The Effect of Acupressure and Mindfulness to Cope With Premenstrual Syndrome (PMS) on PMS and Quality of Life

NCT05709561 | Completed DMC

• 1 other identifier: 2022/3172
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome

Keywords

Acupressure; Mındfulness; Nurse; Quality of life

Outcome Measures

Primary Outcomes (1)

• The Premenstrual Syndrome Scale (PMSS)

  The scale consists of 44 questions. The lowest score that can be obtained from the scale is 44, and the highest score is 220. An increase in the score obtained from the scale indicates that the intensity of PMS symptoms increases. A total score above 110 in the premenstrual syndrome scale indicates the presence of PMS.

  6 month

Secondary Outcomes (1)

• The World Health Organization Quality of Life Assessment Questionnaire

  6 month

Study Arms (3)

Acupressure Group

ACTIVE COMPARATOR

Acupressure was applied to the acupressure group twice a week in the first week by the researcher. Then, in the second week, it was observed that the students themselves applied this application twice this week under the supervision of the researcher.Then the acupressure group was asked to apply acupressure two days a week for 12 weeks, a total of 24 times.

Procedure: Acupresur

Mindfulness Group

ACTIVE COMPARATOR

The researcher and students practiced mindfulness once a week for 8 weeks. Then the students were asked to do 3 cycles of application alone every day. mid-test was applied.

Procedure: Mindfulness

Plasebo Group

PLACEBO COMPARATOR

Acupressure and mindfulness practices were not applied to the control group and they continued their routine care.

Procedure: Plasebo

Interventions

Acupresur PROCEDURE

acupressure application was applied 2 times a week for a total of 12 weeks and 24 times.

Acupressure Group

Mindfulness PROCEDURE

Mindfulness practice was applied with the students once a week for 8 weeks, accompanied by a researcher. Then, students were asked to apply for 3 cycles.

Mindfulness Group

Plasebo PROCEDURE

No intervention was applied to the control group.

Plasebo Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Simge OZTURK

Malatya, Centre, 44900, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Simge ÖZTÜRK, PHD.Student

  T.R. İNÖNÜ UNIVERSITY SCIENTIFIC RESEARCH AND PUBLICATION ETHICS COMMITTEE 2022/3172

  STUDY CHAIR

• Sermin TİMUR TAŞHAN, professor

  T.R. İNÖNÜ UNIVERSITY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Student
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pricipal Investigator

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: December 25, 2022
• First Posted: February 2, 2023
• Study Start: March 31, 2022
• Primary Completion: March 31, 2022
• Study Completion: March 15, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)