VenipunctureNCT06077409
''The Effect of Skin-to-Skin Contact and Gentle Touch Method Applied During Blood Collection on Early Detection of Pain and Physiological Parameters''
A study testing Skin To Skin and Gentle Human Touch in people with Venipuncture and Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
37. babies under the gestational week are considered preterm babies, and babies between 32-37 gestational weeks are considered late preterm babies (WHO, 2023). Dec. While the preterm birth rate in the world is 10%, this rate is 13% in Turkey. Read more about this study
- Who is it for?
- Ages 32 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Venipuncture, Pain, Touch
- What is being tested?
- Skin To Skin and Gentle Human Touch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Feb 2022to 30 Jul 2022
- 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
- Mothers who volunteer to participate in the research,
- Between 32-37 weeks of gestation,
- No analgesics are given until 6 hours before the procedure,
- First blood draw attempt is successful,
- Those who are considered healthy by the physician in the health follow-ups performed after birth
Who cannot join
- Those with congenital anomalies,
- Having any disease,
- Patients whose intravenous blood collection attempt takes more than two minutes,
- Babies previously monitored in the Neonatal Intensive Care Unit will be excluded from the scope of the research.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Provincial Health Directorate Zeynep Kamil Women and Children Diseases Traning and Research Hospital
Istanbul, Üsküdar, 34100
About this study
- babies under the gestational week are considered preterm babies, and babies between 32-37 gestational weeks are considered late preterm babies (WHO, 2023). Dec. While the preterm birth rate in the world is 10%, this rate is 13% in Turkey. The life rate of preterm babies has increased in recent years and they are subjected to many painful interventions for diagnosis, treatment and preventive purposes. At the time of birth, they experience painful interventions such as vitamin K, hepatitis B vaccine administration, heel blood collection. Painful interventions cause an increase in cortisol levels, resulting in impaired blood sugar in infants, impaired brain development, impaired growth and development (Akyildiz et al., 2023). In the short term, they may give signs of a decrease in oxygen saturation, an increase in heart rate, metabolic acidosis( Akcan et al., 2017). Procedural pain management is also important for the neurological development of preterm infants (Perg et al., 2018). For these reasons, the pain of the newborn due to interventional procedures should be managed well.
Read the detailed description
Newborns are often exposed to acute or chronic pain due to different invasive interventions (Akcan and Polat, 2017). The American Pain Society (APS) accepts pain as the fifth physiological parameter (McCharty et al., 2013). The American Academy of Pediatrics (AAP) recommends minimizing pain due to invasive procedures (Aydın et al., 2016). Reducing pain first requires accurate assessment of pain and treatment with pharmacological/non-pharmacological interventions (Hussein, 2015). Pharmacological methods have risks such as drug-related side effects. For this reason, non-pharmacological methods are primarily preferred in acute pain (Hashemi et al., 2016).
Non-pharmacological methods for pain management are diverse. In recent years, non-pharmacological methods such as distraction, wrapping, positioning, aromatherapy, music, games, massage, kangaroo care, and oral sucrose have been used together or separately to reduce pain and/or stress-related behaviors (Abdallah et al., 2013).
In another application, the tent-to-skin contact method, the newborn is laid face down on the parent's chest. The newborn's back is covered to prevent heat loss. It is thought that this situation will relax the newborn and therefore perceive the pain as milder (Mayfield, 2019).
Gentle Human Touch is one of the therapeutic touch methods. Gentle touch, which is a simple and applicable method in newborns, is a non-invasive touch technique that does not require special equipment and technology. The gentle touch method is a sensitive tactile stimulation applied to the skin, without caressing or massage, and provides a relaxing effect on the baby (Dur et al., 2020; Fatohallazade, 2020).
Newborns need their parents, especially their mothers, to be with them during all kinds of interventions. For this reason, the parent should be with the newborn during the invasive interventions and take a primary role in the non-pharmacological interventions; It provides optimum comfort for the nurse, newborn and caregiver. It is important to benefit from the family-centered care model when using non-pharmacological methods. Family-centered care is a care model based on collaboration between health professionals and children's families in the planning, delivery and evaluation of health services. Its general goal is to increase the quality of health services for children and families, increase the satisfaction of families and health professionals, and ensure the effective use of personnel (Yılmaz and Gözen, 2019).
