Heel LancingNCT05001191
The Effect of Gentle Human Touch in Preterm Infants During Heel Lancing
A study testing Gentle Human Touch in people with Heel Lancing, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled experimental study is planned in order to determine the effect of gentle human touch on pain, comfort and physiological parameters in preterm infants during heel lancing matched for gestational age, gender and birth weight. Read more about this study
- Who is it for?
- Ages 32 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Heel Lancing
- What is being tested?
- Gentle Human Touch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2021to 10 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 32 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being 32-37 gestational age weeks,
- being birth weight of 1500 g and above,
- without a congenital anomaly, not having any disease at birth such as neonatal asphyxia, hemolytic status, metabolic disease, skin disease, patent ductus arteriosus (PDA), respiratory distress syndrome (RDS) and sepsis,
- no chest tube,
- not connected to a mechanical ventilator,
- not having intracranial bleeding,
Show all 10Show fewer
- not taking any medication other than antibiotics and vitamin supplements,
- not taking opiates and sedatives within 4 hours before heel lancing,
- no painful intervention is applied at least one hour before the heel lancing,
- preterm infants whose mothers gave verbal and written consent
Who cannot join
- having a congenital anomaly, having any disease at birth such as neonatal asphyxia, hemolytic status, metabolic disease, skin disease, patent ductus arteriosus (PDA), respiratory distress syndrome (RDS) and sepsis,
- being chest tube,
- connected to a mechanical ventilator,
- having intracranial bleeding,
- taking any medication other than antibiotics and vitamin supplements,
- taking opiates and sedatives within 4 hours before heel lancing,
- painful intervention is applied at least one hour before the heel lancing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Gentle Human Touch on Pain, Comfort and Physiological Parameters in Preterm Infants During Heel Lancing
This randomized controlled experimental study is planned in order to determine the effect of gentle human touch on pain, comfort and physiological parameters in preterm infants during heel lancing matched for gestational age, gender and birth weight. The study will be performed with preterm infants hospitalized in the neonatal intensive care unit of a tertiary hospital. Ethical committee approval, institutional permission, parental written consent were obtained. The therapeutic touch will be applied 10 minutes before the heel lancing, it will continue during and after the procedure, a total of 15 minutes of sensitive touch will be applied. The practitioner will place one hand on the baby's head and the other hand on the lower abdomen covering the waist and hips of the preterm baby for 15 minutes. Before and after the study the following were evaluated in preterm infants in the gentle human touch and control group: pain, comfort and physiological parameters.
Read the detailed description
This randomized controlled experimental study is planned in order to determine the effect of gentle human touch on pain, comfort and physiological parameters in preterm infants during heel lancing matched for gestational age, gender and birth weight. The research sample will consist of 50 preterm infants who meet the inclusion criteria. In the literature, the number of infants varies between 11 and 38 in different studies in which gentle human touch was applied to preterm infants. In this study, it was decided that the number of infants in the groups should be 25 according to α=95% confidence level and 90% power. In the study, it was planned to have 25 infants in the gentle human touch (GHT) and control groups. After reaching 50 preterm infants in the study, power analysis will be calculated using pain scores and it will be decided whether the sample size is sufficient or not. The infants in the GHT group will be applied gentle human touch for a total of 15 minutes, starting 10 minutes before the heel lancing and continuing during the heel lancing. The infants in the control group will not be subjected to any intervention other than their clinical routines, only observation will be made. Being 32-37 gestational age weeks, being birth weight of 1500 g and above, without a congenital anomaly, not having any disease at birth such as neonatal asphyxia, hemolytic status, metabolic disease, skin disease, patent ductus arteriosus (PDA), respiratory distress syndrome (RDS) and sepsis, no chest tube, not connected to a mechanical ventilator, not having intracranial bleeding, not taking any medication other than antibiotics and vitamin supplements, not taking opiates and sedatives within 4 hours before heel lancing, no painful intervention is applied at least one hour before the heel lancing, preterm infants whose mothers gave verbal and written consent will be included in the study. Data will be collected with the Questionnare Form, Physiological Parameters Observation Form, Neonatal Infant Pain Scale (NIPS), Premature Infant Comfort Scale (PBIC) and Pulse Oximeter.
- Conditions
- Heel Lancing
- Being tested
- Gentle Human Touch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle Human TouchOther
Gentle human touch, which has a pain and stress-reducing effect, is a sensitive tactile stimulus applied to the skin, without caress or massage, which provides a kind of relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Gentle Human Touch Group | Experimental | Not described Receives: Other: Gentle Human Touch |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature infants comfort scale (PICS) scores
According to the PICS, a score between 7-35 is obtained from the scale. A high score from the scale indicates a low level of comfort. Change= (before the heel lancing, during the heel lancing and after heel lancing 15. minute )
Measured: before the heel lancing, during the heel lancing and after heel lancing 15. minute
Secondary outcomes (1)
Newborn infant pain scale (NIPS) scores
A score between 0-7 is taken from the scale. As the score increases, the severity of the pain also increases (0-2 points no pain, 3-4 points moderate pain, and >4 points severe pain). Change= (before the heel lancing, during the heel lancing and after heel lancing 15. minute )
Measured: before the heel lancing, during the heel lancing and after heel lancing 15. minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start10 Aug 2021
- Primary completion10 Sep 2021
- Study completion10 Sep 2021
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 Heel LancingStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yağmur Sezer Efe, TC Erciyes University
- Investigators
- Yağmur Sezer Efe, Assist. Prof., Principal investigator, ErciyesUniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001191
- Sponsor's protocol ID
- 2021/453
- Status last verified
- Jun 2022
- First submitted
- 8 Jul 2021
- Last updated
- 13 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sezer Efe Y, Erdem E, Caner N, Gunes T. The effect of gentle human touch on pain, comfort and physiological parameters in preterm infants during heel lancing. Complement Ther Clin Pract. 2022 Aug;48:101622. doi: 10.1016/j.ctcp.2022.101622. Epub 2022 Jun 22.
