Pediatric VenipunctureNCT07906210
Therapeutic Holding Versus Traditional Restraint During Pediatric Venipuncture
A study testing Therapeutic Holding and Traditional Restraint in people with Pediatric Venipuncture, run by University of Baghdad.
Trial summary
This study will compare therapeutic holding with traditional restraint during blood-draw venipuncture in children aged 3 to 6 years. The study will include 64 children who require venous blood sampling for routine diagnostic testing. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Pediatric Venipuncture
- What is being tested?
- Therapeutic Holding and Traditional Restraint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Mar 2027
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3-6 years.
- Children requiring peripheral blood-draw venipuncture for diagnostic laboratory investigations at the study setting.
- Children who are clinically stable before the procedure and able to undergo routine blood-draw venipuncture.
- Presence of a parent or legal guardian and their consent to the child's participation in the study.
Who cannot join
- Children whose parent or legal guardian declines participation, or whose scheduled blood-draw venipuncture is cancelled or refused before the procedure.
- Children with neurological, developmental, cognitive, visual, or hearing conditions that may interfere with behavioral assessment or participation in the study procedure.
- Children who have received sedative, analgesic, or anxiolytic medication within the preceding 24 hours.
- Children with acute clinical instability or conditions requiring urgent intervention that may substantially affect pulse rate, respiratory rate, or oxygen saturation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Adraa H Shawq, PhD contact
About this study
Official title: Effect of Therapeutic Holding Versus Traditional Restraint on Children's Distress Behaviors, Vital Signs Stability, and First-Stick Venipuncture Success Rate Among Pediatric Patients
This study will compare therapeutic holding with traditional restraint during blood-draw venipuncture in children aged 3 to 6 years. The study will include 64 children who require venous blood sampling for routine diagnostic testing.
Children will be assigned to one of two groups using a predetermined non-random allocation method. In the therapeutic holding group, the child will sit upright on a parent's or caregiver's lap in a chest-to-chest straddle position. The caregiver will hold the child securely and comfortably while the arm used for venipuncture is safely stabilized. In the traditional restraint group, the child will lie on their back and receive the usual physical stabilization used during venipuncture by a parent, nurse, or assistant.
Read more
The study will assess children's behavioral distress, pulse rate, respiratory rate, and oxygen saturation before, during, and after venipuncture. It will also record whether blood collection is successful on the first needle insertion and the total number of attempts needed.
The purpose of the study is to determine whether therapeutic holding is associated with lower behavioral distress, greater stability of vital signs, and a higher rate of successful first-stick venipuncture compared with traditional restraint.
- Conditions
- Pediatric Venipuncture
- Being tested
- Therapeutic Holding, Traditional Restraint
- Keywords
- Therapeutic Holding, Traditional Restraint, Pediatric Venipuncture, Procedural Distress, Vital Signs, First-Stick Success, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic HoldingProcedure or surgery
Therapeutic holding will be applied using a chest-to-chest straddle position. The child will sit upright on a parent's or caregiver's lap while facing the caregiver. The caregiver will hold the child's trunk securely and comfortably, control the free arm, and maintain the venipuncture arm in a safe and stable position to allow blood collection.
Traditional RestraintProcedure or surgery
Traditional restraint will be performed using the usual restraint method during venipuncture at the study setting. The child will generally be positioned supine on the procedure table, with the body physically stabilized by a parent, nurse, or assistant. The selected arm will be extended and safely stabilized during blood collection.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Holding | Experimental | Children assigned to this arm will undergo clinically indicated venipuncture while positioned upright on a parent's or caregiver's lap in a chest-to-chest straddle position. The caregiver will hold the child securely and comfortably, control the free arm, and help maintain the venipuncture arm in a safe and stable position during blood collection. Receives: Procedure: Therapeutic Holding |
| Traditional Restraint | Active comparator | Children assigned to this arm will undergo clinically indicated venipuncture using the traditional restraint method routinely used at the study setting. The child will generally be positioned supine, with the body physically stabilized by a parent, nurse, or assistant while the selected arm is safely extended and stabilized for blood collection. Receives: Procedure: Traditional Restraint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Distress Across Venipuncture Phases Measured by the PBRS-R
Children's behavioral distress will be assessed using the Procedure Behavior Rating Scale-Revised (PBRS-R). Eleven observable distress behaviors are recorded as present or absent across three procedural phases. The total PBRS-R score ranges from 0 to 33, with higher scores indicating greater behavioral distress.
Measured: Before positioning and before needle insertion; at needle insertion; and after needle removal and completion of venipuncture.
Pulse Rate Across Venipuncture Phases
Pulse rate, measured in beats per minute using a pulse oximeter, will be recorded to assess physiological response and stability across the procedural phases.
Measured: Before application of the assigned holding/restraint method; during venipuncture; and after completion of venipuncture.
Respiratory Rate Across Venipuncture Phases
Respiratory rate, measured in breaths per minute by direct observation, will be recorded to assess physiological response and stability across the procedural phases.
Measured: Before application of the assigned holding/restraint method; during venipuncture; and after completion of venipuncture.
Oxygen Saturation (SpO₂) Across Venipuncture Phases
Peripheral oxygen saturation (SpO₂), expressed as a percentage and measured using a pulse oximeter, will be recorded to assess physiological response and stability across the procedural phases.
Measured: Before application of the assigned holding/restraint method; during venipuncture; and after completion of venipuncture.
First-Stick Venipuncture Success
First-stick venipuncture success is defined as obtaining the required blood sample following the first needle penetration of the skin. The number of attempts will also be recorded. Each new needle penetration through the skin will be considered a new attempt, whereas redirection of the needle while it remains beneath the skin will not be considered an additional attempt.
Measured: During the venipuncture procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric VenipunctureStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasanain dawood salman, University of Baghdad
- Investigators
- Adraa H Shawq, PhD, Principal investigator, University of Baghdad, College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906210
- Sponsor's protocol ID
- TH-TR-PED-VENO
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. Participant data will be maintained confidentially in accordance with the study protocol and institutional ethical requirements.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Therapeutic Holding Versus Traditional Restraint on Children's Distress Behaviors, Vital Signs Stability, and First-Stick Venipuncture Success Rate Among Pediatric Patients
- ClinicalTrials.gov ID
- NCT07906210
- Acronym / sponsor ID
- TH-TR-PED-VENO
- Conditions
- Pediatric Venipuncture
- Keywords
- Therapeutic Holding, Traditional Restraint, Pediatric Venipuncture, Procedural Distress, Vital Signs, First-Stick Success, Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Oct 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 will compare therapeutic holding with traditional restraint during blood-draw venipuncture in children aged 3 to 6 years. The study will include 64 children who require venous blood sampling for routine diagnostic testing.
Children will be assigned to one of two groups using a predetermined non-random allocation method. In the therapeutic holding group, the child will sit upright on a parent's or caregiver's lap in a chest-to-chest straddle position. The caregiver will hold the child securely and comfortably while the arm used for venipuncture is safely stabilized. In the traditional restraint group, the child will lie on their back and receive the usual physical stabilization used during venipuncture by a parent, nurse, or assistant.
The study will assess children's behavioral distress, pulse rate, respiratory rate, and oxygen saturation before, during, and after venipuncture. It will also record whether blood collection is successful on the first needle insertion and the total number of attempts needed.
The purpose of the study is to determine whether therapeutic holding is associated with lower behavioral distress, greater stability of vital signs, and a higher rate of successful first-stick venipuncture compared with traditional restraint.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Holding | Experimental | Procedure: Therapeutic HoldingChildren assigned to this arm will undergo clinically indicated venipuncture while positioned upright on a parent's or caregiver's lap in a chest-to-chest straddle position. The caregiver will hold the child securely and comfortably, control the free arm, and help maintain the venipuncture arm in a safe and stable position during blood collection. |
| Traditional Restraint | Active comparator | Procedure: Traditional RestraintChildren assigned to this arm will undergo clinically indicated venipuncture using the traditional restraint method routinely used at the study setting. The child will generally be positioned supine, with the body physically stabilized by a parent, nurse, or assistant while the selected arm is safely extended and stabilized for blood collection. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 3-6 years.
