Clinical trial NCT05924334: Reiki & Premenstrual Syndrome & Quality of Life
Official title: Effect of Kundalini Reiki Intervention on the Symptoms of Premenstrual Syndrome and Quality of Life in Nursing Students: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: quality of life
reiki
premenstrual syndrome
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is planned to perform a triple blind, randomized and placebo -controlled type in order to determine the effect of Kundalini reiki application on the symptoms of premenstrual syndrome.

Detailed description: Premenstrual syndrome is common as a number of cognitive and emotional symptoms that started about a week before menstruation and has negative effects on the quality of life of women. In this period, symptoms affecting the quality of life are often listed as pain, bloating, edema, appetite changes, weight gain, tenderness, fullness, fatigue, drowsiness, anxiety, depressive symptoms and crying. It is known that women resorted to various methods that are pharmacological or non-pharmacological methods to deal with these symptoms in the premenstrual period. These methods vary from analgesic to hot application or traditional and complementary methods. Reiki is a healing energy that is not exactly included in traditional and complementary practices but has been revealed by research. In short, it is an energy therapy that balances the body and has no negative side effects. There are two types: Usui Reiki and Kundalini Reiki. From this point of view, it is planned to perform a triple blind, randomized and placebo controlled type in order to determine the effect of Kundalini reiki application on the symptoms of premenstrual syndrome. The study is planned to be carried out with Ege University Faculty of Nursing between June 2023 and July 2023. The universe of the study will consist of all students studying at the faculty in 2022-2023. The first stage of the study, which is planned to be carried out in two stages, will be made of descriptive-specific type to determine the students with premenstrual syndrome, no sample selection will not be selected and all the students who meet the criteria of inclusion in the research will be taken. In the second stage, intervention and placebo groups will be identified by randomization among students with premenstrual syndrome. In the Premenstrual periods, Reiki application will be held in the Premenstrual periods and no energy work will be applied to the placebo group. For the second stage, the adequacy of the number of samples will be decided by making power analysis during the study. Research data will be collected by face-to-face interview method using the individual promotion form, premenstrual syndrome scale and SF-36 quality of life scale and SPSS 22.0 package program will be used in statistical data analysis. At the end of the study, although the effectiveness of reiki application against premenstrual symptoms in nursing students is determined, awareness will be created to be used as a applicable method for the development of premenstrual symptom management and quality of life if the result is effective.

Eligibility criteria: Inclusion Criteria:

* PMS scale total score is 110 points and above
* Being a volunteer to participate in the reiki application

Exclusion Criteria:

* Having a pacemaker (Reiki application is not recommended.)
* Being pregnant (Reiki application is not recommended.)

Primary outcomes:
measure: Intensity of premenstrual symptoms evaluated using the Premenstrual Syndrome Scale
timeFrame: change from baseline (before implementation) and 1st week of practice
measure: quality of life evaluated using the SF-36 Scale
timeFrame: change from baseline (before implementation) and 1st week of practice
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Turkey, Ege University
Study officials:
affiliation: Ege University
name: Figen Kazankaya, Master
role: STUDY_CHAIR
affiliation: Ege University
name: Gül Ertem, PhD
role: STUDY_DIRECTOR
References: