Effect of Diaphragmatic Release in Sleep Quality During Pregnancy

February 15, 2024 updated by: shaimaa Mohamed hamed, MTI University

Effect of Diaphragmatic Release in Sleep Quality During Pregnancy, Randomized Controlled Trail

Sleep disordered breathing (SDB) is very common during pregnancy, and is most likely explained by hormonal, physiological and physical changes. Maternal obesity, one of the major risk factors for SDB, together with physiological changes in pregnancy may predispose women to develop SDB. SDB has been associated with poor maternal and fetal outcomes. Thus, early identification, diagnosis and treatment of SDB are important in pregnancy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The present study will be conducted to add a new information to the body of knowledge of physical therapy profession as it will provide scientific basis for the clinical application of diaphragmatic release in sleep disordered breathing during pregnancy

Study Type

Interventional

Enrollment (Estimated)

44

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 Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Mti

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant women (at third trimester), diagnosed with sleep disordered breathing by the gynaecologist.
  • Their ages will range from 30- 40 years old .
  • Their BMI will be 25 to 30kg/m2.
  • All are multipara.

Exclusion criteria:

Women will be excluded from the study if they have:

  • Previous pulmonary surgery.
  • any pulmonary diseases.
  • Asthma.
  • Neurological disorders
  • Musculoskeletal disorders (severe osteoarthritis, osteoporosis)

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: diaphragmatic release
diaphragmatic myofascial release
Other: diaphragmatic release
diaphragmatic myofascial release for 1 months 3 sessions per week
Active Comparator: positioning
positioning instruction for sleep apnea
Other: diaphragmatic release
diaphragmatic myofascial release for 1 months 3 sessions per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pittshurgh sleep quality index
Time Frame: 1 month
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. Developed by researchers at the University of Pittsburgh,
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diaphragmatic excursion assessment
Time Frame: 1 month
diaphragmatic excursion assessment is that measures the movement of the thoracic diaphragm during breathing. Normal diaphragmatic excursion should be 3-5 cm, but can be increased in well-conditioned persons to 7-8 cm2.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MTI 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)

November 1, 2023

Primary Completion (Estimated)

February 29, 2024

Study Completion (Estimated)

March 17, 2024

Study Registration Dates

First Submitted

February 15, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Estimated)

February 23, 2024

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mitu

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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