EarthquakeNCT06013280
The Effect of Relaxation Techniques on Earthquake Survivors
A study testing Progresive Muscle Relaxation and Breathing Exercise in people with Earthquake and Mental Health Issue, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of relaxation and breathing exercises on individuals experiencing post-earthquake stress-related symptoms. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Earthquake, Mental Health Issue
- What is being tested?
- Progresive Muscle Relaxation and Breathing Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2023to 25 Jun 2023
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals with a Beck anxiety inventory score greater than 8 and anxiety experience for more than 1 month
- Individuals who experienced the earthquake of February 6, 2023 Kahramanmaraş / Türkiye and agreed to participate in the study
- Individuals without cognitive impairment
- Individuals who can understand and apply verbal commands in Turkish
Who cannot join
- Any history of psychiatric medication support for the last 6 months
- Any history of psychological problems before the earthquake
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34820
About this study
Official title: The Effect of Relaxation and Breathing Exercise on Post-Earthquake Stress Related Symptoms
The aim of this study is to investigate the effect of relaxation and breathing exercises on individuals experiencing post-earthquake stress-related symptoms.
Read the detailed description
Earthquakes negatively affect survivors both physically and psychologically. Early psychological symptoms after disasters are considered normal responses to an abnormal event. Therefore, it is not unexpected to feel very intense negative emotions after such traumas. However, the chronicity of these negative emotions puts the lives of individuals at risk. Mental problems such as stress, depression, posttraumatic stress disorder and anxiety are seen at high levels among earthquake survivors. In this study, it was aimed to investigate the effect of relaxation and breathing exercises applied to earthquake survivors who experienced post-earthquake stress-related symptoms.
There are two gropus: relaxing exercise group and control group. Relaxing and breathing exercise protocol is only for relaxing exercise group. A protocol consisting of 40 minutes of progressive muscle relaxation exercise and breathing exercises, 3 times a week for 4 weeks, was planned. Control group participants were asked to continue their daily lives. Evaluations were made before and 4 weeks after the intervention and stress-related symptoms were measured.
- Conditions
- Earthquake, Mental Health Issue
- Being tested
- Progresive Muscle Relaxation and Breathing Exercise
- Keywords
- earthquake, physiotherapy, breathing exercise, relaxing exercise, stress, mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progresive Muscle Relaxation and Breathing ExerciseOther
Intervention protocol contains 40 minuntes sessions, which involved tensing and relaxing the body along with deep breathing.
Protocol consisted with; Warm-up (5 minutes breathing exercise) Progressive Muscle Relaxation Exercises (The participants performed PMR for each body part in a particular order, beginning with the face muscles and head, followed by neck, shoulders, chest, abdomen, legs, and feet. This muscle tensing and relaxing procedures were performed in accompaniment with deep breathing.) Cool-down (5 minutes breathing exercise)
| Study group | Role | What they receive |
|---|---|---|
| Relaxing Exercise Group | Experimental | Relaxing exercise group participants applied 40 minutes of progressive muscle relaxation and breathing exercises, 3 times a week for 4 weeks Receives: Other: Progresive Muscle Relaxation and Breathing Exercise |
| Control Group | No intervention | This group received no intervention, continued their daily life as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety (BAI)
Beck Anxiety Inventory is a brief measure of anxiety with a focus on somatic symptoms of anxiety that was developed as a measure adept at discriminating between anxiety and depression. It is a self-report scale consisting of 21 items. Respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The total score ranges from 0-63. The following guidelines are recommended for the interpretation of scores: 0-9, normal or no anxiety; 10-18, mild to moderate anxiety; 19-29, moderate to severe anxiety; and 30-63, severe anxiety.
Measured: four weeks
Secondary outcomes (5)
The Posttraumatic Stress Diagnostic Scale (PDS)
The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report questionnaire designed to measure the severity of PTSD symptoms. A total score of 1-10 is considered as mild symptoms 11-20 moderate symptoms 21-35 as moderate to severe symptoms and 36 or over as is considered to reflect severe symptoms.
Measured: four weeks
Beck Depression Inventory (BDI)
The Beck Depression Inventory Second is a 21-item self-report instrument measuring the existence and severity of symptoms of depression.
Measured: four weeks
Perceived Stress Scale -10
The Perceived Stress Scale (PSS-10) is a widely used and well validated 10 item self report questionnaire designed to measure to what degree the respondent appraises his life situation over the past month. A higher score is associated with greater vulnerability.
Measured: four weeks
Pittsburgh Sleep Quality Index
This scale contains seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efciency, sleep disturbances, use of sleep medication, and daytime dysfunction. There are 19 questions in this questionnaire, with a total score ranging from 0-21. A higher score indicates worse sleep quality.
Measured: four weeks
SF-12
SF-12 evaluates health - related quality of life.It was developed to shorten the SF-36 using a regression method. As per the dimensionality of the SF-36, SF-12 encompasses 12 items that have to be scored in two 0-100 components: the physical component summary (PCS12) and the mental component summary (MCS12). SF-12 items are referred to as physical restrictions, physical functioning, bodily pain, general health compared with others, vitality, social functioning, role limitations due to emotional issues, and mental health (MH). Higher scores indicates higher quality of life.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start20 Mar 2023
- Primary completion25 Jun 2023
- Study completion25 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EarthquakeStudies 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
- Two groups with a control group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sabiha sancaktar, Istanbul Medipol University Hospital
- Investigators
- Sabiha Irem Sancaktar, M.Sc., Principal investigator, Istanbul Medipol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013280
- Sponsor's protocol ID
- IstanbulMUH-FTR-SIS-01
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Relaxation and Breathing Exercise on Post-Earthquake Stress Related Symptoms
- ClinicalTrials.gov ID
- NCT06013280
- Acronym / sponsor ID
- IstanbulMUH-FTR-SIS-01
- Conditions
- Earthquake, Mental Health Issue
- Keywords
- earthquake, physiotherapy, breathing exercise, relaxing exercise, stress, mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 25 Jun 2023 (actual)
- First posted
- 28 Aug 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.
The aim of this study is to investigate the effect of relaxation and breathing exercises on individuals experiencing post-earthquake stress-related symptoms.
Detailed description
Earthquakes negatively affect survivors both physically and psychologically. Early psychological symptoms after disasters are considered normal responses to an abnormal event. Therefore, it is not unexpected to feel very intense negative emotions after such traumas. However, the chronicity of these negative emotions puts the lives of individuals at risk. Mental problems such as stress, depression, posttraumatic stress disorder and anxiety are seen at high levels among earthquake survivors. In this study, it was aimed to investigate the effect of relaxation and breathing exercises applied to earthquake survivors who experienced post-earthquake stress-related symptoms.
There are two gropus: relaxing exercise group and control group. Relaxing and breathing exercise protocol is only for relaxing exercise group. A protocol consisting of 40 minutes of progressive muscle relaxation exercise and breathing exercises, 3 times a week for 4 weeks, was planned. Control group participants were asked to continue their daily lives. Evaluations were made before and 4 weeks after the intervention and stress-related symptoms were measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups with a control group
| Arm | Type | Receives |
|---|---|---|
| Relaxing Exercise Group | Experimental | Other: Progresive Muscle Relaxation and Breathing ExerciseRelaxing exercise group participants applied 40 minutes of progressive muscle relaxation and breathing exercises, 3 times a week for 4 weeks |
| Control Group | No intervention | –This group received no intervention, continued their daily life as usual. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals with a Beck anxiety inventory score greater than 8 and anxiety experience for more than 1 month
- Individuals who experienced the earthquake of February 6, 2023 Kahramanmaraş / Türkiye and agreed to participate in the study
- Individuals without cognitive impairment
- Individuals who can understand and apply verbal commands in Turkish
Key exclusion criteria (2 listed)
- Any history of psychiatric medication support for the last 6 months
- Any history of psychological problems before the earthquake
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 |
|---|---|---|
| Progresive Muscle Relaxation and Breathing ExerciseIntervention protocol contains 40 minuntes sessions, which involved tensing and relaxing the body along with deep breathing. Protocol consisted with; Warm-up (5 minutes breathing exercise) Progressive Muscle Relaxation Exercises (The participants performed PMR for each body part in a particular order, beginning with the face muscles and head, followed by neck, shoulders, chest, abdomen, legs, and feet. This muscle tensing and relaxing procedures were performed in accompaniment with deep breathing.) Cool-down (5 minutes breathing exercise) | Other | Relaxing Exercise Group |
Primary outcome
Beck Anxiety (BAI)
Time frame: four weeks
Beck Anxiety Inventory is a brief measure of anxiety with a focus on somatic symptoms of anxiety that was developed as a measure adept at discriminating between anxiety and depression. It is a self-report scale consisting of 21 items. Respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The total score ranges from 0-63. The following guidelines are recommended for the interpretation of scores: 0-9, normal or no anxiety; 10-18, mild to moderate anxiety; 19-29, moderate to severe anxiety; and 30-63, severe anxiety.
5 secondary outcomes
The Posttraumatic Stress Diagnostic Scale (PDS)
Time frame: four weeks
Beck Depression Inventory (BDI)
Time frame: four weeks
Perceived Stress Scale -10
Time frame: four weeks
Pittsburgh Sleep Quality Index
Time frame: four weeks
SF-12
Time frame: four 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 29 Aug 2023.
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Effects of the Integrated Grief Therapy on Psychological Resilience, Post-Traumatic Growth, Traumatic Stress, and Grief Processes in Earthquake Survivors
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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.
Sabiha Irem Sancaktar, M.Sc. principal investigator
Istanbul Medipol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progresive Muscle Relaxation and Breathing Exercise in people with Earthquake and Mental Health Issue, run by Istanbul Medipol University Hospital 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 4 inclusion and 2 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 29 Aug 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?
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?
Beck Anxiety (BAI) (time frame: four 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 29 Aug 2023.