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Effect of Applying Ujjayi Pranayama on Cortisol in Lupus Patients

Primary Purpose

Systemic Lupus Erythematosus

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ujjayi pranayama
Sponsored by
Badr University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

35 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 40 lupus women Exclusion Criteria: lupus co-morbidities illiteracy

Sites / Locations

  • Badr UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

group number 1

group number 2

Arm Description

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).

The group number 2 will not receive pranayama training, so it serves as control lupus group

Outcomes

Primary Outcome Measures

serum cortisol
it will be taken from women at morning

Secondary Outcome Measures

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

Full Information

First Posted
February 19, 2023
Last Updated
February 19, 2023
Sponsor
Badr University
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1. Study Identification

Unique Protocol Identification Number
NCT05748899
Brief Title
Effect of Applying Ujjayi Pranayama on Cortisol in Lupus Patients
Official Title
Effect of Applying Ujjayi Pranayama on Cortisol in Lupus Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
March 15, 2023 (Anticipated)
Study Completion Date
March 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Badr University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group number 1
Arm Type
Experimental
Arm Description
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).
Arm Title
group number 2
Arm Type
No Intervention
Arm Description
The group number 2 will not receive pranayama training, so it serves as control lupus group
Intervention Type
Behavioral
Intervention Name(s)
Ujjayi pranayama
Intervention Description
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).
Primary Outcome Measure Information:
Title
serum cortisol
Description
it will be taken from women at morning
Time Frame
it will be measured after 6 weeks
Secondary Outcome Measure Information:
Title
systolic blood pressure
Description
it will be assessed by manual sphygmomanometer
Time Frame
it will be measured after 6 weeks
Title
diastolic blood pressure
Description
it will be assessed by manual sphygmomanometer
Time Frame
it will be measured after 6 weeks
Title
pulse rate
Description
it is number of heart pulsation in minute
Time Frame
it will be measured after 6 weeks
Title
respiratory rate
Description
it is number of respiration in minute
Time Frame
it will be measured after 6 weeks
Title
Pittsburgh Sleep Quality Index
Description
it is a questionnaire assessing sleeping quality
Time Frame
it will be measured after 6 weeks
Title
Fatigue severity scale
Description
it is a questionnaire assessing fatigue severity
Time Frame
it will be measured after 6 weeks
Title
Beck Depression Inventory
Description
it is a questionnaire assessing depression
Time Frame
it will be measured after 6 weeks
Title
State Trait Anxiety Inventory
Description
it is a questionnaire assessing Trait Anxiety
Time Frame
it will be measured after 6 weeks
Title
Stress Vulnerability Scale
Description
it is a questionnaire assessing Stress Vulnerability
Time Frame
it will be measured after 6 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
based on self-representation of gender identity
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 40 lupus women Exclusion Criteria: lupus co-morbidities illiteracy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mariam El Ebrashy, lecturer
Phone
02 01001716570.
Email
Mariam.elabrashi@buc.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmed elfahl
Organizational Affiliation
Badr University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Badr University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmed elfahl, lecturer
Phone
01001891218
Email
ahmed.elfahl@buc.edu.eg

12. IPD Sharing Statement

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Effect of Applying Ujjayi Pranayama on Cortisol in Lupus Patients

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