The effect of gentle human touch by the mother during venipuncture on neonatl distress, pain catastrophizing, and maternal distress in mothers of preterm neonate

The effect of gentle human touch by the mother during venipuncture on neonatal distress, pain catastrophizing, and maternal distress in mothers of preterm neonate

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230202057303N5

Enrollment

Registered

2025-12-09

Start date

2026-01-03

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: infant distress. Condition 2: maternal distress. Altered mental status, unspecified Maternal distress during labor and delivery

Interventions

Intervention 1: Intervention group: Gentle human touch by mother. In this method, the mother first washes and disinfects her hands and warms them using the heat of a radiant warmer, then the baby is g

Eligibility

Sex/Gender

All

Age

210 Days to 217 Days

Inclusion criteria

Inclusion criteria: Gestational age of 30 weeks and above Postnatal age less than 7 days Venous blood sampling order Having at least one previous experience of blood sampling in a newborn Hemodynamic stability (pink color of the newborn, body temperature between 36 and 37, arterial oxygen saturation above 84%) Mother's ability to read and understand Persian Mother's physical and mental condition is suitable for the intervention Stability in the family's social status based on mother's self-report

Exclusion criteria

Exclusion criteria: Receiving sedatives or anesthetics and muscle relaxants within the past 24 hours Receiving any painkillers in the prescription Having a skin disease and any contraindications to skin contact Being exposed to any painful procedure at least one hour before the blood collection procedure Congenital anomalies Having metabolic diseases Grade 2 or higher intracranial hemorrhage Presence of heart abnormalities Having a history of drug use by the mother History of surgery in the newborn

Design outcomes

Primary

Measure	Time frame
Pain Catastrophizing. Timepoint: Measuring pain catastrophizing using a questionnaire before and after the blood collection procedure. Method of measurement: Pain Catastrophizing Scale-Parents(PCS-P).;Neonatal distress. Timepoint: Measurement of infant distress at the beginning of the study (before intervention) and after the blood sampling intervention. Method of measurement: Comfort neo scale.;Maternal distress. Timepoint: Measuring maternal distress using a questionnaire before and after the blood collection procedure. Method of measurement: THE VRS (RAPID STRESS ASSESSMENT) SCALE.	—

Measure

Time frame

Pain Catastrophizing. Timepoint: Measuring pain catastrophizing using a questionnaire before and after the blood collection procedure. Method of measurement: Pain Catastrophizing Scale-Parents(PCS-P).;Neonatal distress. Timepoint: Measurement of infant distress at the beginning of the study (before intervention) and after the blood sampling intervention. Method of measurement: Comfort neo scale.;Maternal distress. Timepoint: Measuring maternal distress using a questionnaire before and after the blood collection procedure. Method of measurement: THE VRS (RAPID STRESS ASSESSMENT) SCALE.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMona Alinejad naeini

Iran University of Medical Sciences

mona_alinejad@yahoo.com+98 21 4480 3572

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026