This study is the field trial part of a mixed study conducted in a randomized double-blind way with the approval of the ethics committee of Isfahan University of Medical Sciences in Isfahan, Iran. The study was conducted on 70 women with polycystic ovary syndrome based on Rotterdam criteria , from August 2019 to January 2020 in Isfahan, Iran. The sample size was calculated for a 1:1 allocation ratio by considering presumed depression score reduction after the intervention, estimated sample loss and 95% confidence level and 80% test power with two parallel groups of intervention and control sequentially.
Inclusion criteria consisted of the absence of severe psychological disorders and lack of movement restrictions. Additionally, women undergoing assisted reproductive treatment were not included in the study. Eeligibility assessment was performed by the Ph.D. candidate in reproductive health. Simple random sampling was performed among women referring to the treatment clinics affiliated to Isfahan University of Medical Sciences.
In this study, psychological symptoms were measured on the scales of somatization, interpersonal sensitivity, obsessive-compulsive, depression, anxiety and hostility levels through using SCL-90-R by one researcher. This checklist is set based on a 5-point Likert scale (0-4) ranging from none (0) to so much (4), and the higher the score, the more would be psychological symptoms 30. The participants' score of psychological symptoms were measured before the intervention, one month and three months after the intervention in both groups.
Two midwives, who during a session were familiarized with the process, contributed to the sampling process. For sampling, the files of all patients referring every day to Gynecology and Endocrinology Clinic were evaluated. Then, an initial interview was conducted with the women with even file number and the eligible ones were invited to participate in the study. After obtaining informed consent and recording the baseline information, SCL-90-R was completed as a self-report. After completing the questionnaires, the participants were introduced to the second midwife for random allocation to the intervention and control group using 70 cards marked equally A or B. Each participant took a card out of the envelope identifying one of the research groups. Unlike the first midwife, the participant and the midwife performing the random assignment did not know to which group each color belonged. After determining each group, each participant went to the first midwife to receive either intervention or control program.
Using 5A’s model, an intervention program was developed in order to provide lifestyle counseling and was done by one reproductive health specialist. This model included five stages of ask, advise, agree, assist and arrange, which were presented individually during four sessions of 45-60 minutes. With regard to the Assess stage, not only body mass index was calculated, but also knowledge, beliefs and lifestyle were assessed in terms of physical activity and nutritional behaviors. In the advise step, the disease as well as the effect of lifestyle on the course of the disease and its symptoms, and behavioral problems of nutrition and physical activity was explained. Computational skills were also explained to make a balance between the received and consumed calories. In the Agree stage, behavioral goals were identified based on each person's interests and priorities, and an agreement was reached with the participant for changing behavior and implementing a practical plan to achieve the goals. These three steps were performed in three sessions.
During the fourth session and with regard to the assist step, the participant was helped to discuss barriers to the implementation of lifestyle modification practical programs and barrier removal strategies. Moreover, based on the mentioned barriers, every participant was helped to identify the sources of social support related to their problem.
In the arrange step, based on the participants' preference, their progress status in terms of dietary behaviors and physical activity was followed using the telephone call. For the control group, face-to-face nutritional and physical activity recommendations were provided in two sessions with an interval of one week.
Research data were analyzed using SPSS software version 19 and statistical methods of independent t-test, Chi-square, Mann-Whitney and repeated measure analysis of variance. Significance level in data analysis was lower than 0.05. This field trial was registered at Iranian Registry of Clinical Trials on 03/10/2017 (IRCT2017092736445N1).
Ethics approval and consent to participate
All procedures performed in participants were in accordance with the ethical standards of the Isfahan University of Medical Sciences and informed consent was obtained from all participants.