Cesarean Section ComplicationsNCT05463146
Effects of Deep Breathing Excer. With & Without PMR on Post C Section LBP, QOS & PA
A study testing Deep breathing excercises, Deep breathing exercises +and progressive muscle relaxation techniques and Deep breathing exercises in people with Cesarean Section Complications, run by Riphah International University at 1 site in Pakistan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Deep breathing excercises, Deep breathing exercises +and progressive muscle relaxation techniques and Deep breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jan 2022to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females who had caesarian section
- Age 20-35 years
- No contraindications to exercise stated by an obstetrician
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Conditions
- Cesarean Section Complications
- Being tested
- Deep breathing excercises, Deep breathing exercises +and progressive muscle relaxation techniques, Deep breathing exercises
- Keywords
- Cesarean section, Deep breathing excercises, Low back pain, Progressive muscle relaxation, Physical activity, Quality of sleep
- Medical subject headings
- Low Back Pain, Motor Activity, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep breathing excercisesOther
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
Deep breathing exercises +and progressive muscle relaxation techniquesOther
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 exercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Deep breathing excercises | Experimental | 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 Receives: Other: Deep breathing excercises; Other: Deep breathing exercises +and progressive muscle relaxation techniques; Other: Deep breathing exercises |
| Deep breathing excercise and progressive muscle relaxation | Experimental | PMR involves participants actively contracting muscles to create tension and progressively releasing it. This routine is repeated until participants acquire complete relaxation Receives: Other: Deep breathing excercises; Other: Deep breathing exercises +and progressive muscle relaxation techniques; Other: Deep breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start20 Jan 2022
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Neelam Muneeb, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463146
- Sponsor's protocol ID
- REC/RCR&AHS/22/0514
- Status last verified
- Dec 2022
- First submitted
- 14 Jul 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05463146
- Acronym / sponsor ID
- REC/RCR&AHS/22/0514
- Conditions
- Cesarean Section Complications
- Keywords
- Cesarean section, Deep breathing excercises, Low back pain, Progressive muscle relaxation, Physical activity, Quality of sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep breathing excercises | Experimental | Other: Deep breathing excercises, Other: Deep breathing exercises +and progressive muscle relaxation techniques, Other: Deep breathing exercisesDeep 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 |
| Deep breathing excercise and progressive muscle relaxation | Experimental | Other: Deep breathing excercises, Other: Deep breathing exercises +and progressive muscle relaxation techniques, Other: Deep breathing exercisesPMR involves participants actively contracting muscles to create tension and progressively releasing it. This routine is repeated until participants acquire complete relaxation |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Females who had caesarian section
- Age 20-35 years
- No contraindications to exercise stated by an obstetrician
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep breathing excercisesDeep 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 excercise and progressive muscle relaxation, Deep breathing excercises |
| Deep breathing exercises +and progressive muscle relaxation techniquesBegin 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 excercise and progressive muscle relaxation, Deep breathing excercises |
| Deep breathing exercisesDeep 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 excercise and progressive muscle relaxation, Deep breathing excercises |
Primary outcome
Lowback pain
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hafiza Neelam Muneeb, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep breathing excercises, Deep breathing exercises +and progressive muscle relaxation techniques and Deep breathing exercises in people with Cesarean Section Complications, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lowback pain (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.