Hypoxic-Ischemic EncephalopathyPain in HIENCT07526233
The Effect of Maternal Scent and Knitted Octopus Application on Pain in Infants Diagnosed With Neonatal Asphyxia and Receiving Therapeutic Hypothermia Treatment
A study testing scent in people with Hypoxic-Ischemic Encephalopathy and Pain, run by Alev Sivasli at 1 site in Turkey (Türkiye).
Trial summary
This study was designed to determine the effects of maternal scent and knitted octopus application on pain in infants born with asphyxia beyond 36 weeks' gestation and receiving Therapeutic Hypothermia (TH) treatment in the Neonatal Intensive Care Unit (NICU) of Gaziantep Private Anka Hospital. Read more about this study
- Who is it for?
- Ages Up to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy, Pain
- What is being tested?
- scent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2024to 10 Oct 2025
- 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 Up to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Babies with a gestational age of ≥36 and a postpartum age of ≤6 hours.
- Babies diagnosed with asphyxia and receiving TH treatment in the NICU.
- Babies not receiving respiratory support.
- Newborns with family consent.
Who cannot join
- Babies with congenital disorders,
- Babies with syndromes/chromosomal disorders,
- Babies who experience seizures while being warmed,
- Babies whose parents wish to withdraw from the study during the study period,
- Babies receiving analgesics
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep Private Anka Hospital
Gaziantep, 27590
About this study
This study was designed to determine the effects of maternal scent and knitted octopus application on pain in infants born with asphyxia beyond 36 weeks' gestation and receiving Therapeutic Hypothermia (TH) treatment in the Neonatal Intensive Care Unit (NICU) of Gaziantep Private Anka Hospital. The study is a randomized controlled experimental study. Block randomization will be used as the randomization method.
Read the detailed description
Detailed Description
The neonatal period is characterized by increased sensitivity to environmental stimuli, including olfactory inputs. Early exposure to maternal odors may support physiological stability and behavioral regulation in newborns. In neonatal intensive care settings, maternal scent is commonly introduced using odor-bearing materials placed near the infant. In addition, supportive positioning tools such as soft objects may provide comfort and reduce stress-related responses.
This randomized controlled trial is designed to evaluate the effects of maternal scent exposure and the use of a knitted octopus on pain response in newborns undergoing therapeutic hypothermia for perinatal asphyxia. Participants will be randomly assigned to receive either maternal scent exposure, a knitted octopus intervention, or standard care.
Maternal scent exposure will be provided using maternal clothing and odor-absorbing materials placed near the infant to allow continuous exposure throughout the treatment period. The knitted octopus intervention involves placing a soft, hypoallergenic object in contact with the infant to provide tactile comfort.
Pain assessments will be performed at predefined intervals during the therapeutic hypothermia period using a validated neonatal pain scale. Data will be collected prospectively and analyzed to compare pain responses between groups.
The study aims to determine whether these non-pharmacological interventions can reduce pain and improve comfort in newborns receiving therapeutic hypothermia.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Pain
- Being tested
- scent
- Keywords
- HIE, mother's scent, octopus, neonate
- Medical subject headings
- Hypoxia-Ischemia, Brain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scentOther
Also called knitted octopus
We believe that exposure to the mother's scent and hugging the baby to a knitted octopus will reduce pain in the baby.
| Study group | Role | What they receive |
|---|---|---|
| Plasebo | No intervention | No intervention will be made to this branch |
| intervention arm | Active comparator | This arm will be applied with mother scent and knitted octopus. Receives: Other: scent |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-PASS Pain Score
The Neonatal Pain, Agitation, and Sedation Scale (N-PASS) will be used to assess pain levels in newborns undergoing therapeutic hypothermia. The scale evaluates behavioral and physiological parameters, with higher scores indicating increased pain.
Measured: From 6 hours after initiation of therapeutic hypothermia up to 72 hours (assessed every 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start30 Dec 2024
- Primary completion1 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alev Sivasli
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Nisantasi University
- Responsible party
- Sponsor-investigator, Alev Sivasli, Istanbul Nisantasi University
- Investigators
- Alev Sivasli, Principal investigator, Nisantasi University, Istanbul, TurkeyZerrin Cigdem, Study director, Topkapı University, Istanbul, TurkeyCagri ÇÖVENER ÖZÇELİK, Study director, Marmara University, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526233
- Sponsor's protocol ID
- HIEPAIN
- Acronym
- Pain in HIE
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Maternal Scent and Knitted Octopus Application on Pain in Infants Diagnosed With Neonatal Asphyxia and Receiving Therapeutic Hypothermia Treatment
- ClinicalTrials.gov ID
- NCT07526233
- Acronym / sponsor ID
- Pain in HIE / HIEPAIN
- Conditions
- Hypoxic-Ischemic Encephalopathy, Pain
- Keywords
- HIE, mother's scent, octopus, neonate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Alev SivasliUniversity, hospital or other
- Collaborators
- Istanbul Nisantasi University
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 13 Apr 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.
