Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06294717 |
| Other study ID # |
AtaturkUPhStudentNeslihanATLI |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2024 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
March 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
Caesarean section is a surgical procedure that can be performed before or during birth in
cases where the life of the mother and fetus is threatened or upon the request of the mother
and father. One of the most common problems after cesarean section is abdominal pain.
Progressive relaxation exercises are a method that allows certain muscle groups in the body
to first contract and then relax. Progressive relaxation exercises have been proven to have
positive effects on anxiety. By applying progressive relaxation exercises, the
parasympathetic nervous system is activated; Thus, heart and respiratory rate and blood
pressure can be kept within normal limits. This study will be conducted to determine the
physiological parameters, pain and anxiety levels of progressive relaxation exercises, one of
the non-pharmacological methods, on women giving birth by cesarean section.
Description:
Purpose of the research: (Must be clearly stated and compatible with the subject title) It
will be carried out as a randomized controlled experimental design to determine the effect of
progressive relaxation exercises on physiological parameters, pain and anxiety after cesarean
section.
10. Materials and methods of the research: Type of Study: This research is a randomized
controlled study.
Research Questions/Hypotheses:
Hypothesis 1 (H1): Progressive relaxation exercises after cesarean section have an effect on
physiological parameters.
Hypothesis 2 (H1): Progressive relaxation exercises after cesarean section have no effect on
physiological parameters.
Hypothesis 3 (H2): Progressive relaxation exercises have an effect on pain after cesarean
section.
Hypothesis 4 (H2): Progressive relaxation exercises have no effect on pain after cesarean
section.
Hypothesis 5 (H3): Progressive relaxation exercises after cesarean section have an effect on
anxiety.
Hypothesis 6 (H3): Progressive relaxation exercises have no effect on anxiety after cesarean
section.
Location and Characteristics of the Research: The research will be conducted between
September 1, 2023 and August 1, 2024, in the gynecology service of Şanlıurfa Training and
Research Hospital, with women who gave birth by cesarean section and meet the inclusion
criteria. This hospital was chosen due to its nature as a regional hospital and the density
of cesarean births.
Population-sample of the research: The population of this research will consist of women who
gave birth by cesarean section in the gynecology service of Şanlıurfa Training and Research
Hospital between February 1, 2024 and August 1, 2024, 2024. Taking into account the tests to
be used to calculate the minimum sample size to be included in the study, GPower analysis was
performed and the sample size was calculated as 120 puerperal mothers. A total of 120
postpartum women will be included in the sampling, including 60 postpartum women who meet the
inclusion criteria for the study, who agree to participate in the study, and who gave birth
by cesarean section to which progressive relaxation exercises are applied, and 60 postpartum
women who give birth by cesarean section to which progressive relaxation exercises are not
applied.
Data Collection Forms and Tools:
Postpartum Identification Form:
This form was prepared and developed by the researchers based on the literature. It consists
of questions to determine sociodemographic, medical and obstetric characteristics.
Beck Anxiety Scale: Developed by Beck et al. in 1988, the scale measures the frequency of
anxiety symptoms experienced by a person. The person is asked to indicate how much the listed
anxiety symptoms bother him or her in the last week. The scale, consisting of twenty-one
items, provides a four-point Likert type measurement (0 being not at all, 3 being seriously).
It was used in the study to evaluate the overlap validity of typical anxiety symptoms.
Turkish validity and reliability study was conducted by Ulusoy, Şahin and Erkmen in 1998. The
scale consists of items containing somatic symptoms and subjective anxiety. (Cronba alpha
value=0.93)
Visual Analog Scale (VAS):
It is a pain level measurement method created by Albersnagel (1988). It is used to make the
undetermined feeling of pain numerically meaningful. The validity and reliability study in
our country was conducted by Aydin et al. (2011). The range of 0 (zero) and 10 cm is
determined on a ruler. 0 (zero) means "no pain" and 10 means "worst possible pain". The
patient is asked to mark the place that expresses his pain on the line. The distance marked
by the patient is measured by taking the zero starting distance. The benefit of the Visual
Comparison Scale is that it is a proven scale and has been shown to be sensitive to changes
in a patient's pain experience. It is quick to use and relatively easy to understand for most
patients. It avoids the misuse of descriptive words to describe pain and allows meaningful
comparison of measurements over time.
