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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04416620
• Other study ID #: 2017-PHA 2
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: July 30, 2017

Study information

• Verified date: May 2020
• Source: Applied Science Private University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 30, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• The PCOS pharmaceutical care service
The intervention was provided in the format of oral plus written information. The information provided included the importance of exercise and motivational messages to exercise more at home or in the gym. The 2nd part was about the importance of decreasing the stress levels. Participants were informed to perform a simple breathing exercise on daily basis twice a day. The 3rd part aimed at improving participants' diets. They were informed to follow specific diet recommendations and to avoid certain types of food, explaining to them how it may negatively affect their PCOS condition. The 4th part was about the PCOS treatment that was discussed with the participants. Females were advised on the importance of using their correct treatment. 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.

Locations

Country	Name	City	State
Jordan	Five branches of Pharmacy 1	Amman
Syrian Arab Republic	Almazra pharmacy	Damascus
Syrian Arab Republic	Alwafaa pharmacy	Damascus
Syrian Arab Republic	Kinda Pharmacy	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Applied Science Private University

Countries where clinical trial is conducted

Jordan,  Syrian Arab Republic, 

References & Publications (5)

Benson S, Hahn S, Tan S, Mann K, Janssen OE, Schedlowski M, Elsenbruch S. Prevalence and implications of anxiety in polycystic ovary syndrome: results of an internet-based survey in Germany. Hum Reprod. 2009 Jun;24(6):1446-51. doi: 10.1093/humrep/dep031. — View Citation

Laggari V, Diareme S, Christogiorgos S, Deligeoroglou E, Christopoulos P, Tsiantis J, Creatsas G. Anxiety and depression in adolescents with polycystic ovary syndrome and Mayer-Rokitansky-Küster-Hauser syndrome. J Psychosom Obstet Gynaecol. 2009 Jun;30(2) — View Citation

Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: — View Citation

Thomson RL, Buckley JD, Lim SS, Noakes M, Clifton PM, Norman RJ, Brinkworth GD. Lifestyle management improves quality of life and depression in overweight and obese women with polycystic ovary syndrome. Fertil Steril. 2010 Oct;94(5):1812-6. doi: 10.1016/j — View Citation

Vigorito C, Giallauria F, Palomba S, Cascella T, Manguso F, Lucci R, De Lorenzo A, Tafuri D, Lombardi G, Colao A, Orio F. Beneficial effects of a three-month structured exercise training program on cardiopulmonary functional capacity in young women with p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety prevalence	Anxiety prevalence assessment using the Beck Anxiety Inventory. The BAI scale, consisted of 21-multiple-choice questions, with 4-point scale indicating the degree of anxiety severity (0-3; all questions were scored positively). Points were summed to produce a total measure score, indicating four levels of anxiety severity: 0-7 reflecting minimal level of anxiety, 8-15 reflecting mild level of anxiety, 16-25 reflecting moderate level of anxiety and 26-63 reflecting severe level of anxiety. The possible score for each participant ranged from 0 to 63. Lower scores indicated better anxiety symptoms.	At baseline
Primary	Depression prevalence	Depression prevalence assessment using the Beck Depression Inventory. The BDI is a 4-point scale (0-3) indicating the level of depression severity, with the score referring to six levels: 0-10 indicating the ups and downs reported by the participant were normal, 11-16 reflecting mild mood disturbances, 17-20 reflecting borderline clinical depression, 21-30 reflecting moderate depression, 31-40 reflecting severe depression, and over 40 reflecting extreme depression. The possible score for each participant ranged from 0 to 63. The BDI Questionnaire evaluates pessimistic attitude, loss of appetite, sad mood and feelings of guilt. Lower scores indicated better depression symptoms.	At baseline
Primary	Anxiety scale	Levels of Anxiety severity and mean score assessment were done by the Beck Anxiety Inventory.; The BAI scale, consisted of 21-multiple-choice questions, with 4-point scale indicating the degree of anxiety severity (0-3; all questions were scored positively). Points were summed to produce a total measure score, indicating four levels of anxiety severity: 0-7 reflecting minimal level of anxiety, 8-15 reflecting mild level of anxiety, 16-25 reflecting moderate level of anxiety and 26-63 reflecting severe level of anxiety. The possible score for each participant ranged from 0 to 63. Lower scores indicated better anxiety symptoms.	Change from Baseline and follow-up (up to 17 weeks)
Primary	Depression scale	Levels of Depression severity and mean score assessment were done by the Beck Depression Inventory.; The BDI is a 4-point scale (0-3) indicating the level of depression severity, with the score referring to six levels: 0-10 indicating the ups and downs reported by the participant were normal, 11-16 reflecting mild mood disturbances, 17-20 reflecting borderline clinical depression, 21-30 reflecting moderate depression, 31-40 reflecting severe depression, and over 40 reflecting extreme depression. The possible score for each participant ranged from 0 to 63. The BDI Questionnaire evaluates pessimistic attitude, loss of appetite, sad mood and feelings of guilt. Lower scores indicated better depression symptoms.	Change from Baseline and follow-up (up to 17 weeks)
Primary	Quality of Life scale assessment	Quality of Life assessment using the polycystic ovary syndrome health-related QOL questionnaire (PCOSQ).; It has a 30 questions about symptoms related to menstruation and mood. It can identify seven factors affecting the QOL in PCOS women including: emotional disturbance, hirsutism, weight concerns, infertility, menstrual symptoms, menstrual predictability and acne. The QOL was analyzed individually as a continuous scale out of seven to assess the QOL in patients (the higher the score is, the better the QOL is). After that, each question of the 30 questions included in the PCOSQ questionnaire was analyzed, and the mean score within each question was obtained and compared between baseline and follow-up. After that, each domain included in the QOL questionnaire was analyzed individually. Mean score of each domain was obtained and compared between baseline and follow-u to assess the impact of lifestyle modifications on that domain.	Change from Baseline Quality of Life and follow-up (up to 17 weeks)
Primary	Blood pressure assessment	Systolic and diastolic blood pressure measurements were measured using the right arm, twice after a 10-min rest and averaged by using the gold standard, mercury sphygmomanometers	Change from Baseline Blood Pressure and follow-up (up to 17 weeks)
Primary	Blood Glucose levels	Blood Glucose levels assessment using the Multi-parametric device.	Change from Baseline Blood Glucose levels and Follow-up (up to 17 weeks)
Primary	Blood Cholesterol levels	Blood Cholesterol levels assessment using the Multi-parametric device.	Change from Baseline Blood Cholesterol levels and follow-up (up to 17 weeks)
Primary	Blood Triglycerides levels	Blood Triglycerides levels assessment using the Multi-parametric device.	Change from Baseline Blood Triglycerides levels and Follow-up (up to 17 weeks)
Primary	Body Mass Index	the Body Mass Index was calculated for each participant depending on their weight and hight.	Change from Baseline Body mass index and Follow-up (up to 16 weeks)
Secondary	Smoking frequency	smokers participants recorded the number of cigarettes smoked per day.	Change from Baseline Smoking frequency and Follow-up (up to 17 weeks)
Secondary	Hooka frequency	the frequency hooka habits was recorded.	change from Baseline Hooka frequency and Follow-up (up to 17 weeks)