Endotracheal AspirationNCT06308991
Effect of Touch Methods in Preterm Infants During Endotracheal Aspiration
A study testing Yakson touch, Gentle Human Touch and Routine care in people with Endotracheal Aspiration, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants. Read more about this study
- Who is it for?
- Ages 26 to 36 weeks
- Conditions the study is for
- Endotracheal Aspiration
- What is being tested?
- Yakson touch, Gentle Human Touch and Routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 1 Jun 2023
- 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 26 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants in the 26-36/6 gestational week and at appropriate gestational age (AGA)
- Infants undergoing ventilator support with an endotracheal tube
Who cannot join
- Infants taking opiates and sedatives within four hours, having undergone a painful procedure at least one hour before
- Infants congenital anomalies, sepsis or haemorrhagic disease that might prevent Yakson and GHT
- Infants who underwent surgery and had a chest tube
- Infants with intracranial hemorrhage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Democracy University
Karabağlar, İzmir, 35140
About this study
Official title: The Effect of Yakson and Gentle Touch Method on Pain, Comfort and Physiological Parameters in Preterm Infants During Endotracheal Aspiration
The purpose of this study was to determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants.
Read the detailed description
Background: Preterm infants in the neonatal intensive care unit are exposed to various painful procedures, so different non-pharmacological pain control techniques are used to alleviate pain.
Aims: To determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants.
Design: A randomized controlled crossover trial. Setting: This study was conducted in the neonatal intensive care unit between July 2022 and June 2023.
Methods: Thirty neonates were enrolled in this study based on inclusion criteria. The samples were randomly received a sequence of suctioning with Yakson and GHT and routine care. Neonatal Pain Agitation and Sedation Scale and COMFORT neo were used to collect the data.
- Conditions
- Endotracheal Aspiration
- Being tested
- Yakson touch, Gentle Human Touch, Routine care
- Keywords
- Therapeutic Touch, Pain, Preterm Infant
- Medical subject headings
- Pain, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yakson touchOther
Yakson touch method will be started 5 minutes before the endotracheal aspiration procedure and continued until the completion of the procedure.The Yakson method continued for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes).
Gentle Human TouchOther
Gentle Human Touch (GHT) method will be started 5 minutes before the endotracheal aspiration procedure and continued until the completion of the procedure.The GHT method continued for 15 minutes.
Routine careOther
Infants in the Routine care will be applied swaddling. It will be started 5 minutes before the endotracheal aspiration procedure and continued until the completion of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Yakson touch | Experimental | The Yakson method continued for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes). In the Yakson touch method, the palms of the practitioner and all fingers were kept in close contact so that the infants did not feel pressure.
1. Steady touch (5 minutes): One hand rested on the chest and abdomen of the preterm infant, while the other hand supported the back and hip of the preterm infant.
2. Compassionate Caress (5 minutes): In the same hand position, the practitioner repeated caressing and resting for 5 minutes: Caress (1 minute), rest (30 seconds), caress (1 minute), rest (30 seconds), and caress (2 minutes). The practitioner caressed the infants' chest and belly with a 1 cm diameter clockwise circular movement every 10 seconds.
3. Steady touch (5 minutes): The practitioner followed the steady touch procedure as previously described. Receives: Other: Yakson touch |
| Gentle Human Touch | Experimental | While the practitioner placed one hand on the crown of the preterm infant on the eyebrow line with the fingertip touch for 15 minutes, the other hand was placed on the lower abdomen covering the waist and hip of the infant. Receives: Other: Gentle Human Touch |
| Routine Care | Other | All infants in the control, Yakson, and GHT groups were applied swaddling as the routine practice of the clinic before and during painful procedures. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Pain Agitation and Sedation Scale (N-PASS)
Pain will be evaluated using the Neonatal Pain Agitation and Sedation Scale (N-PASS).This scale was developed by Hummel Puchalski in 2000 for preterm and term babies. The Turkish validity and reliability study was conducted by Açıkgöz et al. 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: Pain was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.
Change in Oxygen saturation
Oxygen saturation of infants before, during, and after endotracheal aspiration were recorded to a computer using a Masimo Radical 7 Pulse Oximeter at 2-second intervals.
Measured: Oxygen saturation was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.
Change in Heart rate
Heart rate of infants before, during, and after endotracheal aspiration were recorded to a computer using a Masimo Radical 7 Pulse Oximeter at 2-second intervals.
Measured: Heart rate was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.
Secondary outcomes (1)
COMFORTneo Scale
This scale was developed by Van Dijk et al. in 2009 for preterm babies. The Turkish validity and reliability study was conducted by Kahraman et al. in 2014. It is a 5-point Likert type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. The lowest score that can be obtained from the scale is 6 and the highest score is 30. It is emphasized that if the total score of the scale is between 9-13, the baby is comfortable, if it is between 14-30, the baby is in pain or distress, the baby is uncomfortable and needs interventions to provide comfort.
Measured: Comfort was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Jul 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
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 Endotracheal AspirationStudies 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
- The order of the 2 different touching methods and routine care practices to be applied to the infants in the research group was determined by randomized method and 3 groups were created. Considering the order of application in each group, it was decided which touch method and routine care would be applied to the infants. Both touch techniques and routine care practices were applied once to each infant. Group 1: Yakson touch, Routine care, Gentle HumanTouch Group 2: Routine care, Gentle HumanTouch, Yakson touch Group 3: Gentle HumanTouch, Yakson touch, Routine care
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadiye Dur, Izmir Democracy University
- Investigators
- Sadiye Dur, PhD, Principal investigator, Izmir Democracy UniversitySeda Caglar, PhD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308991
- Sponsor's protocol ID
- IDU-SBF-SD-01
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caglar S, Dur S, Ustabas Yildiz N, Guney Varal I. The effect of the Yakson and Gentle Human Touch methods applied to preterm infants during endotracheal aspiration on pain, comfort, and physiological parameters. Intensive Crit Care Nurs. 2025 Apr;87:103898. doi: 10.1016/j.iccn.2024.103898. Epub 2024 Nov 19.
PubMed 39566223
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yakson and Gentle Touch Method on Pain, Comfort and Physiological Parameters in Preterm Infants During Endotracheal Aspiration
- ClinicalTrials.gov ID
- NCT06308991
- Acronym / sponsor ID
- IDU-SBF-SD-01
- Conditions
- Endotracheal Aspiration
- Keywords
- Therapeutic Touch, Pain, Preterm Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 13 Mar 2024 (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 purpose of this study was to determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants.
Detailed description
Background: Preterm infants in the neonatal intensive care unit are exposed to various painful procedures, so different non-pharmacological pain control techniques are used to alleviate pain.
Aims: To determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants.
Design: A randomized controlled crossover trial. Setting: This study was conducted in the neonatal intensive care unit between July 2022 and June 2023.
Methods: Thirty neonates were enrolled in this study based on inclusion criteria. The samples were randomly received a sequence of suctioning with Yakson and GHT and routine care. Neonatal Pain Agitation and Sedation Scale and COMFORT neo were used to collect the data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The order of the 2 different touching methods and routine care practices to be applied to the infants in the research group was determined by randomized method and 3 groups were created. Considering the order of application in each group, it was decided which touch method and routine care would be applied to the infants. Both touch techniques and routine care practices were applied once to each infant. Group 1: Yakson touch, Routine care, Gentle HumanTouch Group 2: Routine care, Gentle HumanTouch, Yakson touch Group 3: Gentle HumanTouch, Yakson touch, Routine care
| Arm | Type | Receives |
|---|---|---|
| Yakson touch | Experimental | Other: Yakson touchThe Yakson method continued for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes). In the Yakson touch method, the palms of the practitioner and all fingers were kept in close contact so that the infants did not feel pressure. 1. Steady touch (5 minutes): One hand rested on the chest and abdomen of the preterm infant, while the other hand supported the back and hip of the preterm infant. 2. Compassionate Caress (5 minutes): In the same hand position, the practitioner repeated caressing and resting for 5 minutes: Caress (1 minute), rest (30 seconds), caress (1 minute), rest (30 seconds), and caress (2 minutes). The practitioner caressed the infants' chest and belly with a 1 cm diameter clockwise circular movement every 10 seconds. 3. Steady touch (5 minutes): The practitioner followed the steady touch procedure as previously described. |
| Gentle Human Touch | Experimental | Other: Gentle Human TouchWhile the practitioner placed one hand on the crown of the preterm infant on the eyebrow line with the fingertip touch for 15 minutes, the other hand was placed on the lower abdomen covering the waist and hip of the infant. |
| Routine Care | Other | Other: Routine careAll infants in the control, Yakson, and GHT groups were applied swaddling as the routine practice of the clinic before and during painful procedures. |
Who may qualify
- Ages
- 26 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants in the 26-36/6 gestational week and at appropriate gestational age (AGA)
- Infants undergoing ventilator support with an endotracheal tube
Key exclusion criteria (4 listed)
- Infants taking opiates and sedatives within four hours, having undergone a painful procedure at least one hour before
- Infants congenital anomalies, sepsis or haemorrhagic disease that might prevent Yakson and GHT
- Infants who underwent surgery and had a chest tube
- Infants with intracranial hemorrhage
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 |
|---|---|---|
| Yakson touchYakson touch method will be started 5 minutes before the endotracheal aspiration procedure and continued until the completion of the procedure.The Yakson method continued for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes). | Other | Yakson touch |
| Gentle Human TouchGentle Human Touch (GHT) method will be started 5 minutes before the endotracheal aspiration procedure and continued until the completion of the procedure.The GHT method continued for 15 minutes. | Other | Gentle Human Touch |
| Routine careInfants in the Routine care will be applied swaddling. It will be started 5 minutes before the endotracheal aspiration procedure and continued until the completion of the procedure. | Other | Routine Care |
Primary outcome
Neonatal Pain Agitation and Sedation Scale (N-PASS)
Time frame: Pain was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.
Pain will be evaluated using the Neonatal Pain Agitation and Sedation Scale (N-PASS).This scale was developed by Hummel Puchalski in 2000 for preterm and term babies. The Turkish validity and reliability study was conducted by Açıkgöz et al. 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: Oxygen saturation was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.
Oxygen saturation of infants before, during, and after endotracheal aspiration were recorded to a computer using a Masimo Radical 7 Pulse Oximeter at 2-second intervals.
Change in Heart rate
Time frame: Heart rate was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.
Heart rate of infants before, during, and after endotracheal aspiration were recorded to a computer using a Masimo Radical 7 Pulse Oximeter at 2-second intervals.
1 secondary outcome
COMFORTneo Scale
Time frame: Comfort was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.
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 Mar 2024.
- Derived from this study: PubMed 39566223Caglar S, Dur S, Ustabas Yildiz N, Guney Varal I. The effect of the Yakson and Gentle Human Touch methods applied to preterm infants during endotracheal aspiration on pain, comfort, and physiological parameters. Intensive Crit Care Nurs. 2025 Apr;87:103898. doi: 10.1016/j.iccn.2024.103898. Epub 2024 Nov 19.
- 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.
Sadiye Dur, PhD principal investigator
Izmir Democracy University
Seda Caglar, PhD principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yakson touch, Gentle Human Touch and Routine care in people with Endotracheal Aspiration, run by Izmir Democracy 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 2 inclusion and 4 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 Mar 2024. 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?
Neonatal Pain Agitation and Sedation Scale (N-PASS) (time frame: Pain was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.). 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 NCT06308991, 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 13 Mar 2024.