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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05680649
Other study ID # 573/2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 24, 2022
Est. completion date July 28, 2022

Study information

Verified date December 2022
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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, 65 of whom were in the intervention group and 65 in the control group. Ethics committee approval, institutional permission, and written informed consent from individuals were obtained in the study. 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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date July 28, 2022
Est. primary completion date July 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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, - 20-G catheter will be applied, - pressure pain threshold mean of 8-16 pounds (Lb), (11) individuals who volunteered to participate in the study. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Breathing exercise
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.

Locations

Country Name City State
Turkey Erciyes University Kayseri

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Satisfaction level Satisfaction level measured with Numeric Rating Scale. The number "0" in the scale indicates that the participants are not at all satisfied with the application, and the number "10" indicates the highest level of satisfaction. 3 minutes after catheter insertion
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