Diaphragm; RelaxationNCT05762913
Effect of the Diaphragm Release Technique on Sleep Duration and Quality
A study testing Manual Diaphragm Release Technique in people with Diaphragm; Relaxation, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diaphragm; Relaxation
- What is being tested?
- Manual Diaphragm Release Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2023to 1 Jun 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals between the ages of 18-65 who do not have any chronic disease or any past or present psychological disorder will be included.
Who cannot join
- Individuals with any neurological, psychiatric or cognitive impairment will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Erkan Erol contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Faculty of Health Sciences, Tokat Gaziosmanpaşa University
Tokat Province, 60250
Erkan Erol, PhD, 05547920118, erkanerol@gmail.com
About this study
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.
- Conditions
- Diaphragm; Relaxation
- Being tested
- Manual Diaphragm Release Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Diaphragm Release TechniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragm release | Experimental | 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. Receives: Other: Manual Diaphragm Release Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
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"
Measured: Baseline
Pittsburgh Sleep Quality Index
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"
Measured: 3rd day
Sleep Time
Measurements will be made with the Fitbit® Inspire 2 device
Measured: 3rd day
Heart Rate
Measurements will be made with the Fitbit® Inspire 2 device
Measured: 3rd day
Step Count
Measurements will be made with the Fitbit® Inspire 2 device
Measured: 3rd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start30 Mar 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diaphragm; RelaxationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erkan Erol, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762913
- Sponsor's protocol ID
- GaziosmanpasaU_Erol_07
- Status last verified
- Sep 2023
- First submitted
- 19 Feb 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Erol E, Kurtbogan M. The effects of diaphragm release on sleep quality: a pilot feasibility study. BMC Pulm Med. 2025 Oct 15;25(1):471. doi: 10.1186/s12890-025-03968-4.
PubMed 41094450
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Diaphragm Release Technique on Sleep Duration and Quality
- ClinicalTrials.gov ID
- NCT05762913
- Acronym / sponsor ID
- GaziosmanpasaU_Erol_07
- Conditions
- Diaphragm; Relaxation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 10 Mar 2023 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diaphragm release | Experimental | Other: Manual Diaphragm Release TechniqueThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals between the ages of 18-65 who do not have any chronic disease or any past or present psychological disorder will be included.
Key exclusion criteria (1 listed)
- Individuals with any neurological, psychiatric or cognitive impairment will be excluded from the study.
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 |
|---|---|---|
| Manual Diaphragm Release TechniqueThe 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. | Other | Diaphragm release |
Primary outcome
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"
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"
Sleep Time
Time frame: 3rd day
Measurements will be made with the Fitbit® Inspire 2 device
Heart Rate
Time frame: 3rd day
Measurements will be made with the Fitbit® Inspire 2 device
Step Count
Time frame: 3rd day
Measurements will be made with the Fitbit® Inspire 2 device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 41094450Erol E, Kurtbogan M. The effects of diaphragm release on sleep quality: a pilot feasibility study. BMC Pulm Med. 2025 Oct 15;25(1):471. doi: 10.1186/s12890-025-03968-4.
Related trials for Diaphragm; Relaxation
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Active, not recruiting
Mind Body Balance for Pediatric Migraine
Headache, Headache Disorders
Recruiting
Responding With Evidence and Access for Childhood Headaches
Headache, Headache Disorders
Not yet recruiting
Effect of Progressive Muscle Relaxation and Diaphragmatic Breathing on Sleep Disturbances in Chemotherapy Patients
Sleep Disturbance, Sleep Disorders
Recruiting
Stress Management and Mindfulness Intervention for Patients With Sickle Cell Disease
Sickle Cell Disease
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.
Erkan Erol contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Diaphragm Release Technique in people with Diaphragm; Relaxation, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erkan Erol (erkanerol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05762913, which also lists 1 linked publication.
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 13 Sep 2023.