Clinical Trials Logo

Clinical Trial Summary

This study was planned as a randomized controlled experimental study with posttest and control group in order to evaluate the effect of the solution focused approach method applied to primigravidas on psychosocial health, fear of childbirth and postnatal security sensations


Clinical Trial Description

Pregnancy and childbirth process is a natural life event for women, as well as a period of physiological, psychological and social changes. Biopsychosocial changes experienced during this period increase the risk of encountering factors that may cause anxiety and stress. For this reason, psychosocial health can be negatively affected during pregnancy. One of the most important factors threatening psychosocial health during pregnancy is the fear of childbirth. Fear of childbirth emerges especially in the last trimester, causing the woman to spend the unique and special pregnancy process in restlessness and tension. Fear of childbirth may cause consequences such as preferring not to pregnant, as well as bring about complications related to the childbirth process and postpartum period. Within the scope of studies to manage the fear of childbirth, many approaches are used, such as childbirth preparation classes, breathing techniques, hydrotherapy, hypnosis, doula support, holistic care and support, cognitive and behavioral therapies, psychoeducation. One of the most current methods used in the management of childbirth fear is solution-oriented approach. Solution Focused Approach leads the individual to solution again and again instead of focusing on solving the problem as a separate method, it offers an approach focused on the solution itself. It is stated that the philosophy of solution-oriented approach in line with the individual-centered perspective, principles and values is compatible with the basic value and philosophy of nursing. As a result of the studies, it has been determined that the solution-oriented approach method is a shorter-term and effective counseling approach compared to other alternative approaches, after the approach, improvement / decrease in related behavioral problems is observed and it provides significant positive benefits. It is also stated to be more economical due to its wide application areas. This study was planned as a randomized controlled experimental study with posttest and control group in order to evaluate the effect of the solution focused approach method applied to primigravidas on psychosocial health, fear of childbirth and postnatal security sensations. Preliminary evaluation in the study will be made in the pregnant policlinic of a university hospital in the city center of Konya. Verbal and written permission will be obtained from pregnant women who meet the inclusion criteria according to the result of the preliminary evaluation made in the outpatient clinic. For the sample calculation of the study, an experimental study evaluating the effect of childbirth preparation education on the fear of childbirth, postpartum self-efficacy and posttraumatic stress disorder was taken as reference. The sample calculation of the research was made in G * Power (3.1.9.2) program. In the calculation based on the reference study data (90% power, effect size 0.96, alpha level 0.05, beta level 0.90), it was found that a total of 48 cases, 24 for the experimental group and 24 for the control group, were suitable for statistical analysis. In the literature, it has been determined in the experimental studies on this issue that there is loss of subjects between 10% and 40%. In this study, considering the loss rates in the literature, assuming that there would be 40% loss, it was decided to take 68 pregnant women, 34 to the experimental group and 34 to the control group. Pregnant women included in the research will be assigned to the experimental and control groups by block randomization method according to the randomization list. In the collection of the data, - The introductory information form developed by the researcher using the literature, - The Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ version A and B) - Psychosocial Health Assessment Scale in Pregnancy, - The Mother's Postnatal Sense of Security Scale will be used. İmplementation of the Research Four sessions (one session per week) Solution Focused Approach program will be applied to the pregnants in the experimental group. The duration of each session is planned as 60 minutes. The program will be implemented in groups of five. The first session will start at the 32nd week of pregnancy, and the program will be completed at the end of the 35th week of pregnancy. After the program is completed, a training booklet prepared by the researcher will be given to the pregnant women in the experimental group so that they can repeat the information they have learned until delivery. After the training program is completed (WDEQ) version A and Psychosocial Health Assessment Scale in Pregnancy will be applied again (2nd measurement).With pregnant women, 37-40. between gestational weeks, they will be contacted again, and when they come to the hospital for routine pregnancy follow-up, face-to-face interview method (WDEQ) version A and Psychosocial Health Assessment Scale in Pregnancy (3rd measurement) again will be evaluated. The pregnant women will inform the researcher by phone after the delivery and the researcher will visit the hospital within the first 24 hours after the delivery to evaluate the mothers' birth fear levels (WDEQ) version B (only the posttest). At the end of the first postpartum week, the postnatal senses of security of the mothers (only post-test) will be evaluated by telephone follow-up counseling. Evaluation of the Data Coding and evaluation of data will be done in computer environment with SPSS 22.0 (Statistical Program for Social Sciences) package program. The suitability of the research data to normal distribution will be determined by Kolmogorov-Smirnov test with Lilliefor, normal distribution curve, Skewness and Kurtosis test. Descriptive statistics will be evaluated by the number, percentage, average and standard deviation. For the implementation of the study, the ethics committee permission numbered 2020/2352 was obtained from Necmettin Erbakan University Meram Medical Faculty Pharmaceuticals and Non-Medical Research Ethics Committee and the institutional permission numbered E.33709 from Necmettin Erbakan University Meram Medical Faculty Hospital Chief Physician. Pregnant women who will be included in the research sample will be informed before the study that the purpose of the study and participation in the study is in line with the principle of volunteering, and "Informing and Consent of Volunteers Consent Form" will be signed. Dependent Variables - Pregnant women (W-DEQ) A version scale mean scores, - Pregnant women (W-DEQ) B version scale mean scores, - Psychosocial Health Assessment Scale in Pregnancy mean scores, - The mean scores of the Postnatal Sense of Security Scale of the pregnant women. Independent variable • Solution Focused Approach Program ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04820296
Study type Interventional
Source Necmettin Erbakan University
Contact
Status Completed
Phase N/A
Start date September 20, 2021
Completion date March 1, 2023

See also
  Status Clinical Trial Phase
Completed NCT03442582 - Afluria Pregnancy Registry
Terminated NCT02161861 - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study N/A
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Completed NCT04548102 - Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman N/A
Completed NCT03218956 - Protein Requirement During Lactation N/A
Completed NCT02191605 - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy N/A
Completed NCT02223637 - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Recruiting NCT06049953 - Maternal And Infant Antipsychotic Study
Completed NCT02577536 - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting NCT06336434 - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy Phase 1/Phase 2
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Not yet recruiting NCT05412238 - Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months N/A
Not yet recruiting NCT05028387 - Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Completed NCT02683005 - Study of Hepatitis C Treatment During Pregnancy Phase 1
Completed NCT02783170 - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women Phase 4
Recruiting NCT02507180 - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Recruiting NCT02619188 - Nutritional Markers in Normal and Hyperemesis Pregnancies N/A
Recruiting NCT02564250 - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women N/A
Completed NCT02523755 - Evaluation of Regional Distribution of Ventilation During Labor With or Without Epidural Analgesia Phase 4