VenipunctureNCT05727631
The Effect of Mother's Gentle Human Touch Method on Preterm Pain and Mother's Anxiety Level During Venipuncture
A study testing gentle human touch in people with Venipuncture and Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Newborns are frequently exposed to acute or chronic pain experience due to different invasive interventions. The American Academy of Pediatrics (AAP) recommends minimizing the pain associated with invasive procedures. 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
- What is being tested?
- gentle human touch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2021to 31 Dec 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
- Between 32 and 37 gestational weeks,
- The first blood collection attempt is successful,
- Health follow-ups performed after childbirth are considered healthy by the physician,
Who cannot join
- Analgesic given up to 6 hours before the procedure,
- With a congenital anomaly, • With any disease,
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
Newborns are frequently exposed to acute or chronic pain experience due to different invasive interventions. The American Academy of Pediatrics (AAP) recommends minimizing the pain associated with invasive procedures. Reduction of pain primarily requires accurate assessment of pain, and treatment with pharmacological/nonpharmacological interventions.
Touch is one of the first senses developed in the newborn. Gentle Human Touch (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 stroking or massage, and provides a relaxing effect on the baby. Studies have shown that the gentle touch method increases the sleep level of preterm infants, reduces pain, stress and cortisone levels, reduces restlessness and keeps the heart rate under control.
Read more
Newborns need their parents, especially their mothers, to be by their side during any kind of intervention. For this reason, the presence of the parent next to the newborn during invasive procedures and the primary role in nonpharmacological interventions provides optimal comfort for the nurse, the newborn and the caregiver. When using nonpharmacological methods, it is important to take advantage of the family-centered care model. Family-centered care is a model of care based on cooperation between health professionals and children's families in the planning, delivery and evaluation of health Decency. Its general objective is to improve the quality of health services for children and families, to increase the satisfaction of families and health professionals, and to ensure the effective use of personnel.
Accordingly, this thesis study was planned in a randomized controlled experimental design type in order to determine the importance of family-centered care model and parents' participation in the procedures and the effect of gentle touch method applied by mothers during bloodletting on preterm pain level, physiological parameters, crying time and anxiety level of the mother.
Read the detailed description
June December 2021-Dec 2021, the universe of the research will consist of preterm infants and mothers admitted to Istanbul Zeynep Kamil Women and Children's Diseases Training and Research Hospital Neonatal Outpatient Clinic. The sample will be composed of mothers and preterm infants who have undergone bloodletting between these dates, who meet the sample selection criteria, and who volunteer to participate in the study Dec. At the beginning of the data collection phase, power analysis will be performed to determine the number of samples. Groups of babies will be determined using simple randomization method in computer environment.
Data Collection Process After obtaining the permissions of the ethics committee and the institution of the research, the subject and purpose of the research will be explained to all medical personnel working in the neonatal outpatient clinic of the hospital where the research will be conducted, and the methods to be applied in the research will be explained. After the parents of the babies who meet the case selection criteria are informed about the research, their oral and written consents will be obtained through the "Informed Consent Form". It will be determined by computerized simple randomization method which mothers and their babies who are willing to participate in the research and who meet the sample selection criteria will be included in which group (www.randomizer.org ). The experimental group and the control group will be fitted with a pulse oximeter device 5 minutes before the start of the blood collection procedure and it will be ensured that it is attached until 5 minutes after the procedure. 5 Minutes before the procedure, the procedure sequence and 5 minutes after the procedure, the baby's pain score, the number of heart beats, the oxygen saturation value and the mother's anxiety level will be recorded. The crying time will be recorded as the time elapsed from the moment the baby starts crying until the crying ends. All measurements will be measured by two independent observers and recorded in the observation form. The blood collection procedure will be performed by the same nurse in each of the 2 groups.
- Conditions
- Venipuncture, Pain
- Being tested
- gentle human touch
- Keywords
- NEWBORN, PRETERM, GENTLE HUMAN TOUCH, PAİN
- 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.
