NCT05632874

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

November 1, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

December 1, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

November 9, 2022

Last Update Submit

November 20, 2022

Conditions

Keywords

bone marrow biopsypainbreathing exerciseanxiety

Outcome Measures

Primary Outcomes (1)

  • Visual Analouge Scale

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

    up to 1 mounth

Study Arms (1)

Breathing Exercise

EXPERIMENTAL
Behavioral: relaxing breathing exercise

Interventions

"Kumbhaka Pranayama", "Sama Vritti Pranayama" and "box breathing" breathing techniques will be applied to the patients.

Breathing Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Uskudar Universitesi

Istanbul, 34662, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bone Marrow NeoplasmsPainAnxiety Disorders

Condition Hierarchy (Ancestors)

Hematologic NeoplasmsNeoplasms by SiteNeoplasmsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2022

First Posted

December 1, 2022

Study Start

November 1, 2022

Primary Completion

January 1, 2023

Study Completion

March 1, 2023

Last Updated

December 1, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

Locations