Bone Marrow CancerNCT05632874
The Effect of Relaxing Breathing Exercise Applied to Patients Before Bone Marrow Biopsy on Vital Signs, Pain and Anxiety Levels
A study testing relaxing breathing exercise in people with Bone Marrow Cancer, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
There is no study in the literature that determined the effect of relaxing breathing exercise applied to patients before the BMB procedure on vital signs, pain and anxiety levels. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Marrow Cancer
- What is being tested?
- relaxing breathing exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2022to Mar 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Being between the ages of 18-65
- The fact that a bone marrow biopsy will be performed for the first time
- Absence of sedative, anxiolytic drug use
- Absence of a situation that would hinder communication.
Trial locations and contacts
1 site in 1 country.
About this study
There is no study in the literature that determined the effect of relaxing breathing exercise applied to patients before the BMB procedure on vital signs, pain and anxiety levels.
The aim of this study is to determine the effect of relaxing breathing exercise applied to patients before bone marrow biopsy on vital signs, pain and anxiety levels.
Read more
hypotheses H1. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure reduces the anxiety level of the patients compared to the control group.
H2. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure reduces the pain level of the patients compared to the control group.
H3. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure is effective on the respiratory rate of the patients compared to the control group.
H4. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure is effective on the pulse rate of the patients compared to the control group.
H5. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure is effective on the blood pressure of the patients compared to the control group.
- Conditions
- Bone Marrow Cancer
- Being tested
- relaxing breathing exercise
- Keywords
- bone marrow biopsy, pain, breathing exercise, anxiety
- Medical subject headings
- Bone Marrow Neoplasms, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relaxing breathing exerciseBehavioural
"Kumbhaka Pranayama", "Sama Vritti Pranayama" and "box breathing" breathing techniques will be applied to the patients.
| Study group | Role | What they receive |
|---|---|---|
| Breathing Exercise | Experimental | Not described Receives: Behavioral: relaxing breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analouge Scale
After the application, the pain level of the patients is expected to be low.
Measured: up to 1 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study startNov 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Kolip, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632874
- Sponsor's protocol ID
- UskudarUniveristy
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Relaxing Breathing Exercise Applied to Patients Before Bone Marrow Biopsy on Vital Signs, Pain and Anxiety Levels
- ClinicalTrials.gov ID
- NCT05632874
- Acronym / sponsor ID
- UskudarUniveristy
- Conditions
- Bone Marrow Cancer
- Keywords
- bone marrow biopsy, pain, breathing exercise, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 1 Dec 2022 (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.
There is no study in the literature that determined the effect of relaxing breathing exercise applied to patients before the BMB procedure on vital signs, pain and anxiety levels.
The aim of this study is to determine the effect of relaxing breathing exercise applied to patients before bone marrow biopsy on vital signs, pain and anxiety levels.
hypotheses H1. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure reduces the anxiety level of the patients compared to the control group.
H2. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure reduces the pain level of the patients compared to the control group.
H3. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure is effective on the respiratory rate of the patients compared to the control group.
H4. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure is effective on the pulse rate of the patients compared to the control group.
H5. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure is effective on the blood pressure of the patients compared to the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercise | Experimental | Behavioral: relaxing breathing exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| relaxing breathing exercise"Kumbhaka Pranayama", "Sama Vritti Pranayama" and "box breathing" breathing techniques will be applied to the patients. | Behavioural | Breathing Exercise |
Primary outcome
Visual Analouge Scale
Time frame: up to 1 mounth
After the application, the pain level of the patients is expected to be low.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Individual participant dataSharing planned: Yes
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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.
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 relaxing breathing exercise in people with Bone Marrow Cancer, run by Uskudar 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?
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 1 Dec 2022. 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?
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?
Visual Analouge Scale (time frame: up to 1 mounth). 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 1 Dec 2022.