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AzTrials

İnfant ComfortNCT07660159

EFFECTS OF TWO PAİN MANAGEMENT EDUCATİON METHODS DURİNG HEEL PRİCK PROCEDURES ON MATERNAL ANXİETY AND NEONATAL PAİN

A study testing verbal and brochure-based education and verbal and AI-supported video training in people with İnfant Comfort and Infant, run by Kocaeli University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 to 49 years
Conditions the study is for
İnfant Comfort, Infant, Infant Care
What is being tested?
verbal and brochure-based education and verbal and AI-supported video training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2025to 1 May 2026
Phase
Interventional
Are there results?
None posted in the registry

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 19 to 49 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kocaeli University

    Kocaeli, İ̇zmi̇t

Other trials in Turkey (Türkiye)

About this study

Official title: THE EFFECT OF TWO DİFFERENT PAİN MANAGEMENT EDUCATİON METHODS PROVİDED FOR HEEL PRİCK PROCEDURES ON MOTHERS' USE OF NONPHARMACOLOGİCAL METHODS, ANXİETY LEVELS, AND NEONATAL PAİN

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?

Read the detailed description

The International Association for the Study of Pain has defined pain as "an unpleasant sensory and emotional experience associated with actual or potential injury" (IASP, 1979). However, it has been noted that this definition is insufficient in newborns, who lack verbal communication, as they cannot express pain and have no opportunity to refuse treatment (Anand \& Craig 1996), and later, pain was redefined as an unpleasant sensory and emotional experience associated with or similar to actual or potential tissue damage (Raja et al. 2020). Newborns are frequently exposed to painful procedures during diagnostic and therapeutic processes such as routine newborn screenings, blood glucose measurement, and immunization (WHO, 2017). It has been reported that painful interventions experienced in early childhood can lead to short-term physiological changes as well as neurodevelopmental consequences (AAP 2016; Hatfield \& Ely, 2015). Furthermore, it has been shown that exposure to painful stimuli in early life may be associated with stress responses and behavioral changes later in life (Taddio et al. 1997). The first step in pain management is the accurate assessment of pain. Therefore, it is important to use validated scales in the assessment of pain in newborns and to apply appropriate pain management methods (Costa et al. 2017; Rocha et al. 2021). Although pharmacological methods are frequently used in pain management in infants, interest in non-pharmacological methods has increased in recent years due to the physiological immaturity of newborns and possible side effects of drugs (Allegaert and van den Anker, 2017). Methods such as holding, non-nutritive sucking, breastfeeding, sucrose/glucose solutions, skin-to-skin contact, and swaddling are reported to be effective in reducing pain scores during short-term painful procedures (Mangat et al. 2018). The American Academy of Pediatrics recommends that families be actively involved in the prevention and management of pain in newborns (American Academy of Pediatrics, 2016). Within the framework of the family-centered care approach, parental participation in the care of their babies is encouraged, and it is reported that the education given to parents increases the use of pain management methods (Taddio et al. 2013; Campbell-Yeo et al. 2017; Chambers et al. 2020). However, studies that evaluate the effects of different education methods given to mothers during heel prick blood sampling, one of the frequently performed painful procedures in newborns, on mothers' anxiety levels, non-pharmacological method use, and newborn pain are limited. Therefore, this study aimed to determine mothers' approaches to pain management during heel prick blood sampling performed within the scope of newborn screening and to evaluate the effects of two different education methods given before the procedure on mothers' use of non-pharmacological methods, anxiety levels, and newborn pain.

Being tested
verbal and brochure-based education, verbal and AI-supported video training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • verbal and brochure-based educationOther

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

  • verbal and AI-supported video trainingOther

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

Study groups in NCT07660159
Study groupRoleWhat they receive
Control GroupNo interventionThe mothers underwent the clinic's routine procedure.
verbal and brochure-based educationExperimentalMothers were given training on non-pharmacological pain management through verbal and brochure education.
Receives: Other: verbal and brochure-based education
verbal and AI-assisted video trainingExperimentalMothers were given training in non-pharmacological pain management through verbal instruction and AI-assisted video training.
Receives: Other: verbal and AI-supported video training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mothers' anxiety

    Those scoring between 20 and 80 points indicate anxiety.

    Measured: between 24 and 72 hours after birth

Secondary outcomes (1)
  1. Newborn Pain Scale (NIPS)

    The scale consists of six parameters: facial expression, crying, breathing, arm movements, leg movements, and sleep-wake status.

    Measured: between 24 and 72 hours after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study start1 Feb 2025
  3. Primary completion1 Apr 2026
  4. Study completion1 May 2026

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07660159
Sponsor's protocol ID
2024/256
Status last verified
Jun 2026
First submitted
16 Jun 2026
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing verbal and brochure-based education and verbal and AI-supported video training in people with İnfant Comfort and Infant, run by Kocaeli University at 1 site in Turkey (Türkiye).

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mothers' anxiety (time frame: between 24 and 72 hours after birth). 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 22 Jun 2026.

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