Clinical trial NCT04820296: Effects of Solution-Oriented Approach on Psychosocial Health, Fear of Childbirth and Postnatal Senses of Security
Official title: Effects of Solution-Oriented Approach Applied to Primigravidas on Psychosocial Health, Fear of Childbirth and Postnatal Senses of Security: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Childbirth
Psychosocial Health
Pregnancy
Postpartum
Childbirth
Keywords: Solution-oriented approach
Fear of childbirth
Psychosocial health
mothers
Feelings of security
Pregnancy
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Posttest and control grouped randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed 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

Eligibility criteria: Inclusion Criteria:

* At least primary education graduate
* Speaking and understanding Turkish
* Pregnant women between the ages of 18-35
* Residing at the provincial border of Konya
* Primigravidas
* Women who got pregnant without treatment pregnancy,
* Have no barriers to vaginal birth,
* Pregnant women who are at the 32nd gestational week according to their last menstrual week
* Pregnant women with a single and healthy fetus

Exclusion Criteria:

* Pregnant women with any risky pregnancy history (Placenta previa, preeclampsia, oligohydramnios and polyhydramnios, gestational diabetes etc.),
* Pregnant women with any systemic and neurological disease,
* Pregnant women with chronic and/or psychiatric health problems (based on self-report and clinical diagnosis),
* Pregnant women with cesarean indication,
* Pregnant women participating in any birth preparation training program.

Primary outcomes:
measure: Wijma Birth Expectancy / Experience Scale (W-DEQ) Version A
timeFrame: First assessment will be made at the baseline (pre-intervention).
measure: Wijma Birth Expectancy / Experience Scale (W-DEQ) Version A
timeFrame: The second assessment will take place 4 weeks after the first assessment (after the program is completed).
measure: Wijma Birth Expectancy / Experience Scale (W-DEQ) Version A
timeFrame: Third assessment will take place average 3 weeks after the second assessment.
measure: Wijma Birth Expectancy / Experience Scale (W-DEQ) Version B
timeFrame: The W-DEQ scale version B (only posttest) will be administered within the first 24 hours of postpartum.
Secondary outcomes:
measure: Psychosocial Health Assessment Scale During Pregnancy
timeFrame: First assessment will be made at the baseline (pre-intervention).
measure: Psychosocial Health Assessment Scale During Pregnancy
timeFrame: The second assessment will take place 4 weeks after the first assessment (after the program is completed).
measure: Psychosocial Health Assessment Scale During Pregnancy
timeFrame: Third assessment will take place average 3 weeks after the second assessment.
measure: Mother's Postnatal Senses of Security Scale
timeFrame: At the end of the 7th postpartum day, follow-up counseling will be provided by telephone and the Postpartum Sense of Security Scale (posttest only) will be filled.
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
Study officials:
affiliation: Necmettin Erbakan University
name: YEŞİM ANIK, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Necmettin Erbakan University
name: KAMİLE ALTUNTUĞ, PhD
role: STUDY_DIRECTOR
References: