Back to resultsEffect of Breathing Exercise During Peripheral Intravenous Catheter
Primary Purpose
Venipuncture
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Breathing exercise
Sponsored by
About this trial
This is an interventional other trial for Venipuncture focused on measuring Anxiety, Breathing exercise, Nursing, Pain, peripheral intravenous catheterization
Eligibility Criteria
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
Sites / Locations
- Erciyes University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Breathing exercise
Standard practice
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05680649
First Posted
December 15, 2022
Last Updated
December 23, 2022
Sponsor
TC Erciyes University
1. Study Identification
Unique Protocol Identification Number
NCT05680649
Brief Title
Effect of Breathing Exercise During Peripheral Intravenous Catheter
Official Title
Effect of Breathing Exercise During Peripheral Intravenous Catheter Implementation on Pain, Anxiety, and Patient Satisfaction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
July 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venipuncture
Keywords
Anxiety, Breathing exercise, Nursing, Pain, peripheral intravenous catheterization
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Breathing exercise
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard practice
Intervention Type
Other
Intervention Name(s)
Breathing exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain level
Description
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.
Time Frame
3 minutes after catheter insertion
Title
Anxiety level
Description
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.
Time Frame
3 minutes after catheter insertion
Secondary Outcome Measure Information:
Title
Satisfaction level
Description
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.
Time Frame
3 minutes after catheter insertion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevda Korkut
Organizational Affiliation
TC Erciyes University
Official's Role
Study Director
Facility Information:
Facility Name
Erciyes University
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Breathing Exercise During Peripheral Intravenous Catheter
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