Design and setting
This quasi experimental study was implemented on 60 women with polycystic ovary syndrome, referring to health centers in Kerman, Iran, from April to the end of September 2021.
Participants included women with PCOS who referred to health centers in Kerman. Out of 16 health centers, 2 centers in the north and 2 centers in the south of the city were selected by lottery to conduct research.
Sample Size And Sampling
The sample size was calculated for each group by comparing means. 30 people were determined for each group by using the formula below and taking into account the 10% Sample shedding.
Women with PCOS who referred to health care centers were divided into two intervention and control groups by lottery, if they were eligble for entry and consent to participate in the study.
Inclusion criteria included: Diagnosis of PCOS based on Rotterdam method, aged between15 to 45 years old, literate, resident of Kerman, lack of known chronic disease like; Cardiac, pulmonary, diabetes, anemia, immunodeficiency, hemophilia, Malnutrition, lack of drug and other psychotropic substance use, lack of known mental disorders, lack of hyperprolactinemia, lack of special diet, lack of Cushing's syndrome and, Adrenal Hyperplasia.
Exclusion Criteria were adverse psychological events such as the death of a first-degree relative during the study, failure to attend two counseling sessions, reluctance to continue the study, participation in counseling sessions other than the current program and pregnancy during the study [10].
Measures
For pre assessment phase the Demographic Information Questionnaire included questions such as age, level of education, spouse's education, employment status, spouse's job, weight, age of onset of menstruation, time of onset of symptoms, and a researcher-made questionnaire on the worries of women with polycystic ovary syndrome was completed by the participants in both group. The questionnaire on the worries of women with polycystic ovary syndrome was consisted of 34 questions with six subscales which includes worries related to mental complications(8 questions), interpersonal problems (5 questions), non-pregnancy physical complications(7 questions), pregnancy complications(6 questions), sexual complications(5 questions), and religion issues(3 questions). It was sent to 10 professors for narration, which included faculty members of the midwifery and gynecology department and a psychologist. Reliability was determined by calculating Cronbach's alpha coefficient, which was calculated to be 95%. The questionnaire was prepared on a 5-point Likert scale, which “always” got a score of 5 and “never” a score of 1. The lowest score is 34 and the highest score is 170. A lower score was less worry and a higher score was more worry.
Intervention
After obtaining informed written consent and giving the essntial information about the objectives of the study, women with PCOS completed the measures. After selecting the eligible women, they were divided into two groups of intervention and control based on randomized sampling technique.
MBSR was conducted in eight 90-minute sessions twice a week for 30 women in intervention group .The intervention was given by ZS who had previously been trained in this regard and AA was facilitator. Attendance sessions were held in a room in one of health centers with good ventilation, observance of social distance and the use of personal protective equipment such as masks. At the end of each meeting, the date and time of the next meeting was announced in coordination with the participants.Researchers performed the intervention session with discussion methode and using a video projector. In the last session, the results of the sessions were measured by post-test. And again, a month later, the questionnaires were completed for both groups. During the intervention, control group were in waiting list. It should be noted that the next meeting was held at certain times with the agreement of the attendees. The content of counseling sessions is shown in Table 1
Table 1
Summary of sessions of counseling based on MBSR approach for reduction of worry in women with PCOS
session | Content |
1 | Greeting and declaration of counseling rules, definition of the concepts of mindfulness and the main variables, description of the internal and external flow of the mind, Eating raisins, home works. |
2 | Reviewing previous home works, mindful thinking, Mindful examination of body and sitting meditation, home works. |
3 | Reviewing previous home works, focus on being present, practice seeing and hearing consciously in three minutes, focus on five senses in five minutes, home works. |
4 | Reviewing previous home works, stress and the body's reaction, Practicing thoughts-emotions-body senses-behavior relationships, three minutes of concentration on an unpleasant event, mindful walking, home works. |
5 | Reviewing previous home works, effective responses to stress, Three-Minute Breathing Space (3MBS), meditation in daily life, home works. |
6 | Reviewing previous home works, conscious mind interactions, take care of yourself, practicing speaking and listening consciously, practicing consecutive thoughts in an hour, getting feedback from participants from practicing, presenting homework Homemade. |
7 | Reviewing previous home works, being more careful, Mindful Yoga, making the unpleasant event enjoyable, providing homework |
8 | Reviewing previous home works, mountain meditation, summarization of all sessions, homework [12]. |
Data analysis
The descriptive statistics were reported as frequency, percent and mean(SD). To analyze the data, independent t-test, paired t-test, Chi- square test were used. The significance level was 0.05. SPSS version 22 of IBM company was used for analysis.
Ethical Considerations
This manuscript was derived from a master counselling in midwifery thesis (project code No. 97001078) and was approved by the Ethics Committee of Kerman University of Medical Sciences, Iran (the code of ethics No. Kmu.ac.ir.1398.163). Written informed consent was obtained to enter the study ,and participants were easy to withdraw the study whenever they were willing. At the request of the ethics committee, the study was conducted in accordance with the Declaration of Helsinki and Ethics Publication on Committee (COPE). Special codes were used for each of the participants to ensure the information confidentiality.