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Effects of Deep Breathing Excer. With & Without PMR on Post C Section LBP, QOS & PA

Primary Purpose

Cesarean Section Complications

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Deep breathing excercises
Deep breathing exercises +and progressive muscle relaxation techniques
Deep breathing exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section Complications focused on measuring Cesarean section, Deep breathing excercises, Low back pain, Progressive muscle relaxation, Physical activity, Quality of sleep

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Females who had caesarian section
  • Age 20-35 years
  • No contraindications to exercise stated by an obstetrician

Exclusion Criteria:

  • Females having heart disease,
  • Females with Diabetes mellitus,
  • Pre-eclampsia or eclampsia
  • Complications during the operation
  • Diseases of the nervous system, e.g. MS, stroke, Respiratory diseases, Diabetes, Cancer &rheumatic diseases

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

Deep breathing is 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

PMR involves participants actively contracting muscles to create tension and progressively releasing it. This routine is repeated until participants acquire complete relaxation

Outcomes

Primary Outcome Measures

Lowback pain
The Oswestry Disability Index also known as the Oswestry Low Back Pain Disability Questionnaire and is an extremely important tool The test is considered the 'gold standard' of low back functional outcome tools.Most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living.
Quality of sleep
The Pittsburgh Sleep Quality Index (PSQI )is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.
Physical activity
Physical activity limitation questionnaire is used to assess the limitation of physical activities due to pain after C-section. It consists of 8 items (sitting in bed, standing up, walking, performing personal hygiene, bathing, breastfeeding, eating and using a toilet) which rated as: 0= easy performed, 1= performed with difficulties, 2= performed with assistance, and 3=can't perform. The total scores ranged from 0 to 24. The women are considered to have: 0-6= No limitation of the physical activities 7-12 = Mild limitation of the physical activities 13- 18= Moderate limitation of the physical activities 19-24 = Severe limitation of the physical activities

Secondary Outcome Measures

Full Information

First Posted
July 14, 2022
Last Updated
December 7, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05463146
Brief Title
Effects of Deep Breathing Excer. With & Without PMR on Post C Section LBP, QOS & PA
Official Title
Effects of Deep Breathing Excercises With and Without Progressive Muscle Relaxation Technique on Post Cesarean Section Low Back Pain, Quality of Sleep and Physical Activity.
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 Post Cesarean Section low back Pain, Quality of Sleep and Physical Activity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications
Keywords
Cesarean section, Deep breathing excercises, Low back pain, Progressive muscle relaxation, Physical activity, Quality of sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep breathing excercises
Arm Type
Experimental
Arm Description
Deep breathing is 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
Arm Title
Deep breathing excercise and progressive muscle relaxation
Arm Type
Experimental
Arm Description
PMR involves participants actively contracting muscles to create tension and progressively releasing it. This routine is repeated until participants acquire complete relaxation
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
Intervention Type
Other
Intervention Name(s)
Deep breathing exercises
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
Primary Outcome Measure Information:
Title
Lowback pain
Description
The Oswestry Disability Index also known as the Oswestry Low Back Pain Disability Questionnaire and is an extremely important tool The test is considered the 'gold standard' of low back functional outcome tools.Most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living.
Time Frame
8 weeks
Title
Quality of sleep
Description
The Pittsburgh Sleep Quality Index (PSQI )is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.
Time Frame
8 weeks
Title
Physical activity
Description
Physical activity limitation questionnaire is used to assess the limitation of physical activities due to pain after C-section. It consists of 8 items (sitting in bed, standing up, walking, performing personal hygiene, bathing, breastfeeding, eating and using a toilet) which rated as: 0= easy performed, 1= performed with difficulties, 2= performed with assistance, and 3=can't perform. The total scores ranged from 0 to 24. The women are considered to have: 0-6= No limitation of the physical activities 7-12 = Mild limitation of the physical activities 13- 18= Moderate limitation of the physical activities 19-24 = Severe limitation of the physical activities
Time Frame
8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Females who had caesarian section Age 20-35 years No contraindications to exercise stated by an obstetrician Exclusion Criteria: Females having heart disease, Females with Diabetes mellitus, Pre-eclampsia or eclampsia Complications during the operation Diseases of the nervous system, e.g. MS, stroke, Respiratory diseases, Diabetes, Cancer &rheumatic diseases
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

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Effects of Deep Breathing Excer. With & Without PMR on Post C Section LBP, QOS & PA

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