Back to resultsEffects of Deep Breathing Excercises With and Without PMR on Depression & QOL in Females With Hystrectomy
Primary Purpose
Post-Hysterectomy Vaginal Vault Prolapse
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Deep breathing excercises
Deep breathing exercises +and progressive muscle relaxation techniques
Sponsored by
About this trial
This is an interventional treatment trial for Post-Hysterectomy Vaginal Vault Prolapse focused on measuring Depression, Hysterectomy, Progressive muscle relaxation technique
Eligibility Criteria
Inclusion Criteria:
- Age 35-55
- Females gone through all types of hysterotomy
- Hysterotomy done due to heavy menstrual bleeding, fibroids, pelvic pain, endometriosis and MAP ( Morbidly adherent placenta ).
Exclusion Criteria:
- Females with hormonal replacement therapy
- Any history of cancer
- Diagnosed patient of any psychiatric illness
Sites / Locations
- Jinnah hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Deep breathing excercises
Deep breathing excercise and progressive muscle relaxation
Arm Description
is a technique that is based on the notion that mind and body integration produces relaxation technique requires participants to contract the diaphragm, slowly inhaling and exhaling. Deep breathing appears to amplify blood oxygen levels, massages the inner organs located in or close to the abdomen, and possibly stimulates the vagus nerve
Begin with a deep breathing exercise. Inhale deeply through your nose, feeling your abdomen rise as you fill your body with air. Then slowly exhale out the mouth, the navel pulling in toward the spine as you expel the stale air out. Repeat 3-5 cycles
Outcomes
Primary Outcome Measures
Beck Depression Inventory
The Beck Depression Inventory (BDI) created by Aaron T. Beck, is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Its development marked a shift among mental health professionals, who had until then, viewed depression from a psychodynamic perspective, instead of it being rooted in the patient's own thoughts.
WHOQOL-BREFF
Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale (16, 17). The physical health domain includes items on mobility, daily activities, functional capacity, energy, pain, and sleep.
Secondary Outcome Measures
Full Information
NCT ID
NCT05460962
First Posted
July 14, 2022
Last Updated
December 7, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05460962
Brief Title
Effects of Deep Breathing Excercises With and Without PMR on Depression & QOL in Females With Hystrectomy
Official Title
Effects of Deep Breathing Excercises With and Without Progressive Muscle Relaxation Technique on Depression and Quality of Life in Females With Hystrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To find out the Effects of deep breathing exercises with and without Progressive Muscle Relaxation Technique on depression and Quality of life in females with hysterotomy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Hysterectomy Vaginal Vault Prolapse
Keywords
Depression, Hysterectomy, Progressive muscle relaxation technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deep breathing excercises
Arm Type
Experimental
Arm Description
is a technique that is based on the notion that mind and body integration produces relaxation technique requires participants to contract the diaphragm, slowly inhaling and exhaling. Deep breathing appears to amplify blood oxygen levels, massages the inner organs located in or close to the abdomen, and possibly stimulates the vagus nerve
Arm Title
Deep breathing excercise and progressive muscle relaxation
Arm Type
Experimental
Arm Description
Begin with a deep breathing exercise. Inhale deeply through your nose, feeling your abdomen rise as you fill your body with air. Then slowly exhale out the mouth, the navel pulling in toward the spine as you expel the stale air out. Repeat 3-5 cycles
Intervention Type
Other
Intervention Name(s)
Deep breathing excercises
Intervention Description
Deep breathing, which is also known as diaphragmatic breathing, is a technique that is based on the notion that mind and body integration produces relaxation technique requires participants to contract the diaphragm, slowly inhaling and exhaling. Deep breathing appears to amplify blood oxygen levels, massages the inner organs located in or close to the abdomen, and possibly stimulates the vagus nerve
Intervention Type
Other
Intervention Name(s)
Deep breathing exercises +and progressive muscle relaxation techniques
Intervention Description
Begin with a deep breathing exercise. Inhale deeply through your nose, feeling your abdomen rise as you fill your body with air. Then slowly exhale out the mouth, the navel pulling in toward the spine as you expel the stale air out. Repeat 3-5 cycles
Primary Outcome Measure Information:
Title
Beck Depression Inventory
Description
The Beck Depression Inventory (BDI) created by Aaron T. Beck, is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Its development marked a shift among mental health professionals, who had until then, viewed depression from a psychodynamic perspective, instead of it being rooted in the patient's own thoughts.
Time Frame
8 weeks
Title
WHOQOL-BREFF
Description
Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale (16, 17). The physical health domain includes items on mobility, daily activities, functional capacity, energy, pain, and sleep.
Time Frame
8 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 35-55
Females gone through all types of hysterotomy
Hysterotomy done due to heavy menstrual bleeding, fibroids, pelvic pain, endometriosis and MAP ( Morbidly adherent placenta ).
Exclusion Criteria:
Females with hormonal replacement therapy
Any history of cancer
Diagnosed patient of any psychiatric illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiza Neelam Muneeb, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Deep Breathing Excercises With and Without PMR on Depression & QOL in Females With Hystrectomy
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