Clinical trial NCT06872671: The Effect of Breathing Exercises and the Valsalva Maneuver on Pain Reduction During Peripheral Intravenous Catheterization
Official title: The Effect of Breathing Exercises and the Valsalva Maneuver on Pain Reduction During Peripheral Intravenous Catheterization: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pain
nursing
breathing exercises
valsalva maneuver
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel 3 group
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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,
  * 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.

Exclusion Criteria:

* Patients who do not meet the inclusion criteria will not be included in the study.

Primary outcomes:
measure: Patient Identification Information Form
timeFrame: up to 12 weeks
measure: Baseline Algometer (66 Lb/30 Kg)
timeFrame: up to 12 weeks
measure: Visual Comparison Scale
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Hatay Mustafa Kemal University
Study officials:
References:
citation: 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.
citation: 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.