty scale
Time Frame: To both group postpartum 3 month
The Intolerance of Uncertainty Scale was developed by Carleton et al. (2007). The scale was adapted to Turkish culture by Sarıçam et al. (2014). The scale has 12 items designed in the form of a five-point Likert scale. The scale has two sub-dimensions (future-oriented anxiety and debilitating anxiety) and a total score can be taken from the scale. The general internal consistency coefficient of the Intolerance of Uncertainty Scale is 0.88. Sample items of the scale; "Unexpected events bother me so much", "I have to stay away from all uncertain situations" (Sarıçam et al., 2014).
Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: To both group postpartum 3 month
The Edinburgh Postpartum Depression Scale was developed by Cox in 1987. The scale aims to screen postpartum depression in women. The most widely used screening instrument for perinatal depression in both international and Turkish research.The validity and reliability study of the scale in our country was conducted by Engindeniz (1996). The scale consists of 10 items. Items are evaluated in a 4-point Likert format and scored between 0-3. The lowest score that can be obtained from the scale is 0, and the highest score is 30. The cut-off point of the scale is calculated as 12. Individuals who score above this score are considered as a risk group for depression.
Psychological Well-Being Scale :
Time Frame: To both group postpartum 3 month
It was developed by Diener et al. (2009) to measure socio-psychological well-being as a complement to existing measures of well-being. The items of the scale, which was adapted into Turkish by Telef (2013) and whose validity and reliability studies were conducted, are answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). The scale has a single factor structure and the Cronbach alpha coefficient is 0.80. All items are expressed positively. Scores range from 8 (strongly disagree to all items) to 56 (strongly agree to all items). A high score indicates that the person has many psychological resources and strengths. Although the scale does not provide individual measures of well-being, it does provide an overview of positive functioning in different areas believed to be important.
Program Evaluation and Satisfaction Survey
Time Frame: Experimental group immediately after the intervention
The questionnaire to be applied to pregnant women who participated in the cognitive-behavioral approach-based stress reduction program applied to high-risk pregnants aims to measure the satisfaction level of the participants. This form, prepared by the researcher for the intervention group, contains closed-ended questions and will be applied after the intervention.
Depression, Anxiety and Stress Scale (DASS-21)
Time Frame: To both group postpartum 3 month
DAS-21 was created by Lovibond and Lovibond as an abbreviation of DAS-42. The validity and reliability study of the Turkish version of the "Depression Anxiety Stress-21 (DAS-21) scale in normal and clinical samples" was conducted by Sarıçam (2018). In the normal sample, it was found to be 0.85 for the depression subscale, 0.80 for the anxiety and 0.77 for the stress, respectively. For the clinical sample, it was 0.87 for depression, 0.85 for anxiety and 0.81 for stress. This scale is a 4-point Likert-type scale and consists of seven questions each measuring "depression, stress and anxiety dimensions". Getting 5 points or more from the depression sub-dimension, 4 points or more from anxiety, and 8 points or more from stress indicates that the individual has a related problem.
Psychological Well-Being Scale :
Time Frame: To both group immediately after the intervention
It was developed by Diener et al. (2009) to measure socio-psychological well-being as a complement to existing measures of well-being. The items of the scale, which was adapted into Turkish by Telef (2013) and whose validity and reliability studies were conducted, are answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). The scale has a single factor structure and the Cronbach alpha coefficient is 0.80. All items are expressed positively. Scores range from 8 (strongly disagree to all items) to 56 (strongly agree to all items). A high score indicates that the person has many psychological resources and strengths. Although the scale does not provide individual measures of well-being, it does provide an overview of positive functioning in different areas believed to be important.
Depression, Anxiety and Stress Scale (DASS-21)
Time Frame: To both group at baseline ( before intervention)
DAS-21 was created by Lovibond and Lovibond as an abbreviation of DAS-42. The validity and reliability study of the Turkish version of the "Depression Anxiety Stress-21 (DAS-21) scale in normal and clinical samples" was conducted by Sarıçam (2018). In the normal sample, it was found to be 0.85 for the depression subscale, 0.80 for the anxiety and 0.77 for the stress, respectively. For the clinical sample, it was 0.87 for depression, 0.85 for anxiety and 0.81 for stress. This scale is a 4-point Likert-type scale and consists of seven questions each measuring "depression, stress and anxiety dimensions". Getting 5 points or more from the depression sub-dimension, 4 points or more from anxiety, and 8 points or more from stress indicates that the individual has a related problem.
Depression, Anxiety and Stress Scale (DASS-21)
Time Frame: To both group immediately after the intervention
DAS-21 was created by Lovibond and Lovibond as an abbreviation of DAS-42. The validity and reliability study of the Turkish version of the "Depression Anxiety Stress-21 (DAS-21) scale in normal and clinical samples" was conducted by Sarıçam (2018). In the normal sample, it was found to be 0.85 for the depression subscale, 0.80 for the anxiety and 0.77 for the stress, respectively. For the clinical sample, it was 0.87 for depression, 0.85 for anxiety and 0.81 for stress. This scale is a 4-point Likert-type scale and consists of seven questions each measuring "depression, stress and anxiety dimensions". Getting 5 points or more from the depression sub-dimension, 4 points or more from anxiety, and 8 points or more from stress indicates that the individual has a related problem.
Depression, Anxiety and Stress Scale (DASS-21)
Time Frame: To both group postpartum 4-6 week
DAS-21 was created by Lovibond and Lovibond as an abbreviation of DAS-42. The validity and reliability study of the Turkish version of the "Depression Anxiety Stress-21 (DAS-21) scale in normal and clinical samples" was conducted by Sarıçam (2018). In the normal sample, it was found to be 0.85 for the depression subscale, 0.80 for the anxiety and 0.77 for the stress, respectively. For the clinical sample, it was 0.87 for depression, 0.85 for anxiety and 0.81 for stress. This scale is a 4-point Likert-type scale and consists of seven questions each measuring "depression, stress and anxiety dimensions". Getting 5 points or more from the depression sub-dimension, 4 points or more from anxiety, and 8 points or more from stress indicates that the individual has a related problem.
Psychological Well-Being Scale :
Time Frame: To both group at baseline ( before intervention)
It was developed by Diener et al. (2009) to measure socio-psychological well-being as a complement to existing measures of well-being. The items of the scale, which was adapted into Turkish by Telef (2013) and whose validity and reliability studies were conducted, are answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). The scale has a single factor structure and the Cronbach alpha coefficient is 0.80. All items are expressed positively. Scores range from 8 (strongly disagree to all items) to 56 (strongly agree to all items). A high score indicates that the person has many psychological resources and strengths. Although the scale does not provide individual measures of well-being, it does provide an overview of positive functioning in different areas believed to be important.
Psychological Well-Being Scale :
Time Frame: To both group postpartum 4-6 week
It was developed by Diener et al. (2009) to measure socio-psychological well-being as a complement to existing measures of well-being. The items of the scale, which was adapted into Turkish by Telef (2013) and whose validity and reliability studies were conducted, are answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). The scale has a single factor structure and the Cronbach alpha coefficient is 0.80. All items are expressed positively. Scores range from 8 (strongly disagree to all items) to 56 (strongly agree to all items). A high score indicates that the person has many psychological resources and strengths. Although the scale does not provide individual measures of well-being, it does provide an overview of positive functioning in different areas believed to be important.
Intolerance of uncertainty scale
Time Frame: To both group at baseline ( before intervention)
The Intolerance of Uncertainty Scale was developed by Carleton et al. (2007). The scale was adapted to Turkish culture by Sarıçam et al. (2014). The scale has 12 items designed in the form of a five-point Likert scale. The scale has two sub-dimensions (future-oriented anxiety and debilitating anxiety) and a total score can be taken from the scale. The general internal consistency coefficient of the Intolerance of Uncertainty Scale is 0.88. Sample items of the scale; "Unexpected events bother me so much", "I have to stay away from all uncertain situations" (Sarıçam et al., 2014).
Intolerance of uncertainty scale
Time Frame: To both group immediately after the intervention
The Intolerance of Uncertainty Scale was developed by Carleton et al. (2007). The scale was adapted to Turkish culture by Sarıçam et al. (2014). The scale has 12 items designed in the form of a five-point Likert scale. The scale has two sub-dimensions (future-oriented anxiety and debilitating anxiety) and a total score can be taken from the scale. The general internal consistency coefficient of the Intolerance of Uncertainty Scale is 0.88. Sample items of the scale; "Unexpected events bother me so much", "I have to stay away from all uncertain situations" (Sarıçam et al., 2014).
Intolerance of uncertainty scale
Time Frame: To both group postpartum 4-6 week
The Intolerance of Uncertainty Scale was developed by Carleton et al. (2007). The scale was adapted to Turkish culture by Sarıçam et al. (2014). The scale has 12 items designed in the form of a five-point Likert scale. The scale has two sub-dimensions (future-oriented anxiety and debilitating anxiety) and a total score can be taken from the scale. The general internal consistency coefficient of the Intolerance of Uncertainty Scale is 0.88. Sample items of the scale; "Unexpected events bother me so much", "I have to stay away from all uncertain situations" (Sarıçam et al., 2014).
Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: To both group postpartum 4-6 week
The Edinburgh Postpartum Depression Scale was developed by Cox in 1987. The scale aims to screen postpartum depression in women. The most widely used screening instrument for perinatal depression in both international and Turkish research.The validity and reliability study of the scale in our country was conducted by Engindeniz (1996). The scale consists of 10 items. Items are evaluated in a 4-point Likert format and scored between 0-3. The lowest score that can be obtained from the scale is 0, and the highest score is 30. The cut-off point of the scale is calculated as 12. Individuals who score above this score are considered as a risk group for depression.
Secondary Outcomes
No secondary outcomes reported
Investigators
Nesibe Kalyoncu
PhD Candidate Nurse
Istanbul University