Pain, AcuteNCT04967118
Neonatal Pain Management and Pain Monitoring Using New Methods
A study testing Skin-to-skin contact, Mother's heartbeats as sound and vibration and 30% oral glucose in people with Pain, Acute and Procedural Pain, run by University of Oulu at 1 site in Finland.
Trial summary
The aim of this randomized controlled study with crossover design is to examine the effectiveness of mother-driven interventions, skin-to-skin contact (SSC) and recorded mother's heartbeats as sound and vibration (MHB), compared to oral glucose in relieving neonatal acute pain related to heel lance as a painful… Read more about this study
- Who is it for?
- Ages 32 to 42 weeks
- Conditions the study is for
- Pain, Acute, Procedural Pain, Infant
- What is being tested?
- Skin-to-skin contact, Mother's heartbeats as sound and vibration and 30% oral glucose
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFinland
- Study dates
- 2 May 2023to 31 Dec 2024
- 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 32 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational Age (GA) at birth 32+0 - 42+0
- Admitted to NICU
- Parents are able to read, write and speak Finnish
Who cannot join
- With a postnatal age of 14 days or more
- Apgar points were 6 or less at 5 minutes of age
- Has been found grade III or IV cerebral haemorrhage
- Major congenital anomalies
- Has intubated or receiving a nCPAP
- Has received analgesics or sedatives for less than 24 hours prior to the study
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Oulu University Hospita
Oulu, 90029
Anna-Kaija Palomaa, +358400892159, annakaija.palomaa@gmail.com
Tarja Pölkki, profesor, +358405817069, tarja.polkki@oulu.fi
About this study
Official title: Neonatal Pain Management and Pain Monitoring Using New Methods: A Randomized Controlled Trial With Crossover Design
The aim of this randomized controlled study with crossover design is to examine the effectiveness of mother-driven interventions, skin-to-skin contact (SSC) and recorded mother's heartbeats as sound and vibration (MHB), compared to oral glucose in relieving neonatal acute pain related to heel lance as a painful procedure.
The effectiveness of interventions will be assessed using validated pain scales (PIPP-R and NIAPAS), changes in sensory cortex activation (near-infrared spectroscopy, NIRS) and changes in physiological indicators (oxygen saturation, heart rate, respiratory rate). The secondary objectives will include evaluating the effectiveness of interventions in relation to infant recovery and evaluating the use of NIRS monitoring in relation to neonatal pain assessment scales.
- Conditions
- Pain, Acute, Procedural Pain, Infant
- Being tested
- Skin-to-skin contact, Mother's heartbeats as sound and vibration, 30% oral glucose
- Medical subject headings
- Acute Pain, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin-to-skin contactBehavioural
Also called Kangaroo Mother Care
Diaper clad baby will be placed ventral position on bare chest of mother 30 minute prior to the heel lance
Mother's heartbeats as sound and vibrationBehavioural
The mother's heartbeat will be recorded and the heartbeat sounds will be saved to the platform. The platform will be placed under the infant's mattress and the heartbeat will be started 30 minute prior to the heel lance.
30% oral glucoseDrug
Also called Sweet taste
The infant will be given 30% oral glucose solution 2 minutes before the injection
| Study group | Role | What they receive |
|---|---|---|
| Skin-to-skin contact | Experimental | Neonates will be placed ventral skin-to-skin position with their mother at least thirty minutes prior the heel lance to give time to calm down following transfer. Skin-to-skin positioning will be taken account comfortable position as possible for mother and the baby, easy to access heel for blood sample and interference minimizing during video recording and continuous NIRS, ECG and oxygen saturation measurement. Skin-to-skin contact will be continued for approximately fifteen minutes after completion of blood sampling. In addition, the neonates will be given a 30% oral glucose solution two minutes prior the heel lance. Receives: Behavioral: Skin-to-skin contact |
| Mother's heartbeats as sound and vibration | Experimental | Neonates will be placed in an incubator or a cot, depending on their gestational age, and will be supported on side position by nest-shaped rolls according to department's normal practice. The platform on which the mother's heartbeat will be played will be placed under mattress of the incubator or crib. The playing of the mother's recorded heartbeats will be started thirty minutes prior the heel lance and will be continued during and fifteen minutes after the blood sampling. In addition, the neonates will be given a 30% oral glucose solution two minutes prior the heel lance. Receives: Behavioral: Mother's heartbeats as sound and vibration |
| 30% oral glucose | Active comparator | Neonates will be placed on in an incubator or a cot, depending on their gestational age, and will be supported on side position by nest-shaped rolls according to department's normal practice. The neonates will be given a 30% oral glucose solution two minutes prior the heel lance Receives: Drug: 30% oral glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
Pain intensity will be assessed using pain assessment tool, the Premature Infant Pain Profile Revised (PIPP-R). PIPP-R is an internationally widely used multidimensional pain assessment scale consisting of three behavioral indicators, two physiological indicators, and two contextual indicators.
