Clinical trial NCT05709561: The Effect of Acupressure and Mindfulness to Cope With Premenstrual Syndrome (PMS) on PMS and Quality of Life
Official title: The Effect of Acupressure and Mindfulness to Cope With Premenstrual Syndrome on Premenstrual Symptoms and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: Acupressure
Mındfulness
Nurse
Quality of life
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion criteria

* Regular menstruation (between 21-35 days), being over 18 years old,
* Being single,
* Not using analgesics during menstruation,
* Not having any psychiatric diagnosis or gynecological disease (abnormal uterine bleeding, uterine fibroids, ovarian cysts, etc.),
* Not using contraceptives,
* Not having tissue deformities in the extremities and not having any health problems that can prevent physical exercise,
* A score of \>110 on the PMSS scale.

Exclusion criteria

* Not participating in at least two mindfulness groups,
* Not having regular menstruation in the last 3 months,
* It is the use of analgesics during menstruation during the period of participating in the research.

Primary outcomes:
measure: The Premenstrual Syndrome Scale (PMSS)
timeFrame: 6 month
Secondary outcomes:
measure: The World Health Organization Quality of Life Assessment Questionnaire
timeFrame: 6 month
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Simge OZTURK
state: Centre
Study officials:
affiliation: T.R. İNÖNÜ UNIVERSITY SCIENTIFIC RESEARCH AND PUBLICATION ETHICS COMMITTEE 2022/3172
name: Simge ÖZTÜRK, PHD.Student
role: STUDY_CHAIR
affiliation: T.R. İNÖNÜ UNIVERSITY
name: Sermin TİMUR TAŞHAN, professor
role: STUDY_DIRECTOR
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