The Effect of Stress Reduction Program on Pregnancy Process and Mental Health in High Risk Pregnant Women

NCT05573009 | Completed

• 1 other identifier: IstanbulU-NKALYONCU-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy, High Risk; Depression, Postpartum; Anxiety in Pregnancy; Stress Disorder

Keywords

pregnancy, high risk; depression, postpartum; anxiety in pregnancy

Outcome Measures

Primary Outcomes (16)

• Information Form

  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.

  To both group at baseline ( before intervention)

• Depression, Anxiety and Stress Scale (DASS-21)

  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.

  To both group at baseline ( before intervention)

• Depression, Anxiety and Stress Scale (DASS-21)

  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.

  To both group immediately after the intervention

• Depression, Anxiety and Stress Scale (DASS-21)

  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.

  To both group postpartum 4-6 week

• Depression, Anxiety and Stress Scale (DASS-21)

  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.

  To both group postpartum 3 month

• Psychological Well-Being Scale :

  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.

  To both group at baseline ( before intervention)

• Psychological Well-Being Scale :

  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.

  To both group immediately after the intervention

• Psychological Well-Being Scale :

  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.

  To both group postpartum 4-6 week

• Psychological Well-Being Scale :

  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.

  To both group postpartum 3 month

• Intolerance of uncertainty scale

  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).

  To both group at baseline ( before intervention)

• Intolerance of uncertainty scale

  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).

  To both group immediately after the intervention

• Intolerance of uncertainty scale

  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).

  To both group postpartum 4-6 week

• Intolerance of uncertainty scale

  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).

  To both group postpartum 3 month

• Edinburgh Postnatal Depression Scale (EPDS)

  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.

  To both group postpartum 4-6 week

• Edinburgh Postnatal Depression Scale (EPDS)

  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.

  To both group postpartum 3 month

• Program Evaluation and Satisfaction Survey

  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.

  Experimental group immediately after the intervention

Study Arms (2)

Training Group

EXPERIMENTAL

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.

Behavioral: cognitive behavioral approach-based stress reduction program

Control Group

NO INTERVENTION

Routine nursing care will be provided to the control group along with a stress management manual.

Interventions

cognitive behavioral approach-based stress reduction program BEHAVIORAL

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. Session main topics are: Session 1 - Introducing the purpose and content of the program - Stress Psychoeducation Session 2 - Cognitive restructuring Session 3 -Behavioral coping Session 4 - Problem solving training Session 5-Upcoming parenthood

Training Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine

Istanbul, 34100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression, Postpartum; Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Trauma and Stressor Related Disorders

Study Officials

• Sevil Yılmaz, Assit.Prof.

  Istanbul University-Cerrahpasa Florence Nightingale Nursing Faculty

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate Nurse

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 10, 2022
• Study Start: March 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: July 31, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

TU (1)