Measured: Baseline 1, measured pre-intervention
Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
Pain intensity will be assessed using pain assessment tool, the Premature Infant Pain Profile Revised (PIPP-R). PIPP-R is an internationally widely used multidimensional pain assessment scale consisting of three behavioral indicators, two physiological indicators, and two contextual indicators.
Measured: Baseline 2, measured pre-procedure
Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
Pain intensity will be assessed using pain assessment tool, the Premature Infant Pain Profile Revised (PIPP-R). PIPP-R is an internationally widely used multidimensional pain assessment scale consisting of three behavioral indicators, two physiological indicators, and two contextual indicators.
Measured: Measured during painful procedure
Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
Pain intensity will be assessed using pain assessment tool, the Premature Infant Pain Profile Revised (PIPP-R). PIPP-R is an internationally widely used multidimensional pain assessment scale consisting of three behavioral indicators, two physiological indicators, and two contextual indicators.
Measured: Measured immediately after painful procedure
Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
Pain intensity will be assessed using pain assessment tool, the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). NIAPAS is multidimensional pain assessment scale used in Finland. It consist of five behavioral indicators, three physiological indicators, and one contextual indicator.
Measured: Baseline 1, measured pre-intervention
Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
Pain intensity will be assessed using pain assessment tool, the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). NIAPAS is multidimensional pain assessment scale used in Finland. It consist of five behavioral indicators, three physiological indicators, and one contextual indicator.
Measured: Baseline 2, measured pre-procedure
Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
Pain intensity will be assessed using pain assessment tool, the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). NIAPAS is multidimensional pain assessment scale used in Finland. It consist of five behavioral indicators, three physiological indicators, and one contextual indicator.
Measured: Measured during painful procedure
Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
Pain intensity will be assessed using pain assessment tool, the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). NIAPAS is multidimensional pain assessment scale used in Finland. It consist of five behavioral indicators, three physiological indicators, and one contextual indicator.
Measured: Measured immediately after painful procedure
Change in the activation in the somatosensory cortical areas following the noxious stimulation (baseline)
In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 2-channel NIRS will be used. The emitted probe provides near-infrared light through on optical fiber will be is placed slightly posterior to Cz position with reference to the international EEG 10-20 system. The receive probes will be fastened over somatosensory and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 to 4 cm from the emitted probe so that they are placed slightly behind C3 or C4 point. The occipital region receive probe will be attached 2 to 4 cm from the emitted probe.
Measured: Baseline 1, measured pre-intervention
Change in the activation in the somatosensory cortical areas following the noxious stimulation
In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 2-channel NIRS will be used. The emitted probe provides near-infrared light through on optical fiber will be is placed slightly posterior to Cz position with reference to the international EEG 10-20 system. The receive probes will be fastened over somatosensory and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 to 4 cm from the emitted probe so that they are placed slightly behind C3 or C4 point. The occipital region receive probe will be attached 2 to 4 cm from the emitted probe.
Measured: Baseline 2, measured pre-procedure
Change of the activation in the somatosensory cortical areas following the noxious stimulation
In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 2-channel NIRS will be used. The emitted probe provides near-infrared light through on optical fiber will be is placed slightly posterior to Cz position with reference to the international EEG 10-20 system. The receive probes will be fastened over somatosensory and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 to 4 cm from the emitted probe so that they are placed slightly behind C3 or C4 point. The occipital region receive probe will be attached 2 to 4 cm from the emitted probe.
