Functional Dyspepsia Response to Relaxation Therapy and Physical Activity

May 12, 2022 updated by: Ali Mohamed Ali ismail, Cairo University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dokki
      • Giza, Dokki, Egypt
        • Recruiting
        • Faculty of physical therapy cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group A
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
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)
Active Comparator: Group B
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cortisol
Time Frame: It will be measured after 8 weeks
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
Time Frame: It will be measured after 8 weeks
it is questionnaire assessing severity of dyspepsia
It will be measured after 8 weeks
Visual analogue scale
Time Frame: It will be measured after 8 weeks
it is a scale for assessment of severity of abdominal syymptoms
It will be measured after 8 weeks
depression anxiety stress scales-42
Time Frame: 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
It will be measured after 8 weeks
Pittsburgh sleep quality index
Time Frame: It will be measured after 8 weeks
it is a questionnaire for sleep quality assessment
It will be measured after 8 weeks
Estradiol
Time Frame: It will be measured after 8 weeks
one of endogenous estrogen in the serum of women
It will be measured after 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

June 15, 2022

Study Completion (Anticipated)

June 15, 2022

Study Registration Dates

First Submitted

May 12, 2022

First Submitted That Met QC Criteria

May 12, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/003657

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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