Functional Dyspepsia Response to Relaxation Therapy and Physical Activity

Study Overview
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Brief Summary
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Functional dyspepsia (FD) is a common gastrointestinal disease with high morbidity. Due to the drop in estrogen level, perimenopausal women with FD (PMFD) have an increase in emotional disorders such as depression, anxiety and sleep disorder.

Detailed Description
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the research will include 30 FD women during their perimenopause to receive for 8 weeks the following: relaxation therapy (Benson relaxation), physical exercise (on treadmill), and proton pump inhibitors. Also, the research will include another 30 FD women during their perimenopause to receive for 8 weeks the following: relaxation therapy (Benson relaxation) and proton pump inhibitors

Official Title
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Functional Dyspepsia Response to Relaxation Therapy Alone or Combined With Physical Activity

Conditions
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Dyspepsia

Intervention / Treatment
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* Behavioral: relaxation and physical activity
* Behavioral: relaxation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: perimenopausal women With FD symptoms Exclusion Criteria: other gastrointestinal disease Cardiovascular, metabolic, respiratory, renal complaints Pregnancy Women in Lactation neurological / Psychic Women

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>This FD women group will include 30 females who will be treated for 8 weeks with oral proton pump inhibitors (taken one time daily with 40 mg pantoprazole-tablet dose), Benson relaxation daily sessions (twenty minutes at morning time and another 20 minutes at the evening time), physical activity ( five session per the week conducted on treadmill, 30 minutes in the first treatment month and 40 minutes in the second treatment month) | Behavioral: relaxation and physical activity<br>* This FD women group will include 30 females who will be treated for 8 weeks with oral proton pump inhibitors (taken one time daily with 40 mg pantoprazole-tablet dose), Benson relaxation daily sessions (twenty minutes at morning time and another 20 minutes at the evening time), physical activity ( five session per the week conducted on treadmill, 30 minutes in the first treatment month and 40 minutes in the second treatment month)<br>|
| Active Comparator: Group B<br>This FD women group will include 30 females who will be treated for 8 weeks with oral proton pump inhibitors (taken one time daily with 40 mg pantoprazole-tablet dose) and Benson relaxation daily sessions (twenty minutes at morning time and another 20 minutes at the evening time) | Behavioral: relaxation<br>* This FD women group will include 30 females who will be treated for 8 weeks with oral proton pump inhibitors (taken one time daily with 40 mg pantoprazole-tablet dose) and Benson relaxation daily sessions (twenty minutes at morning time and another 20 minutes at the evening time)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cortisol | stress hormone will be measured in serum | It will be measured after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow dyspepsia severity score | it is questionnaire assessing severity of dyspepsia | It will be measured after 8 weeks | 
| Visual analogue scale | it is a scale for assessment of severity of abdominal syymptoms | It will be measured after 8 weeks | 
| depression anxiety stress scales-42 | it is a 42 item self-report scale designed to measure the negative emotional states of depression, anxiety and stress | It will be measured after 8 weeks | 
| Pittsburgh sleep quality index | it is a questionnaire for sleep quality assessment | It will be measured after 8 weeks | 
| Estradiol | one of endogenous estrogen in the serum of women | It will be measured after 8 weeks |