The Effect of Relaxing Breathing Exercise Applied to Patients Before Bone Marrow Biopsy on Vital Signs, Pain and Anxiety Levels

• Sponsor: Uskudar University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05632874
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 3.9
• Patients Per Site Per Month: 18.3

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Marrow Cancer	Behavioral: relaxing breathing exercise	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Relaxing Breathing Exercise Applied to Patients Before Bone Marrow Biopsy on Vital Signs, Pain and Anxiety Levels
• Anticipated Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Breathing Exercise	Behavioral: relaxing breathing exercise; "Kumbhaka Pranayama", "Sama Vritti Pranayama" and "box breathing" breathing techniques will be applied to the patients.

Outcome Measures

Primary Outcome Measures

1. Visual Analouge Scale [up to 1 mounth]

   After the application, the pain level of the patients is expected to be low.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uskudar Universitesi	Istanbul		Turkey	34662

Sponsors and Collaborators

• Uskudar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmet Kolip, Principal Investigator, Uskudar University
• ClinicalTrials.gov Identifier: NCT05632874
• Other Study ID Numbers: UskudarUniveristy
• First Posted: Dec 1, 2022
• Last Update Posted: Dec 1, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ahmet Kolip, Principal Investigator, Uskudar University: bone marrow biopsy; pain; breathing exercise; anxiety
• Additional relevant MeSH terms: Bone Marrow Neoplasms; Respiratory Aspiration

Study Results

No Results Posted as of Dec 1, 2022