Effect of Applying Ujjayi Pranayama on Cortisol in Lupus Patients

February 19, 2023 updated by: Ahmed Mohamed Abdelhalim Elfahl, Badr University
stress vulnerability is very common in lupus patients, specifically women, hence the rates of depression , insomnia, easy fatigue perception, anxiety are high in those women. pranayama is a yogic intervention that may treat the above problems

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

lupus patients, specifically 40 women, will divided to group number 1 and group number 2. the women in every group will be 20 women. Group number 1 will receive home-based ujjayi pranayama for six weeks (fifteen minutes in the morning and 15 min in the evening, this training will be online supervised). The group number 2 will not receive Ujjayi pranayama, so it serves as control lupus group

Study Type

Interventional

Enrollment (Anticipated)

40

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 Contact

Study Locations

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

35 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 40 lupus women

Exclusion Criteria:

  • lupus co-morbidities
  • illiteracy

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 number 1
Group number 1 will receive home-based daily ujjayi pranayama for six weeks (fifteen minutes in the morning and 15 min in the evening, this training will be online supervised).
Behavioral: Ujjayi pranayama
this group will receive home-based daily ujjayi pranayama for six weeks (fifteen minutes in the morning and 15 min in the evening, this training will be online supervised).
No Intervention: group number 2
The group number 2 will not receive pranayama training, so it serves as control lupus group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum cortisol
Time Frame: it will be measured after 6 weeks
it will be taken from women at morning
it will be measured after 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
systolic blood pressure
Time Frame: it will be measured after 6 weeks
it will be assessed by manual sphygmomanometer
it will be measured after 6 weeks
diastolic blood pressure
Time Frame: it will be measured after 6 weeks
it will be assessed by manual sphygmomanometer
it will be measured after 6 weeks
pulse rate
Time Frame: it will be measured after 6 weeks
it is number of heart pulsation in minute
it will be measured after 6 weeks
respiratory rate
Time Frame: it will be measured after 6 weeks
it is number of respiration in minute
it will be measured after 6 weeks
Pittsburgh Sleep Quality Index
Time Frame: it will be measured after 6 weeks
it is a questionnaire assessing sleeping quality
it will be measured after 6 weeks
Fatigue severity scale
Time Frame: it will be measured after 6 weeks
it is a questionnaire assessing fatigue severity
it will be measured after 6 weeks
Beck Depression Inventory
Time Frame: it will be measured after 6 weeks
it is a questionnaire assessing depression
it will be measured after 6 weeks
State Trait Anxiety Inventory
Time Frame: it will be measured after 6 weeks
it is a questionnaire assessing Trait Anxiety
it will be measured after 6 weeks
Stress Vulnerability Scale
Time Frame: it will be measured after 6 weeks
it is a questionnaire assessing Stress Vulnerability
it will be measured after 6 weeks

Collaborators and Investigators

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

Sponsor

Badr University

Investigators

  • Principal Investigator: ahmed elfahl, Badr 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)

December 15, 2022

Primary Completion (Anticipated)

March 15, 2023

Study Completion (Anticipated)

March 15, 2023

Study Registration Dates

First Submitted

February 19, 2023

First Submitted That Met QC Criteria

February 19, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 19, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004288

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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