VenipunctureNCT05680649
Effect of Breathing Exercise During Peripheral Intravenous Catheter
A study testing Breathing exercise in people with Venipuncture, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Venipuncture
- What is being tested?
- Breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2022to 28 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Venipuncture
- Being tested
- Breathing exercise
- Keywords
- Anxiety, Breathing exercise, Nursing, Pain, peripheral intravenous catheterization
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Breathing exercise Receives: Other: Breathing exercise |
| Control | No intervention | Standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 minutes after catheter insertion
Secondary outcomes (1)
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.
Measured: 3 minutes after catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start24 Feb 2022
- Primary completion28 Jul 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VenipunctureStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Korkut, TC Erciyes University
- Investigators
- Sevda Korkut, Study director, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680649
- Sponsor's protocol ID
- 573/2022
- Status last verified
- Dec 2022
- First submitted
- 15 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38430076
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breathing Exercise During Peripheral Intravenous Catheter Implementation on Pain, Anxiety, and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT05680649
- Acronym / sponsor ID
- 573/2022
- Conditions
- Venipuncture
- Keywords
- Anxiety, Breathing exercise, Nursing, Pain, peripheral intravenous catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Breathing exerciseBreathing exercise |
| Control | No intervention | –Standard practice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing exerciseDiaphragmatic 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. | Other | Intervention |
Primary outcome
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.
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.
1 secondary outcome
Satisfaction level
Time frame: 3 minutes after catheter insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Derived from this study: PubMed 38430076Ozkan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevda Korkut study director
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercise in people with Venipuncture, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: 3 minutes after catheter insertion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05680649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.