Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Childbirth
  • Fear of Childbirth
  • Postpartum
  • Pregnancy
  • Psychosocial Health
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Posttest and control grouped randomized controlled clinical trialMasking: Single (Outcomes Assessor)Masking Description: SinglePrimary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 35 years
Gender
Only males

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, psychosocia...

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, Data collection form on the childbirth process and its results developed by using the literature The Mother's Postnatal Sense of Security Scale will be used. ?mplementation of the Research Pregnants in the experimental group will be administered the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ version A) and Psychosocial Health Assessment Scale in Pregnancy before the intervention. Pregnant women in the experimental group will be given 4 sessions of counseling based on Solution-Oriented Approach to coping with the fear of childbirth, starting at the 32th week of pregnancy. The sessions in the solution-focused approach program will be held in groups of 5, taking into account the hours when group members are available. In the solution-focused approach program, sessions will be completed once a week, with a total of 4 sessions. Each session will be scheduled for approximately 90 minutes with 15 minutes intervals. After the counseling program is completed (at the 35th week), a training booklet will be provided for pregnant women to repeat the information they have learned until the childbirth process. In addition, the pregnant women will be given follow-up counseling by telephone at two-week intervals from 35th gestational week to delivery, and repeated measurements will be made (at 35, 38 weeks of gestation and when hospitalization for childbirth). The Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ version A) will be repeatedly measured at 35 weeks and 38 weeks of pregnancy and when the pregnant women are hospitalized for childbirth (by visiting the hospital by the researcher). When the pregnant women are hospitalized for childbirth, the Psychosocial Health Assessment Scale in Pregnancy (posttest) measurement will be made. In the first 24 hours after childbirth mothers will be visited by the researcher in the hospital, posttests will be applied and the application phase of the research will be completed. The researcher will visit the hospital within the first 24 hours of the postpartum, and the Data Collection Form on the Childbirth Process and Results and Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ version B) (only posttest) will be measured. At the end of the first week of the postpartum, follow-up counseling will be made by phone, and the Postnatal Sense of Security Scale (only the posttest) will be filled. Pregnant women in the control group will only receive routine care. Pregnant women in the control group will be administered the same scales simultaneously with the experimental group. 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, Childbirth results of pregnant women (cesarean section frequency, childbirth time, intervention status during childbirth, complication development, newborn's health status, 1st and 5th minute APGAR score, newborn's weight). The mean scores of the Postnatal Sense of Security Scale of the pregnant women. Independent variable • Counseling based on Solution-Oriented Approach to coping with the fear of childbirth.

Tracking Information

NCT #
NCT04820296
Collaborators
Not Provided
Investigators
Principal Investigator: YE??M ANIK, MSc Necmettin Erbakan University Study Director: KAM?LE ALTUNTU?, PhD Necmettin Erbakan University