It was planned as a randomized controlled experimental design type in order to determine the importance of the family-centered care model and parents' participation in the procedures and to determine the effect of non-pharmacological methods applied to preterm newborns by their mothers on the pain occurring during blood collection and the effect on preterm physiological parameters.
- Conditions
- Venipuncture, Pain, Touch
- Being tested
- Skin To Skin, Gentle Human Touch
- Keywords
- pain, pretem, physiological findings, gentle human touch, skin to skin, touch
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin To SkinOther
Skin to Skin Contact Group The temperature of the environment where kangaroo care will be carried out will be adjusted between 22-26 degrees C. The mother will be allowed to disinfect her hands and warm them until her hand temperature is at least 34 C. Only the baby's diaper, hat and socks will be left behind, and the baby will be placed face down on the mother's chest, with its head upright and its legs under the breasts in a frog position. The baby's face will be turned towards the mother and eye contact will be made. The baby will be in an upright position between the mother's breasts and skin to skin with the mother.
Skin-to-skin contact will begin 5 minutes before blood collection, continue throughout the procedure, and kangaroo care will continue until 5 minutes after the procedure.
Gentle Human TouchBehavioural
Experimental Group (Gentle Touch/Gentle Human Touch-GHT); After the mother is dressed in a clean apron, her hands are washed and disinfected, and it is safe to warm the hand temperature with a non-contact thermometer device until the measured value is 34 ºC. The mother, who was previously informed about the method, will be placed on the eyebrow line with the crown piece that will separate the fingertips and tuft of one hand, while the other hand will be placed on the lower abdomen, which will mark the waist and hips (Figure 1). The blood collection amount of GHT application will be started 5 minutes before, make sure that the blood collection is done and the blood collection will continue until 5 minutes later.
| Study group | Role | What they receive |
|---|---|---|
| Gentle Human Touch Group | Active comparator | After the mother is dressed in a clean apron, she will be provided to wash and disinfect her hands and heat her hand temperature with a non-contact fire meter device until the measurement value is 34 ºC.Jul. The mother, who was previously informed about the method, will place the fingertips and palm of one hand above the eyebrow line so that it touches the baby's crown part, while placing the other hand on the lower abdomen surrounding the baby's waist and hips (Figure 1). The GHT application will be started 5 minutes before the blood collection procedure, it will be continued during the blood collection procedure and until 5 minutes after the end of the blood collection procedure. Receives: Behavioral: Gentle Human Touch |
| Skin to Skin Group | Active comparator | The temperature of the environment where skin to skin will be carried out will be adjusted between 22-26 degrees C. The mother will be allowed to disinfect her hands and warm them until her hand temperature is at least 34 C. Only the baby's diaper, hat and socks will be left behind, and the baby will be placed face down on the mother's chest, with its head upright and its legs under the breasts in a frog position. The baby's face will be turned towards the mother and eye contact will be made. The baby will be in an upright position between the mother's breasts and skin to skin with the mother.
Skin-to-skin contact will begin 5 minutes before blood collection, continue throughout the procedure, and skin to skin will continue until 5 minutes after the procedure. Receives: Other: Skin To Skin |
| Control Group | No intervention | The standard procedure of the clinic was applied to preterm infants in the control group. In the standart prosedure of the clinic, the mother was with her baby in the blood collection room and did not perform any procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm Pain
Neonatal İnfant Pain Scale
Measured: 5 minutes. At the first mınute of venipuncture Scores will be given between 0-7 points.
Preterm Crying
Stopwatch
Measured: 5 mınutes. During blood collection, the stopwatch will turn on when the baby starts crying and turn off when the baby stops crying.
Secondary outcomes (2)
Heart Rate
Measured 3 times in total
Measured: 1.Five minutes before the blood collection procedure, 2. In the first minute of the blood collection process 3. Five minutes after the blood collection procedure
Oxygen Saturatıon
Measured 3 times in total
Measured: 1.Five minutes before the blood collection procedure, 2. In the first minute of the blood collection process 3. Five minutes after the blood collection procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start17 Feb 2022
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for VenipunctureStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Model description
- Premature babies who apply to the blood collection room to take blood, were included in the gentle human touch, skin to skin and control groups. Randomization occurred on: www.randomizer.org
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DERYA KILINÇ, Istanbul University - Cerrahpasa
- Investigators
- Derya Kılınç, 1, Principal investigator, Istanbul Cerrahpaşa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077409
- Sponsor's protocol ID
- 177
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdallah B, Badr LK, Hawwari M. The efficacy of massage on short and long term outcomes in preterm infants. Infant Behav Dev. 2013 Dec;36(4):662-9. doi: 10.1016/j.infbeh.2013.06.009. Epub 2013 Aug 7.
PubMed 23932956Aydin D, Sahiner NC, Ciftci EK. Comparison of the effectiveness of three different methods in decreasing pain during venipuncture in children: ball squeezing, balloon inflating and distraction cards. J Clin Nurs. 2016 Aug;25(15-16):2328-35. doi: 10.1111/jocn.13321. Epub 2016 Apr 26.
PubMed 27112434Ayyildiz TK, Tanriverdi E, Tank DY, Akkoc B, Topan A. The effect of swaddling method applied to preterm infants during the aspiration procedure on pain. J Pediatr Nurs. 2023 May-Jun;70:61-67. doi: 10.1016/j.pedn.2022.05.025. Epub 2023 Feb 18.
PubMed 36801626Baley J; COMMITTEE ON FETUS AND NEWBORN. Skin-to-Skin Care for Term and Preterm Infants in the Neonatal ICU. Pediatrics. 2015 Sep;136(3):596-9. doi: 10.1542/peds.2015-2335.
PubMed 26324876Dur 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 32601011Fatollahzade M, Parvizi S, Kashaki M, Haghani H, Alinejad-Naeini M. The effect of gentle human touch during endotracheal suctioning on procedural pain response in preterm infant admitted to neonatal intensive care units: a randomized controlled crossover study. J Matern Fetal Neonatal Med. 2022 Apr;35(7):1370-1376. doi: 10.1080/14767058.2020.1755649. Epub 2020 Apr 21.
PubMed 32316790Hashemi F, Taheri L, Ghodsbin F, Pishva N, Vossoughi M. Comparing the effect of swaddling and breastfeeding and their combined effect on the pain induced by BCG vaccination in infants referring to Motahari Hospital, Jahrom, 2010-2011. Appl Nurs Res. 2016 Feb;29:217-21. doi: 10.1016/j.apnr.2015.05.013. Epub 2015 May 30.
PubMed 26856517McCarthy M, Glick R, Green J, Plummer K, Peters K, Johnsey L, Deluca C. Comfort First: an evaluation of a procedural pain management programme for children with cancer. Psychooncology. 2013 Apr;22(4):775-82. doi: 10.1002/pon.3061. Epub 2012 Mar 13.
PubMed 22416039Pavlyshyn H, Sarapuk I. Skin-to-skin contact-An effective intervention on pain and stress reduction in preterm infants. Front Pediatr. 2023 Mar 22;11:1148946. doi: 10.3389/fped.2023.1148946. eCollection 2023.
PubMed 37033163Peng HF, Yin T, Yang L, Wang C, Chang YC, Jeng MJ, Liaw JJ. Non-nutritive sucking, oral breast milk, and facilitated tucking relieve preterm infant pain during heel-stick procedures: A prospective, randomized controlled trial. Int J Nurs Stud. 2018 Jan;77:162-170. doi: 10.1016/j.ijnurstu.2017.10.001. Epub 2017 Oct 8.
PubMed 29100198
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ''The Effect of Skin-to-Skin Contact and Gentle Touch Method Applied During Blood Collection on Early Detection of Pain and Physiological Parameters''
- ClinicalTrials.gov ID
- NCT06077409
- Acronym / sponsor ID
- 177
- Conditions
- Venipuncture, Pain, Touch
- Keywords
- pain, pretem, physiological findings, gentle human touch, skin to skin, touch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 11 Oct 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.
- babies under the gestational week are considered preterm babies, and babies between 32-37 gestational weeks are considered late preterm babies (WHO, 2023). Dec. While the preterm birth rate in the world is 10%, this rate is 13% in Turkey. The life rate of preterm babies has increased in recent years and they are subjected to many painful interventions for diagnosis, treatment and preventive purposes. At the time of birth, they experience painful interventions such as vitamin K, hepatitis B vaccine administration, heel blood collection. Painful interventions cause an increase in cortisol levels, resulting in impaired blood sugar in infants, impaired brain development, impaired growth and development (Akyildiz et al., 2023). In the short term, they may give signs of a decrease in oxygen saturation, an increase in heart rate, metabolic acidosis( Akcan et al., 2017). Procedural pain management is also important for the neurological development of preterm infants (Perg et al., 2018). For these reasons, the pain of the newborn due to interventional procedures should be managed well.
Detailed description
Newborns are often exposed to acute or chronic pain due to different invasive interventions (Akcan and Polat, 2017). The American Pain Society (APS) accepts pain as the fifth physiological parameter (McCharty et al., 2013). The American Academy of Pediatrics (AAP) recommends minimizing pain due to invasive procedures (Aydın et al., 2016). Reducing pain first requires accurate assessment of pain and treatment with pharmacological/non-pharmacological interventions (Hussein, 2015). Pharmacological methods have risks such as drug-related side effects. For this reason, non-pharmacological methods are primarily preferred in acute pain (Hashemi et al., 2016).
Non-pharmacological methods for pain management are diverse. In recent years, non-pharmacological methods such as distraction, wrapping, positioning, aromatherapy, music, games, massage, kangaroo care, and oral sucrose have been used together or separately to reduce pain and/or stress-related behaviors (Abdallah et al., 2013).
In another application, the tent-to-skin contact method, the newborn is laid face down on the parent's chest. The newborn's back is covered to prevent heat loss. It is thought that this situation will relax the newborn and therefore perceive the pain as milder (Mayfield, 2019).
Gentle Human Touch is one of the therapeutic touch methods. Gentle touch, which is a simple and applicable method in newborns, is a non-invasive touch technique that does not require special equipment and technology. The gentle touch method is a sensitive tactile stimulation applied to the skin, without caressing or massage, and provides a relaxing effect on the baby (Dur et al., 2020; Fatohallazade, 2020).
Newborns need their parents, especially their mothers, to be with them during all kinds of interventions. For this reason, the parent should be with the newborn during the invasive interventions and take a primary role in the non-pharmacological interventions; It provides optimum comfort for the nurse, newborn and caregiver. It is important to benefit from the family-centered care model when using non-pharmacological methods. Family-centered care is a care model based on collaboration between health professionals and children's families in the planning, delivery and evaluation of health services. Its general goal is to increase the quality of health services for children and families, increase the satisfaction of families and health professionals, and ensure the effective use of personnel (Yılmaz and Gözen, 2019).
