Effect Of integration of cold And vibration On anxiety And pain during intravenous cannulation among children

Not yet recruiting

• Conditions: New Technology,

• Registration Number: CTRI/2018/10/015950
• Lead Sponsor: Megha

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-09-10
• Study Start: 2018-10-14

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Study includes: Children of age 6 to12 yearswho require Intravenous Cannulation Children undergoing first time intravenous Cannulation.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fear and anxiety with Children fear scale and pain with FLACC behavioral pain assessment scale	3-5 MIN.

Secondary Outcome Measures

Name	Time	Method
Significant association of post interventional level of anxiety and pain among children with their selected demographic data at p0.05 level	3- 5 MIN.

Trial Locations

Locations (1)

AIIMS Rishikesh; 🇮🇳 Dehradun, UTTARANCHAL, India

AIIMS Rishikesh

🇮🇳Dehradun, UTTARANCHAL, India

Megha

Principal investigator

9953496956

gahlawatmegha@gmail.com