NCT07775547

Brief Summary

This study aims to evaluate pain in children during and after K-wire (Kirschner wire) removal and to investigate the effect of the intervention on pain. Children who are scheduled for K-wire removal will be included in the study. Participants will be assigned to an intervention group or a control group. Pain intensity will be assessed using the Visual Analog Scale (VAS), scored from 0 to 10. Pain assessments will be performed before and after the procedure. In addition to the child's pain rating, pain will also be assessed by the parent and the researcher. The pain scores will be compared to evaluate differences between the groups and changes in pain before and after the procedure.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
41

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jul 2025

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 20, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2026

Completed
Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

1.1 years

First QC Date

August 15, 2026

Last Update Submit

August 18, 2026

Conditions

Keywords

Pain managementPediatric pain;acupressureanxietyfair

Outcome Measures

Primary Outcomes (2)

  • Primary Outcome Measure-Pain

    Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). Pain scores will be assessed during and after K-wire removal.

    Baseline and 2 hours

  • Anxiety assessed using the Child Anxiety Thermometeranxiety

    Anxiety level will be assessed using the Child Anxiety Thermometer, a visual analog scale ranging from 0 (no anxiety) to 10 (very high anxiety). Anxiety scores will be assessed before, during, and after K-wire removal.

    Baseline and 2 hours

Study Arms (2)

Acupressure group

EXPERIMENTAL

Participants will receive acupressure before K-wire removal.

Behavioral: acupressure

Control (Plasebo ) group

PLACEBO COMPARATOR

Participants will receive placebo acupressure before K-wire removal

Other: control (placebo) group

Interventions

acupressureBEHAVIORAL

Participants in the placebo group will receive a touch procedure at the LI4 acupressure point without therapeutic acupressure stimulation. Pain will be assessed during and after K-wire removal. Anxiety and fear will be assessed before, during, and after the procedure.

Acupressure group

Participants in the control group will receive a placebo acupressure procedure. Pressure will be applied to a location distant from the LI4 acupressure point, without stimulating the therapeutic LI4 point. Pain will be assessed during and after K-wire removal, while anxiety and fear will be assessed before, during, and after the procedure.

Control (Plasebo ) group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- Children aged 6-12 years. First-time K-wire removal following treatment for an elbow fracture. Able to communicate verbally and understand and speak Turkish. No chronic pain, psychiatric, developmental, or sensory disorders. No physical condition preventing acupressure application at the LI4 point. No opioid, narcotic analgesic, or sedative medication use within 8 hours before the procedure.
  • Written informed consent obtained from both the child and parent after being informed about the study.

You may not qualify if:

  • Neurological or psychiatric disorders that may affect pain perception. Developmental or sensory disabilities. Inability to communicate or cooperate during the procedure. Use of opioid, narcotic analgesic, or sedative medication within 8 hours before the procedure.
  • Requirement for analgesic or sedative medication during the procedure. K-wire removal not completed in a single session. Complications during the procedure, such as prolonged or traumatic K-wire removal.
  • Wound, infection, dressing, fracture, inflammation, or other local contraindications at the LI4 acupressure site.
  • Withdrawal of informed consent by the child or parent during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yuzuncu Yıl University

Van, Tuşba, 65080, Turkey (Türkiye)

Location

Related Publications (3)

  • Çalışır, H., & Karataş, P. (2019). Pediatri Hemşireliğinde Atravmatik Bakım Yaklaşımı: Ağrı, Stres ve Anksiyeteyi Azaltmada Farmakolojik Olmayan Uygulamalar•. Journal of Education & Research in Nursing/Hemşirelikte Eğitim ve Araştırma Dergisi, 16(3).

    BACKGROUND
  • Zhamilov V, Turgut A, Reisoglu A, Basa CD, Kacmaz IE, Kazimoglu C. Analysis of the factors affecting pain level during K-wire removal among pediatric elbow fractures. J Pediatr Orthop B. 2023 Mar 1;32(2):134-138. doi: 10.1097/BPB.0000000000001010. Epub 2022 Sep 20.

  • Sorenson SM, Hennrikus W. Pain during office removal of K-wires from the elbow in children. J Pediatr Orthop. 2015 Jun;35(4):341-4. doi: 10.1097/BPO.0000000000000269.

MeSH Terms

Conditions

PainAgnosiaAnxiety Disorders

Interventions

AcupressurePopulation Groups

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationDemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Acupressure group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 15, 2026

First Posted

August 20, 2026

Study Start

July 1, 2025

Primary Completion

August 20, 2026

Study Completion

August 20, 2026

Last Updated

August 20, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations