PainPainNCT06872671
The Effect of Breathing Exercises and the Valsalva Maneuver on Pain Reduction During Peripheral Intravenous Catheterization
A study testing Experimental: Breathing Exercise Group and Valsalva Manoeuvre Group in people with Pain, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
Peripheral intravenous catheter (PIVC) insertion is a painful procedure due to its invasive nature. During the procedure, damage to the endothelial layer and improper interventions can further increase pain levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Experimental: Breathing Exercise Group and Valsalva Manoeuvre Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2025to 1 Jun 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be 18 years of age or older,
- Hospitalised in the general surgery ward with PIC indication,
- Non-users of central nervous system drugs,
- No heart and lung disease,
- Absence of phlebitis, scar tissue, dermatitis, incision and infection in the area to be accessed,
- No analgesic or anaesthetic agent has been administered 24 hours prior to PIC administration,
Show all 13Show fewer
- No pain in any part of the body that may affect the results of the study,
- No PIK experience in the last month, The one with the -20-G catheter,
- Pressure pain threshold averages 8-16 pounds (Lb),
- No communication problems,
- Capable of breathing exercise practice,
- No mental problems,
- Patients who agree to participate in the study will be included.
Who cannot join
- Patients who do not meet the inclusion criteria will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breathing Exercises and the Valsalva Maneuver on Pain Reduction During Peripheral Intravenous Catheterization: A Randomized Controlled Trial
Peripheral intravenous catheter (PIVC) insertion is a painful procedure due to its invasive nature. During the procedure, damage to the endothelial layer and improper interventions can further increase pain levels. Additionally, pain can cause vasoconstriction, negatively affecting venous filling and reducing the success rate of IV catheter insertion. Both pharmacological and non-pharmacological methods are used to alleviate invasive pain associated with PIVC. However, pharmacological methods are often considered disadvantageous due to their high cost, potential adverse effects, and increased medication use. In contrast, non-pharmacological approaches are preferred as they are cost-effective, have fewer side effects, and pose a lower risk of complications.
Read the detailed description
One of the non-pharmacological methods used for pain reduction is breathing exercises. As a distraction technique, breathing exercises have been increasingly utilized to alleviate invasive pain experienced during blood collection and cannulation procedures. By enhancing lung ventilation, deep breathing maximizes oxygen intake, leading to relaxation in the patient. This state of relaxation contributes to a sense of comfort and reduces the perception of pain.
A review of the literature revealed only one study specifically evaluating the effectiveness of breathing exercises in reducing pain during PIVC insertion. Existing research has reported that breathing exercises have a positive impact on pain experienced during PIVC placement. In these studies, individuals were first positioned comfortably. They were then instructed to take a slow, deep breath through the nose, hold it briefly, and exhale slowly through the mouth. During inhalation, participants were guided to expand their abdomen and push the diaphragm downward, while during exhalation, they were asked to contract the abdominal muscles, draw the abdomen inward, and push the diaphragm upward. Additionally, individuals were instructed to silently count to four while inhaling, holding their breath, and exhaling. The breathing exercise began one minute before the procedure and continued throughout its duration.
Another non-pharmacological method used for pain reduction is the Valsalva maneuver, a well-known breathing technique. The Valsalva maneuver involves a forceful exhalation against a closed airway, stimulating the vagus nerve and causing physiological changes, particularly in heart rate and blood pressure. These physiological effects make the Valsalva maneuver a valuable diagnostic and therapeutic tool for terminating supraventricular tachycardia, assessing cardiac murmurs and left ventricular function, managing neuropathy, and controlling pain.
A review of the literature identified a few studies evaluating the effects of the Valsalva maneuver on pain, anxiety, and vital signs during PIVC insertion. The findings of these studies indicate that the Valsalva maneuver has a positive effect in reducing pain experienced during the procedure.
- Conditions
- Pain
- Being tested
- Experimental: Breathing Exercise Group, Valsalva Manoeuvre Group
- Keywords
- pain, nursing, breathing exercises, valsalva maneuver
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Breathing Exercise GroupOther
Eyes will be closed first. Head and neck will be relaxed. Breathing will be taken through the nose for three seconds. Then the breath will be held for three seconds. In the last step, breath will be exhaled through the mouth for three seconds. The patient will be instructed to take five normal breaths between each breathing exercise. The patient will be asked to count to three and will be told that he/she can count by using his/her fingers. The exercise will be started two minutes before the catheterisation procedure and the patient will be instructed to perform the breathing exercise twice. The patient will be asked to continue doing the breathing exercise until the PIC application process is completed.
Valsalva Manoeuvre GroupOther
The valsalva manoeuvre will be performed by blowing into a plastic tube connected through a sphygmomanometer. Patients will be allowed to raise the manometer by 30 mmHg for at least 20 seconds. Care will be taken to ensure that the PIC procedure is performed by the same nurse for the patients in the Valsalva manoeuvre group. The nurses performing the PIC procedure will be informed about the research subject and will be told that the patients will start the valsalva manoeuvre before the PIC procedure. Patients who can perform the valsalva manoeuvre by the researcher will be included in the study. Haemodynamic variables (blood pressure, pulse, saturation) of the patients will be recorded before the valsalva manoeuvre. Afterwards, the researcher will instruct the patients to blow into the plastic tube for 20 seconds after a deep breath to create 30 mmHg pressure.
| Study group | Role | What they receive |
|---|---|---|
| Breathing Exercise Group | Experimental | After patients receive training on the breathing exercise, nurses responsible for performing the PIVC procedure will be provided with the necessary information regarding the intervention. It will be emphasized that patients should begin the breathing exercise before the PIVC procedure. Additionally, nurses will be instructed to perform the catheterization during the fifth step of the breathing exercise.
Before the PIVC procedure in the breathing exercise group, the researcher will be present alongside the nurse performing the intervention. Nurses will be informed that they should initiate the PIVC procedure three seconds after the patient reaches the fourth step, which involves breath-holding. Furthermore, efforts will be made to ensure that the same nurse performs the PIVC procedure for each patient in the breathing exercise group.
Hemodynamic variables, including blood pressure, pulse rate, and oxygen saturation, will be recorded before and after the breathing exercise. Receives: Other: Experimental: Breathing Exercise Group |
| Valsalva Manoeuvre Group | Experimental | Care will be taken to ensure that the PIC procedure is performed by the same nurse for the patients in the Valsalva manoeuvre group. The nurses performing the PIC procedure will be informed about the subject of the research and will be told that the patients will start the valsalva manoeuvre before the PIC procedure. Patients who can perform the valsalva manoeuvre by the researcher will be included in the study. Haemodynamic variables (blood pressure, pulse, saturation) of the patients will be recorded before the application of the Valsalva manoeuvre. Afterwards, the researcher will instruct the patients to blow into the plastic tube for 20 seconds after a deep breath to create 30 mmHg pressure. After the application of the Valsalva manoeuvre, haemodynamic variables (blood pressure, pulse, saturation) of the patients will be recorded. Receives: Other: Valsalva Manoeuvre Group |
| Control Group | No intervention | In the control group, the routine PIVC procedure will be performed by the same nurse for all patients. No additional interventions will be applied. Each patient's pain will be assessed and recorded before, during, and after the PIVC procedure by an independent nurse who is not involved in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Identification Information Form
A descriptive information form was created by examining the studies with patients who underwent peripheral intravenous catheterisation. In the descriptive information form; 6 questions including the patient's age, height, weight, pressure pain threshold value and haemodynamic indicators (blood pressure, pulse, saturation) were asked.
Measured: up to 12 weeks
Baseline Algometer (66 Lb/30 Kg)
Algometer is a widely used device for determining pressure pain threshold measurements. Pressure pain threshold can be defined as the minimum force applied to elicit pain. The measurement assessed with a pressure algometer is a manual procedure that requires a perceptual response from the individual. In order to introduce the Baseline Algometer (66 Lb/30 Kg) tool to the patients who are considered to be included in the study, pressure will be applied to a different area (above the wrist) outside the area to be measured. Patients will be asked to give the "stop" command at the first sensation of pain and the application will be repeated 3 times in all patients to ensure that the patients adapt to the real application. Then, the mean pressure pain threshold will be determined after three measurements made at 5-second intervals from the right antecubital region of the patients. Patients with an average pressure pain threshold of 8-16 pounds
Measured: up to 12 weeks
Visual Comparison Scale
The Turkish validity and reliability of this scale developed by Price et al. (1994) to evaluate the severity of pain was performed by Eti Aslan (2004) by evaluating the presence of pain in patients in the postoperative period. The scale is graded from 0 to 10, where 0 = no pain and 10 = unbearable pain. The severity of pain before, during (during peripheral intravenous catheterisation) and after PIC application will be recorded by a nurse independent of the study.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start3 Mar 2025
- Primary completion3 Mar 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel 3 group
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumeyye Akcoban, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872671
- Sponsor's protocol ID
- HMKU-KMY-SA-03
- Acronym
- Pain
- Status last verified
- Jun 2025
- First submitted
- 28 Feb 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yilmaz D, Gunes UY. The effect on pain of three different nonpharmacological methods in peripheral intravenous catheterisation in adults. J Clin Nurs. 2018 Mar;27(5-6):1073-1080. doi: 10.1111/jocn.14133. Epub 2018 Jan 8.
