Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05340101 |
| Other study ID # |
77082166 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2022 |
| Est. completion date |
September 15, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
Gazi University |
| Contact |
Sidika PELIT AKSU, PhD |
| Phone |
+905069583180 |
| Email |
sidikapelit[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this study, it was aimed to evaluate the effect of progressive muscle relaxation exercise
on dysmenorrhea, menstrual symptoms and quality of life in university students with common
primary dysmenorrhea. The research is a single center, parallel group block randomized
controlled experimental study. This study will be conducted in the Department of Nursing,
Faculty of Health Sciences, of a state university in Turkey. The universe of the research
will be Gazi University Faculty of Health Sciences, third year and last year nursing students
(N: 451). In order to determine the sample size in the research, power analysis was performed
using the G Power 3.1.0 program. For this purpose, the study results of Sis Çelik and Ejder
Apay (2021), which were similar to our study, were taken as reference. According to the power
analysis made by calculating the effect size; It was determined that the sample of the study
should consist of a total of 42 people, 21 in each group, will be randomized.
The data of the research; Personal information form will be collected using Visual Analogue
Scale (VAS), SF-12 Quality of Life Scale Short Form, Menstrual Symptom Scale, Dysmenorrhea
Monitoring Form. The implementation of the research is planned between April 15, 2022 and
August 15, 2022. Third and fourth year nursing students will be included in the study. First
of all, it will be evaluated according to the sampling inclusion criteria using the
pre-evaluation form. Women who meet the inclusion criteria will be informed about the purpose
and importance of the research, and women who agree to participate in the study will be
determined. Informed consent form will be signed by the women who accepted to participate in
the study, Visual Analogue Scale, Menstrual Symptom Scale and SF 12 Short Form will be
applied. Randomization will be done after obtaining consent and filling out the forms.
Description:
Non-pharmacological methods include body therapies, mind-body based therapies, Chinese herbal
medicine and vitamin mineral supplements. In particular, physical exercises, acupuncture,
aromatherapy, Chinese herbal medicine and yoga are non-pharmacological methods frequently
used in the management of dysmenorrhea. Progressive muscle relaxation exercise (PMRE), one of
the mind-body based therapies, is frequently used in pain management, but there are limited
studies on its effect on primary dysmenorrhea. Progressive muscle relaxation exercise focuses
on recognizing muscle tension and then reducing this tension. Studies conducted in different
populations have found that progressive muscle relaxation exercise reduces pain and improves
quality of life.
There is insufficient evidence for the effect of progressive muscle relaxation exercises in
the management of primary dysmenorrhea. Therefore, in this study, it was aimed to evaluate
the effect of progressive muscle relaxation exercise on dysmenorrhea, menstrual symptoms and
quality of life in university students with common primary dysmenorrhea.
METHOD Type of Research The research is a single center, parallel group block randomized
controlled experimental study.
Location and Characteristics of the Research This study will be conducted in the Department
of Nursing, Faculty of Health Sciences, of a state university in Turkey.
Population and Sample of the Research The universe of the research will be Gazi University
Faculty of Health Sciences, third year and last year nursing students (N: 451). In order to
determine the sample size in the research, power analysis was performed using the G Power
3.1.0 program. For this purpose, the study results of Sis Çelik and Ejder Apay (2021), which
were similar to our study, were taken as reference. According to the power analysis made by
calculating the effect size; It was determined that the sample of the study should consist of
a total of 24 participants, 12 in the intervention group and 12 in the control group (α=0.05,
1-β =0.99, Effect size d= 1.9111974, tail(s)=two). Considering the drop out rate of the study
as 36%, a total of 42 people, 21 in each group, will be randomized.
Inclusion criteria for the study;
- Having primary dysmenorrhea,
- Being Nulligravida,
- Having a history of regular menstrual cycles in the last six months (cycle duration
21-35 days),
- Not using hormonal contraceptives,
- A score of 5 or more on the visual analog scale (VAS).
- Not to have metabolic disease, cancer, heart disease and diabetes, diagnosed psychiatric
disease, and not using antidepressant medication that would prevent him from performing
PCGE.
- Not doing any other body-mind based practice
- Using a smartphone
- Not having any communication problems (mental, auditory, visual, etc.)
- To be willing to participate in the study. Exclusion criteria,
- Use of complementary therapies, anti-inflammatory therapy, antidepressants or
anxiolytics during the study
- Occurrence of menstrual cycle irregularity
- Performing PKGE 3 times a week or less in a row Validity-Reliability Selection criteria
have been determined to prevent selection bias. Inclusion criteria for the study; Having
primary dysmonaea, being nulligravida, having a history of regular menstrual cycles in
the last six months (cycle duration 21-35 days), not using hormonal contraceptives,
having a score of 5 or more on the visual analog scale (VAS) Metabolic disease that will
prevent performing PCI, Not having cancer, heart disease and diabetes, not having a
diagnosed psychiatric disease and not using antidepressant drugs, not using
anti-inflammatory drugs, not using any other body-mind based application, using a smart
phone, having any communication problems (mental, auditory, visual, etc.) .) and
volunteering to participate in the study. Block randomization will be used for
randomization. Permutation series and assignment list to be used for group assignments
will be created in computer environment (www.randomizer.org).
In this study on application bias, researcher and participant blinding will not be done.
Because the researcher will make the application himself and placebo cannot be used in the
intervention. Blinding will not be done in this study.
