| CTRI Number |
CTRI/2025/09/094853 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
study on pain relief with external cold and vibrating device in children with needle pain during blood tests or cannulation. |
|
Scientific Title of Study
|
Clinical efficacy of external cold and vibrating device in decreasing pain in children undergoing venipuncture in paediatric hospital |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharadha M |
| Designation |
Assistant professor |
| Affiliation |
indira gandhi institute of child health, bengaluru |
| Address |
Department of anaesthesia
indira gandhi institute of child health
2nd floor, near SICU
hospital building
IGICH, jayanagar 1st block, dharmaram college post, bangalore
Office, indira gandhi institute of child health, south hospital complex, dharmaram college post, 1st block, jayanagar, bengaluru, 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
09148884706 |
| Fax |
|
| Email |
www.sharadharadhamanju@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharadha M |
| Designation |
Assistant professor |
| Affiliation |
indira gandhi institute of child health, bengaluru |
| Address |
Department of anaesthesia
indira gandhi institute of child health
2nd floor, near SICU
hospital building
IGICH, jayanagar 1st block, dharmaram college post, bangalore
Office, indira gandhi institute of child health, south hospital complex, dharmaram college post, 1st block, jayanagar, bengaluru, 560029
Bangalore
KARNATAKA
562114
India |
| Phone |
09148884706 |
| Fax |
|
| Email |
www.sharadharadhamanju@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharadha M |
| Designation |
Assistant professor |
| Affiliation |
indira gandhi institute of child health, bengaluru |
| Address |
Department of anaesthesia
indira gandhi institute of child health
2nd floor, near SICU
hospital building
IGICH, jayanagar 1st block, dharmaram college post, bangalore
Office, indira gandhi institute of child health, south hospital complex, dharmaram college post, 1st block, jayanagar, bengaluru, 560029
Bangalore
KARNATAKA
562114
India |
| Phone |
09148884706 |
| Fax |
|
| Email |
www.sharadharadhamanju@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira gandhi institute of child health, South hospital complex, dharmaram college post, jayanagar, bangalore
karnataka, India
560029 |
|
|
Primary Sponsor
|
| Name |
inira gandhi institute of child health |
| Address |
South hospital complex, dharmaram college post, jayanagar 1st block, bengaluru 560011 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sharadha M |
Indira Gandhi Institute of Child Health |
Department of anaesthesia, 2nd floor, 1st block jayanagar, south hospital complex, Dharmaram college post, Bengaluru 560029
Bangalore
KARNATAKA |
9148884706
www.sharadharadhamanju@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Indira gandhi institute of child health, bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
standard of care of hospital while venipuncture or intravenous cannulation is carried out on children like distraction methods and parental reassurance. The pain, acceptance (likert) and anxiety scores are recorded while attempting iv cannulation or venipuncture without any aid of device, similar to intervention group. |
| Intervention |
External cold and vibrating device |
External cold and vibrating device used in our study is called BUZZY which is class 1 FDA approved, over the counter low grade device which has vibration frequency of 100 Hz and an optional ice pack for cold sensation. The device will be kept just above the area of skin where the needle prick is intended for 30 seconds, following which the device will be moved 2 to 3 cms above (gate control theory of pain reduction).The area will be cleaned and venipuncture or iv cannulation will be attempted. Frequency is once only, we will record the pain relief, acceptance of the device (likert questionnaire) and anxiety level of the patient using appropriate scores. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
presence of atleast one parent/ care giver |
|
| ExclusionCriteria |
| Details |
Cghildren with significant altered emotional state, cognitive dysfunction, who refuse to wear device, with bleeding disorders, with neuropathy/ nerve damage, who are critically ill/ unstable.
absence of atleast one parent or caregiver, lack of parental consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of external cold and vibrating device in decreasing pain during venipuncturr compared to standard care in tge age group of 3 to 12 yearts admitted in paediatric surgical wards as assessed by modified wong baker scale and numerical rating scales of pain. |
During or immidiately after the procedure, once only. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the acceptance of the device using appropriate likert questionnaire
and to assess the level of anxiety in children undergoing cannulation using children fear scale |
During or immediately after the procedure, once only |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
01/10/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dear sir or madam
This is a study titled Clinical efficacy of external cold and vibrating device in decreasing pain in children undergoing venipuncture in a paediatric hospital Needle prick procedures like IV cannulation and venipunctures are essential for diagnosis and treatment for children in hospitals but at the same time most distressful events and this can impact children both emotionally and pscycologically In this study we use an external cold and vibrating device versus standard hospital care for needle pricks like venipuncture to asses how useful is this device in reduction of pain compared to standard care like distraction while needle pricks We include children between 3 to 12 years with at least one caregiver and exclude all the children with critical illnesses including bleeding disorders or neuropathy primary outcome is to evaluate efficacy of the device in reduction of pain as assessed by pain scores and secondary outcomes are to assess acceptance of the device with appropriate likert questionnaire and to assess the level of anxiety of children undergoing venipuncture using children fear scale randomised active parellel study which is open label randomisation will be done by computer generated envelopes sample size was calculated by a pilot study and the sample size is 72 with 36 in each group ethical committee approval is attatched in this application kindly do the needful
thank you
|