NCT05680649

Brief Summary

This study was carried out to determine the effect of breathing exercise performed during peripheral intravenous catheter (PIVC) application on pain, anxiety and patient satisfaction. The study was completed as a randomized controlled experimental study with a total of 130 individuals who met the inclusion criteria. The Descriptive Characteristics Questionnaire, the State-Trait Anxiety Inventory, and the Numerical Rating Scale were used to collect the data of the study. In addition, Algometer (66 Lb/30 Kg) device was used to evaluate the pain pressure threshold in determining the individuals to be included in the research sample. The individuals in the intervention group were given diaphragmatic breathing exercise while applying the catheter, and the individuals in the control group were inserted without any application.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 24, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
Last Updated

January 11, 2023

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

December 15, 2022

Last Update Submit

December 23, 2022

Conditions

Venipuncture

Keywords

AnxietyBreathing exerciseNursingPainperipheral intravenous catheterization

Outcome Measures

Primary Outcomes (2)

  • Pain level

    Pain level measured with Numeric Rating Scale. The number "0" on the scale means that they do not feel any pain and the number "10" refers to the worst pain.

    3 minutes after catheter insertion

  • Anxiety level

    Anxiety level measured with Numeric Rating Scale. The number "0" on the scale means that they do not feel any anxiety and the number "10" refers to the highest level of anxiety.

    3 minutes after catheter insertion

Secondary Outcomes (1)

  • Satisfaction level

    3 minutes after catheter insertion

Study Arms (2)

Intervention

EXPERIMENTAL

Breathing exercise

Other: Breathing exercise

Control

NO INTERVENTION

Standard practice

Interventions

Breathing exerciseOTHER

Diaphragmatic breathing exercises were taught to the individuals by the researcher and they were asked to start breathing exercises before starting PIVC. While the PIVC was being placed, the individuals continued the breathing exercise and the breathing exercise was terminated at the end of the application.

Intervention

Eligibility Criteria

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

You may qualify if:

  • able to speak and understand Turkish,
  • between the ages of 18-65,
  • having orientation to place and time,
  • without any psychiatric disease and hearing problems,
  • not using central nervous system drugs,
  • people who having PIVC indication,
  • no analgesic or anesthetic agent was applied 24 hours before PIVC application,
  • not have any pain in any part of the body that may affect the results of the study,
  • no PIVC experience in the last month,
  • G catheter will be applied,
  • pressure pain threshold mean of 8-16 pounds (Lb), (11) individuals who volunteered to participate in the study.

You may not qualify if:

  • Infection in the area where PIVC will be applied, -having previous operation, scarring, psoriasis, active dermatitis in the area - -
  • where PIVC will be applied,
  • with peripheral nerve disease,
  • no catheter applied to the forearm veins,
  • having diabetes,
  • with peripheral neuropathy,
  • diagnosed with cancer,
  • receiving cancer treatment,
  • with respiratory disease,
  • who have an obstacle to breathing exercise,
  • in the post-surgical period,
  • individuals who did not volunteer to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (1)

  • Ozkan O, Korkut S. Effect of Breathing Exercise During Peripheral Venous Catheterization on Pain, Anxiety, and Patient Satisfaction: A Randomized Controlled Trial. J Perianesth Nurs. 2024 Aug;39(4):630-637. doi: 10.1016/j.jopan.2023.11.006. Epub 2024 Feb 29.

    PMID: 38430076DERIVED

MeSH Terms

Conditions

Anxiety DisordersPain

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Sevda Korkut

    TC Erciyes University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 15, 2022

First Posted

January 11, 2023

Study Start

February 24, 2022

Primary Completion

July 28, 2022

Study Completion

July 28, 2022

Last Updated

January 11, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)