PainNCT07775547
Acupressure in Pediatric K-wire Removal
A study testing acupressure in people with Pain and Pain Management, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Pain Management
- What is being tested?
- acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 20 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF ACUPRESSURE ON PAİN, FEAR, ANXİETY, AND PHYSİOLOGİCAL PARAMETERS DURİNG KİRSCHNER WİRE REMOVAL İN CHİLDREN: A RANDOMİZED CONTROLLED TRİAL
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.
Read the detailed description
This study is designed to evaluate pain associated with K-wire (Kirschner wire) removal in children and to compare pain outcomes between an intervention group and a control group. Children who meet the study eligibility criteria and are scheduled for K-wire removal will be included.
Participants will be assigned to an intervention group or a control group according to the study protocol. Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). Pain will be assessed immediately before and after K-wire removal.
Pain assessments will be obtained independently from three perspectives: the child, the parent, and the researcher. The agreement among these three assessments will also be evaluated.
The primary purpose of the study is to determine whether the intervention is associated with a greater reduction in pain compared with the control condition. Pain scores before and after the procedure will be compared within and between the study groups.
The findings of this study may contribute to a better understanding of pain management during K-wire removal in children and may help inform clinical approaches for reducing procedural pain.
- Conditions
- Pain, Pain Management
- Being tested
- acupressure, control (placebo) group
- Keywords
- Pain management, Pediatric pain;, acupressure, anxiety, fair
- Medical subject headings
- Pain, Agnosia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressureBehavioural
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.
control (placebo) groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure group | Experimental | Participants will receive acupressure before K-wire removal. Receives: Behavioral: acupressure |
| Control (Plasebo ) group | Placebo comparator | Participants will receive placebo acupressure before K-wire removal Receives: Other: control (placebo) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Jul 2025
- Primary completion20 Aug 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Acupressure group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahri AŞKAN, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775547
- Sponsor's protocol ID
- VANYYU-2025-07-06
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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).
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.
PubMed 36125889Sorenson 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.
PubMed 25105985
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF ACUPRESSURE ON PAİN, FEAR, ANXİETY, AND PHYSİOLOGİCAL PARAMETERS DURİNG KİRSCHNER WİRE REMOVAL İN CHİLDREN: A RANDOMİZED CONTROLLED TRİAL
- ClinicalTrials.gov ID
- NCT07775547
- Acronym / sponsor ID
- VANYYU-2025-07-06
- Conditions
- Pain, Pain Management
- Keywords
- Pain management, Pediatric pain;, acupressure, anxiety, fair
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed to evaluate pain associated with K-wire (Kirschner wire) removal in children and to compare pain outcomes between an intervention group and a control group. Children who meet the study eligibility criteria and are scheduled for K-wire removal will be included.
Participants will be assigned to an intervention group or a control group according to the study protocol. Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). Pain will be assessed immediately before and after K-wire removal.
Pain assessments will be obtained independently from three perspectives: the child, the parent, and the researcher. The agreement among these three assessments will also be evaluated.
The primary purpose of the study is to determine whether the intervention is associated with a greater reduction in pain compared with the control condition. Pain scores before and after the procedure will be compared within and between the study groups.
The findings of this study may contribute to a better understanding of pain management during K-wire removal in children and may help inform clinical approaches for reducing procedural pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Acupressure group
| Arm | Type | Receives |
|---|---|---|
| Acupressure group | Experimental | Behavioral: acupressureParticipants will receive acupressure before K-wire removal. |
| Control (Plasebo ) group | Placebo comparator | Other: control (placebo) groupParticipants will receive placebo acupressure before K-wire removal |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupressureParticipants 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. | Behavioural | Acupressure group |
| control (placebo) groupParticipants 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. | Other | Control (Plasebo ) group |
Primary outcome
Primary Outcome Measure-Pain
Time frame: Baseline and 2 hours
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.
Anxiety assessed using the Child Anxiety Thermometeranxiety
Time frame: Baseline and 2 hours
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- BackgroundÇalışır, 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).
- Results publication: PubMed 36125889Zhamilov 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.
- Results publication: PubMed 25105985Sorenson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure in people with Pain and Pain Management, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure-Pain (time frame: Baseline and 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07775547, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.