Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06265935 |
| Other study ID # |
Ataturk University - Neslihan |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2024 |
| Est. completion date |
October 15, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Ataturk University |
| Contact |
Neslihan ATLI |
| Phone |
05456330214 |
| Email |
neslihanatli96[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Gestational diabetes mellitus (GDM) is one of the most common medical complications of
pregnancy. GDM, which is in the high-risk pregnancy category, causes fatigue during pregnancy
due to both hormonal changes and pregnancy complications (1). Fatigue is a general complaint
that occurs in almost all physical and mental diseases. Fatigue also negatively affects an
individual's well-being, daily performance, activities of daily living (ADLs) and
relationships. Fatigue is one of the symptoms that, if not controlled, negatively affects the
individual's daily living activities and quality of life (2). While breathing itself is a way
of relaxation, it is also a part of all relaxation exercises and is an exercise that can be
used in daily life. Breathing correctly and deeply is the first step in learning to relax.
(3). It is important to identify fatigue, minimize it, plan daily living activities and
improve quality of life in patients with GDM. This study will be conducted as a randomized
controlled study to determine the fatigue and quality of life of diaphragmatic breathing
exercises, one of the non-pharmacological methods, on pregnant women with gestational
diabetes.
Description:
It will be carried out as a randomized controlled experimental design to determine the
fatigue and quality of life of pregnant women with gestational diabetes.
Material and method of the research:
Type of Study: This research is a randomized controlled study.
Research Questions/Hypotheses:
Hypothesis 0 (H0): Diaphragmatic breathing exercise has no effect on fatigue and quality of
life in pregnant women with gestational diabetes.
Hypothesis 1 (H1): Diaphragmatic breathing exercise has an effect on fatigue and quality of
life in pregnant women with gestational diabetes.
Location and Characteristics of the Research: The research will be conducted with pregnant
women with gestational diabetes who applied to the gynecology outpatient clinic of Şanlıurfa
Training and Research Hospital between 1 August 2023 and 1 August 2024 and who meet the
inclusion criteria. This hospital was chosen due to its nature as a regional hospital and its
density of pregnant women.
Population-sample of the research: The population of this research will consist of pregnant
women with gestational diabetes who were followed in the gynecology outpatient clinic of
Şanlıurfa Training and Research Hospital between 1 August 2023 and 1 August 2024. The sample
size was calculated as 60 pregnant women by performing GPower analysis, taking into account
the tests to be used to calculate the minimum sample size to be included in the study. The
sampling will include a total of 60 primiparous pregnant women, including 30 pregnant women
diagnosed with gestational diabetes, who meet the inclusion criteria for the study, who agree
to participate in the study, who are subjected to diaphragmatic breathing exercise, and 30
pregnant women diagnosed with gestational diabetes, who are not applied diaphragmatic
breathing exercise.
Data Collection Forms and Tools Pregnancy Identification Form: This form was prepared and
developed by researchers based on the literature. It consists of questions aimed at
determining the sociodemographic, medical and obstetric characteristics of pregnant women
with gestational diabetes.
SF-36 Quality of Life Scale: SF-36 Quality of Life Scale is a self-assessment scale
consisting of 36 questions and eight subscales, developed by Ware in 1987 to measure care
outcomes in general, not specific to age, disease or treatment, and to examine health-related
quality of life. . The second question of the scale includes the perception of change in
health in the last 12 months, and the other questions are evaluated considering the last four
weeks. The Physical and Mental Health Summary Score is obtained by weighting the scores of
the questions containing the subscales of the SF-36 Quality of Life Scale. Total score
calculation is not possible. The resulting summary scores and subscale scores are expressed
as continuous variables ranging from 0 to 100. Zero indicates bad health, 100 indicates
well-being. The scale has no cut-off point. The validity and reliability of the scale in
Turkey was conducted by Pınar in 1995 on 50 cardiology, 50 hemodialysis and 80 diabetes
mellitus patients. According to this; Regardless of patient groups, the test-retest
reliability coefficient of the scale was found to be 0.94, and the Crohnbach's Alpha value,
which indicates internal consistency, was 0.92 .
Visual Similarity Scale for Fatigue: It was developed by Lee et al. in 1990 to measure the
level of fatigue in various populations, including healthy adults and those with chronic
diseases. The validity and reliability study of the scale for our country was conducted by
Yurtsever and Bedük in 2003. YİGBS consists of 18 items. Of these items, 13 items measure
Fatigue and five items measure Energy sublevel. Each item of the scale has a 10 cm horizontal
line with positive statements at one end and negative statements at the other end. People who
fill out this scale are asked to mark the point that best reflects the emotion they feel when
reading the statements on the scale. Then, the intersection point at the marked location is
measured with a ruler separately for each question, and the measured length is determined as
the score of that item and evaluated objectively. The highest score that can be obtained from
the fatigue subscale is 130 and the lowest score is 0. The highest score that can be obtained
from the energy subscale is 50 and the lowest score is 0. A high score from the Fatigue
subscale and a low score from the Energy subscale indicate that the severity of fatigue is
high.[2] Cronbach's Alpha internal consistency coefficient for the 13-item fatigue subscale
of the scale was found to be 0.90, and for the five-item energy subscale was 0.74.