PubMed 29076581Ozkan 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 38430076Akcoban S, Tosun B. Breathing Exercises, Valsalva Maneuver Reduce Pain in Peripheral Intravenous Catheterization: Randomized Trial. Pain Manag Nurs. 2026 Jun;27(3):e426-e432. doi: 10.1016/j.pmn.2025.10.010. Epub 2025 Nov 21.
PubMed 41274790
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breathing Exercises and the Valsalva Maneuver on Pain Reduction During Peripheral Intravenous Catheterization: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06872671
- Acronym / sponsor ID
- Pain / HMKU-KMY-SA-03
- Conditions
- Pain
- Keywords
- pain, nursing, breathing exercises, valsalva maneuver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 12 Mar 2025 (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.
Peripheral intravenous catheter (PIVC) insertion is a painful procedure due to its invasive nature. During the procedure, damage to the endothelial layer and improper interventions can further increase pain levels. Additionally, pain can cause vasoconstriction, negatively affecting venous filling and reducing the success rate of IV catheter insertion. Both pharmacological and non-pharmacological methods are used to alleviate invasive pain associated with PIVC. However, pharmacological methods are often considered disadvantageous due to their high cost, potential adverse effects, and increased medication use. In contrast, non-pharmacological approaches are preferred as they are cost-effective, have fewer side effects, and pose a lower risk of complications.
Detailed description
One of the non-pharmacological methods used for pain reduction is breathing exercises. As a distraction technique, breathing exercises have been increasingly utilized to alleviate invasive pain experienced during blood collection and cannulation procedures. By enhancing lung ventilation, deep breathing maximizes oxygen intake, leading to relaxation in the patient. This state of relaxation contributes to a sense of comfort and reduces the perception of pain.
A review of the literature revealed only one study specifically evaluating the effectiveness of breathing exercises in reducing pain during PIVC insertion. Existing research has reported that breathing exercises have a positive impact on pain experienced during PIVC placement. In these studies, individuals were first positioned comfortably. They were then instructed to take a slow, deep breath through the nose, hold it briefly, and exhale slowly through the mouth. During inhalation, participants were guided to expand their abdomen and push the diaphragm downward, while during exhalation, they were asked to contract the abdominal muscles, draw the abdomen inward, and push the diaphragm upward. Additionally, individuals were instructed to silently count to four while inhaling, holding their breath, and exhaling. The breathing exercise began one minute before the procedure and continued throughout its duration.
Another non-pharmacological method used for pain reduction is the Valsalva maneuver, a well-known breathing technique. The Valsalva maneuver involves a forceful exhalation against a closed airway, stimulating the vagus nerve and causing physiological changes, particularly in heart rate and blood pressure. These physiological effects make the Valsalva maneuver a valuable diagnostic and therapeutic tool for terminating supraventricular tachycardia, assessing cardiac murmurs and left ventricular function, managing neuropathy, and controlling pain.
A review of the literature identified a few studies evaluating the effects of the Valsalva maneuver on pain, anxiety, and vital signs during PIVC insertion. The findings of these studies indicate that the Valsalva maneuver has a positive effect in reducing pain experienced during the procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel 3 group
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercise Group | Experimental | Other: Experimental: Breathing Exercise GroupAfter patients receive training on the breathing exercise, nurses responsible for performing the PIVC procedure will be provided with the necessary information regarding the intervention. It will be emphasized that patients should begin the breathing exercise before the PIVC procedure. Additionally, nurses will be instructed to perform the catheterization during the fifth step of the breathing exercise. Before the PIVC procedure in the breathing exercise group, the researcher will be present alongside the nurse performing the intervention. Nurses will be informed that they should initiate the PIVC procedure three seconds after the patient reaches the fourth step, which involves breath-holding. Furthermore, efforts will be made to ensure that the same nurse performs the PIVC procedure for each patient in the breathing exercise group. Hemodynamic variables, including blood pressure, pulse rate, and oxygen saturation, will be recorded before and after the breathing exercise. |
| Valsalva Manoeuvre Group | Experimental | Other: Valsalva Manoeuvre GroupCare will be taken to ensure that the PIC procedure is performed by the same nurse for the patients in the Valsalva manoeuvre group. The nurses performing the PIC procedure will be informed about the subject of the research and will be told that the patients will start the valsalva manoeuvre before the PIC procedure. Patients who can perform the valsalva manoeuvre by the researcher will be included in the study. Haemodynamic variables (blood pressure, pulse, saturation) of the patients will be recorded before the application of the Valsalva manoeuvre. Afterwards, the researcher will instruct the patients to blow into the plastic tube for 20 seconds after a deep breath to create 30 mmHg pressure. After the application of the Valsalva manoeuvre, haemodynamic variables (blood pressure, pulse, saturation) of the patients will be recorded. |
| Control Group | No intervention | –In the control group, the routine PIVC procedure will be performed by the same nurse for all patients. No additional interventions will be applied. Each patient's pain will be assessed and recorded before, during, and after the PIVC procedure by an independent nurse who is not involved in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- To be 18 years of age or older,
Key exclusion criteria (1 listed)
- Patients who do not meet the inclusion criteria will not be included in the study.
