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).
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.
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.
- Conditions
- İnfant Comfort, Infant, Infant Care, Newborn Pain, Nonpharmacological Interventions, Postpartum Anxiety
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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.
mothers' anxiety
Those scoring between 20 and 80 points indicate anxiety.
Measured: between 24 and 72 hours after birth
Secondary outcomes (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.
- First posted22 Jun 2026
- Study start1 Feb 2025
- Primary completion1 Apr 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for İnfant ComfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Öztürkler, Kocaeli University
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07660159
- Acronym / sponsor ID
- 2024/256
- Conditions
- İnfant Comfort, Infant, Infant Care, Newborn Pain, Nonpharmacological Interventions, Postpartum Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The mothers underwent the clinic's routine procedure. |
| verbal and brochure-based education | Experimental | Other: verbal and brochure-based educationMothers were given training on non-pharmacological pain management through verbal and brochure education. |
| verbal and AI-assisted video training | Experimental | Other: verbal and AI-supported video trainingMothers were given training in non-pharmacological pain management through verbal instruction and AI-assisted video training. |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| verbal and brochure-based educationNon-pharmacological pain management methods for newborns were explained to mothers verbally and through brochures during heel prick blood tests. | Other | verbal and brochure-based education |
| verbal and AI-supported video trainingNon-pharmacological pain management methods for newborns were explained to mothers through verbal and AI-supported video training during heel prick blood sampling. | Other | verbal and AI-assisted video training |
Primary outcome
mothers' anxiety
Time frame: between 24 and 72 hours after birth
Those scoring between 20 and 80 points indicate anxiety.
1 secondary outcome
Newborn Pain Scale (NIPS)
Time frame: between 24 and 72 hours after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.