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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05748899
Other study ID # P.T.REC/012/004288
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 15, 2022
Est. completion date March 15, 2023

Study information

Verified date February 2023
Source Badr University
Contact mariam El Ebrashy, lecturer
Phone 02 01001716570.
Email Mariam.elabrashi@buc.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 15, 2023
Est. primary completion date March 15, 2023
Accepts healthy volunteers No
Gender Female
Age group 35 Years to 55 Years
Eligibility Inclusion Criteria: - 40 lupus women Exclusion Criteria: - lupus co-morbidities - illiteracy

Study Design


Intervention

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).

Locations

Country Name City State
Egypt Badr University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Badr University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum cortisol it will be taken from women at morning it will be measured after 6 weeks
Secondary systolic blood pressure it will be assessed by manual sphygmomanometer it will be measured after 6 weeks
Secondary diastolic blood pressure it will be assessed by manual sphygmomanometer it will be measured after 6 weeks
Secondary pulse rate it is number of heart pulsation in minute it will be measured after 6 weeks
Secondary respiratory rate it is number of respiration in minute it will be measured after 6 weeks
Secondary Pittsburgh Sleep Quality Index it is a questionnaire assessing sleeping quality it will be measured after 6 weeks
Secondary Fatigue severity scale it is a questionnaire assessing fatigue severity it will be measured after 6 weeks
Secondary Beck Depression Inventory it is a questionnaire assessing depression it will be measured after 6 weeks
Secondary State Trait Anxiety Inventory it is a questionnaire assessing Trait Anxiety it will be measured after 6 weeks
Secondary Stress Vulnerability Scale it is a questionnaire assessing Stress Vulnerability it will be measured after 6 weeks
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