Functional Dyspepsia Response to Relaxation Therapy and Physical Activity

Cairo University (CU)

Status: Unknown

Conditions: Dyspepsia

Treatments: Behavioral: relaxation; Behavioral: relaxation and physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT05378009

P.T.REC/012/003657

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: Female

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• perimenopausal women With FD symptoms

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

group A

Experimental group

Description:

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)

Treatment:

Behavioral: relaxation and physical activity

Group B

Active Comparator group

Description:

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)

Treatment:

Behavioral: relaxation