NCT07063498

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Jan 2026Sep 2026

First Submitted

Initial submission to the registry

July 3, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

January 22, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2026

Last Updated

January 23, 2026

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

July 3, 2025

Last Update Submit

January 22, 2026

Conditions

Keywords

bone marrow aspiration and biopsyPainStress

Outcome Measures

Primary Outcomes (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.

    Immediately after the procedure.

Study Arms (3)

Cough Group

EXPERIMENTAL

Voluntary Coughing Maneuver

Behavioral: Coughing Maneuver

control phase

NO INTERVENTION

Patients undergo biopsy without any additional intervention.

Stress Ball Group

EXPERIMENTAL

Stress Ball Intervention

Behavioral: Stress ball

Interventions

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.

Cough Group
Stress ballBEHAVIORAL

2\. 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.

Stress Ball Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with communication problems
  • Patients with psychiatric problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Gül DURAL, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 14, 2025

Study Start

January 22, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 20, 2026

Last Updated

January 23, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share