It was planned as a randomized controlled experimental design type in order to determine the importance of the family-centered care model and parents' participation in the procedures and to determine the effect of non-pharmacological methods applied to preterm newborns by their mothers on the pain occurring during blood collection and the effect on preterm physiological parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Premature babies who apply to the blood collection room to take blood, were included in the gentle human touch, skin to skin and control groups. Randomization occurred on: www.randomizer.org
| Arm | Type | Receives |
|---|---|---|
| Gentle Human Touch Group | Active comparator | Behavioral: Gentle Human TouchAfter the mother is dressed in a clean apron, she will be provided to wash and disinfect her hands and heat her hand temperature with a non-contact fire meter device until the measurement value is 34 ºC.Jul. The mother, who was previously informed about the method, will place the fingertips and palm of one hand above the eyebrow line so that it touches the baby's crown part, while placing the other hand on the lower abdomen surrounding the baby's waist and hips (Figure 1). The GHT application will be started 5 minutes before the blood collection procedure, it will be continued during the blood collection procedure and until 5 minutes after the end of the blood collection procedure. |
| Skin to Skin Group | Active comparator | Other: Skin To SkinThe temperature of the environment where skin to skin will be carried out will be adjusted between 22-26 degrees C. The mother will be allowed to disinfect her hands and warm them until her hand temperature is at least 34 C. Only the baby's diaper, hat and socks will be left behind, and the baby will be placed face down on the mother's chest, with its head upright and its legs under the breasts in a frog position. The baby's face will be turned towards the mother and eye contact will be made. The baby will be in an upright position between the mother's breasts and skin to skin with the mother. Skin-to-skin contact will begin 5 minutes before blood collection, continue throughout the procedure, and skin to skin will continue until 5 minutes after the procedure. |
| Control Group | No intervention | –The standard procedure of the clinic was applied to preterm infants in the control group. In the standart prosedure of the clinic, the mother was with her baby in the blood collection room and did not perform any procedure. |
Who may qualify
- Ages
- 32 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Mothers who volunteer to participate in the research,
- Between 32-37 weeks of gestation,
- No analgesics are given until 6 hours before the procedure,
- First blood draw attempt is successful,
- Those who are considered healthy by the physician in the health follow-ups performed after birth
Key exclusion criteria (4 listed)
- Those with congenital anomalies,
- Having any disease,
- Patients whose intravenous blood collection attempt takes more than two minutes,
- Babies previously monitored in the Neonatal Intensive Care Unit will be excluded from the scope of the research.
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 SkinSkin to Skin Contact Group The temperature of the environment where kangaroo care will be carried out will be adjusted between 22-26 degrees C. The mother will be allowed to disinfect her hands and warm them until her hand temperature is at least 34 C. Only the baby's diaper, hat and socks will be left behind, and the baby will be placed face down on the mother's chest, with its head upright and its legs under the breasts in a frog position. The baby's face will be turned towards the mother and eye contact will be made. The baby will be in an upright position between the mother's breasts and skin to skin with the mother. Skin-to-skin contact will begin 5 minutes before blood collection, continue throughout the procedure, and kangaroo care will continue until 5 minutes after the procedure. | Other | Skin to Skin Group |
| Gentle Human TouchExperimental Group (Gentle Touch/Gentle Human Touch-GHT); After the mother is dressed in a clean apron, her hands are washed and disinfected, and it is safe to warm the hand temperature with a non-contact thermometer device until the measured value is 34 ºC. The mother, who was previously informed about the method, will be placed on the eyebrow line with the crown piece that will separate the fingertips and tuft of one hand, while the other hand will be placed on the lower abdomen, which will mark the waist and hips (Figure 1). The blood collection amount of GHT application will be started 5 minutes before, make sure that the blood collection is done and the blood collection will continue until 5 minutes later. | Behavioural | Gentle Human Touch Group |
Primary outcome
Preterm Pain
Time frame: 5 minutes. At the first mınute of venipuncture Scores will be given between 0-7 points.
Neonatal İnfant Pain Scale
Preterm Crying
Time frame: 5 mınutes. During blood collection, the stopwatch will turn on when the baby starts crying and turn off when the baby stops crying.
Stopwatch
2 secondary outcomes
Heart Rate
Time frame: 1.Five minutes before the blood collection procedure, 2. In the first minute of the blood collection process 3. Five minutes after the blood collection procedure
Oxygen Saturatıon
Time frame: 1.Five minutes before the blood collection procedure, 2. In the first minute of the blood collection process 3. Five minutes after the blood collection 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 11 Oct 2023.
- Background: PubMed 23932956Abdallah B, Badr LK, Hawwari M. The efficacy of massage on short and long term outcomes in preterm infants. Infant Behav Dev. 2013 Dec;36(4):662-9. doi: 10.1016/j.infbeh.2013.06.009. Epub 2013 Aug 7.
- Background: PubMed 27112434Aydin D, Sahiner NC, Ciftci EK. Comparison of the effectiveness of three different methods in decreasing pain during venipuncture in children: ball squeezing, balloon inflating and distraction cards. J Clin Nurs. 2016 Aug;25(15-16):2328-35. doi: 10.1111/jocn.13321. Epub 2016 Apr 26.
