The Impact of a Pharmaceutical Care Model on Improving Polycystic Ovary Syndrome
Mots clés
Abstrait
La 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.
Rendez-vous
Dernière vérification: | 04/30/2020 |
Première soumission: | 05/21/2020 |
Inscription estimée soumise: | 06/02/2020 |
Première publication: | 06/03/2020 |
Dernière mise à jour soumise: | 06/02/2020 |
Dernière mise à jour publiée: | 06/03/2020 |
Date de début réelle de l'étude: | 01/31/2017 |
Date d'achèvement primaire estimée: | 02/28/2017 |
Date estimée d'achèvement de l'étude: | 07/29/2017 |
Condition ou maladie
Intervention / traitement
Other: The PCOS pharmaceutical care service
Phase
Groupes d'armes
Bras | Intervention / traitement |
---|---|
Active Comparator: The active group of Syria Participants in the active group received the 'pharmacist standard counseling' plus the 'pharmaceutical care service' designed by the research group. Both services were delivered by one female clinical pharmacist who has a Master's degree in pharmaceutical sciences, 5-year work experience in community pharmacies, and comprehensive knowledge of PCOS. The time it took to deliver the counseling and education to each participant in the active group was formally assessed. This time assessment excluded data collection and questionnaire filling time (which was planned to take around 15 min).
Participants in the active group received the usual care delivered at the community pharmacies plus the pharmaceutical care service designed by the research group and provided by the clinical pharmacist. The intervention was delivered via oral advice and recommendations, and written material, with a special focus on diet and exercise. | |
No Intervention: The control group of Syria Participants in the control group received the usual care only which is the 'pharmacist standard counseling' involved dispensing the prescribed medication (delivered by the pharmacist in charge), counseling on how to take the dispensed medications, and a brief reply to questions if asked by the participants. The 'pharmacist standard counseling' followed what was normally delivered to females with PCOS by pharmacists working at community pharmacies in both countries. This 'pharmacist standard counseling' was established based on what was observed and reported by the project research team after viewing the usual pharmacists' interaction with females with PCOS for two weeks in each country before the start of the study.
Participants in the control group were informed that the educational intervention (the pharmaceutical care service) will be delivered to them after the end of the study (for ethical reasons). | |
Active Comparator: The active group of Jordan Participants in the active group received the usual care delivered at the community pharmacies plus the pharmaceutical care service designed by the research group and provided by the clinical pharmacist. The intervention was delivered via oral advice and recommendations, and written material, with a special focus on diet and exercise. | |
No Intervention: The control group of Jordan Participants in the control group received the usual care only which is the 'pharmacist standard counseling' involved dispensing the prescribed medication (delivered by the pharmacist in charge), counseling on how to take the dispensed medications, and a brief reply to questions if asked by the participants. The 'pharmacist standard counseling' followed what was normally delivered to females with PCOS by pharmacists working at community pharmacies in both countries. This 'pharmacist standard counseling' was established based on what was observed and reported by the project research team after viewing the usual pharmacists' interaction with females with PCOS for two weeks in each country before the start of the study.
Participants in the control group were informed that the educational intervention (the pharmaceutical care service) will be delivered to them after the end of the study (for ethical reasons). |
Critère d'éligibilité
Âges éligibles aux études | 16 Years À 16 Years |
Sexes éligibles à l'étude | Female |
Accepte les bénévoles en santé | Oui |
Critères | Inclusion Criteria: - Females who had a doctor-diagnosis of PCOS. - Above the age of 16. - Able to complete the 4-month study. Exclusion Criteria: - Females with an old diagnosis of PCOS with no doctor visit in the past month. - Can not speak and understand Arabic. |
Résultat
Mesures des résultats primaires
1. Anxiety prevalence [At baseline]
2. Depression prevalence [At baseline]
3. Anxiety scale [Change from Baseline and follow-up (up to 17 weeks)]
4. Depression scale [Change from Baseline and follow-up (up to 17 weeks)]
5. Quality of Life scale assessment [Change from Baseline Quality of Life and follow-up (up to 17 weeks)]
6. Blood pressure assessment [Change from Baseline Blood Pressure and follow-up (up to 17 weeks)]
7. Blood Glucose levels [Change from Baseline Blood Glucose levels and Follow-up (up to 17 weeks)]
8. Blood Cholesterol levels [Change from Baseline Blood Cholesterol levels and follow-up (up to 17 weeks)]
9. Blood Triglycerides levels [Change from Baseline Blood Triglycerides levels and Follow-up (up to 17 weeks)]
10. Body Mass Index [Change from Baseline Body mass index and Follow-up (up to 16 weeks)]
Mesures des résultats secondaires
1. Smoking frequency [Change from Baseline Smoking frequency and Follow-up (up to 17 weeks)]
2. Hooka frequency [change from Baseline Hooka frequency and Follow-up (up to 17 weeks)]