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临床试验/NCT04820296
NCT04820296已完成不适用

Effects of Solution-Oriented Approach Applied to Primigravidas on Psychosocial Health, Fear of Childbirth and Postnatal Senses of Security: A Randomized Controlled Study

Necmettin Erbakan University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2021年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
Wijma Birth Expectancy / Experience Scale (W-DEQ) Version A

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Single

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

Experimental group

Experimental

Pregnant women in the experimental group will be given 4 sessions Solution-Oriented Approach program, starting at the 32th week of pregnancy. Pregnants in the experimental group will be administered the Wijma Birth Expectation/Experience Scale (W-DEQ-A) and Pregnancy Psychosocial Health Assessment Scale (PPHAS) before the intervention. After the program is completed, a training booklet will be provided for pregnant women and (W-DEQ-A) and PPHAS will be applied again. With pregnant women, 37-40. between gestational weeks, they will be contacted again, face-to-face interview method (W-DEQ-A) and PPHAS 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 Scale (W-DEQ-B). At the end of the first postpartum week, the postnatal senses of security of the mothers will be evaluated by telephone follow-up counseling.

干预措施: Solution-Oriented Approach (Other)

Control group

No Intervention

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.

结局指标

主要结局

Wijma Birth Expectancy / Experience Scale (W-DEQ) Version A

时间窗: Third assessment will take place average 3 weeks after the second assessment.

It is a Likert-type scale consisting of 33 items and 6 sub-dimensions that measure stress and fear during birth. The validity and reliability study of the scale was conducted by Körükcü et al. (2012). The first sub-dimension will determine the thoughts about childbirth contractions and how the birth will be in general, the second sub-dimension will determine the characteristics of childbirth contractions and the characteristics of contractions felt during childbirth, the third sub-dimension will determine what the woman will feel during childbirth, the fourth sub-dimension will determine what the woman will be when the contractions are most intense. The fifth sub-dimension consists of questions about the emotions imagined at the birth of the baby, and the sixth dimension consists of questions for evaluating the woman's thoughts about childbirth and delivery in the last month. Answers in the scale are scored between 0 and 5. Higher item total score indicates high level of fear.

Wijma Birth Expectancy / Experience Scale (W-DEQ) Version B

时间窗: The W-DEQ scale version B (only posttest) will be administered within the first 24 hours of postpartum.

W-DEQ version B was developed by Klaas and Barbro Wijma (1998) to measure the experiences of women with fear of childbirth in the postpartum period. Körükcü et al. (2014), the scale, which was adapted to Turkish and valid and reliable, consists of 32 items and six sub-dimensions. The sub-dimensions of the scale are, respectively, anxiety about labor pain, inadequacy of positive behavior, loneliness, inadequate positive emotions, anxiety about delivery, and anxiety about the baby. Answers in the scale are scored between 0 and 5. While the minimum score in the scale is 0, the maximum score is 160. As the score increases, the fear of childbirth that women experience increases.

Wijma Birth Expectancy / Experience Scale (W-DEQ) Version A

时间窗: First assessment will be made at the baseline (pre-intervention).

It is a Likert-type scale consisting of 33 items and 6 sub-dimensions that measure stress and fear during birth. The validity and reliability study of the scale was conducted by Körükcü et al. (2012). The first sub-dimension will determine the thoughts about childbirth contractions and how the birth will be in general, the second sub-dimension will determine the characteristics of childbirth contractions and the characteristics of contractions felt during childbirth, the third sub-dimension will determine what the woman will feel during childbirth, the fourth sub-dimension will determine what the woman will be when the contractions are most intense. The fifth sub-dimension consists of questions about the emotions imagined at the birth of the baby, and the sixth dimension consists of questions for evaluating the woman's thoughts about childbirth and delivery in the last month. Answers in the scale are scored between 0 and 5. Higher item total score indicates high level of fear.

Wijma Birth Expectancy / Experience Scale (W-DEQ) Version A

时间窗: The second assessment will take place 4 weeks after the first assessment (after the program is completed).

It is a Likert-type scale consisting of 33 items and 6 sub-dimensions that measure stress and fear during birth. The validity and reliability study of the scale was conducted by Körükcü et al. (2012). The first sub-dimension will determine the thoughts about childbirth contractions and how the birth will be in general, the second sub-dimension will determine the characteristics of childbirth contractions and the characteristics of contractions felt during childbirth, the third sub-dimension will determine what the woman will feel during childbirth, the fourth sub-dimension will determine what the woman will be when the contractions are most intense. The fifth sub-dimension consists of questions about the emotions imagined at the birth of the baby, and the sixth dimension consists of questions for evaluating the woman's thoughts about childbirth and delivery in the last month. Answers in the scale are scored between 0 and 5. Higher item total score indicates high level of fear.

次要结局

  • Psychosocial Health Assessment Scale During Pregnancy(Third assessment will take place average 3 weeks after the second assessment.)
  • Mother's Postnatal Senses of Security Scale(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.)
  • Psychosocial Health Assessment Scale During Pregnancy(First assessment will be made at the baseline (pre-intervention).)
  • Psychosocial Health Assessment Scale During Pregnancy(The second assessment will take place 4 weeks after the first assessment (after the program is completed).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yeşim Anık

Research Assistant

Necmettin Erbakan University

研究点 (1)

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