PretermNCT05784857
The Effect of Touch Methods on Pain and Physiological Parameters in Preterm Infants During Endotracheal Aspiration
A study testing Touch Methods in people with Preterm and Pain, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Recurrent and painful interventions such as heel lancing, venipuncture, dressing change, endotracheal aspiration are frequently performed in neonatal intensive care units (NICU). Touch is one of the infant's earliest developing senses. Therefore it is very important among individualized supportive care practices. Read more about this study
- Who is it for?
- Ages 24 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm, Pain, Infant ALL
- What is being tested?
- Touch Methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 24 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The gestational week of the infant is less than 38
- Absence of congenital anomaly
- Mechanical ventilator support
- Absence of comorbid disease
- Not having undergone surgery
- No analgesic medication has been administered in the last hour
Who cannot join
- Infants with diseases such as sepsis that interfere with the application of touch technique
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem Health Group Ataşehir Hospital
Istanbul, Ataşehir, 34750
Zehra Kan Öntürk, Assist Prof, 02165004163, zehra.kan@acibadem.edu.tr
Zehra Kan Öntürk, Asist Prof, 02165004163, zehra.kan@acibadem.edu.tr
About this study
Recurrent and painful interventions such as heel lancing, venipuncture, dressing change, endotracheal aspiration are frequently performed in neonatal intensive care units (NICU). Touch is one of the infant's earliest developing senses. Therefore it is very important among individualized supportive care practices. Correct stimulation of the infant's sense of touch affects psychosocial development positively. In addition, it is reported that touch has a calming and analgesic effect during invasive interventions. Therefore, there is a need for touch appropriate for development of newborn.
The aim of this study was determine the effect of Yakson and Gentle Human Touch on pain and physiologic parameters in preterm infants during endotracheal aspiration.
Read the detailed description
It was designed as a prospective, quasi-experimental.In this study, each intubated infant will be followed up during 3 aspiration procedures. The first aspiration procedure will be performed without intervention. During the second and third aspiration procedure, yakson and gentle touch will be applied, respectively.Physiological parameters and pain score of newborn will be evaluated before, during and immediately after aspiration.
Yakson touch: Yakson touch is defined in traditional Korean culture as a kind of therapeutic touch that a mother believes will treat her sick child by stroking it with a compassionate, sincere and loving attitude. The Yakson protocol was developed by Im and Kim (2009) in an understandable form that can be easily implemented. While newborn is in supine position, practitioner applies Yakson touch. The Yakson touch method continue for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes). In this method, the palms of the practitioner and all fingers keep in close contact so that the babies don't feel pressure.
- Steady touch (5 minutes): One hand rest on the chest and abdomen of the preterm infant, while the other hand support the back and hip of the preterm infant.
- Compassionate Caress (5 minutes): In the same hand position, the practitioner repeat caressing and resting for 5 minutes: Caress (1 minutes), rest (30 seconds), caress (1 minutes), rest (30 seconds), and caress (2 minutes). The practitioner caress the infants' chest and belly with a 1 cm diameter clockwise circular movement every 10 second.
- Steady touch (5 minutes): The practitioner follow the steady touch procedure as previously describe.
Gentle Human Touch: Gentle human touch refers to steady contact of the skin without caressing or massaging. While the practitioner place one hand on the crown of the preterm infant on the eyebrow line with the fingertip touch for 15 minutes, the other hand was place on the lower abdomen covering the waist and hip of the infants.
- Conditions
- Preterm, Pain, Infant ALL
- Being tested
- Touch Methods
- Keywords
- touch, preterm infant, pain
- Medical subject headings
- Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Touch MethodsOther
The Yakson touch method continue for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes). In this method, the palms of the practitioner and all fingers keep in close contact so that the babies don't feel pressure.
Gentle human touch refers to steady contact of the skin without caressing or massaging. While the practitioner place one hand on the crown of the preterm infant on the eyebrow line with the fingertip touch for 15 minutes, the other hand was place on the lower abdomen covering the waist and hip of the infants.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention and Touch Group | Other | Each intubated infant will be follewed up during 3 aspiration procedures. Different touching techniques will be used for preterm infants in each aspiration application.
The first aspiration procedure will be performed without intervention. During the second aspiration procedure, yakson touch will be applied.Third aspiration procedure, gentle human touch will be applied. Receives: Other: Touch Methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Score
Pain will be evaluated using the Neonatal Pain Agitation and Sedation Scale (N-PASS).This scale was developed for preterm and term babies. The Turkish validity and reliability study was conducted in 2017. Crying, irritability, behavior-state, facial expression, extremity tone, and vital signs parameters are evaluated in the N-PASS scale. In this scale is evaluated with triple likert type and pain score can be between "0" and "10". Permission was obtained from the authors to use the scale.
Measured: Data will be collected from 5 minutes before the aspiration up to the 15th minute. Change in this time intervals will be assessed during 15 minutes.
Change in Oxygen saturation
Oxygen saturation will be evaluated using the pulse oximeter
Measured: Data will be collected from 5 minutes before the aspiration up to the 15th minute. Change in this time intervals will be assessed during 15 minutes.
Change in Heart rate
Heart rate will be evaluated using the monitor
Measured: Data will be collected from 5 minutes before the aspiration up to the 15th minute. Change in this time intervals will be assessed during 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start24 Feb 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Kan Onturk, Acibadem University
- Investigators
- Zehra Kan Öntürk, Assist Prof, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784857
- Sponsor's protocol ID
- ATADEK-2022/17
- Status last verified
- Mar 2025
- First submitted
- 28 Feb 2023
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nist MD, Robinson A, Harrison TM, Pickler RH. An integrative review of clinician-administered comforting touch interventions and acute stress responses of preterm infants. J Pediatr Nurs. 2022 Nov-Dec;67:e113-e122. doi: 10.1016/j.pedn.2022.08.020. Epub 2022 Sep 20.
PubMed 36137912Dur S, Caglar S, Yildiz NU, Dogan P, Guney Varal I. The effect of Yakson and Gentle Human Touch methods on pain and physiological parameters in preterm infants during heel lancing. Intensive Crit Care Nurs. 2020 Dec;61:102886. doi: 10.1016/j.iccn.2020.102886. Epub 2020 Jun 27.
PubMed 32601011Im H, Kim E. Effect of Yakson and Gentle Human Touch versus usual care on urine stress hormones and behaviors in preterm infants: a quasi-experimental study. Int J Nurs Stud. 2009 Apr;46(4):450-8. doi: 10.1016/j.ijnurstu.2008.01.009. Epub 2008 Mar 18.
PubMed 18353332Bahman Bijari B, Iranmanesh S, Eshghi F, Baneshi MR. Gentle Human Touch and Yakson: The Effect on Preterm's Behavioral Reactions. ISRN Nurs. 2012;2012:750363. doi: 10.5402/2012/750363. Epub 2012 Jun 25.
PubMed 22792482
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Touch Methods on Pain and Physiological Parameters in Preterm Infants During Endotracheal Aspiration
- ClinicalTrials.gov ID
- NCT05784857
- Acronym / sponsor ID
- ATADEK-2022/17
- Conditions
- Preterm, Pain, Infant ALL
- Keywords
- touch, preterm infant, pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 27 Mar 2023 (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.
Recurrent and painful interventions such as heel lancing, venipuncture, dressing change, endotracheal aspiration are frequently performed in neonatal intensive care units (NICU). Touch is one of the infant's earliest developing senses. Therefore it is very important among individualized supportive care practices. Correct stimulation of the infant's sense of touch affects psychosocial development positively. In addition, it is reported that touch has a calming and analgesic effect during invasive interventions. Therefore, there is a need for touch appropriate for development of newborn.
The aim of this study was determine the effect of Yakson and Gentle Human Touch on pain and physiologic parameters in preterm infants during endotracheal aspiration.
Detailed description
It was designed as a prospective, quasi-experimental.In this study, each intubated infant will be followed up during 3 aspiration procedures. The first aspiration procedure will be performed without intervention. During the second and third aspiration procedure, yakson and gentle touch will be applied, respectively.Physiological parameters and pain score of newborn will be evaluated before, during and immediately after aspiration.
Yakson touch: Yakson touch is defined in traditional Korean culture as a kind of therapeutic touch that a mother believes will treat her sick child by stroking it with a compassionate, sincere and loving attitude. The Yakson protocol was developed by Im and Kim (2009) in an understandable form that can be easily implemented. While newborn is in supine position, practitioner applies Yakson touch. The Yakson touch method continue for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes). In this method, the palms of the practitioner and all fingers keep in close contact so that the babies don't feel pressure.
- Steady touch (5 minutes): One hand rest on the chest and abdomen of the preterm infant, while the other hand support the back and hip of the preterm infant.
- Compassionate Caress (5 minutes): In the same hand position, the practitioner repeat caressing and resting for 5 minutes: Caress (1 minutes), rest (30 seconds), caress (1 minutes), rest (30 seconds), and caress (2 minutes). The practitioner caress the infants' chest and belly with a 1 cm diameter clockwise circular movement every 10 second.
- Steady touch (5 minutes): The practitioner follow the steady touch procedure as previously describe.
Gentle Human Touch: Gentle human touch refers to steady contact of the skin without caressing or massaging. While the practitioner place one hand on the crown of the preterm infant on the eyebrow line with the fingertip touch for 15 minutes, the other hand was place on the lower abdomen covering the waist and hip of the infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Intervention and Touch Group | Other | Other: Touch MethodsEach intubated infant will be follewed up during 3 aspiration procedures. Different touching techniques will be used for preterm infants in each aspiration application. The first aspiration procedure will be performed without intervention. During the second aspiration procedure, yakson touch will be applied.Third aspiration procedure, gentle human touch will be applied. |
Who may qualify
- Ages
- 24 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The gestational week of the infant is less than 38
- Absence of congenital anomaly
- Mechanical ventilator support
- Absence of comorbid disease
- Not having undergone surgery
Key exclusion criteria (1 listed)
- Infants with diseases such as sepsis that interfere with the application of touch technique
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 |
|---|---|---|
| Touch MethodsThe Yakson touch method continue for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes). In this method, the palms of the practitioner and all fingers keep in close contact so that the babies don't feel pressure. Gentle human touch refers to steady contact of the skin without caressing or massaging. While the practitioner place one hand on the crown of the preterm infant on the eyebrow line with the fingertip touch for 15 minutes, the other hand was place on the lower abdomen covering the waist and hip of the infants. | Other | No Intervention and Touch Group |
Primary outcome
Change in Pain Score
Time frame: Data will be collected from 5 minutes before the aspiration up to the 15th minute. Change in this time intervals will be assessed during 15 minutes.
Pain will be evaluated using the Neonatal Pain Agitation and Sedation Scale (N-PASS).This scale was developed for preterm and term babies. The Turkish validity and reliability study was conducted in 2017. Crying, irritability, behavior-state, facial expression, extremity tone, and vital signs parameters are evaluated in the N-PASS scale. In this scale is evaluated with triple likert type and pain score can be between "0" and "10". Permission was obtained from the authors to use the scale.
Change in Oxygen saturation
Time frame: Data will be collected from 5 minutes before the aspiration up to the 15th minute. Change in this time intervals will be assessed during 15 minutes.
Oxygen saturation will be evaluated using the pulse oximeter
Change in Heart rate
Time frame: Data will be collected from 5 minutes before the aspiration up to the 15th minute. Change in this time intervals will be assessed during 15 minutes.
Heart rate will be evaluated using the monitor
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Results publication: PubMed 36137912Nist MD, Robinson A, Harrison TM, Pickler RH. An integrative review of clinician-administered comforting touch interventions and acute stress responses of preterm infants. J Pediatr Nurs. 2022 Nov-Dec;67:e113-e122. doi: 10.1016/j.pedn.2022.08.020. Epub 2022 Sep 20.
- Results publication: PubMed 32601011Dur S, Caglar S, Yildiz NU, Dogan P, Guney Varal I. The effect of Yakson and Gentle Human Touch methods on pain and physiological parameters in preterm infants during heel lancing. Intensive Crit Care Nurs. 2020 Dec;61:102886. doi: 10.1016/j.iccn.2020.102886. Epub 2020 Jun 27.
- Results publication: PubMed 18353332Im H, Kim E. Effect of Yakson and Gentle Human Touch versus usual care on urine stress hormones and behaviors in preterm infants: a quasi-experimental study. Int J Nurs Stud. 2009 Apr;46(4):450-8. doi: 10.1016/j.ijnurstu.2008.01.009. Epub 2008 Mar 18.
- Results publication: PubMed 22792482Bahman Bijari B, Iranmanesh S, Eshghi F, Baneshi MR. Gentle Human Touch and Yakson: The Effect on Preterm's Behavioral Reactions. ISRN Nurs. 2012;2012:750363. doi: 10.5402/2012/750363. Epub 2012 Jun 25.
- 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.
Zehra Kan Öntürk, Assist Prof principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Touch Methods in people with Preterm and Pain, run by Acibadem 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 6 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: looking for participants now, as of the sponsor's last update on 5 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zehra Kan Öntürk, Assist Prof (02165004163, zehra.kan@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Score (time frame: Data will be collected from 5 minutes before the aspiration up to the 15th minute. Change in this time intervals will be assessed during 15 minutes.). The study lists 3 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 NCT05784857, which also lists 4 linked publications.
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 5 Mar 2025.