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

Do we have to restrain children forcefully and make them suffer in health care? Evaluating an intervention for healthcare professionals to reduce anxiety and pain in children during needle-related medical procedures in healthcare

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12280133

Enrollment

300

Registered

2023-04-24

Start date

2023-07-01

Completion date

Unknown

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety and pain in children during needle-related medical procedures in healthcare Other

Interventions

This project comprises three phases. The first phase forms the baseline, pre-intervention phase (Study 1) and is based on observations and self-reported pain- and anxiety-preventing strategies used in

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Does not meet the inclusion criteria

Design outcomes

Primary

Measure	Time frame
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 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 3. Healthcare providers' (HCPs) use of pain and anxiety-preventing strategies measured using a questionnaire at the same time, during 2023	—

Measure

Time frame

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 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 3. Healthcare providers' (HCPs) use of pain and anxiety-preventing strategies measured using a questionnaire at the same time, during 2023

—

Secondary

Measure	Time frame
1. Level of pain and anxiety in children and parents after the intervention compared to before the intervention 2. Observed use of the strategies after the intervention compared to before the intervention 3. HCPs’ self-rated use of the strategies after the intervention compared to before the intervention 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 5. Injection phobia measured using the Injection Phobia Scale - Anxiety (IPSA) and the Injection Phobia Scale - Avoidance (IPSAV) before the procedure 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	—

Measure

Time frame

1. Level of pain and anxiety in children and parents after the intervention compared to before the intervention 2. Observed use of the strategies after the intervention compared to before the intervention 3. HCPs’ self-rated use of the strategies after the intervention compared to before the intervention 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 5. Injection phobia measured using the Injection Phobia Scale - Anxiety (IPSA) and the Injection Phobia Scale - Avoidance (IPSAV) before the procedure 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

—

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026