Comparison of the Effect of Two Different Interventions

Not Applicable

Completed

• Conditions: To Compare the Effect of Two Different Nonpharmacological Methods on Pain and Fear During Peripheral Intravenous Catheterization

• Registration Number: NCT06772259
• Lead Sponsor: Sakarya University

Brief Summary

The goal of this clinical trial is to compare the effect of two different non-pharmacologic interventions with the control group in reducing pain due to peripheral intravenous catheterization application in children aged 5-12 years.

Hypotheses:

H1: Pain level differs in the group that received PIK with Palm Stimulator compared to the control group.

H2: The level of fear in the group with PIK application with Palm Stimulator differs from the control group.

H3: Satisfaction level is different in the group with PIK application with Palm Stimulator compared to the control group.

H4: The pain level differs in the group that received PIK application by watching cartoons compared to the control group.

H5: The level of fear is different in the group that received PIK application by watching cartoons compared to the control group.

H6: Satisfaction level is different in the group that received PIK application by watching cartoons compared to the control group.

H7: Pain level is different in the Palm Stimulator PIK group compared to the cartoon group.

H8: The level of fear is different in the Palm Stimulator PIK group compared to the cartoon group.

H9: The satisfaction level in the group with PIK application with Palm Stimulator is different from the cartoon group.

H10: PIK application time is different in the palm stimulator group compared to the control group.

H11: PIK application time is different in the cartoon group compared to the co

Detailed Description

1. To measure the pain and fear levels of children by placing a palm stimulator on their palms during PIK application

2. Measuring pain and fear levels by watching cartoons to children during PIK application

Study Timeline

• Study Start: 2023-10-01
• Primary Completion: 2023-12-01
• Study Completion: 2024-03-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-24
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Voluntary participation in the study,
2. Pediatric patients for whom written and verbal consent has been obtained from the parent,
3. Pediatric patients for whom verbal consent was obtained,

(3) Not under the influence of sedative/anticonvulsant/analgesic drugs, (4) Pediatric patients aged 5-12 years, (5) Pediatric patients who can communicate, understand, and carry out commands and are not dependent on technological devices.

Exclusion Criteria

1. Not volunteering to participate in the study,
2. More than one PIK attempt,
3. Children with a chronic, acute, or life-threatening illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Measurement	3 months	Before, during, and after the PIK procedure in intervention and control groups. Wong-Baker FACES Pain Scale: The scale used to diagnose pain in children was developed by Donna Lee Wong and Connie Morain Baker. The Wong-Baker Scale has been reported to be safe to use in children aged 3-18 who can verbally describe the level of pain. The scale includes facial expressions and numbers. The scale has a total of six facial expressions, and pain is graded between 0-10 (Wong \& Baker, 1988).
Fear	3 months	Fear assessment before, during, and after the PIK procedure in intervention and control groups.; Child Fear Scale: The Turkish psychometric properties of the scale adapted to pediatric patients as "Children's Fear Scale" by McMurty et al. (2011) were evaluated by Özalp Gerçeker et al. The CSA is a scale consisting of five drawn facial expressions ranging from neutral expression (0=no anxiety) to frightened face (4=severe anxiety) and evaluated between 0 and 4 (Özalp Gerçeker et al., 2018). It can be used by families and researchers to assess pain and anxiety before and during the procedure and is intended for children aged 5-10 years. In the Turkish reliability and validity study, the content validity index of the scale was found to be 0.89 (Özalp Gerçeker et al., 2018).

Secondary Outcome Measures

Name	Time	Method
Saticfaction	3 months	Satisfaction assessment after the PIK procedure in intervention and control groups.; Individuals were asked to give a score between 0-10 to determine their satisfaction. A score of "0" means "not at all satisfied", while a score of "10" means "very satisfied".

Trial Locations

Locations (1)

Sakarya University; 🇹🇷 Sakarya, Serdivan, Turkey