Deep Breathing ManeuverDeep breathingNCT06972173
SHORT-TERM EFFECTS OF DEEP BREATHING AND PROGRESSIVE MUSCLE RELAXATION EXERCISES ON MUSCULOSKELETAL PAIN AND WELL-BEING IN HIGH SCHOOL STUDENTS
A study testing DEEP BREATHING AND PROGRESSIVE MUSCLE RELAXATION EXERCISES in people with Deep Breathing Maneuver and PROGRESSIVE MUSCLE RELAXATION EXERCISES, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
Exam stress in high school students, long hours of studying in the static posture, and lack of physical activity habits can cause physical and psychological discomfort in them. This discomfort can be physically seen as musculoskeletal pain, while as psychologically it can be observed as a decrease in well-being. Read more about this study
- Who is it for?
- Ages 13 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Breathing Maneuver, PROGRESSIVE MUSCLE RELAXATION EXERCISES
- What is being tested?
- DEEP BREATHING AND PROGRESSIVE MUSCLE RELAXATION EXERCISES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Aug 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 13 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The inclusion criteria were voluntary acceptance to participate in the exercise program with parental consent, the absence of an orthopedic, neurological or psychiatric disorder that would affect participation in exercises, and full participation in exercise sessions.
Who cannot join
- Those who did not meet the inclusion criteria and did not voluntarily agree to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırklareli ANATOLIA HIGH SCHOOL
Kırklareli, Central, 39000
About this study
Official title: By the WHO and ICMJE for Studies With a Study Start Date That is Before June 1, 2024
Exam stress in high school students, long hours of studying in the static posture, and lack of physical activity habits can cause physical and psychological discomfort in them. This discomfort can be physically seen as musculoskeletal pain, while as psychologically it can be observed as a decrease in well-being. This situation can cause the acute onset of musculoskeletal pain in students to become chronic with a decrease in well-being. On the contrary, we can observe an increase in musculoskeletal pain due to stress that may occur due to a decrease in well-being.
Musculoskeletal pain is a condition that is not fatal but severely impairs health and well-being (1). According to the biopsychosocial model, pain occurs in a complex interaction between biological, psychological and social factors (2). Therefore, pain is both a subjective experience and a physical sensation with large individual differences (3). Relaxation is now a non-pharmacological intervention that has been increasingly accepted in recent years to reduce and cope with pain (4). A person who is relaxed usually has a physical and psychological well-being and feelings of calmness (5). With relaxation exercises, the person starts to reduce anxiety level by coping with stress (6). In addition to relaxation techniques, deep breathing exercise, also known as diaphragmatic breathing, is a technique based on the idea that mind and body integration provides relaxation (7). Breathing exercises are easy to learn and practice and benefit can be obtained from deep breathing exercises performed in a short time (5 minutes of practice may be sufficient) (8). In studies in which both techniques were used separately, it was reported to provide physical and psychological relaxation.
Read more
The unique aspect of this study is the investigation of the effects of both techniques on pain and well-being in high school students using both techniques simultaneously.
For this purpose, we planned to investigate the short-term effects of deep breathing and progressive muscle relaxation exercises on musculoskeletal pain and well-being in high school students.
- Being tested
- DEEP BREATHING AND PROGRESSIVE MUSCLE RELAXATION EXERCISES
- Keywords
- Deep breathing exercises, progressive muscle relaxation exercises, high school students, musculoskeletal pain, well-being
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEEP BREATHING AND PROGRESSIVE MUSCLE RELAXATION EXERCISESOther
For deep breathing exercises, students were asked to place their dominant hand on their abdomen and non-dominant hand on their chest in the semi-fowler position. Afterwards, they were instructed to breath deeply through their nose for 4 seconds and exhale through their mouth for 8 seconds. These exercises were performed as 4 repetitions with 2 minutes rest time between the exercises. When the deep breathing exercises were finished, the students lay on their backs and rested for 1 minute and then progressive muscle relaxation exercise was started (10,11).
For the progressive muscle relaxation exercise, the students were asked to contract and then relax the right foot, left foot, right leg, left leg, hip, abdominal muscles, chest muscles and back muscles, right hand, left hand, right arm, left arm, neck and shoulders, and facial muscles respectively. Respectively, from bottom to top, all the major muscles are contracted while inhaling deeply and slowly, and relaxed and r
| Study group | Role | What they receive |
|---|---|---|
| EXERCISE GROUP | Experimental | The exercise program consisting of deep breathing and progressive muscle relaxation exercises was applied to the students in the exercise group. The first exercise session was started the day after the training about the study. During the study period, the program was started at the end of school hours of high school students for a total of 20 sessions (4 weeks, every weekday), each session lasting 30 minutes. The sessions started with deep breathing exercises, continued with progressive muscle relaxation exercises, and ended with deep breathing exercises.
For deep breathing exercises, students were asked to place their dominant hand on their abdomen and non-dominant hand on their chest in the semi-fowler position. Afterwards, they were instructed to breath deeply through their nose for 4 seconds and exhale through their mouth for 8 seconds. These exercises were performed as 4 repetitions with 2 minutes rest time between the exercises. When the deep breathing exercise Receives: Other: DEEP BREATHING AND PROGRESSIVE MUSCLE RELAXATION EXERCISES |
| CONTROL GROUP | No intervention | no treatment was applied to student in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
musculoskeletal pain
Cornell Musculoskeletal Disorder Questionnaire (CMDQ): The scale was adapted into Turkish by Erdinç et al. in 2008. This scale assesses the frequency and severity of pain, soreness or discomfort in 11 different body parts (neck, shoulder, back, upper arm, waist, forearm, wrist, hip, upper leg, knee and lower leg) in the last 7 days and whether it interferes with work. Weight scores are calculated according to the answers given for frequency, severity and inability to work.The frequency of pain, aching or discomfort was graded from never (0) to many times every day (4); the severity was graded from mildly severe (1) to very severe (3); and the effect on work performance was graded from never interfered (1) to very much interfered (3). The weighted score for each body part takes a value between 0 and 90.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (1)
WELL-BEING
Well-being Star Scale (WSS): It is a questionnaire developed by Korkut and Owen in 2016 at the university. The first dimension 'making sense of life and being goal-oriented' consists of seven items (1, 6, 11, 16, 21, 23, 24). The second dimension 'cognitive dimension' consists of four items (2, 7, 12, 17). The third dimension, 'emotional dimension', consists of five items (3, 8, 13, 18, 22). The fourth (4, 9, 14, 19) and fifth (5, 10, 15, 20) dimensions consist of four items each and are named as 'physical dimension' and 'social dimension' respectively. The items are scored using a five-point Likert scale. The scores that can be obtained from the scale vary between 24-120 and the higher the score, the more positive the individual's well-being is interpreted.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Oct 2023
- Primary completion1 May 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Breathing ManeuverStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exercise and control groups/RCT
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Özüberk, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972173
- Sponsor's protocol ID
- 202300022
- Acronym
- Deep breathing
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- By the WHO and ICMJE for Studies With a Study Start Date That is Before June 1, 2024
- ClinicalTrials.gov ID
- NCT06972173
- Acronym / sponsor ID
- Deep breathing / 202300022
- Keywords
- Deep breathing exercises, progressive muscle relaxation exercises, high school students, musculoskeletal pain, well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 14 May 2025 (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.
Exam stress in high school students, long hours of studying in the static posture, and lack of physical activity habits can cause physical and psychological discomfort in them. This discomfort can be physically seen as musculoskeletal pain, while as psychologically it can be observed as a decrease in well-being. This situation can cause the acute onset of musculoskeletal pain in students to become chronic with a decrease in well-being. On the contrary, we can observe an increase in musculoskeletal pain due to stress that may occur due to a decrease in well-being.
Musculoskeletal pain is a condition that is not fatal but severely impairs health and well-being (1). According to the biopsychosocial model, pain occurs in a complex interaction between biological, psychological and social factors (2). Therefore, pain is both a subjective experience and a physical sensation with large individual differences (3). Relaxation is now a non-pharmacological intervention that has been increasingly accepted in recent years to reduce and cope with pain (4). A person who is relaxed usually has a physical and psychological well-being and feelings of calmness (5). With relaxation exercises, the person starts to reduce anxiety level by coping with stress (6). In addition to relaxation techniques, deep breathing exercise, also known as diaphragmatic breathing, is a technique based on the idea that mind and body integration provides relaxation (7). Breathing exercises are easy to learn and practice and benefit can be obtained from deep breathing exercises performed in a short time (5 minutes of practice may be sufficient) (8). In studies in which both techniques were used separately, it was reported to provide physical and psychological relaxation.
The unique aspect of this study is the investigation of the effects of both techniques on pain and well-being in high school students using both techniques simultaneously.
For this purpose, we planned to investigate the short-term effects of deep breathing and progressive muscle relaxation exercises on musculoskeletal pain and well-being in high school students.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Exercise and control groups/RCT
| Arm | Type | Receives |
|---|---|---|
| EXERCISE GROUP | Experimental | Other: DEEP BREATHING AND PROGRESSIVE MUSCLE RELAXATION EXERCISESThe exercise program consisting of deep breathing and progressive muscle relaxation exercises was applied to the students in the exercise group. The first exercise session was started the day after the training about the study. During the study period, the program was started at the end of school hours of high school students for a total of 20 sessions (4 weeks, every weekday), each session lasting 30 minutes. The sessions started with deep breathing exercises, continued with progressive muscle relaxation exercises, and ended with deep breathing exercises. For deep breathing exercises, students were asked to place their dominant hand on their abdomen and non-dominant hand on their chest in the semi-fowler position. Afterwards, they were instructed to breath deeply through their nose for 4 seconds and exhale through their mouth for 8 seconds. These exercises were performed as 4 repetitions with 2 minutes rest time between the exercises. When the deep breathing exercise |
| CONTROL GROUP | No intervention | –no treatment was applied to student in the control group. |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The inclusion criteria were voluntary acceptance to participate in the exercise program with parental consent, the absence of an orthopedic, neurological or psychiatric disorder that would affect participation in exercises, and full participation in exercise sessions.
Key exclusion criteria (1 listed)
- Those who did not meet the inclusion criteria and did not voluntarily agree to participate in 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 |
|---|---|---|
| DEEP BREATHING AND PROGRESSIVE MUSCLE RELAXATION EXERCISESFor deep breathing exercises, students were asked to place their dominant hand on their abdomen and non-dominant hand on their chest in the semi-fowler position. Afterwards, they were instructed to breath deeply through their nose for 4 seconds and exhale through their mouth for 8 seconds. These exercises were performed as 4 repetitions with 2 minutes rest time between the exercises. When the deep breathing exercises were finished, the students lay on their backs and rested for 1 minute and then progressive muscle relaxation exercise was started (10,11). For the progressive muscle relaxation exercise, the students were asked to contract and then relax the right foot, left foot, right leg, left leg, hip, abdominal muscles, chest muscles and back muscles, right hand, left hand, right arm, left arm, neck and shoulders, and facial muscles respectively. Respectively, from bottom to top, all the major muscles are contracted while inhaling deeply and slowly, and relaxed and r | Other | EXERCISE GROUP |
Primary outcome
musculoskeletal pain
Time frame: From enrollment to the end of treatment at 4 weeks
Cornell Musculoskeletal Disorder Questionnaire (CMDQ): The scale was adapted into Turkish by Erdinç et al. in 2008. This scale assesses the frequency and severity of pain, soreness or discomfort in 11 different body parts (neck, shoulder, back, upper arm, waist, forearm, wrist, hip, upper leg, knee and lower leg) in the last 7 days and whether it interferes with work. Weight scores are calculated according to the answers given for frequency, severity and inability to work.The frequency of pain, aching or discomfort was graded from never (0) to many times every day (4); the severity was graded from mildly severe (1) to very severe (3); and the effect on work performance was graded from never interfered (1) to very much interfered (3). The weighted score for each body part takes a value between 0 and 90.
1 secondary outcome
WELL-BEING
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Yes. all collected IPD
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEEP BREATHING AND PROGRESSIVE MUSCLE RELAXATION EXERCISES in people with Deep Breathing Maneuver and PROGRESSIVE MUSCLE RELAXATION EXERCISES, run by Kırklareli 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: finished, as of the sponsor's last update on 18 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
musculoskeletal pain (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2025.