Functional Dyspepsia Response to Relaxation Therapy and Physical Activity

Not Applicable

• Conditions: Dyspepsia
• Interventions: Behavioral: relaxation and physical activity; Behavioral: relaxation

• Registration Number: NCT05378009
• Lead Sponsor: Cairo University

Brief Summary

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

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

Study Timeline

• Study Start: 2022-03-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-12
• Last Update Submitted: 2022-05-12
• Study First Posted: 2022-05-17
• Last Update Posted: 2022-05-17
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• perimenopausal women With FD symptoms

Exclusion Criteria

• other gastrointestinal disease
• Cardiovascular, metabolic, respiratory, renal complaints
• Pregnancy
• Women in Lactation
• neurological / Psychic Women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	relaxation and physical activity	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)
Group B	relaxation	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)

Primary Outcome Measures

Name	Time	Method
cortisol	It will be measured after 8 weeks	stress hormone will be measured in serum

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Physical Therapy Cairo University; 🇪🇬 Giza, Dokki, Egypt