This study was designed to determine the effects of maternal scent and knitted octopus application on pain in infants born with asphyxia beyond 36 weeks' gestation and receiving Therapeutic Hypothermia (TH) treatment in the Neonatal Intensive Care Unit (NICU) of Gaziantep Private Anka Hospital. The study is a randomized controlled experimental study. Block randomization will be used as the randomization method.
Detailed description
Detailed Description
The neonatal period is characterized by increased sensitivity to environmental stimuli, including olfactory inputs. Early exposure to maternal odors may support physiological stability and behavioral regulation in newborns. In neonatal intensive care settings, maternal scent is commonly introduced using odor-bearing materials placed near the infant. In addition, supportive positioning tools such as soft objects may provide comfort and reduce stress-related responses.
This randomized controlled trial is designed to evaluate the effects of maternal scent exposure and the use of a knitted octopus on pain response in newborns undergoing therapeutic hypothermia for perinatal asphyxia. Participants will be randomly assigned to receive either maternal scent exposure, a knitted octopus intervention, or standard care.
Maternal scent exposure will be provided using maternal clothing and odor-absorbing materials placed near the infant to allow continuous exposure throughout the treatment period. The knitted octopus intervention involves placing a soft, hypoallergenic object in contact with the infant to provide tactile comfort.
Pain assessments will be performed at predefined intervals during the therapeutic hypothermia period using a validated neonatal pain scale. Data will be collected prospectively and analyzed to compare pain responses between groups.
The study aims to determine whether these non-pharmacological interventions can reduce pain and improve comfort in newborns receiving therapeutic hypothermia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasebo | No intervention | –No intervention will be made to this branch |
| intervention arm | Active comparator | Other: scentThis arm will be applied with mother scent and knitted octopus. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Babies with a gestational age of ≥36 and a postpartum age of ≤6 hours.
- Babies diagnosed with asphyxia and receiving TH treatment in the NICU.
- Babies not receiving respiratory support.
- Newborns with family consent.
Key exclusion criteria (5 listed)
- Babies with congenital disorders,
- Babies with syndromes/chromosomal disorders,
- Babies who experience seizures while being warmed,
- Babies whose parents wish to withdraw from the study during the study period,
- Babies receiving analgesics
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 |
|---|---|---|
| scentAlso: knitted octopusWe believe that exposure to the mother's scent and hugging the baby to a knitted octopus will reduce pain in the baby. | Other | intervention arm |
Primary outcome
N-PASS Pain Score
Time frame: From 6 hours after initiation of therapeutic hypothermia up to 72 hours (assessed every 3 hours)
The Neonatal Pain, Agitation, and Sedation Scale (N-PASS) will be used to assess pain levels in newborns undergoing therapeutic hypothermia. The scale evaluates behavioral and physiological parameters, with higher scores indicating increased pain.
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 13 Apr 2026.
- Individual participant dataSharing planned: Yes. all collected IPD
Related trials for Hypoxic-Ischemic Encephalopathy
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
RecruitingPhase 2
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Neonatal Seizure, Neonatal Encephalopathy
RecruitingObservational study
Continuous Monitoring of Body Temperature in Neonates During Therapeutic Hypothermia
Therapeutic Hypothermia, Neonatal Hypoxic-Ischemic Encephalopathy
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.
Alev Sivasli principal investigator
Nisantasi University, Istanbul, Turkey
Zerrin Cigdem study director
Topkapı University, Istanbul, Turkey
Cagri ÇÖVENER ÖZÇELİK study director
Marmara University, Istanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scent in people with Hypoxic-Ischemic Encephalopathy and Pain, run by Alev Sivasli 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 4 inclusion and 5 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 13 Apr 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?
N-PASS Pain Score (time frame: From 6 hours after initiation of therapeutic hypothermia up to 72 hours (assessed every 3 hours)). 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 13 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.