| CTRI Number |
CTRI/2018/10/015950 [Registered on: 09/10/2018] Trial Registered Prospectively |
| Last Modified On: |
09/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of integration of cold And
vibration On anxiety And pain during intravenous cannulation among children |
|
Scientific Title of Study
|
A Randomized Control Trial To Assess Effectiveness Of External Cold And Thermomechanical Stimulation On Anxiety And Pain During Intravenous Cannulation Among Children At All India Institute Of Medical Sciences, Rishikesh
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Megha |
| Designation |
M.Sc. Nursing |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room No.142, Student Nursing Hostel,All India Institute of Medical Sciences, Virbhadra Marg, Pashulok, Rishikesh (Uttarakhand)
College of Nursing, All India Institute of Medical Sciences,Virbhadra Marg, Pashulok, Rishikesh (Uttarakhand)
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9953496956 |
| Fax |
|
| Email |
gahlawatmegha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Malar Kodi S |
| Designation |
Assistant Professor, College of Nursing, All India Institute of Medical Sciences, Rishikesh |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Type III, 3/4 AIIMS Residential complex opposite to Barrage Rishikesh, Uttarakhand
College of Nursing, All India Institute of Medical Sciences,Virbhadra Marg, Pashulok, Rishikesh (Uttarakhand)
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7533800333 |
| Fax |
|
| Email |
malargeethu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Megha |
| Designation |
M.Sc. Nursing |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room No.142, Student Nursing Hostel,All India Institute of Medical Sciences, Virbhadra Marg, Pashulok, Rishikesh (Uttarakhand)
College of Nursing, All India Institute of Medical Sciences,Virbhadra Marg, Pashulok, Rishikesh (Uttarakhand)
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9953496956 |
| Fax |
|
| Email |
gahlawatmegha@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Virbhadra Road, Rishikesh
Uttarakhand Pin No : 249203 |
|
|
Primary Sponsor
|
| Name |
Megha |
| Address |
College of Nursing, All India Institute of Medical Sciences,Virbhadra Marg, Pashulok, Rishikesh (Uttarakhand) |
| Type of Sponsor |
Other [Principal investigator ] |
|
|
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 |
| Megha |
AIIMS Rishikesh |
Paediatric Department, All India Institute Of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand Pin No : 249201
Dehradun
UTTARANCHAL |
9953496956
gahlawatmegha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Rishikesh, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: X||New Technology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
External cold and thermomechanical stimulation through a Buzzy device |
Experimental group will be provided with external cold and thermomechanical stimulation through a Buzzy device.During the peripheral IV cannulation, the nurse used the dorsum of the child’s left or right hand, depending on whether the child was left- or right handed. In left-handed children, the peripheral IV cannulation was inserted in the dorsum of the right hand. In right-handed children, it was inserted in the dorsum of the left hand. The dorsum of the child’s hand area was cleaned and cannulated with Buzzy. Buzzy was administered about 5 cm above the application area just before the procedure, and the vibration was continued until the end of the procedure |
| Comparator Agent |
USUAL PRACTICE |
Control group will be dealt with standard protocol of hospital routine . |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Study includes:
Children of age 6 to12 yearswho require Intravenous Cannulation
Children undergoing first time intravenous Cannulation
|
|
| ExclusionCriteria |
| Details |
Study excludes child who is having:
Break or abrasion on the skin where the device will be placed
Nerve damage in the affected extremity
Critical or chronic illness or neurodevelopmental delay.
History of use of analgesic within the last 6 hours
History of syncope due to blood sampling collection or immunization.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fear and anxiety with Children fear scale and pain with FLACC behavioral pain assessment scale |
3-5 MIN. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant association of post interventional level of anxiety and pain among children with their selected demographic data at p0.05 level |
3- 5 MIN. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
14/10/2018 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a Parallel group, single blinded randomized control trial to assess the efficacy of external cold and thermomechanical stimulation on anxiety and pain during intravenous cannulation that will be conducted in the Pediatric Department of AIIMS Rishikesh. The primary outcome will be significant reduction on level of anxiety and pain during Intravenous cannulation among children by using external cold and thermomechanical stimulation through Buzzy device at p<0.05 level. The secondary outcome will be significant association of post interventional level of anxiety and pain among children with their selected demographic data at p<0.05 level |