PubMed 35759976
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gentle Human Touch on Pain, Comfort and Physiological Parameters in Preterm Infants During Heel Lancing
- ClinicalTrials.gov ID
- NCT05001191
- Acronym / sponsor ID
- 2021/453
- Conditions
- Heel Lancing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 11 Aug 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.
This randomized controlled experimental study is planned in order to determine the effect of gentle human touch on pain, comfort and physiological parameters in preterm infants during heel lancing matched for gestational age, gender and birth weight. The study will be performed with preterm infants hospitalized in the neonatal intensive care unit of a tertiary hospital. Ethical committee approval, institutional permission, parental written consent were obtained. The therapeutic touch will be applied 10 minutes before the heel lancing, it will continue during and after the procedure, a total of 15 minutes of sensitive touch will be applied. The practitioner will place one hand on the baby's head and the other hand on the lower abdomen covering the waist and hips of the preterm baby for 15 minutes. Before and after the study the following were evaluated in preterm infants in the gentle human touch and control group: pain, comfort and physiological parameters.
Detailed description
This randomized controlled experimental study is planned in order to determine the effect of gentle human touch on pain, comfort and physiological parameters in preterm infants during heel lancing matched for gestational age, gender and birth weight. The research sample will consist of 50 preterm infants who meet the inclusion criteria. In the literature, the number of infants varies between 11 and 38 in different studies in which gentle human touch was applied to preterm infants. In this study, it was decided that the number of infants in the groups should be 25 according to α=95% confidence level and 90% power. In the study, it was planned to have 25 infants in the gentle human touch (GHT) and control groups. After reaching 50 preterm infants in the study, power analysis will be calculated using pain scores and it will be decided whether the sample size is sufficient or not. The infants in the GHT group will be applied gentle human touch for a total of 15 minutes, starting 10 minutes before the heel lancing and continuing during the heel lancing. The infants in the control group will not be subjected to any intervention other than their clinical routines, only observation will be made. Being 32-37 gestational age weeks, being birth weight of 1500 g and above, without a congenital anomaly, not having any disease at birth such as neonatal asphyxia, hemolytic status, metabolic disease, skin disease, patent ductus arteriosus (PDA), respiratory distress syndrome (RDS) and sepsis, no chest tube, not connected to a mechanical ventilator, not having intracranial bleeding, not taking any medication other than antibiotics and vitamin supplements, not taking opiates and sedatives within 4 hours before heel lancing, no painful intervention is applied at least one hour before the heel lancing, preterm infants whose mothers gave verbal and written consent will be included in the study. Data will be collected with the Questionnare Form, Physiological Parameters Observation Form, Neonatal Infant Pain Scale (NIPS), Premature Infant Comfort Scale (PBIC) and Pulse Oximeter.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gentle Human Touch Group | Experimental | Other: Gentle Human Touch |
| Control group | No intervention | – |
Who may qualify
- Ages
- 32 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Being 32-37 gestational age weeks,
- being birth weight of 1500 g and above,
- without a congenital anomaly, not having any disease at birth such as neonatal asphyxia, hemolytic status, metabolic disease, skin disease, patent ductus arteriosus (PDA), respiratory distress syndrome (RDS) and sepsis,
- no chest tube,
- not connected to a mechanical ventilator,
Key exclusion criteria (7 listed)
- having a congenital anomaly, having any disease at birth such as neonatal asphyxia, hemolytic status, metabolic disease, skin disease, patent ductus arteriosus (PDA), respiratory distress syndrome (RDS) and sepsis,
- being chest tube,
- connected to a mechanical ventilator,
- having intracranial bleeding,
- taking any medication other than antibiotics and vitamin supplements,
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 |
|---|---|---|
| Gentle Human TouchGentle human touch, which has a pain and stress-reducing effect, is a sensitive tactile stimulus applied to the skin, without caress or massage, which provides a kind of relaxation. | Other | Gentle Human Touch Group |
Primary outcome
Premature infants comfort scale (PICS) scores
Time frame: before the heel lancing, during the heel lancing and after heel lancing 15. minute
According to the PICS, a score between 7-35 is obtained from the scale. A high score from the scale indicates a low level of comfort. Change= (before the heel lancing, during the heel lancing and after heel lancing 15. minute )
1 secondary outcome
Newborn infant pain scale (NIPS) scores
Time frame: before the heel lancing, during the heel lancing and after heel lancing 15. minute
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 Jun 2022.
- Derived from this study: PubMed 35759976Sezer Efe Y, Erdem E, Caner N, Gunes T. The effect of gentle human touch on pain, comfort and physiological parameters in preterm infants during heel lancing. Complement Ther Clin Pract. 2022 Aug;48:101622. doi: 10.1016/j.ctcp.2022.101622. Epub 2022 Jun 22.
- Individual participant dataSharing planned: No
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.
Yağmur Sezer Efe, Assist. Prof. principal investigator
ErciyesUniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gentle Human Touch in people with Heel Lancing, run by TC Erciyes 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 10 inclusion and 7 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 Jun 2022. 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?
Premature infants comfort scale (PICS) scores (time frame: before the heel lancing, during the heel lancing and after heel lancing 15. minute). 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 NCT05001191, 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 Jun 2022.