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Functional Dyspepsia Response to Relaxation Therapy and Physical Activity

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05378009
Enrollment
60
Registered
2022-05-17
Start date
2022-03-01
Completion date
2022-06-15
Last updated
2022-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia

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

Interventions

BEHAVIORALrelaxation 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)

BEHAVIORALrelaxation

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)

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* perimenopausal women With FD symptoms

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
cortisolIt will be measured after 8 weeksstress hormone will be measured in serum

Secondary

MeasureTime frameDescription
Glasgow dyspepsia severity scoreIt will be measured after 8 weeksit is questionnaire assessing severity of dyspepsia
Visual analogue scaleIt will be measured after 8 weeksit is a scale for assessment of severity of abdominal syymptoms
depression anxiety stress scales-42It will be measured after 8 weeksit is a 42 item self-report scale designed to measure the negative emotional states of depression, anxiety and stress
Pittsburgh sleep quality indexIt will be measured after 8 weeksit is a questionnaire for sleep quality assessment
EstradiolIt will be measured after 8 weeksone of endogenous estrogen in the serum of women

Countries

Egypt

Contacts

Primary ContactAli Ismail, lecturer
allooka2012@gmail.com02 01005154209

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026