- Background: PubMed 36801626Ayyildiz TK, Tanriverdi E, Tank DY, Akkoc B, Topan A. The effect of swaddling method applied to preterm infants during the aspiration procedure on pain. J Pediatr Nurs. 2023 May-Jun;70:61-67. doi: 10.1016/j.pedn.2022.05.025. Epub 2023 Feb 18.
- Background: PubMed 26324876Baley J; COMMITTEE ON FETUS AND NEWBORN. Skin-to-Skin Care for Term and Preterm Infants in the Neonatal ICU. Pediatrics. 2015 Sep;136(3):596-9. doi: 10.1542/peds.2015-2335.
- Background: 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.
- Background: PubMed 32316790Fatollahzade M, Parvizi S, Kashaki M, Haghani H, Alinejad-Naeini M. The effect of gentle human touch during endotracheal suctioning on procedural pain response in preterm infant admitted to neonatal intensive care units: a randomized controlled crossover study. J Matern Fetal Neonatal Med. 2022 Apr;35(7):1370-1376. doi: 10.1080/14767058.2020.1755649. Epub 2020 Apr 21.
- Background: PubMed 26856517Hashemi F, Taheri L, Ghodsbin F, Pishva N, Vossoughi M. Comparing the effect of swaddling and breastfeeding and their combined effect on the pain induced by BCG vaccination in infants referring to Motahari Hospital, Jahrom, 2010-2011. Appl Nurs Res. 2016 Feb;29:217-21. doi: 10.1016/j.apnr.2015.05.013. Epub 2015 May 30.
- Background: PubMed 22416039McCarthy M, Glick R, Green J, Plummer K, Peters K, Johnsey L, Deluca C. Comfort First: an evaluation of a procedural pain management programme for children with cancer. Psychooncology. 2013 Apr;22(4):775-82. doi: 10.1002/pon.3061. Epub 2012 Mar 13.
- Background: PubMed 37033163Pavlyshyn H, Sarapuk I. Skin-to-skin contact-An effective intervention on pain and stress reduction in preterm infants. Front Pediatr. 2023 Mar 22;11:1148946. doi: 10.3389/fped.2023.1148946. eCollection 2023.
- Background: PubMed 29100198Peng HF, Yin T, Yang L, Wang C, Chang YC, Jeng MJ, Liaw JJ. Non-nutritive sucking, oral breast milk, and facilitated tucking relieve preterm infant pain during heel-stick procedures: A prospective, randomized controlled trial. Int J Nurs Stud. 2018 Jan;77:162-170. doi: 10.1016/j.ijnurstu.2017.10.001. Epub 2017 Oct 8.
- Akcan, E. \& Polat, S. (2017). Yenidoğanlarda Ağrı ve Ağrı Yönetiminde Hemşirenin Rolü. Acıbadem Üniversitesi Sağlık Bilimleri Dergisi, (2): 64-69Link provided by the sponsor.
- Mayfield, A. (2019). Effects of Kangaroo Mother Care on Mother-Infant Interaction: Infant Behaviors (Doctoral dissertation, Southeast Missouri State University).Link provided by the sponsor.
- WHO Preterm Birth DetailLink provided by the sponsor.
- Yılmaz, Ö. E., \& Gözen, D. (2019). Pediatri Hemşireliğinde Aile Merkezli Bakımın Önemi ve Bakım Kalitesini Geliştirmedeki Değeri. Türkiye Klinikleri Çocuk Sağlığı ve Hastalıkları Hemşireliği-Özel Konular, 5(2), 5-11.Link provided by the sponsor.
- 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.
Derya Kılınç, 1 principal investigator
Istanbul Cerrahpaşa
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 and Gentle Human Touch in people with Venipuncture and Pain, run by Istanbul University - Cerrahpasa 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 5 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 11 Oct 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 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?
Preterm Pain (time frame: 5 minutes. At the first mınute of venipuncture Scores will be given between 0-7 points.). The study lists 2 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 NCT06077409, which also lists 10 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 11 Oct 2023.