Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07906210
NA

Therapeutic Holding Versus Traditional Restraint During Pediatric Venipuncture

Sponsor: University of Baghdad

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

3 Years - 6 Years

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2026-12

Completion Date

2027-03

Last Updated

2026-10-30

Healthy Volunteers

No

Interventions

PROCEDURE

Therapeutic Holding

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.

PROCEDURE

Traditional Restraint

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.