Measured: Measured during painful procedure
Change of the activation in the somatosensory cortical areas following the noxious stimulation
In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 2-channel NIRS will be used. The emitted probe provides near-infrared light through on optical fiber will be is placed slightly posterior to Cz position with reference to the international EEG 10-20 system. The receive probes will be fastened over somatosensory and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 to 4 cm from the emitted probe so that they are placed slightly behind C3 or C4 point. The occipital region receive probe will be attached 2 to 4 cm from the emitted probe.
Measured: Measured immediately after painful procedure
Change in heart rate (HR)
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in heart rate using bedside patient monitor.
Measured: Baseline 1, measured pre-intervention
Change in heart rate (HR)
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in heart rate using bedside patient monitor.
Measured: Baseline 2, measured pre-procedure
Change in heart rate (HR)
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in heart rate using bedside patient monitor.
Measured: Measured during painful procedure
Change in heart rate (HR)
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in heart rate using bedside patient monitor.
Measured: Measured immediately after procedure
Change in oxygen saturation
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in oxygen saturation using bedside patient monitor.
Measured: Baseline 1, measured pre-intervention
Change in oxygen saturation
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in oxygen saturation using bedside patient monitor.
Measured: Baseline 2, measured pre-procedure
Change in oxygen saturation
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in oxygen saturation using bedside patient monitor.
Measured: Measured during painful procedure
Change in oxygen saturation
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in oxygen saturation using bedside patient monitor.
Measured: Measured immediately after painful procedure
Change in respiratory rate
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in respiratory rate using bedside patient monitor.
Measured: Baseline 1, measured pre-intervention
Change in respiratory rate
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in respiratory rate using bedside patient monitor.
Measured: Baseline 2, measured pre-procedure
Change in respiratory rate
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in respiratory rate using bedside patient monitor.
Measured: Measured during procedure
Change in respiratory rate
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in respiratory rate using bedside patient monitor.
Measured: Measured immediately after procedure
Secondary outcomes (18)
Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)
Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' PIPP-R scores returns to baseline values.
Measured: 3 minutes after painful procedure
Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)
Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' PIPP-R scores returns to baseline values.
Measured: 5 minutes after painful procedure
Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)
Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' PIPP-R scores returns to baseline values.
Measured: 10 minutes after painful procedure
Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' NIAPAS scores returns to baseline values.
Measured: 3 minutes after painful procedure
Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' NIAPAS scores returns to baseline values.
Measured: 5 minutes after painful procedure
Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the neonates' NIAPAS scores returns to baseline values.
Measured: 10 minutes after painful procedure
Recovery as measured by changes in somatosensory cortex activation
Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the activation in the somatosensory cortical area measured by NIRS returns to baseline values.
Measured: 3 minutes after painful procedure
Recovery as measured by changes in somatosensory cortex activation
Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the activation in the somatosensory cortical area measured by NIRS returns to baseline values.
Measured: 5 minutes after painful procedure
Recovery as measured by changes in somatosensory cortex activation
Time to recovery from painful stimulus will be considered the amount of time in minutes that pass until the activation in the somatosensory cortical area measured by NIRS returns to baseline values
Measured: 10 minutes after painful procedure
Recovery as measured by changes in heart rate (HR)
The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor.
Measured: 3 minutes after painful procedure
Recovery as measured by changes in heart rate (HR)
The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor.
Measured: 5 minutes after painful procedure
Recovery as measured by changes in heart rate (HR)
The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor.
Measured: 10 minutes after painful procedure
Recovery as measured by changes in oxygen saturation
The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in oxygen saturation using a patient monitor.
Measured: 3 minutes after painful procedure
Recovery as measured by changes in oxygen saturation
The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in oxygen saturation using a patient monitor.
Measured: 5 minutes after painful procedure
Recovery as measured by changes in oxygen saturation
The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in oxygen saturation using a patient monitor.
Measured: 10 minutes after painful procedure
Recovery as measured by changes in respiratory rate
The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor.
Measured: 3 minutes after painful procedure
Recovery as measured by changes in respiratory rate
The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor.
Measured: 5 minutes after painful procedure
Recovery as measured by changes in respiratory rate
The physiological responses of neonates to recovery from the pain of the procedure are continuously monitored and measured by recording changes in respiratory rate using a patient monitor.
Measured: 10 minutes after painful procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start2 May 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A crossover design with each child as his or her own control will be used to minimize interchild variability. Order of interventions will be randomly assigned by computer-generated program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna-Kaija Palomaa, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967118
- Sponsor's protocol ID
- 296/2018
- Status last verified
- Nov 2023
- First submitted
- 17 Mar 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Palomaa AK, Talus E, Keskitalo-Leskinen S, Polkki T. Mothers' Views and Experiences of Digital Maternal Presence Intervention and Skin-to-Skin Contact for Neonatal Pain Relief: A Qualitative Study. Nurs Open. 2026 May;13(5):e70577. doi: 10.1002/nop2.70577.
PubMed 42054232
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Pain Management and Pain Monitoring Using New Methods: A Randomized Controlled Trial With Crossover Design
- ClinicalTrials.gov ID
- NCT04967118
- Acronym / sponsor ID
- 296/2018
- Conditions
- Pain, Acute, Procedural Pain, Infant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Jul 2021 (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 randomized controlled study with crossover design is to examine the effectiveness of mother-driven interventions, skin-to-skin contact (SSC) and recorded mother's heartbeats as sound and vibration (MHB), compared to oral glucose in relieving neonatal acute pain related to heel lance as a painful procedure.
The effectiveness of interventions will be assessed using validated pain scales (PIPP-R and NIAPAS), changes in sensory cortex activation (near-infrared spectroscopy, NIRS) and changes in physiological indicators (oxygen saturation, heart rate, respiratory rate). The secondary objectives will include evaluating the effectiveness of interventions in relation to infant recovery and evaluating the use of NIRS monitoring in relation to neonatal pain assessment scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A crossover design with each child as his or her own control will be used to minimize interchild variability. Order of interventions will be randomly assigned by computer-generated program.
| Arm | Type | Receives |
|---|---|---|
| Skin-to-skin contact | Experimental | Behavioral: Skin-to-skin contactNeonates will be placed ventral skin-to-skin position with their mother at least thirty minutes prior the heel lance to give time to calm down following transfer. Skin-to-skin positioning will be taken account comfortable position as possible for mother and the baby, easy to access heel for blood sample and interference minimizing during video recording and continuous NIRS, ECG and oxygen saturation measurement. Skin-to-skin contact will be continued for approximately fifteen minutes after completion of blood sampling. In addition, the neonates will be given a 30% oral glucose solution two minutes prior the heel lance. |
| Mother's heartbeats as sound and vibration | Experimental | Behavioral: Mother's heartbeats as sound and vibrationNeonates will be placed in an incubator or a cot, depending on their gestational age, and will be supported on side position by nest-shaped rolls according to department's normal practice. The platform on which the mother's heartbeat will be played will be placed under mattress of the incubator or crib. The playing of the mother's recorded heartbeats will be started thirty minutes prior the heel lance and will be continued during and fifteen minutes after the blood sampling. In addition, the neonates will be given a 30% oral glucose solution two minutes prior the heel lance. |
| 30% oral glucose | Active comparator | Drug: 30% oral glucoseNeonates will be placed on in an incubator or a cot, depending on their gestational age, and will be supported on side position by nest-shaped rolls according to department's normal practice. The neonates will be given a 30% oral glucose solution two minutes prior the heel lance |
Who may qualify
- Ages
- 32 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational Age (GA) at birth 32+0 - 42+0
- Admitted to NICU
- Parents are able to read, write and speak Finnish
Key exclusion criteria (6 listed)
- With a postnatal age of 14 days or more
- Apgar points were 6 or less at 5 minutes of age
- Has been found grade III or IV cerebral haemorrhage
- Major congenital anomalies
- Has intubated or receiving a nCPAP
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 |
|---|---|---|
| Skin-to-skin contactAlso: Kangaroo Mother CareDiaper clad baby will be placed ventral position on bare chest of mother 30 minute prior to the heel lance | Behavioural | Skin-to-skin contact |
| Mother's heartbeats as sound and vibrationThe mother's heartbeat will be recorded and the heartbeat sounds will be saved to the platform. The platform will be placed under the infant's mattress and the heartbeat will be started 30 minute prior to the heel lance. | Behavioural | Mother's heartbeats as sound and vibration |
| 30% oral glucoseAlso: Sweet tasteThe infant will be given 30% oral glucose solution 2 minutes before the injection | Drug | 30% oral glucose |
Primary outcome
Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
Time frame: Baseline 1, measured pre-intervention
Pain intensity will be assessed using pain assessment tool, the Premature Infant Pain Profile Revised (PIPP-R). PIPP-R is an internationally widely used multidimensional pain assessment scale consisting of three behavioral indicators, two physiological indicators, and two contextual indicators.
Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
Time frame: Baseline 2, measured pre-procedure
Pain intensity will be assessed using pain assessment tool, the Premature Infant Pain Profile Revised (PIPP-R). PIPP-R is an internationally widely used multidimensional pain assessment scale consisting of three behavioral indicators, two physiological indicators, and two contextual indicators.
Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
Time frame: Measured during painful procedure
Pain intensity will be assessed using pain assessment tool, the Premature Infant Pain Profile Revised (PIPP-R). PIPP-R is an internationally widely used multidimensional pain assessment scale consisting of three behavioral indicators, two physiological indicators, and two contextual indicators.
Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale
Time frame: Measured immediately after painful procedure
Pain intensity will be assessed using pain assessment tool, the Premature Infant Pain Profile Revised (PIPP-R). PIPP-R is an internationally widely used multidimensional pain assessment scale consisting of three behavioral indicators, two physiological indicators, and two contextual indicators.
Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
Time frame: Baseline 1, measured pre-intervention
Pain intensity will be assessed using pain assessment tool, the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). NIAPAS is multidimensional pain assessment scale used in Finland. It consist of five behavioral indicators, three physiological indicators, and one contextual indicator.
Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
Time frame: Baseline 2, measured pre-procedure
Pain intensity will be assessed using pain assessment tool, the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). NIAPAS is multidimensional pain assessment scale used in Finland. It consist of five behavioral indicators, three physiological indicators, and one contextual indicator.
Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
Time frame: Measured during painful procedure
Pain intensity will be assessed using pain assessment tool, the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). NIAPAS is multidimensional pain assessment scale used in Finland. It consist of five behavioral indicators, three physiological indicators, and one contextual indicator.
Change in scores of Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
Time frame: Measured immediately after painful procedure
Pain intensity will be assessed using pain assessment tool, the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). NIAPAS is multidimensional pain assessment scale used in Finland. It consist of five behavioral indicators, three physiological indicators, and one contextual indicator.
Change in the activation in the somatosensory cortical areas following the noxious stimulation (baseline)
Time frame: Baseline 1, measured pre-intervention
In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 2-channel NIRS will be used. The emitted probe provides near-infrared light through on optical fiber will be is placed slightly posterior to Cz position with reference to the international EEG 10-20 system. The receive probes will be fastened over somatosensory and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 to 4 cm from the emitted probe so that they are placed slightly behind C3 or C4 point. The occipital region receive probe will be attached 2 to 4 cm from the emitted probe.
Change in the activation in the somatosensory cortical areas following the noxious stimulation
Time frame: Baseline 2, measured pre-procedure
In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 2-channel NIRS will be used. The emitted probe provides near-infrared light through on optical fiber will be is placed slightly posterior to Cz position with reference to the international EEG 10-20 system. The receive probes will be fastened over somatosensory and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 to 4 cm from the emitted probe so that they are placed slightly behind C3 or C4 point. The occipital region receive probe will be attached 2 to 4 cm from the emitted probe.
Change of the activation in the somatosensory cortical areas following the noxious stimulation
Time frame: Measured during painful procedure
In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 2-channel NIRS will be used. The emitted probe provides near-infrared light through on optical fiber will be is placed slightly posterior to Cz position with reference to the international EEG 10-20 system. The receive probes will be fastened over somatosensory and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 to 4 cm from the emitted probe so that they are placed slightly behind C3 or C4 point. The occipital region receive probe will be attached 2 to 4 cm from the emitted probe.
Change of the activation in the somatosensory cortical areas following the noxious stimulation
Time frame: Measured immediately after painful procedure
In this study pain will be assessed measuring changes cortical hemodynamics by near-infrared spectroscopy (NIRS). A 2-channel NIRS will be used. The emitted probe provides near-infrared light through on optical fiber will be is placed slightly posterior to Cz position with reference to the international EEG 10-20 system. The receive probes will be fastened over somatosensory and occipital area. In the area of the somatosensory cortex, receive probes will be placed 2 to 4 cm from the emitted probe so that they are placed slightly behind C3 or C4 point. The occipital region receive probe will be attached 2 to 4 cm from the emitted probe.
