Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05709561 |
| Other study ID # |
2022/3172 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 31, 2022 |
| Est. completion date |
March 15, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
Inonu University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The research was carried out to determine the effect of acupressure and mindfulness practice
to cope with premenstrual syndrome on premenstrual symptoms and quality of life. The sample
of the study consisted of a total of 270 students, 90 of which were acupressure, 90
mindfulness and 90 control groups. In the study, data were collected with the Participant
Information Form, PMSS and WHOQOL-BREF. The acupressure group was asked to apply acupressure
two days a week for 12 weeks, a total of 24 times. In the mindfulness group, 8 weeks of
Conscious Awareness Stress Reduction Program was applied, after which the students were asked
to practice mindfulness for 3 cycles. Students in both experimental groups were asked to stop
the practices after acupressure and mindfulness practices. PMSS and WHOQOL-BREF were applied
to both experimental and control groups as an intermediate test 12 weeks after the pre-test
and a post-test 24 weeks later.
Description:
Premenstrual syndrome (PMS) is a gynecological condition consisting of physical,
psychological and behavioral symptoms that occur 7-10 days before menstruation and end with
the onset of menstruation. Symptoms are divided into three groups as mild, moderate and
severe. The prevalence of PMS is reported to be 47.8% on average worldwide. About 20% of
these are severe symptoms and may affect women's daily activities, while 27.8% are mild to
moderate symptoms. PMS reduces daily activities, sleep quality and cognitive functions of
women of reproductive age. However, it can negatively affect women's health, interpersonal
relationships, academic performance, attendance at work and school, and quality of life. In
the treatment of PMS, 80% of women prefer non-pharmacological treatment. Non-pharmacological
methods such as lifestyle changes, music, massage, yoga, aromatherapy, reflexology,
homeopathy, cognitive behavioral therapy, emotional liberation technique, reiki, acupuncture,
mindfulness, acupressure methods are frequently used in the treatment of PMS. The population
of the research consists of 1006 female students, 598 of whom are studying at İnönü
University Faculty of Nursing and 408 female students studying at Bartın University Faculty
of Health Sciences. The sample of the study was determined by power analysis with an effect
size of 0.22, a confidence interval of 0.95 determined by an error level of 0.05, a sample
size of 90 for each group (90 in the acupressure group, 90 in the mindfulness group, and 90
in the control group) with 0.95 universe representation power. group 90) female students with
a total of 270 PMS were determined. However, it was decided to include an additional 10
students for each group, taking into account the losses that may occur during the study. In
the study, 100 acupressure, 100 mindfulness and 100 female students formed the control group.
In the study, which university would be included in the control and experimental groups was
determined by drawing lots. The draw was made blind by an academic independent of the
research. As a result of the lottery, the control group of the research was formed by the
students of İnönü University Faculty of Nursing, and the experimental groups were students
studying at the Faculty of Health Sciences of Bartın University. Students from each faculty
to be included in the study were determined using a computer-assisted simple random sampling
method. Students in the experimental and control groups were determined according to an
algorithm created by a computer program called Research Randomizer. For the control group,
598 female students in İnönü University Nursing Department, numbers from 1 to 598 were
randomly divided into a single set.For the experimental groups, 408 female students from the
Faculty of Health Sciences of Bartın University were randomly divided into two sets (100
acupressure, 100 mindfulness), numbers numbered from 1 to 200. Which set will be acupressure
and mindfulness group was determined by drawing lots. A research-independent academician made
the selection blindly. As a result of the draw, it was determined that the first set was the
acupressure group, and the second set was the mindfulness group. The assignment of the
students to the experimental and control groups was made using the simple randomization
method. Students were sorted by student number before randomization. Experimental and control
groups were determined by the order given by the computer program Research Randomizer. The
students who scored 110 and above were included in the study, after which the PMSS scale was
applied to the determined students. In the study, it was accepted that 338 students who
scored 110 and above from the scale experienced PMS. In the study, data were collected with
the Participant Information Form, PMSS and WHOQOL-BREF. The acupressure group was asked to
apply acupressure two days a week for 12 weeks, a total of 24 times. In the mindfulness
group, 8 weeks of Conscious Awareness Stress Reduction Program was applied, after which the
students were asked to practice mindfulness for 3 cycles. Students in both experimental
groups were asked to stop the practices after acupressure and mindfulness practices. PMSS and
WHOQOL-BREF were applied to both experimental and control groups as an intermediate test 12
weeks after the pre-test and a post-test 24 weeks later.
