Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures

Randomized Controlled Trial Examining the Effectiveness of Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures

This study Will contribute in the knowledge of pediatric nurses during painful procedures such venipuncture

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain
• Intervention / Treatment: Behavioral: TICK-B; Drug: TKTX-Cream; Other: TICK-B and TKTX-C

Detailed Description

Children frequently undergo unexpected and procedure-related pain while in hospital settings, leading to adverse emotional and psychological effects. The exposure to painful procedures, particularly venipuncture, commonly occurs in emergency units, upon admission, during hospital stays, or during follow-up visits. The mere act of inserting needles stands out as one of the most distressing medical procedures for children, resulting in frightening and upsetting experiences for both the children and their parents throughout the hospitalization period.

In the realm of pain management, interventions can generally be classified into pharmacological and non-pharmacological approaches. Within pharmacological interventions, local anesthetics play a key role in addressing needle-related pain. These anesthetics can permeate the cuticle and epidermal layers of intact skin, reaching the dermis where nerve endings are situated, thereby alleviating pain. Notably, a eutectic mixture of local anesthetics (EMLA) emulsion, composed of 25 mg lidocaine and 25 mg prilocaine per gram, has been explored in pediatric settings for managing venipuncture pain due to its effectiveness and minimally invasive nature.

On the non-pharmacological front, various strategies have been investigated for needle procedures in children, including distraction techniques, cognitive and behavioral therapy, hypnosis, and memory alteration. Among these interventions, distraction stands out as a straightforward method that can be promptly applied and requires minimal prior training. A systematic review has demonstrated the effectiveness of distraction in alleviating pain associated with needle-related procedures.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Erbil
    • Duhok, Erbil, Iraq, 42012
      • Sherzad Khudeida Suleman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion:

School-aged 6-12 years old. Children who require PIVC.

Exclusion:

1. Chronic diseases,
2. Physical impairment,
3. Disability contributes to difficult communication,
4. Children of unsatisfied parents,
5. Children with neurodevelopment delays,
6. Cognitive impairment, hearing impairment, or visual impairment,
7. Taking an analgesic within 6 hours, or those with a syncope history.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TICK-B; active distraction technique as non-pharmacology in treating children's pain and fear during venipuncture procedure.	Behavioral: TICK-B; TICK-B as art-based distraction
Experimental: TkTx-Cream; as Pharmacological approach will be use in managing children's pain and fear during venipuncture procedure.	Drug: TKTX-Cream; TKTX-Cream as local anesthesia cream; Other Names: Local anesthesia
Experimental: TICK-B and TkTx-C; Pharmacological approache and non-Pharmacological will be use in managing children's pain and fear during venipuncture procedure.	Other: TICK-B and TKTX-C; TICK-B and TkTx-C as combined intervention approche (pharmacology and non-pharmacology); Other Names: Combination approach
No Intervention: Control Group; No intervention will applied in this group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severity of Pain	Severity of pain will be assessed using Wong-Baker FACES Pain Rating Scale, a validated self-reporting tool widely utilized in clinical settings. Participants will be instructed to rate their pain on a scale from 0 (indicating no pain) to 10 (representing the worst imaginable pain). The Wong-Baker FACES Pain Rating Scale will be administered promptly after the completion of the procedure.	baseline, during, and immediately post-procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear	level of fear will be assessed using the Child Fear Scale (CFS), a validated instrument designed to measure the level of fear in pediatric populations. Participants will be asked to express their feelings of fear related to the procedure through the Child Fear Scale.	baseline, during, and immediately post-procedure.

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Sherzad Suleman, MsC, Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): April 10, 2024
• Study Completion (Estimated): April 10, 2024

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: March 16, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: pain, anxiety, painful procedures
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pain
• Other Study ID Numbers: SherzadSH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes