The Impact of a Pharmaceutical Care Model on Improving Polycystic Ovary Syndrome Associated Factors Amongst Females in Jordan and Syria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 4
- 主要终点
- Anxiety scale
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The study is a single-blinded randomized controlled trial. The patients 'study groups were only known for the clinical pharmacist.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females who had a doctor-diagnosis of PCOS.
- •Above the age of
- •Able to complete the 4-month study.
排除标准
- •Females with an old diagnosis of PCOS with no doctor visit in the past month.
- •Can not speak and understand Arabic.
结局指标
主要结局
Anxiety scale
时间窗: Change from Baseline and follow-up (up to 17 weeks)
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.
Blood Triglycerides levels
时间窗: Change from Baseline Blood Triglycerides levels and Follow-up (up to 17 weeks)
Blood Triglycerides levels assessment using the Multi-parametric device.
Body Mass Index
时间窗: Change from Baseline Body mass index and Follow-up (up to 16 weeks)
the Body Mass Index was calculated for each participant depending on their weight and hight.
Anxiety prevalence
时间窗: At baseline
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.
Depression scale
时间窗: Change from Baseline and follow-up (up to 17 weeks)
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.
Quality of Life scale assessment
时间窗: Change from Baseline Quality of Life and follow-up (up to 17 weeks)
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.
Blood Glucose levels
时间窗: Change from Baseline Blood Glucose levels and Follow-up (up to 17 weeks)
Blood Glucose levels assessment using the Multi-parametric device.
Blood Cholesterol levels
时间窗: Change from Baseline Blood Cholesterol levels and follow-up (up to 17 weeks)
Blood Cholesterol levels assessment using the Multi-parametric device.
Depression prevalence
时间窗: At baseline
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.
Blood pressure assessment
时间窗: Change from Baseline Blood Pressure and follow-up (up to 17 weeks)
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
次要结局
- Smoking frequency(Change from Baseline Smoking frequency and Follow-up (up to 17 weeks))
- Hooka frequency(change from Baseline Hooka frequency and Follow-up (up to 17 weeks))