The Impact of a Pharmaceutical Care Model on Improving Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title: The Impact of a Pharmaceutical Care Model on Improving Polycystic Ovary Syndrome Associated Factors Amongst Females in Jordan and Syria

Status Completed

Clinical Trial Summary

The primary aim of this study was to estimate the prevalence of anxiety disorder and depression amongst Syrian and Jordanian women who are suffering from PCOS in Damascus and Amman.

The secondary aim was to assess the effectiveness of a PCOS pharmaceutical care service on selected patient's biochemical parameters, QOL, anxiety, and depression scale. The third aim is to identify the factors associated with QOL, anxiety and depression scores' change across the study.

Null Hypothesis (research hypothesis):

The intervention of PCOS pharmaceutical care service will lead to no significant differences in patient's depression, anxiety, QOL, and some biochemical parameters in comparison to females who will not receive this intervention in both Syria and Jordan.

Alternative Hypothesis (research hypothesis):

The intervention of PCOS pharmaceutical care service will have a significant impact on patient's depression, anxiety, QOL, and some biochemical parameters in comparison to patients who will not receive this intervention in both Syria and Jordan.

Clinical Trial Description

The information provided in the PCOS pharmaceutical care service was delivered in the format of oral plus written information (most important facts to remember and take-home messages regarding lifestyle modifications). The information provided included the importance of exercise and motivational messages to exercise more at home or in the gym. Participants were informed of previous study results which showed that 8-12 weeks of exercise can ameliorate cardiovascular risk factors and improve mental health.

The second part of the educational service was about the importance of decreasing the stress levels. The participants were informed that markers of oxidative stress were found to be out of range in PCOS women and that it was proven beneficial to do breathing exercises to reduce stress. It was clarified that the breathing exercise does not only relieve stress but also may help to gain better sleep and relieve anxiety symptoms. Participants were informed to perform a simple breathing exercise on daily basis (twice a day, morning and night) where they inhale through the nose for the account of four, and then exhale through the nose for the count of four, with the possibility to increase the counting to 6 then to 8.

The third part of the educational service aimed at improving participants' diets. They were informed to follow specific diet recommendations as follows:

to consume the majority of their daily calories prior to 12 pm (shown to improve insulin and glucose levels and decrease testosterone levels), to focus on food with low glycemic load e.g. chicken, meat, eggs and avocado (shown to decrease insulin levels).

to increase their vitamin C and calcium intake e.g. kiwi, orange and lemons (shown to improve body mass index and menstrual abnormalities, along with other PCOS-related symptoms).

to include adequate magnesium intake in their diet e.g. legume, spinach, broccoli, banana and pineapple (shown to lower the risk of heart disease, diabetes, and stroke).

to increase chromium intake, found in onions, garlic, grapefruit and tomatoes (shown to help regulate insulin and glucose levels).

to increase their consumption of omega-3, found in food such as tuna, salmon, fish, and walnuts (shown to help in decreasing androgen levels and testosterone).

In addition, participants were informed to avoid or to minimize certain types of food, explaining to them how it may negatively affect their PCOS condition. Such food types included caffeine beverages (as it may increase the estrogen level and affect fertility).

hydrogenated oils including margarine, corn oil, and coffee creamers (as it decreases the HDL (the good cholesterol), and increases the LDL (the bad cholesterol).

white sugary foods like cookies, cakes, and candies (as it can increase glucose levels).

dairy products (since it can cause allergic reactions and digestion problems, in addition to raising the testosterone levels).

Processed food (because it has a negative effect on insulin level). PCOS treatment was also discussed (orally only) with the participants (Fourth part of the service). Females were advised on the importance of using their correct treatment, for example using the pill for hormonal balance. They were informed of the importance of adhering to their prescribed medications, accepting that it was a long term treatment plan, and to consult with their specialist if their treatment was not effective, or in the case of medication side effects. ;

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

• NCT number: NCT04416620
• Study type: Interventional
• Source: Applied Science Private University
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Completion date: July 30, 2017