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

NCT ID: NCT06326125

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2024-04-10

Brief Summary

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

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

TICK-B

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

Group Type: EXPERIMENTAL

TICK-B

Intervention Type: BEHAVIORAL

TICK-B as art-based distraction

TkTx-Cream

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

Group Type: EXPERIMENTAL

TKTX-Cream

Intervention Type: DRUG

TKTX-Cream as local anesthesia cream

TICK-B and TkTx-C

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

Group Type: EXPERIMENTAL

TICK-B and TKTX-C

Intervention Type: OTHER

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

Control Group

No intervention will applied in this group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TICK-B

TICK-B as art-based distraction

Intervention Type: BEHAVIORAL

TKTX-Cream

TKTX-Cream as local anesthesia cream

Intervention Type: DRUG

TICK-B and TKTX-C

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

Intervention Type: OTHER

Other Intervention Names

Local anesthesia; Combination approach

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Sherzad Khudeida Suleman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherzad Suleman, MsC

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Sherzad Khudeida Suleman

Duhok, Erbil, Iraq

Countries

Iraq

References

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.

Reference Type: DERIVED

PMID: 39251366 (View on PubMed)

Other Identifiers

SherzadSH

Identifier Type: -

Identifier Source: org_study_id