- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05762913
Effect of the Diaphragm Release Technique on Sleep Duration and Quality
September 11, 2023 updated by: Erkan Erol, Tokat Gaziosmanpasa University
Even in healthy individuals, there may be tensions in the diaphragm muscle due to factors such as wrong posture, wrong breathing pattern, sedentary lifestyle, and it cannot fully fulfill its function.
As a result of this tension in the diaphragm muscle, the breathing pattern deteriorates and sleep quality decreases.
The aim of this study is to examine the effect of diaphragm release technique on sleep duration and sleep quality in healthy individuals.
In this study, sleep quality of individuals will be evaluated with Pittsburgh Sleep Quality Index (PUKI), sleep duration, heart rate and step count with Fitbit® Inspire 2. 32 individuals living in Tokat will be included in the study.
After obtaining the sociodemographic information of the individuals, the average of sleep duration, heart rate and step counts will be recorded for 3 days with the Fitbit® Inspire 2 wearable technology to be provided within the scope of the project.
Sleep quality will be recorded with PUKI.
The diaphragm release technique will be applied in 3 sessions, with 2 days of rest in between.
After the applications are finished, sleep time, heart rate and step counts will be recorded for 3 days with Fitbit® Inspire 2 wearable technology.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
32
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
- Name: Erkan Erol
- Email: erkanerol@gmail.com
Study Locations
-
-
-
Tokat, Turkey, 60250
- Recruiting
- Faculty of Health Sciences, Tokat Gaziosmanpaşa University
-
Contact:
- Erkan Erol, PhD
- Phone Number: 05547920118
- Email: erkanerol@gmail.com
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Individuals between the ages of 18-65 who do not have any chronic disease or any past or present psychological disorder will be included.
Exclusion Criteria:
- Individuals with any neurological, psychiatric or cognitive impairment will be excluded from the study.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diaphragm release
The therapist passes his fingers under the costal arch, during inspiration the therapist accompanies the movement of the ribs, while during expiration he takes his fingers deeper, increasing his pressure.
The therapist progresses progressively deeper into the costal arch with each breath.
The maneuver will be performed in two sets of 10 deep breaths.
The diaphragm release technique will be applied in 3 sessions, with 2 days of rest in between.
|
The therapist passes his fingers under the costal arch, during inspiration the therapist accompanies the movement of the ribs, while during expiration he takes his fingers deeper, increasing his pressure.
The therapist progresses progressively deeper into the costal arch with each breath.
The maneuver will be performed in two sets of 10 deep breaths.
The diaphragm release technique will be applied in 3 sessions, with 2 days of rest in between.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pittsburgh Sleep Quality Index
Time Frame: Baseline
|
In the scale consisting of 24 questions in total, 19 questions are answered by the person, while the other 5 questions are filled by the person's bedmate.
7 sub-dimensions (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, daytime dysfunction) are evaluated with 19 questions answered by the individual.
Each item in the scale scores between 0 (no distress)-3 (severe distress).
The sum of the scores of the seven sub-dimensions gives the total PSQI score (between 0-21).
Those with a total score of 5≥ "good sleep", and those with a score of <5 are considered "poor sleep quality"
|
Baseline
|
|
Pittsburgh Sleep Quality Index
Time Frame: 3rd day
|
In the scale consisting of 24 questions in total, 19 questions are answered by the person, while the other 5 questions are filled by the person's bedmate.
7 sub-dimensions (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, daytime dysfunction) are evaluated with 19 questions answered by the individual.
Each item in the scale scores between 0 (no distress)-3 (severe distress).
The sum of the scores of the seven sub-dimensions gives the total PSQI score (between 0-21).
Those with a total score of 5≥ "good sleep", and those with a score of <5 are considered "poor sleep quality"
|
3rd day
|
|
Sleep Time
Time Frame: 3rd day
|
Measurements will be made with the Fitbit® Inspire 2 device
|
3rd day
|
|
Heart Rate
Time Frame: 3rd day
|
Measurements will be made with the Fitbit® Inspire 2 device
|
3rd day
|
|
Step Count
Time Frame: 3rd day
|
Measurements will be made with the Fitbit® Inspire 2 device
|
3rd day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 30, 2023
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
February 19, 2023
First Submitted That Met QC Criteria
February 28, 2023
First Posted (Actual)
March 10, 2023
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 11, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- GaziosmanpasaU_Erol_07
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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