FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/10/046386 [Registered on: 12/10/2022] Trial Registered Prospectively
Last Modified On: 11/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effectiveness of Thermomechanical Stimulation on Pain and Anxiety during Peripheral Intravenous Cannulation among Chronic Liver Disease Patients 
Scientific Title of Study   Effectiveness of Thermomechanical Stimulation during Peripheral Intravenous Cannulation on Pain and Anxiety among patients with chronic liver disease. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kumari Sangam 
Designation  Student 
Affiliation  Institute of Liver and Biliary Sciences, New Delhi 
Address  Room No. C-8 Adhayaan Hostel, College Of Nursing, Institute Of Liver and Biliary Sciences
Room No. C-8 adhyaan Hostel, Institute of Liver and Biliary Sciences
South West
DELHI
110070
India 
Phone  9085203231  
Fax  8630885827  
Email  sangamkumari61@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Tarika Sharma 
Designation  Lecturer 
Affiliation  Institute of Liver and Biliary Sciences, New Delhi 
Address  Room No. C-8 Adhayaan Hostel, College Of Nursing, Institute Of Liver and Biliary Sciences, Vasant Kunj. New Delhi- 110070
staff room no. 2 College Of Nursing, Adhayaan Hostel, Institute Of Liver and Biliary Sciences, Vasant Kunj. New Delhi- 110070
South West
DELHI
110070
India 
Phone  8219228244  
Fax    
Email  tarikasharma91@gmai.com  
 
Details of Contact Person
Public Query  
Name  Kumari Sangam 
Designation  Student 
Affiliation  Institute of Liver and Biliary Sciences, New Delhi 
Address  Room No. C-8 Adhayaan Hostel, Institute Of Liver and Biliary Sciences, Vasant Kunj.
staff room no. 2 Adhayaan Hostel, Institute of Liver and Biliary Sciences. Vasant Kunj.
South West
DELHI
110070
India 
Phone  9085203231  
Fax    
Email  sangamkumari61@gmail.com  
 
Source of Monetary or Material Support  
Institute Of Liver and Biliary Sciences 
 
Primary Sponsor  
Name  ILBS 
Address  Institute of Liver and Biliary Sciences, Vasant Kunj 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ms Kumari Sangam  Institute of Liver and Biliary Sciences  Hepatology General Ward section A and B, 2nd Floor Phase 2 .
South West
DELHI 		 9085203231

sangamkumari61@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of the Decision of the College of Nursing Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo   In the Control Group, the Placebo through Switching off the Vibration and application of normal ice pack in Thermomechanical Stimulation Device will be introduced. Before starting the Intravenous cannulation, the nurse gently rub or clean the site in which the needle was placed in order to administer Intravenous therapy and the procedure will remain same as in Experimental Group. Whether in the Control or the Experimental group, none of them will receive pharmacological pain therapies.  
Intervention  Thermomechanical Stimulation  In this study Thermomechanical Stimulation refers to the application of cold and vibration using a device during Peripheral Intravenous Cannulation 5-10 cm above the site till the procedure for assessing pain and anxiety within 5 minutes after Procedure among Chronic Liver Disease patients.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Inclusion Criteria
1. Chronic Liver Disease Patients admitted at
General Wards.
2. Aged 18 or more.

3. Patients who are hemodynamically stable not
requiring immediate intensive care

4. Can communicate in Hindi/English.

5. Who are mentally alert.

6. Patients undergoing Intravenous Cannulation on
forearm, wrist, or hand.
 
 
ExclusionCriteria 
Details  Exclusion Criteria
1. Patients not requiring cannulation or already
cannulated.

2. Patients with Central Line.

3. Patient have diseases associated with cold
sensitivity.

4. Patients who are mentally not alert.

5. Who had pain medications just before procedure.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in pain and anxiety of patients  one time assessment 
 
Secondary Outcome  
Outcome  TimePoints 
Better quality care to patients  one time assessment 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.


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.

 

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.


 
Close