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 |
|---|---|---|
| Experimental: Breathing Exercise GroupEyes will be closed first. Head and neck will be relaxed. Breathing will be taken through the nose for three seconds. Then the breath will be held for three seconds. In the last step, breath will be exhaled through the mouth for three seconds. The patient will be instructed to take five normal breaths between each breathing exercise. The patient will be asked to count to three and will be told that he/she can count by using his/her fingers. The exercise will be started two minutes before the catheterisation procedure and the patient will be instructed to perform the breathing exercise twice. The patient will be asked to continue doing the breathing exercise until the PIC application process is completed. | Other | Breathing Exercise Group |
| Valsalva Manoeuvre GroupThe valsalva manoeuvre will be performed by blowing into a plastic tube connected through a sphygmomanometer. Patients will be allowed to raise the manometer by 30 mmHg for at least 20 seconds. Care will be taken to ensure that the PIC procedure is performed by the same nurse for the patients in the Valsalva manoeuvre group. The nurses performing the PIC procedure will be informed about the research subject and will be told that the patients will start the valsalva manoeuvre before the PIC procedure. Patients who can perform the valsalva manoeuvre by the researcher will be included in the study. Haemodynamic variables (blood pressure, pulse, saturation) of the patients will be recorded before the valsalva manoeuvre. Afterwards, the researcher will instruct the patients to blow into the plastic tube for 20 seconds after a deep breath to create 30 mmHg pressure. | Other | Valsalva Manoeuvre Group |
Primary outcome
Patient Identification Information Form
Time frame: up to 12 weeks
A descriptive information form was created by examining the studies with patients who underwent peripheral intravenous catheterisation. In the descriptive information form; 6 questions including the patient's age, height, weight, pressure pain threshold value and haemodynamic indicators (blood pressure, pulse, saturation) were asked.
Baseline Algometer (66 Lb/30 Kg)
Time frame: up to 12 weeks
Algometer is a widely used device for determining pressure pain threshold measurements. Pressure pain threshold can be defined as the minimum force applied to elicit pain. The measurement assessed with a pressure algometer is a manual procedure that requires a perceptual response from the individual. In order to introduce the Baseline Algometer (66 Lb/30 Kg) tool to the patients who are considered to be included in the study, pressure will be applied to a different area (above the wrist) outside the area to be measured. Patients will be asked to give the "stop" command at the first sensation of pain and the application will be repeated 3 times in all patients to ensure that the patients adapt to the real application. Then, the mean pressure pain threshold will be determined after three measurements made at 5-second intervals from the right antecubital region of the patients. Patients with an average pressure pain threshold of 8-16 pounds
Visual Comparison Scale
Time frame: up to 12 weeks
The Turkish validity and reliability of this scale developed by Price et al. (1994) to evaluate the severity of pain was performed by Eti Aslan (2004) by evaluating the presence of pain in patients in the postoperative period. The scale is graded from 0 to 10, where 0 = no pain and 10 = unbearable pain. The severity of pain before, during (during peripheral intravenous catheterisation) and after PIC application will be recorded by a nurse independent of the study.
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 3 Jun 2025.
- Results publication: PubMed 29076581Yilmaz D, Gunes UY. The effect on pain of three different nonpharmacological methods in peripheral intravenous catheterisation in adults. J Clin Nurs. 2018 Mar;27(5-6):1073-1080. doi: 10.1111/jocn.14133. Epub 2018 Jan 8.
- Results publication: 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.
- Derived from this study: PubMed 41274790Akcoban S, Tosun B. Breathing Exercises, Valsalva Maneuver Reduce Pain in Peripheral Intravenous Catheterization: Randomized Trial. Pain Manag Nurs. 2026 Jun;27(3):e426-e432. doi: 10.1016/j.pmn.2025.10.010. Epub 2025 Nov 21.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Breathing Exercise Group and Valsalva Manoeuvre Group in people with Pain, run by Mustafa Kemal 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 13 inclusion and 1 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 3 Jun 2025. 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?
Patient Identification Information Form (time frame: up to 12 weeks). The study lists 3 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 NCT06872671, which also lists 3 linked publications.
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 3 Jun 2025.