Functional Dyspepsia Response to Relaxation Therapy and Physical Activity

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05378009
• Other study ID #: P.T.REC/012/003657
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 15, 2022

Study information

• Verified date: May 2022
• Source: Cairo University
• Contact: Ali Ismail, lecturer
• Phone: 02 01005154209
• Email: allooka2012[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

Inclusion Criteria:

• perimenopausal women With FD symptoms

Exclusion Criteria:

• other gastrointestinal disease

• Cardiovascular, metabolic, respiratory, renal complaints

• Pregnancy

• Women in Lactation

• neurological / Psychic Women

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Behavioral:
• 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)
• 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)

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy Cairo University	Giza	Dokki

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cortisol	stress hormone will be measured in serum	It will be measured after 8 weeks
Secondary	Glasgow dyspepsia severity score	it is questionnaire assessing severity of dyspepsia	It will be measured after 8 weeks
Secondary	Visual analogue scale	it is a scale for assessment of severity of abdominal syymptoms	It will be measured after 8 weeks
Secondary	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
Secondary	Pittsburgh sleep quality index	it is a questionnaire for sleep quality assessment	It will be measured after 8 weeks
Secondary	Estradiol	one of endogenous estrogen in the serum of women	It will be measured after 8 weeks