Physiological Parameters:
Physiological Measurements Form; vital signs of the woman giving birth; It is a chart where
pulse, respiration, systolic blood pressure, diastolic blood pressure and oxygen saturation
are recorded.
Progressive Relaxation Exercises: All muscles in the body contract and relax in a coordinated
manner. Progressive relaxation exercises, which have been studied in cancer pain, for symptom
control in cancer patients receiving chemotherapy, for improving nausea and vomiting after
chemotherapy, and for improving quality of life, have been adopted to reduce anxiety, pain,
and other stress symptoms, and to increase mental health. The exercise involves
systematically tensing and relaxing our muscles. In this way, the exact location of the
muscles and their state of tension are known.
Collection of Data:
The data will be obtained from postpartum women who gave birth by cesarean section in the
gynecology service of Şanlıurfa Training and Research Hospital and meet the sample selection
criteria. Before the application, an explanation will be given to the postpartum women about
the purpose of the research, and if they volunteer, their verbal and written permission will
be obtained through the "Informed Volunteer Consent Form". Information about postpartum women
will be collected by the researcher.
Application of Research
Experimental Group:
Postpartum women will be informed about the research and their written and verbal permissions
will be obtained.
Information about postpartum women will be recorded. Women who gave birth by cesarean section
who agree to participate in the study will be assigned to 2 groups by randomization method:
experimental (group to which progressive relaxation exercises will be applied) and control
(group to which progressive relaxation exercises will not be applied).
Progressive relaxation exercises will be explained and taught to the puerperant after
cesarean section. Experimental Group (in the group where progressive relaxation exercises
were applied); The first application will be made at the 8th postoperative hour. Before the
application, the Puerperal Identification Form, Beck Anxiety Scale, Visual Analogue Scale
(VAS) and Physiological Parameters forms will be filled out. Starting from the 8th post-op
hour, the second and third application will be made eight hours apart within a 48-hour
period. On the second day, progressive relaxation exercises will be performed once, twice and
three times at eight-hour intervals. At the end of the second day, the Postpartum Definition
Form, Beck Anxiety Scale, Visual Analogue Scale (VAS) and Physiological Parameters forms will
be filled in again (posttest).
The patient is placed in a supine position. First, the right palm is placed just below the
navel, the left hand is placed on the chest and the eyes are closed.
Before inhaling, the lungs are emptied thoroughly by exhaling. When exhaling, the lungs
should not be strained and the breath should come out on its own without being forced.
When you start breathing, the lung capacity is divided into two imaginary and the lung is
filled completely by counting "one" and "two". Wait for a short time, count "one-two" and
evacuate in twice the time you breathe. The right hand should feel the breastbones opening to
the side, like a movable bridge31. Wait two seconds before taking another breath.
Take another deep breath and repeat the same process. After repeating slow and deep breathing
exercises a few times, progressive relaxation exercises should be started.
In progressive relaxation exercises, all major muscles, in order from bottom to top; right
foot, left foot, right leg, left leg, hip, abdominal muscles, back muscles, chest muscles,
right hand, left hand, right arm, left arm, neck, shoulders and facial muscles contract while
breathing slowly, then exhale It is released by loosening while giving After each muscle
contraction and relaxation process, slow and deep breathing exercises should be performed 4-5
times in between before moving on to a new muscle group.
After the relaxation exercises are done and completed in all muscle groups, all muscles
contract simultaneously while inhaling and relaxed simultaneously while exhaling. Then, the
progressive relaxation exercise is completed with several deep breathing movements.
Control Group:
No application will be carried out with the participants in the control group. At the 8th
postoperative hour, the Puerperal Identification Form, Beck Anxiety Scale, Visual Analogue
Scale (VAS) and Physiological Parameters forms will be filled out. These participants will be
asked not to engage in regular physical activity or sports for 2 days and not to make any
changes in their living habits.
During the interview two days later, the Postpartum Identification Form, Beck Anxiety Scale,
Visual Analogue Scale (VAS) and Physiological Parameters forms will be filled out again by
the puerperant women.
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 women who gave birth by cesarean section at
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, verbal and
written consent will be obtained from women who gave birth by cesarean section through the
"Informed Volunteer Consent Form", if they volunteer, by explaining the purpose of the
research.
