NCT05463146

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

July 14, 2022

Last Update Submit

December 7, 2022

Conditions

Keywords

Cesarean sectionDeep breathing excercisesLow back painProgressive muscle relaxationPhysical activityQuality of sleep

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

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

Other: Deep breathing excercisesOther: Deep breathing exercises +and progressive muscle relaxation techniquesOther: 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

Other: Deep breathing excercisesOther: Deep breathing exercises +and progressive muscle relaxation techniquesOther: Deep breathing exercises

Interventions

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 excercise and progressive muscle relaxationDeep breathing excercises

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 excercise and progressive muscle relaxationDeep 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

Deep breathing excercise and progressive muscle relaxationDeep breathing excercises

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Low Back PainMotor ActivitySleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Hafiza Neelam Muneeb, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2022

First Posted

July 18, 2022

Study Start

January 20, 2022

Primary Completion

July 15, 2022

Study Completion

July 15, 2022

Last Updated

December 9, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations