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

NCT06326125 | Enrolling By Invitation DMC

• 1 other identifier: SherzadSH
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

pain, anxiety, painful procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fear

  baseline, during, and immediately post-procedure.

Study Arms (4)

TICK-B

EXPERIMENTAL

active distraction technique as non-pharmacology in treating children's pain and fear during venipuncture procedure.

Behavioral: TICK-B

TkTx-Cream

EXPERIMENTAL

as Pharmacological approach will be use in managing children's pain and fear during venipuncture procedure.

Drug: TKTX-Cream

TICK-B and TkTx-C

EXPERIMENTAL

Pharmacological approache and non-Pharmacological will be use in managing children's pain and fear during venipuncture procedure.

Other: TICK-B and TKTX-C

Control Group

NO INTERVENTION

No intervention will applied in this group

Interventions

TICK-B BEHAVIORAL

TICK-B as art-based distraction

TICK-B

TKTX-Cream DRUG

TKTX-Cream as local anesthesia cream

Also known as: Local anesthesia

TkTx-Cream

TICK-B and TKTX-C OTHER

TICK-B and TkTx-C as combined intervention approche (pharmacology and non-pharmacology)

Also known as: Combination approach

TICK-B and TkTx-C

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Sherzad Khudeida Suleman

Duhok, Erbil Governorate, 42012, Iraq

Location

Related Publications (1)

• Suleman SK, Yahya N, Nilsson S, Enskar K. Comparative efficacy of pharmacological and non-pharmacological interventions for mitigating pain and anxiety associated with venipuncture: a randomised controlled trial. BMJ Paediatr Open. 2024 Sep 9;8(1):e002881. doi: 10.1136/bmjpo-2024-002881.

  PMID: 39251366 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Sherzad Suleman, MsC

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 22, 2024
• Study Start: December 15, 2023
• Primary Completion: April 10, 2024
• Study Completion: April 10, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

IR (1)