An interventional study of Therapeutic Holding and Traditional Restraint in Pediatric Venipuncture, sponsored by University of Baghdad. Not yet recruiting. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by University of Baghdad · Not applicable, Interventional, and Supportive care
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.
University of Baghdad is the lead sponsor of 169 studies on the registry; 68 are open to participants now.
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Exclusion Criteria
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.
Procedure: Therapeutic Holding
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.
Procedure: Traditional Restraint
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 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the venipuncture procedure.
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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