Change in heart rate (HR)
Time frame: Baseline 1, measured pre-intervention
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in heart rate using bedside patient monitor.
Change in heart rate (HR)
Time frame: Baseline 2, measured pre-procedure
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in heart rate using bedside patient monitor.
Change in heart rate (HR)
Time frame: Measured during painful procedure
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in heart rate using bedside patient monitor.
Change in heart rate (HR)
Time frame: Measured immediately after procedure
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in heart rate using bedside patient monitor.
Change in oxygen saturation
Time frame: Baseline 1, measured pre-intervention
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in oxygen saturation using bedside patient monitor.
Change in oxygen saturation
Time frame: Baseline 2, measured pre-procedure
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in oxygen saturation using bedside patient monitor.
Change in oxygen saturation
Time frame: Measured during painful procedure
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in oxygen saturation using bedside patient monitor.
Change in oxygen saturation
Time frame: Measured immediately after painful procedure
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in oxygen saturation using bedside patient monitor.
Change in respiratory rate
Time frame: Baseline 1, measured pre-intervention
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in respiratory rate using bedside patient monitor.
Change in respiratory rate
Time frame: Baseline 2, measured pre-procedure
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in respiratory rate using bedside patient monitor.
Change in respiratory rate
Time frame: Measured during procedure
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in respiratory rate using bedside patient monitor.
Change in respiratory rate
Time frame: Measured immediately after procedure
Neonates' physiological reactions to procedural pain during heel lance will be monitored continuously and measured by recording changes in respiratory rate using bedside patient monitor.
18 secondary outcomes
Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)
Time frame: 3 minutes after painful procedure
Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)
Time frame: 5 minutes after painful procedure
Recovery measured by change in scores of the Premature Infant Pain profile-Revised (PIPP-R)
Time frame: 10 minutes after painful procedure
Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
Time frame: 3 minutes after painful procedure
Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
Time frame: 5 minutes after painful procedure
Recovery measured by change in scores of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS)
Time frame: 10 minutes after painful procedure
Recovery as measured by changes in somatosensory cortex activation
Time frame: 3 minutes after painful procedure
Recovery as measured by changes in somatosensory cortex activation
Time frame: 5 minutes after painful procedure
Recovery as measured by changes in somatosensory cortex activation
Time frame: 10 minutes after painful procedure
Recovery as measured by changes in heart rate (HR)
Time frame: 3 minutes after painful procedure
Recovery as measured by changes in heart rate (HR)
Time frame: 5 minutes after painful procedure
Recovery as measured by changes in heart rate (HR)
Time frame: 10 minutes after painful procedure
Recovery as measured by changes in oxygen saturation
Time frame: 3 minutes after painful procedure
Recovery as measured by changes in oxygen saturation
Time frame: 5 minutes after painful procedure
Recovery as measured by changes in oxygen saturation
Time frame: 10 minutes after painful procedure
Recovery as measured by changes in respiratory rate
Time frame: 3 minutes after painful procedure
Recovery as measured by changes in respiratory rate
Time frame: 5 minutes after painful procedure
Recovery as measured by changes in respiratory rate
Time frame: 10 minutes after painful procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Derived from this study: PubMed 42054232Palomaa AK, Talus E, Keskitalo-Leskinen S, Polkki T. Mothers' Views and Experiences of Digital Maternal Presence Intervention and Skin-to-Skin Contact for Neonatal Pain Relief: A Qualitative Study. Nurs Open. 2026 May;13(5):e70577. doi: 10.1002/nop2.70577.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin-to-skin contact, Mother's heartbeats as sound and vibration and 30% oral glucose in people with Pain, Acute and Procedural Pain, run by University of Oulu at 1 site in Finland.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Nov 2023. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna-Kaija Palomaa (+358400892159, annakaija.palomaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores of Premature Infant Pain profile-Revised (PIPP-R) scale (time frame: Baseline 1, measured pre-intervention). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04967118, which also lists 1 linked publication.
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 30 Nov 2023.