Effect of the Diaphragm Release Technique on Sleep Duration and Quality

Diaphragm; Relaxation Clinical Trial

Official title:

Effect of the Diaphragm Release Technique on Sleep Duration and Quality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05762913
• Other study ID #: GaziosmanpasaU_Erol_07
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: September 2023
• Source: Tokat Gaziosmanpasa University
• Contact: Erkan Erol
• Email: erkanerol[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diaphragm; Relaxation

Intervention

Other:
• Manual Diaphragm Release Technique
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.

Locations

Country	Name	City	State
Turkey	Faculty of Health Sciences, Tokat Gaziosmanpasa University	Tokat

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"	Baseline
Primary	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"	3rd day
Primary	Sleep Time	Measurements will be made with the Fitbit® Inspire 2 device	3rd day
Primary	Heart Rate	Measurements will be made with the Fitbit® Inspire 2 device	3rd day
Primary	Step Count	Measurements will be made with the Fitbit® Inspire 2 device	3rd day