NCT07660159

Brief Summary

The aim of this research is to evaluate the effects of two different methods of education (verbal instruction + written brochure and verbal instruction + AI-assisted video presentation) given to new mothers on neonatal pain management, their use of non-pharmacological methods, anxiety levels, and neonatal pain, and to examine the relationship between them. Research Questions Do two different pain management education methods affect mothers' use of nonpharmacological methods? Do two different pain management education methods affect mothers' anxiety levels? Do two different pain management education methods affect neonatal pain during heel prick procedures? Is there a difference between verbal instruction combined with a written brochure and verbal instruction combined with video demonstration in terms of mothers' use of nonpharmacological methods? Is there a difference between verbal instruction combined with a written brochure and verbal instruction combined with video demonstration in terms of maternal anxiety levels? Is there a difference between verbal instruction combined with a written brochure and verbal instruction combined with video demonstration in terms of neonatal pain during heel prick procedures? Is there a relationship between mothers' use of nonpharmacological methods and their anxiety levels? Is there a relationship between mothers' use of nonpharmacological methods and neonatal pain levels?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

June 16, 2026

Last Update Submit

June 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • mothers' anxiety

    Those scoring between 20 and 80 points indicate anxiety.

    between 24 and 72 hours after birth

Secondary Outcomes (1)

  • Newborn Pain Scale (NIPS)

    between 24 and 72 hours after birth

Study Arms (3)

Control Group

NO INTERVENTION

The mothers underwent the clinic's routine procedure.

verbal and brochure-based education

EXPERIMENTAL

Mothers were given training on non-pharmacological pain management through verbal and brochure education.

Other: verbal and brochure-based education

verbal and AI-assisted video training

EXPERIMENTAL

Mothers were given training in non-pharmacological pain management through verbal instruction and AI-assisted video training.

Other: verbal and AI-supported video training

Interventions

Non-pharmacological pain management methods for newborns were explained to mothers verbally and through brochures during heel prick blood tests.

verbal and brochure-based education

Non-pharmacological pain management methods for newborns were explained to mothers through verbal and AI-supported video training during heel prick blood sampling.

verbal and AI-assisted video training

Eligibility Criteria

Age19 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being 19 years of age or older Being a primiparous mother Voluntarily agreeing to participate in the study Not having a psychiatric diagnosis Having a healthy term newborn baby (born at 38-42 gestational weeks) Having a blood sample taken for the Guthrie screening test

You may not qualify if:

  • Lack of Turkish reading and comprehension skills in the participant Incomplete completion of the survey form Having a baby with a congenital anomaly Having received any analgesia before the procedure Refusal to have a blood sample taken for the Guthrie screening test History of the baby staying in intensive care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, İ̇zmi̇t, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 22, 2026

Study Start

February 1, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations