Pain, AcuteNCT05064072
Pain Felt During Removal of the Products From Infant's Skin Used in Nasogastric Tube Fixation
A study testing Water-based barrier tape, Hydrocolloid barrier tape and Silk tape in people with Pain, Acute, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The present study was planned to evaluate the pain of 4-6 weeks infants felt during removal of the adhesive products from newborn's skin used in the fixation of nasogastric tube in neonatal and infant units. Read more about this study
- Who is it for?
- Ages 4 to 6 weeksHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Water-based barrier tape, Hydrocolloid barrier tape and Silk tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 15 Sep 2021
- 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 4 to 6 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All the 4-6 weeks infants including interventional process and without any skin diseases
Who cannot join
- The infants receiving treatment without any interventional process
- Those having a skin disease
- Those infants having peripherally inserted central venous catheter
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun University Women and Children's Hospital
Giresun
About this study
Official title: The Evaluation of Pain Felt During Removal of the Products From Infant's Skin Used in Nasogastric Tube Fixation: Randomized Controlled Study
The present study was planned to evaluate the pain of 4-6 weeks infants felt during removal of the adhesive products from newborn's skin used in the fixation of nasogastric tube in neonatal and infant units. The hypothesis of the study is "Water-based barrier tape is more effective to reduce pain than hydrocolloid barrier tape.
Read the detailed description
The study was planned as randomized controlled and experimental design to compare the efficiency of three different methods reducing pain during removal adhesive products for 4-6 weeks infants. The universe of the study consisted of 4-6 weeks infants in neonatal and infants clinics of Giresun Women's and Children's Hospital between the dates of July-September 2021. Power analysis was performed through G*Power (v3.1.7) programme in order to determine the number of the sample. At the beginning of the study, a reference study (Kemer, 2020) was used for sample calculation. The effect size was calculated as d=0.561 regarding the assessment of skin condition scores and 120 participants in total should be included in the study as 40 participants for each groups in order to obtain 80% power in the level of α=0.05. Block randomization technique is applied in the study as a randomization method. "As for data collection "Infant description form" and "Neonatal Infant Pain Scale" was used. The scale was filled by two independent observer via double-blind method.
- Conditions
- Pain, Acute
- Being tested
- Water-based barrier tape, Hydrocolloid barrier tape, Silk tape
- Keywords
- infant, pain, adhesives, fixation
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-based barrier tapeDevice
The infants in experiment 1 group will be applied water-based barrier tape. The area will be covered by water-based barrier tape to fix nasogastric tube and after waiting 1 minute for drying up it will be fastened by silk tape used in clinic. The silk tape will be 5 cm long and it will be changed in every 24 hours. Following the removal of silk tape on the water-based barrier tape, the pain felt by the infants evaluated through "Neonatal Infant Pain Scale" and the score recorded in the chart. This procedure actualized 3 min. before procedure, during and 3 min after procedure.
Hydrocolloid barrier tapeDevice
As for experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube. The hydrocolloid barrier tape, which was cut and shaped appropriately beforehand, will be applied to the area in order to stabilize the nasogastric tube and the tube will be stabilized with silk tape used in clinic. The silk tape will be 5 cm long and it will be changed in every 24 hours. Following the removal of silk tape on the hydrocolloid barrier tape, the pain felt by the infants evaluated with "Neonatal Infant Pain Scale" and the score recorded in the chart. Since the hydrocolloid barrier tape can stay on the skin for 7 days and the assessment of the pain realized in 7th day and noted down to the chart. Pain score evaluated in 7th day 3 min. before procedure, during and 3 min after procedure
Silk tapeDevice
The silk tape used in clinic routinely will be used for control group infants to fix the nasogastric tube without any barrier. The silk tape will be 5cm long and it will be changed in every 24 hours. Following the removal of silk tape on the silk tape, the pain felt by the infants evaluated through "Neonatal Infant Pain Scale" and the score recorded in the chart. This procedure actualized 3 min. before procedure, during and 3 min after procedure
| Study group | Role | What they receive |
|---|---|---|
| Water-based barrier tape | Experimental | The infants in experiment 1 group will be applied water-based barrier tape will be used to fix the nasogastric tube Receives: Device: Water-based barrier tape |
| Hydrocolloid barrier tape | Experimental | The infants in experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube Receives: Device: Hydrocolloid barrier tape |
| Silk plaster | Active comparator | The silk plaster used in clinic routinely will be used for control group infants to fix the nasogastric tube Receives: Device: Silk tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Water-based barrier tape
To evaluate pain felt by infants following the removal of silk adhesive from water-based barrier tape
Measured: 24 hours
Hydrocolloid barrier tape
To evaluate pain felt by infants following the removal of silk adhesive from hydrocolloid barrier tape
Measured: 24 hours
Silk Tape
To evaluate pain felt by infants following the removal of silk adhesive from infants skin without any barrier tape
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start1 Jul 2021
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064072
- Sponsor's protocol ID
- 23618724
- Status last verified
- Sep 2021
- First submitted
- 29 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Field T. Preterm newborn pain research review. Infant Behav Dev. 2017 Nov;49:141-150. doi: 10.1016/j.infbeh.2017.09.002. Epub 2017 Sep 9.
PubMed 28898671Maxwell LG, Fraga MV, Malavolta CP. Assessment of Pain in the Newborn: An Update. Clin Perinatol. 2019 Dec;46(4):693-707. doi: 10.1016/j.clp.2019.08.005. Epub 2019 Aug 19.
PubMed 31653303Kemer D, İşler Dalgıç A. Yenidoğanlarda Ağrı Yönetiminde Kullanılan Kanıt Temelli Non-Farmakolojik Hemşirelik Uygulamaları. Balıkesir Sağlık Bilimleri Dergisi. 2020; 9(3):197-204.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Pain Felt During Removal of the Products From Infant's Skin Used in Nasogastric Tube Fixation: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05064072
- Acronym / sponsor ID
- 23618724
- Conditions
- Pain, Acute
- Keywords
- infant, pain, adhesives, fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 1 Oct 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 present study was planned to evaluate the pain of 4-6 weeks infants felt during removal of the adhesive products from newborn's skin used in the fixation of nasogastric tube in neonatal and infant units. The hypothesis of the study is "Water-based barrier tape is more effective to reduce pain than hydrocolloid barrier tape.
Detailed description
The study was planned as randomized controlled and experimental design to compare the efficiency of three different methods reducing pain during removal adhesive products for 4-6 weeks infants. The universe of the study consisted of 4-6 weeks infants in neonatal and infants clinics of Giresun Women's and Children's Hospital between the dates of July-September 2021. Power analysis was performed through G*Power (v3.1.7) programme in order to determine the number of the sample. At the beginning of the study, a reference study (Kemer, 2020) was used for sample calculation. The effect size was calculated as d=0.561 regarding the assessment of skin condition scores and 120 participants in total should be included in the study as 40 participants for each groups in order to obtain 80% power in the level of α=0.05. Block randomization technique is applied in the study as a randomization method. "As for data collection "Infant description form" and "Neonatal Infant Pain Scale" was used. The scale was filled by two independent observer via double-blind method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Water-based barrier tape | Experimental | Device: Water-based barrier tapeThe infants in experiment 1 group will be applied water-based barrier tape will be used to fix the nasogastric tube |
| Hydrocolloid barrier tape | Experimental | Device: Hydrocolloid barrier tapeThe infants in experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube |
| Silk plaster | Active comparator | Device: Silk tapeThe silk plaster used in clinic routinely will be used for control group infants to fix the nasogastric tube |
Who may qualify
- Ages
- 4 to 6 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All the 4-6 weeks infants including interventional process and without any skin diseases
Key exclusion criteria (3 listed)
- The infants receiving treatment without any interventional process
- Those having a skin disease
- Those infants having peripherally inserted central venous catheter
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 |
|---|---|---|
| Water-based barrier tapeThe infants in experiment 1 group will be applied water-based barrier tape. The area will be covered by water-based barrier tape to fix nasogastric tube and after waiting 1 minute for drying up it will be fastened by silk tape used in clinic. The silk tape will be 5 cm long and it will be changed in every 24 hours. Following the removal of silk tape on the water-based barrier tape, the pain felt by the infants evaluated through "Neonatal Infant Pain Scale" and the score recorded in the chart. This procedure actualized 3 min. before procedure, during and 3 min after procedure. | Device | Water-based barrier tape |
| Hydrocolloid barrier tapeAs for experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube. The hydrocolloid barrier tape, which was cut and shaped appropriately beforehand, will be applied to the area in order to stabilize the nasogastric tube and the tube will be stabilized with silk tape used in clinic. The silk tape will be 5 cm long and it will be changed in every 24 hours. Following the removal of silk tape on the hydrocolloid barrier tape, the pain felt by the infants evaluated with "Neonatal Infant Pain Scale" and the score recorded in the chart. Since the hydrocolloid barrier tape can stay on the skin for 7 days and the assessment of the pain realized in 7th day and noted down to the chart. Pain score evaluated in 7th day 3 min. before procedure, during and 3 min after procedure | Device | Hydrocolloid barrier tape |
| Silk tapeThe silk tape used in clinic routinely will be used for control group infants to fix the nasogastric tube without any barrier. The silk tape will be 5cm long and it will be changed in every 24 hours. Following the removal of silk tape on the silk tape, the pain felt by the infants evaluated through "Neonatal Infant Pain Scale" and the score recorded in the chart. This procedure actualized 3 min. before procedure, during and 3 min after procedure | Device | Silk plaster |
Primary outcome
Water-based barrier tape
Time frame: 24 hours
To evaluate pain felt by infants following the removal of silk adhesive from water-based barrier tape
Hydrocolloid barrier tape
Time frame: 24 hours
To evaluate pain felt by infants following the removal of silk adhesive from hydrocolloid barrier tape
Silk Tape
Time frame: 24 hours
To evaluate pain felt by infants following the removal of silk adhesive from infants skin without any barrier tape
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 1 Oct 2021.
- Results publication: PubMed 28898671Field T. Preterm newborn pain research review. Infant Behav Dev. 2017 Nov;49:141-150. doi: 10.1016/j.infbeh.2017.09.002. Epub 2017 Sep 9.
- Results publication: PubMed 31653303Maxwell LG, Fraga MV, Malavolta CP. Assessment of Pain in the Newborn: An Update. Clin Perinatol. 2019 Dec;46(4):693-707. doi: 10.1016/j.clp.2019.08.005. Epub 2019 Aug 19.
- Results publicationKemer D, İşler Dalgıç A. Yenidoğanlarda Ağrı Yönetiminde Kullanılan Kanıt Temelli Non-Farmakolojik Hemşirelik Uygulamaları. Balıkesir Sağlık Bilimleri Dergisi. 2020; 9(3):197-204.
- Individual participant dataSharing planned: Undecided
Related trials for Pain, Acute
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water-based barrier tape, Hydrocolloid barrier tape and Silk tape in people with Pain, Acute, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 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 1 Oct 2021. 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?
Water-based barrier tape (time frame: 24 hours). 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 NCT05064072, which also lists 3 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 1 Oct 2021.