跳至主要内容
临床试验/NCT06872671
NCT06872671已完成不适用

The Effect of Breathing Exercises and the Valsalva Maneuver on Pain Reduction During Peripheral Intravenous Catheterization: A Randomized Controlled Trial

Mustafa Kemal University1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2025年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
138
试验地点
1
主要终点
Patient Identification Information Form

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

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.

干预措施: Experimental: Breathing Exercise Group (Other)

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.

干预措施: Valsalva Manoeuvre Group (Other)

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.

结局指标

主要结局

Patient Identification Information Form

时间窗: 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)

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sumeyye Akcoban

Principal Investigator

Mustafa Kemal University

研究点 (1)

Loading locations...

相似试验