Pre-tests to prevent detection bias and randomization assignment of women will be done by an
independent nurse.
The data obtained from the research aimed at preventing reporting bias will be coded as A and
B by an independent researcher and transferred to the SPSS program. Analysis of the data will
also be done by an independent statistician.
In order to prevent attrition bias, Intention to Treat Test will be used in case of
decrease/reduction in the sample group or if post-tests are not filled.
Application Data Collection Tools The data of the research; Personal information form will be
collected using Visual Analogue Scale (VAS), SF-12 Quality of Life Scale Short Form,
Menstrual Symptom Scale, Dysmenorrhea Monitoring Form.
Personal Information Form:
The personal information form consists of 27 questions. It was prepared by researchers in
line with literature information in order to identify students with primary and secondary
dysmenorrhea (Ferries-Rowe et al., 2020; ACOG, 2018). In addition, the sociodemographic
characteristics of the students and their methods of coping with dysmenorrhea, if any, were
also questioned in the prepared form. Students who do not meet the eligibility criteria of
the study will be excluded.
Visual Analog Scale (VAS): In the 10 cm Visual Analog Scale (VAS), "0" indicates no pain and
"10" indicates the most severe level of pain. As the score on the scale increases, the
severity of the pain increases.
Short Form of Quality of Life Scale SF-12 It was created as a short form of SF-36, which was
developed by Ware et al. in 1995 to evaluate quality of life. It contains the same
sub-dimensions as the SF-36. The Turkish validity and reliability study of the SF-12 scale
was conducted by Soylu and Kütük (2021). The scale is used in the evaluation of physical
(FIM-12) and mental health (MBI-12), which are the two main components of general health
status. The scale includes physical functionality (2 items), physical role (2 items), body
pain (1 item), general health (1 item), energy (1 item), social functionality (1 item),
emotional role (2 items), and mental health. It consists of 8 sub-dimensions, including
health (2 items) and 12 items. The higher the score obtained from the scale, the higher the
quality of life. The Cronbach's alpha value of the FIM-12 sub-dimension of the scale was
0.73, and the Cronbach's alpha value of the MDS-12 sub-dimension was 0.72.
Menstruation Symptom Scale The Menstruation Symptom Scale (MSI) was developed by Chesney and
Tasto in 1975 to assess menstrual pain and symptoms. Turkish validity and reliability study
Güvenç et al. (2014) by It consists of 3 sub-dimensions including Negative Effects/Somatic
Complaints, Pain Symptoms and Coping Methods. The scale has a 5-point likert structure. The
scale score is calculated by calculating the MSÖ score, the total score average of the items
in the scale. An increase in the mean score indicates an increase in the severity of
menstrual symptoms. The score obtained from the sub-dimensions is calculated by taking the
total score average of the items in the sub-dimensions. An increase in the score indicates
that the severity of the symptoms in that sub-dimension increases. The total Cronbach's alpha
value of the scale was found to be 0.92. The Cronbach's alpha value for the sub-dimensions
was 0.90 for "Negative Effects/Somatic Complaints", 0.81 for "Pain Symptoms" and 0.74 for
"Coping Methods".
Dysmenorrhea Monitoring Form: This form was prepared by the authors in accordance with the
literature (Coşkuner and Kömürcü, 2014; Çelik and Apay 2021). The form provides a prospective
measurement of pain intensity. Students in the experimental and control groups will be asked
to record their initial (first three days of the first cycle) pain severity level on the VAS
form. Progressive relaxation exercises will be used for two menstrual cycles in the
experimental group. The students in the experimental group will be asked to record on the VAS
the dysmenorrhea felt before and after PBGE in the first three days of the menstrual cycle.
The control group would not receive any intervention for dysmenorrhea pain in the second and
third cycles when they marked their pain level.
Progressive Muscle Relaxation Exercise Tracking Chart It was prepared by the researcher in
order to facilitate the follow-up of female students' PCGE application status. At the top of
the chart are the student's name-surname and the start date of the application. On the other
hand, the table includes the application weeks and whether the PCG is applied or not. The
duration of the schedule application will vary according to the length of the menstrual
cycle. For each week, boxes have been created to mark the days of the week and whether the
application has been made or not. In the first menstrual cycle after being included in the
study, no marking will be made on the chart. From the end of the first cycle, progressive
muscle relaxation exercise should be performed 4 times a week for two menstrual cycles and
recorded in the chart.
Analysis of Data The data will be stored in the computer environment using the Statistical
Package for Social Sciences 20 (SPSS 20) statistical program. Kolmogorov-Smirnov test will be
performed in order to determine the conformity of the scale scores to the normal
distribution. Non-parametric tests (Mann-Whitney U test, Wilcoxon Test) will be used in
statistical analysis since it was determined that the scores were not suitable for normal
distribution. Mean and standard deviation will be used in the evaluation of quantitative
variables, and frequency and percentage values will be used in the evaluation of qualitative
variables. The p=0.05 value will be accepted as statistical significance in all statistical
analyses. The effect size was determined by calculating Cohen's d (small-0.2, medium-0.5 and
large effect-0.8). The Cronbach-α coefficient will be used to evaluate the reliability of the
scales used in the study.
Ethical Dimension of Research Before the application, written permission from the institution
where the research was conducted, approval from the Ethics Committee and written informed
consent from the students will be obtained. After the implementation of the research is over,
it will be planned to teach and practice progressive muscle relaxation exercises to the
students in the control group.
