- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05680649
Effect of Breathing Exercise During Peripheral Intravenous Catheter
Effect of Breathing Exercise During Peripheral Intravenous Catheter Implementation on Pain, Anxiety, and Patient Satisfaction
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.
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kayseri, Turkey, 38039
- Erciyes University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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.
|
|
No Intervention: Control
Standard practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain level
Time Frame: 3 minutes after catheter insertion
|
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
Time Frame: 3 minutes after catheter insertion
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction level
Time Frame: 3 minutes after catheter insertion
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sevda Korkut, TC Erciyes University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 573/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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