- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05460962
Effects of Deep Breathing Excercises With and Without PMR on Depression & QOL in Females With Hystrectomy
December 7, 2022 updated by: Riphah International University
Effects of Deep Breathing Excercises With and Without Progressive Muscle Relaxation Technique on Depression and Quality of Life in Females With Hystrectomy
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
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
30
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
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Jinnah hospital
-
-
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:
- 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
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Deep breathing excercises
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
|
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
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
|
Experimental: Deep breathing excercise and progressive muscle relaxation
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
|
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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Inventory
Time Frame: 8 weeks
|
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.
|
8 weeks
|
WHOQOL-BREFF
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hafiza Neelam Muneeb, Ms, Riphah International 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)
January 20, 2022
Primary Completion (Actual)
July 15, 2022
Study Completion (Actual)
July 15, 2022
Study Registration Dates
First Submitted
July 14, 2022
First Submitted That Met QC Criteria
July 14, 2022
First Posted (Actual)
July 15, 2022
Study Record Updates
Last Update Posted (Estimate)
December 9, 2022
Last Update Submitted That Met QC Criteria
December 7, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/22/0515
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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