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

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.

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Other: Deep breathing excercises; Other: Deep breathing exercises +and progressive muscle relaxation techniques; Other: Deep breathing exercises

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Jinnah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deep breathing excercises; 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	Other: Deep breathing excercises; 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; Other: Deep breathing exercises +and progressive muscle relaxation techniques; 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; Other: Deep breathing exercises; 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
Experimental: Deep breathing excercise and progressive muscle relaxation; PMR involves participants actively contracting muscles to create tension and progressively releasing it. This routine is repeated until participants acquire complete relaxation	Other: Deep breathing excercises; 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; Other: Deep breathing exercises +and progressive muscle relaxation techniques; 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; Other: Deep breathing exercises; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks
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.	8 weeks
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	8 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Hafiza Neelam Muneeb, Ms, Riphah International University

Study record dates

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 18, 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

• Keywords: Low back pain; Physical activity; Cesarean section; Progressive muscle relaxation; Deep breathing excercises; Quality of sleep
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: REC/RCR&AHS/22/0514

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