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Bone Marrow Aspiration and BiopsyNCT07063498

Fake Coughing During Bone Marrow Aspiration and Biopsy

A study testing Coughing Maneuver and Stress ball in people with Bone Marrow Aspiration and Biopsy and Pain, run by Firat University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Hematology patients go through many difficult periods during the diagnosis process. One of the most commonly used methods in the diagnosis of hematological diseases is bone marrow aspiration and biopsy (BMAB). BMAB is an invasive procedure and may cause pain in patients. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Coughing Maneuver and Stress ball
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
22 Jan 2026to 20 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with cancer at least 3 months ago
  • Over 18 years of age
  • Able to communicate adequately
  • No psychiatric problems
  • Willing to participate in the study

Who cannot join

  • Patients with communication problems
  • Patients with psychiatric problems

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Gül DURAL, PhD contact

+904242370000

gulkaya@firat.edu.tr

About this study

Official title: The Effect of Fake Coughing and Stress Ball Application on Pain During Bone Marrow Aspiration and Biopsy

Hematology patients go through many difficult periods during the diagnosis process. One of the most commonly used methods in the diagnosis of hematological diseases is bone marrow aspiration and biopsy (BMAB). BMAB is an invasive procedure and may cause pain in patients. For this purpose, a local anesthetic agent is used during the procedure. However, no effective method has been developed to prevent pain in patients. Both pharmacological and non-pharmacological methods are used to manage pain. Among non-pharmacological methods, cognitive distraction techniques such as feigned coughing and stress balls are used to reduce pain and stress. Some studies have reported that "fake coughing" reduces pain during procedures that cause temporary, sharp pain, such as parenteral injections or venipuncture. A literature review revealed that patients undergoing bone marrow aspiration and biopsy experience intense stress and pain, but there are insufficient studies examining these concepts. This study is expected to contribute to the nursing literature. The aim of this study is to determine the effect of fake coughing and stress ball application on pain during bone marrow aspiration and biopsy.

Read the detailed description

Hematology patients go through many difficult periods during the diagnostic process. One of the most commonly used methods in the diagnosis of hematological diseases is bone marrow aspiration and biopsy (BMAB). BMAB is an important examination performed to reveal the cellular characteristics of the bone marrow and the involvement of solid organs or hematological malignancies when there is suspicion in peripheral blood. This procedure plays an important role in the diagnosis of primary and secondary malignant diseases as well as hematological diseases. It can also assist in the staging and sometimes diagnosis of lymphoproliferative diseases, the investigation of unexplained fever, and the diagnosis of disseminated fungal infections and storage diseases. Furthermore, bone marrow aspirations and biopsies have proven useful in detecting non-hematological malignancies in cases where malignancies are not clinically suspected. When both procedures are performed simultaneously, they complement each other, providing more material to examine the morphology and distribution pattern of cells. BMB can be performed in both inpatient and outpatient settings. The posterior iliac crest is the preferred and most common target site for KİAB due to its superficial location, technical ease, and the absence of critical structures along the needle path. The excellent safety profile and high diagnostic yield of KİAB have been established in the literature, making this intervention a critical component of patient management in contemporary medical practice.

Due to its invasive nature, KİAB may cause pain in patients. For this purpose, a local anesthetic agent is used during the procedure. However, no effective method has been developed to prevent pain in patients. In addition to pain, these patients may experience anxiety symptoms such as worry and uncertainty before the procedure. The literature acknowledges the lack of information on pain reduction during the KİAB procedure. Since the importance of more information in this area is recognized, there are no clear guidelines on how to use data on pain-causing factors to prevent or manage pain in patients undergoing this type of biopsy. Nevertheless, the limited studies conducted to reduce procedure-related pain have not changed clinical practice, and pain continues to be a significant burden for many hematological patients.

There are many independent factors that have been investigated in relation to pain in KİAB. These include gender, age, body mass index (BMI), educational level, pre-procedure knowledge, previous KİAB experience, KİAB indication, KİAB site, operator experience, duration, and procedure difficulty. When considering separate characteristics such as BMI, age, or operator experience, study results are often inconsistent. The correlation between procedure duration and difficulty and pain has been documented in various studies. Both pharmacological and non-pharmacological methods are used in pain management. Among non-pharmacological methods, cognitive distraction techniques such as feigned coughing and stress balls are used to reduce pain and stress.

Some studies have reported that "fake coughing" reduces pain during procedures that cause temporary, sharp pain, such as parenteral injections or venipuncture. In this technique, the patient is instructed to cough during the injection or venipuncture procedure. There are several theories about how this maneuver reduces pain, including distraction, stimulation of the autonomic nervous system (coughing has been theorized for this purpose), and increased pressure activating segmental pain-blocking pathways in the subarachnoid space .

It is noted that stress is a result of being unable to cope with emotional or physical threats, and that a person's mental health is closely and directly related to perceived stress. Although there are many methods for reducing stress, it is thought that a stress ball, which is inexpensive and easily accessible, can be used as a method of distracting or redirecting attention. The use of stress balls during minimally invasive venous surgery has been found to reduce anxiety and pain levels.

A literature review revealed that patients undergoing bone marrow aspiration and biopsy experience intense stress and pain, but there are insufficient studies examining these concepts. This study is expected to contribute to the nursing literature. The aim of this study is to determine the effect of feigned coughing and stress ball application on pain during bone marrow aspiration and biopsy.

Being tested
Coughing Maneuver, Stress ball
Keywords
bone marrow aspiration and biopsy, Pain, Stress
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coughing ManeuverBehavioural

    1. Voluntary Coughing Maneuver (Hileli Öksürük): Patients in this group were instructed to perform a voluntary coughing maneuver immediately prior to the percutaneous biopsy procedure. The maneuver was demonstrated by the clinician, and patients were asked to perform 2-3 forceful coughs while in the biopsy position, 30 seconds before needle insertion, to reduce anxiety and procedural pain perception.
  • Stress ballBehavioural

    1. Stress Ball Intervention: Patients were given a standard-sized rubber stress ball to hold and repeatedly squeeze during the entire percutaneous biopsy procedure. The intervention began 1 minute before needle insertion and continued until the procedure was completed. The aim was to provide a behavioral distraction to alleviate anxiety and pain.
Study groups in NCT07063498
Study groupRoleWhat they receive
Cough GroupExperimentalVoluntary Coughing Maneuver
Receives: Behavioral: Coughing Maneuver
control phaseNo interventionPatients undergo biopsy without any additional intervention.
Stress Ball GroupExperimentalStress Ball Intervention
Receives: Behavioral: Stress ball

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Intensity During Bone Marrow Aspiration and Biopsy

    Patient-reported pain intensity during bone marrow aspiration and biopsy procedures measured by a 10-point Visual Analog Scale (VAS), where 0 = no pain and 10 = worst pain imaginable.

    Measured: Immediately after the procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2025
  2. Study start22 Jan 2026 (estimated)
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion20 Sep 2026 (estimated)

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07063498
Sponsor's protocol ID
2024/03-04
Status last verified
Sep 2025
First submitted
3 Jul 2025
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Coughing Maneuver and Stress ball in people with Bone Marrow Aspiration and Biopsy and Pain, run by Firat University.

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 5 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: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gül DURAL, PhD (+904242370000, gulkaya@firat.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity During Bone Marrow Aspiration and Biopsy (time frame: Immediately after the procedure.). 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 23 Jan 2026.

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