- Children requiring peripheral blood-draw venipuncture for diagnostic laboratory investigations at the study setting.
- Children who are clinically stable before the procedure and able to undergo routine blood-draw venipuncture.
- Presence of a parent or legal guardian and their consent to the child's participation in the study.
Key exclusion criteria (4 listed)
- Children whose parent or legal guardian declines participation, or whose scheduled blood-draw venipuncture is cancelled or refused before the procedure.
- Children with neurological, developmental, cognitive, visual, or hearing conditions that may interfere with behavioral assessment or participation in the study procedure.
- Children who have received sedative, analgesic, or anxiolytic medication within the preceding 24 hours.
- Children with acute clinical instability or conditions requiring urgent intervention that may substantially affect pulse rate, respiratory rate, or oxygen saturation.
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 |
|---|---|---|
| Therapeutic HoldingTherapeutic holding will be applied using a chest-to-chest straddle position. The child will sit upright on a parent's or caregiver's lap while facing the caregiver. The caregiver will hold the child's trunk securely and comfortably, control the free arm, and maintain the venipuncture arm in a safe and stable position to allow blood collection. | Procedure or surgery | Therapeutic Holding |
| Traditional RestraintTraditional restraint will be performed using the usual restraint method during venipuncture at the study setting. The child will generally be positioned supine on the procedure table, with the body physically stabilized by a parent, nurse, or assistant. The selected arm will be extended and safely stabilized during blood collection. | Procedure or surgery | Traditional Restraint |
Primary outcome
Behavioral Distress Across Venipuncture Phases Measured by the PBRS-R
Time frame: Before positioning and before needle insertion; at needle insertion; and after needle removal and completion of venipuncture.
Children's behavioral distress will be assessed using the Procedure Behavior Rating Scale-Revised (PBRS-R). Eleven observable distress behaviors are recorded as present or absent across three procedural phases. The total PBRS-R score ranges from 0 to 33, with higher scores indicating greater behavioral distress.
Pulse Rate Across Venipuncture Phases
Time frame: Before application of the assigned holding/restraint method; during venipuncture; and after completion of venipuncture.
Pulse rate, measured in beats per minute using a pulse oximeter, will be recorded to assess physiological response and stability across the procedural phases.
Respiratory Rate Across Venipuncture Phases
Time frame: Before application of the assigned holding/restraint method; during venipuncture; and after completion of venipuncture.
Respiratory rate, measured in breaths per minute by direct observation, will be recorded to assess physiological response and stability across the procedural phases.
Oxygen Saturation (SpO₂) Across Venipuncture Phases
Time frame: Before application of the assigned holding/restraint method; during venipuncture; and after completion of venipuncture.
Peripheral oxygen saturation (SpO₂), expressed as a percentage and measured using a pulse oximeter, will be recorded to assess physiological response and stability across the procedural phases.
First-Stick Venipuncture Success
Time frame: During the venipuncture procedure.
First-stick venipuncture success is defined as obtaining the required blood sample following the first needle penetration of the skin. The number of attempts will also be recorded. Each new needle penetration through the skin will be considered a new attempt, whereas redirection of the needle while it remains beneath the skin will not be considered an additional attempt.
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 30 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. Participant data will be maintained confidentially in accordance with the study protocol and institutional ethical requirements.
Related trials for Pediatric Venipuncture
Active, not recruitingObservational study
A New Landmark-formula for Cephalic Vein in Children
Venipuncture, Ultrasound
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.
Adraa H Shawq, PhD contact
Adraa H Shawq, PhD principal investigator
University of Baghdad, College of Nursing
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Holding and Traditional Restraint in people with Pediatric Venipuncture, run by University of Baghdad.
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 4 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Hasanain D Salman (+9647829198804, hasanein.dawood2504m@conursing.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Distress Across Venipuncture Phases Measured by the PBRS-R (time frame: Before positioning and before needle insertion; at needle insertion; and after needle removal and completion of venipuncture.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.