Diaphragmatic Breathing Exercise: In diaphragmatic breathing exercise; Individuals lie on
their back with their legs flexed, a pillow under their head, and place their dominant hand
on their abdomen and the other hand on their chest. While breathing slowly through the nose,
they need to pay attention to the hand in the abdominal area and reduce the rib cage movement
by increasing the abdominal movement. During inspiration, as air fills the lungs, the hand on
the abdomen should rise up and the hand on the chest should not move too much. It makes
participants feel relaxed and relaxed with breathing exercise.
Collection of Data Data will be obtained from pregnant women with gestational diabetes who
apply to the gynecology clinic of Şanlıurfa Training and Research Hospital and meet the
sample selection criteria. Before the application, an explanation will be given to the
pregnant women about the purpose of the research, and if they volunteer, their verbal and
written consent will be obtained through the "Informed Volunteer Consent Form". Information
about pregnant women will be collected by the researcher.
Application of Research Pregnant women will be informed about the research and written and
verbal permissions will be obtained.
Information about pregnant women will be recorded. Pregnant women with gestational diabetes,
whose diagnosis of gestational diabetes has been decided by the physician and who have given
consent to participate in the study, will be assigned to 2 groups by randomization method:
experimental (diaphragmatic breathing exercise group) and control (diaphragmatic breathing
exercise group).
The first evaluations of pregnant women in both groups will be carried out between
10:00-12:00, and the Pregnancy Identification Form, Visual Similarity Scale for Fatigue and
SF-36 Quality of Life Scale will be applied to the pregnant women before the training.
Experimental Group: Breathing exercise will be explained to the pregnant woman in a way she
can understand, will be taught and will be applied for 5 minutes. When doing the
diaphragmatic breathing exercise, participants will be told to take one chest breath after
4-5 diaphragmatic breaths to avoid hyperventilation. The pregnant woman will be advised to
close her eyes during exercise and concentrate on breathing and focus her attention in this
direction. If there is tremors, sweating, restlessness, palpitations, numbness in the hands
or lips, or uterine contraction, participants will be told to stop the exercise and rest for
a few minutes. Pregnant women will be given a phone number they can reach at any time during
the one-month program. Feedback will be received, questions will be answered, a training
brochure will be given and the program will be completed.
During their follow-up two weeks later, pregnant women will be asked to bring the survey form
with them. The Visual Similarity Scale for Fatigue and the SF-36 Quality of Life Scale will
be completed again. How he did the exercise, whether he felt any effects, and his
satisfaction will be questioned. Their questions will be answered. Participants will be
informed that participants need to come for a re-check in two weeks.
The Visual Similarity Scale for Fatigue and the SF-36 Quality of Life Scale will be filled
out again during the follow-up after the fourth week. At the end of 30 days, the program will
be completed and the survey form will be received.
Control Group: No application will be performed with the participants in the control group,
and these participants will be asked not to engage in regular physical activity or sports for
4 weeks and not to make any changes in their living habits.
During their follow-up two weeks later, pregnant women will be asked to bring the survey form
with them. The Visual Similarity Scale for Fatigue and the SF-36 Quality of Life Scale will
be completed again. Participants will be informed that participants need to come for a
re-check in two weeks.
The Visual Similarity Scale for Fatigue and the SF-36 Quality of Life Scale will be filled
out again during the follow-up after the fourth week. At the end of 30 days, the program will
be completed and the forms will be filled.
Evaluation of Data Evaluation of the data obtained as a result of the research will be
analyzed using the SPSS (Statistical Package For Social Sciences) 25.0 package program.
Limitation of the Study: It is limited to pregnant women who applied to Şanlıurfa Training
and Research Hospital affiliated with Şanlıurfa Provincial Health Directorate.
Ethical and Legal Aspects of Research Permission will be obtained from Atatürk University
Clinical Research Ethics Committee before data collection. Institutional permission will be
obtained from Şanlıurfa Provincial Health Directorate. Before the application, pregnant women
with gestational diabetes will be informed about the purpose of the research, and if they
volunteer, their verbal and written consent will be obtained through the "Informed Volunteer
Consent Form".
