Do we have to restrain children forcefully and make them suffer in health care?

Not Applicable

• Conditions: Anxiety and pain in children during needle-related medical procedures in healthcare; Not Applicable

• Registration Number: ISRCTN12280133
• Lead Sponsor: Akademiska Barnsjukhuset

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-24
• Last Update Posted: 8 May 2023
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Children, parents, and HCPs from study 1 in the developmental phase
2. In the intervention phase, HCPs from the same functions as in Study 1

Exclusion Criteria

Does not meet the inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Pain in children measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale for 0-2-year-olds, the Faces Pain Scale-Revised (FPS-R) for 4-7-year-olds and a Numeric Rating Scale (NRS) for 8-17-year-olds before, during, and immediately after the needle-related medical procedure <br>2. Anxiety in children aged 4-17 years old measured using the State-Trait Anxiety Inventory (STAI) short version and the Visual Analogue Scale for Anxiety (VAS-A) before and immediately after the needle-related medical procedure<br>3. Healthcare providers' (HCPs) use of pain and anxiety-preventing strategies measured using a questionnaire at the same time, during 2023

Secondary Outcome Measures

Name	Time	Method
1. Level of pain and anxiety in children and parents after the intervention compared to before the intervention<br>2. Observed use of the strategies after the intervention compared to before the intervention<br>3. HCPs’ self-rated use of the strategies after the intervention compared to before the intervention<br>4. Parent anxiety measured using the State-Trait Anxiety Inventory (STAI) short version and the Visual Analogue Scale for Anxiety (VAS-A) before and immediately after the needle-related medical procedure<br>5. Injection phobia measured using the Injection Phobia Scale - Anxiety (IPSA) and the Injection Phobia Scale - Avoidance (IPSAV) before the procedure<br>6. Immediate reflections and perspectives related to the pain and anxiety-preventing strategies used during the procedure, measured using a short interview with the first 20 participating families in each function (in total n = 80), including children =4 years of age, their parents and involved HCPs, after the observation<br><br><br>