Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06082895 |
| Other study ID # |
TOGU-HEM-TS-02 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 5, 2023 |
| Est. completion date |
March 10, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Tokat Gaziosmanpasa University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Birth enables women to assume the role of parent, but experiencing labor pain is seen as a
very stressful event. Birth pain is described as one of the most severe pains women
experience throughout their lives. Different pharmacological and non-pharmacological methods
are used to cope with labor pain. Non-pharmacological coping includes physiological coping
(such as breathing techniques, relaxation, postural changes, and movement during labor),
psychological coping (including social support, increasing self-efficacy, and increasing
self-confidence), and cognitive coping (including distraction, illustration). , and focus).
Birth self-efficacy refers to the mother's confidence or perception in her own ability to
give birth, which may influence her future birth choices. Women with high efficacy
expectations (i.e., high confidence regarding childbirth) may use cognitive coping behaviors
to cope with labor pain and therefore reduce the likelihood of medical intervention.It has
been found that a woman's confidence in her ability to cope with childbirth contributes
significantly to her perception of pain during labor and can foster a positive perception of
birth. Pregnant women with low self-efficacy also have low self-confidence during birth,
which negatively affects their ability to take an active role during birth and causes an
increase in cesarean delivery rates. Various approaches such as antenatal training, cognitive
behavioral approach, and psychoeducation program are used to reduce the negative consequences
that fear of birth may cause and to help pregnant women cope with the fear of birth and
increase birth self-efficacy. One of the approaches that include these strategies is seen as
the motivational interviewing method. The motivational interviewing method is a goal-oriented
and more participant-centered counseling approach that aims to facilitate and activate
participants' intrinsic motivation to change their behavior. Motivational interviewing is a
method that encourages the participant to think about changes that can be made, rather than
the counselor offering suggestions. The basic concepts of motivational interviewing are that
the participant recognizes and accepts the need to make changes in their lives; This approach
encourages participants to consider whether they are ready to change their behavior.
Description:
Type of Research: The research will be conducted as a randomized controlled, experimental
study to increase birth self-efficacy in pregnant women using the motivational interviewing
method.
Population of the Research: The population of the research consists of pregnant women who
came to the Gynecology and Obstetrics outpatient clinic between October 2023 and December
2023.
The sample of the Research G*Power version 3.1.9.7 program was used to calculate the research
sample size and power value. It was calculated by taking a study as a reference in the sample
size calculation. According to G power analysis, 5% margin of error, 95% power (representing
the universe) and effect size were calculated as 70 in total, 35 in both groups. In the
sample selection, pregnant women who have fear of childbirth and low self-efficacy will be
selected as the main parameter of the study. In the literature review, it is seen that the
fear of birth begins from the 20th week of pregnancy and increases throughout pregnancy.
Therefore, pregnant women at or above the 20th week of pregnancy were included in the study.
Pregnant women after 34 weeks were not included so that the training program was 4 weeks long
and the participating pregnant women could complete the prenatal education. Taking into
account the loss of pregnant women who met the research criteria and agreed to participate in
the study, the sample size was determined as 90 participants, 45 for both groups. Creation of
the Control and Experimental Group: After meeting the pregnant women who came for routine
pregnancy examination and evaluating their suitability according to the research criteria,
the Personal Information Form and the Short Version of the Self-Efficacy Scale in Labor were
filled out by the pregnant women who met the inclusion criteria and volunteered to
participate in the study. Pregnant women who had fear of childbirth and low self-efficacy
were informed about the study and their written and verbal consent was obtained from the
voluntary consent form. In addition, a list was prepared containing the name, surname,
estimated date of birth based on the last menstrual period and contact information of the
pregnant women.
Randomization Randomization technique was used to assign participants to groups.
Stratification randomization technique will be used to ensure homogeneity according to the
data obtained from the pregnant women (educational status, age and gestational week).
Blinding: Double blinding is not appropriate because the researcher included in the study
provided training according to the motivational interviewing method, collected data on fear
of birth, prenatal attachment and anxiety, and took part in the analysis of these data.
However, pregnant women were assigned to the experimental and control groups by
randomization, and one-sided blinding would be applied because the individuals did not
interact with each other and did not know which group they were in.
Implementation of the Research The research was carried out in two separate stages. Stage 1:
Preparatory phase Birth self-efficacy training program based on motivational interviewing
method Phase 2: Implementation phase of the training program Preparation Process of the
Training Program The first aim of the training program is to help women who are still
pregnant cope with the fear of childbirth and low self-efficacy. For this purpose, studies
and educational contents were examined to detect the negative emotional state caused by fear
of birth and low self-efficacy and to develop positive emotional states. Specific to the
motivational interviewing method in each session of the program; Open-ended questioning,
reflective listening, confirmation and summarizing communication methods will be used. The
first stage of motivational interviewing is to create internal motivation for change. In this
direction; Session 1; Developing contradiction is an important method to reveal the talk of
change in pregnant women. Conflict issues in pregnancy will be discussed by discussing the
pregnant woman's thoughts, feelings, concerns, fears regarding birth and the effect of fear
of birth on labor.
Session 2; In the first session, the interview will start with the homework given to the
pregnant woman and the decision balance regarding the positive and negative characteristics
of vaginal and cesarean birth. In this direction; Training will be given via computer slide
presentation on the signs of labor onset, stages of labor, and cesarean delivery.
3rd Session; In order to evaluate the change process of the pregnant woman, her emotional
state regarding the fear of birth will be reviewed and this issue will be discussed. A
conflict will be created by evaluating the methods of coping with labor contractions and the
level of knowledge about the birth environment.
4th Session; We will continue to develop a change plan and reveal commitment to strengthen
commitment to change. The pregnant woman's birth-related goals are clarified and possible
methods to achieve the chosen goals will be evaluated.
Implementation of the Experimental Group Training Program Within the scope of the research,
pregnant women in the experimental group will be interviewed to determine the suitability of
the place, time and hour of the training. After all pregnant women are interviewed and the
appropriate time and day are determined for everyone, days when there is no training at the
hospital's pregnancy training school will be planned. Birth Self-Efficacy Increasing Training
Program Based on Motivational Interviewing Method for Pregnant Women 20-34. A four-session
training program will be implemented, once a week for four weeks between weeks.
Control Group Within the scope of the research, no intervention will be made to the pregnant
women in the control group between the 20th and 34th weeks, apart from the routine hospital
practices.
Analysis of Research Data The descriptive statistics for the quantitative variables of the
research determined by measurement will be shown as mean and standard deviation and
percentage. First of all, the conformity of the data to the normal distribution will be
evaluated with the Shapiro-Wilk test. In the analysis of normally distributed data as a
result of the Shapiro-Wilk test, ANOVA between three or more variables and t-test in
independent groups in pairwise comparisons, Mann-Whitney U test in pairwise comparisons
between two-category variables in the analysis of non-parametric data, and Kruskal-Wallis
H-test in order to find the differences between variables with three or more categories.
Correlation analysis will be performed to reveal the relationship between dependent
variables. In addition, Wilcoxon test (significance test of difference between two spouses)
will be used to test the difference in two different measurement times obtained from the same
individuals. The difference between categorical variables will be evaluated with the Pearson
chi-square test. A value of 0.05 will be accepted as the level of significance in the entire
study.
