Effectiveness of Thermomechanical Stimulation on Pain and Anxiety during Peripheral Intravenous Cannulation among Chronic Liver Disease Patients
- Conditions
- Other and unspecified cirrhosis ofliver,
- Registration Number
- CTRI/2022/10/046386
- Lead Sponsor
- ILBS
- Brief Summary
A randomized control trial is planned to be implemented on 120 subjects meeting the inclusion criteria to assess for effectiveness of thermomechanical stimulation on pain and anxiety during peripheral intravenous cannulation.
Goal of the study is to assess the effectiveness of thermomechanical stimulation on pain and anxiety during peripheral intravenous cannulation among chronic liver disease patients.
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|**Setting of the study**
General Wards of Institute of Liver and Biliary Sciences
|**Population**
**Target Population** - Chronic Liver Disease Patients Undergoing Peripheral Intravenous Cannulation.
**Accessible Population** – Chronic Liver Disease Patients
Undergoing Peripheral Intravenous Cannulation at General Wards of ILBS.
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|**Sampling Technique**
Simple Random sampling (Computer Generated Random
Number).
|**Sample Size**
120 Subjects (60+60)
Duration of Intervention - application of device for maximum 60 seconds provided only once
**Intervention Protocol.**
Intervention planned for the study is the application of Thermomechanical Stimulation Device; at the insertion site after assessment of vein for a period of 1 minute.
This will be followed by placing the device 5-10 cm above needle insertion site till the Cannulation.
**Procedures**
**Description**
Experimental group In the Experimental group, Intervention using the Thermomechanical Stimulation during Peripheral Intravenous Cannulation will be introduced. Thermomechanical Stimulation device mechanism is based on gate control theory of pain. According to which cryotherapy and vibration will block the sensory impulse carried by nociceptors to brain nerve cells. Peripheral site selection will be done by the nurse at the same time. The nurse places the device with the frozen wings on patients’ skin for 1minute at the cannulation site. Then nurse position the Device at 5-10 cm from the possible Peripheral Intravenous Cannulation location. Before starting the Peripheral Intravenous Cannulation, the Researcher will on the device and inform the Patient in order to start the vibration as well as cold application. The Device will remain on till the successful insertion of the Intravenous Peripheral Cannulation. Finally, the nurse assesses patients Pain, Anxiety and Satisfaction within 5 minutes after Procedure with the Numerical Pain Rating Scale, State Anxiety Trait Inventory, and Satisfaction Scale respectively.
Control Group In the Control Group, the Placebo through Switching off the Vibration and use of a gel pack (at normal temperature) in Thermomechanical Stimulation Device will be introduced. Before starting the Intravenous cannulation, the nurse gently rubs or clean the site in which the needle will be placed in order to administer Intravenous therapy and the procedure for IV cannulation will remain same as mentioned above in Experimental Group. Whether in the Control or the Experimental group, none of them will receive pharmacological pain therapies for Peripheral Intravenous Cannulation related pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 120
- Inclusion Criteria 1.
- Chronic Liver Disease Patients admitted at General Wards.
- Aged 18 or more.
- Patients who are hemodynamically stable not requiring immediate intensive care 4.
- Can communicate in Hindi/English.
- Who are mentally alert.
- Patients undergoing Intravenous Cannulation on forearm, wrist, or hand.
- Exclusion Criteria 1.
- Patients not requiring cannulation or already cannulated.
- Patients with Central Line.
- Patient have diseases associated with cold sensitivity.
- Patients who are mentally not alert.
- Who had pain medications just before procedure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in pain and anxiety of patients one time assessment
- Secondary Outcome Measures
Name Time Method Better quality care to patients one time assessment
Trial Locations
- Locations (1)
Institute of Liver and Biliary Sciences
🇮🇳West, DELHI, India
Institute of Liver and Biliary Sciences🇮🇳West, DELHI, IndiaMs Kumari SangamPrincipal investigator9085203231sangamkumari61@gmail.com