gentle human touchOther
Also called yok
Mother will apply gentle human touch touch technique during venous blood collection from preterm babies between 32-37 weeks of gestation
| Study group | Role | What they receive |
|---|---|---|
| gentle human touch | Experimental | In the study, after the mother in the experimental group was dressed in a clean apron, she was allowed to wash and disinfect her hands. When the temperature of the mother's hand was measured with a non-contact thermometer, it was allowed to warm it under a radiant heater until it reached 34 ºC. The mother, who was informed about the method before, was allowed to place the palm of one hand on the baby's crown, with her fingertips touching the eyebrow line. She placed her other hand on her lower abdomen, encircling the baby's waist and hips. It has been provided to perform sensitive touch operation without pressure and massage. The mother started the gentle touch method 5 minutes before the blood draw, and continued to do the touching during the blood draw and 5 minutes after the blood draw was finished. Receives: Other: gentle human touch |
| Control group | No intervention | The standard procedure of the clinic was applied to preterm infants in the control group. In the standard procedure of the clinic, the mother was with her baby in the blood collection room and did not perform any procedure. IN ALL BABIES IN THE CONTROL AND EXPERIMENTAL GROUP., Before the procedure, 5 minutes after the procedure and 20 minutes after the procedure, the mother filled out the STAI-I form. The NIPS scale to measure the infant's pain was scored by two independent observers before, during, and five minutes after the procedure. KTA, SPO2 values of the baby were recorded before, during and five minutes after the procedure. The baby's crying time was started when the crying started, and stopped when the crying stopped. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRETERM PAİN
Neonatal Infant Pain Scale
Measured: AT THE FIRST MINUTE OF VENİPUNCTURE
MOTHER'S ANXIETY
State-Trait Anxiety Scale
Measured: FIVE MINUTES AFTER VENIPUNCTURE
Secondary outcomes (3)
HEART RATE
Measured 3 times in total
Measured: AT THE FIRST MINUTE OF VENİPUNCTURE
OXYGEN SATURATION
Measured 3 times in total
Measured: AT THE FIRST MINUTE OF VENİPUNCTURE
CRYING TIME
measured with a stopwatch
Measured: METER STARTED WHEN BABY CRYING DURING THE PROCEDURE, STOPPED WHEN CRYING STOPPED
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start30 Jun 2021
- Primary completion31 Aug 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Preterm babies who apply to the blood collection room to draw blood, will be included in the experimental and control group. Randomization was done at www.randomizer.org.
- Masking
- None (open label)
- Enrolment
- 80 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 KILINÇ, 1, Principal investigator, ISTANBUL CERRAHPAŞA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727631
- Sponsor's protocol ID
- 190
- Status last verified
- Feb 2023
- First submitted
- 12 Dec 2022
- Last updated
- 14 Feb 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 23932956Akcan, E., & Polat, S. (2017). The role of the nurse in pain and pain management in newborns. Acıbadem University Journal of Health Sciences, (2), 64-69.
Aydin 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 27112434Dur 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 26856517Liaw JJ, Yang L, Katherine Wang KW, Chen CM, Chang YC, Yin T. Non-nutritive sucking and facilitated tucking relieve preterm infant pain during heel-stick procedures: a prospective, randomised controlled crossover trial. Int J Nurs Stud. 2012 Mar;49(3):300-9. doi: 10.1016/j.ijnurstu.2011.09.017. Epub 2011 Oct 14.
PubMed 22001561Mayfield, A. (2019). Effects of Kangaroo Mother Care on Mother-Infant Interaction: Infant Behaviors (Doctoral dissertation, Southeast Missouri State University).
McCarthy 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 22416039Morrow C, Hidinger A, Wilkinson-Faulk D. Reducing neonatal pain during routine heel lance procedures. MCN Am J Matern Child Nurs. 2010 Nov-Dec;35(6):346-54; quiz 354-6. doi: 10.1097/NMC.0b013e3181f4fc53.
PubMed 20926970Yilmaz, O. E., & Gözen, D. (2019). The Importance of Family Centered Care in Pediatric Nursing and Its Value in Improving the Quality of Care. Turkiye Klinikleri Child Health and Diseases Nursing-Special Topics, 5(2), 5-11.
Zempsky WT. Optimizing the management of peripheral venous access pain in children: evidence, impact, and implementation. Pediatrics. 2008 Nov;122 Suppl 3:S121-4. doi: 10.1542/peds.2008-1055c. No abstract available.
PubMed 18978004Kilinc D, Caglar S. The Effect of Mother's Gentle Human Touch on Preterm Neonate's Pain and Maternal Anxiety During Venipuncture in Turkiye. Res Nurs Health. 2025 Aug;48(4):487-496. doi: 10.1002/nur.22472. Epub 2025 May 20.
PubMed 40392177
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mother's Gentle Human Touch Method on Preterm Pain and Mother's Anxiety Level During Venipuncture
- ClinicalTrials.gov ID
- NCT05727631
- Acronym / sponsor ID
- 190
- Conditions
- Venipuncture, Pain
- Keywords
- NEWBORN, PRETERM, GENTLE HUMAN TOUCH, PAİN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Feb 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.
Newborns are frequently exposed to acute or chronic pain experience due to different invasive interventions. The American Academy of Pediatrics (AAP) recommends minimizing the pain associated with invasive procedures. Reduction of pain primarily requires accurate assessment of pain, and treatment with pharmacological/nonpharmacological interventions.
Touch is one of the first senses developed in the newborn. Gentle Human Touch (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 stroking or massage, and provides a relaxing effect on the baby. Studies have shown that the gentle touch method increases the sleep level of preterm infants, reduces pain, stress and cortisone levels, reduces restlessness and keeps the heart rate under control.
Newborns need their parents, especially their mothers, to be by their side during any kind of intervention. For this reason, the presence of the parent next to the newborn during invasive procedures and the primary role in nonpharmacological interventions provides optimal comfort for the nurse, the newborn and the caregiver. When using nonpharmacological methods, it is important to take advantage of the family-centered care model. Family-centered care is a model of care based on cooperation between health professionals and children's families in the planning, delivery and evaluation of health Decency. Its general objective is to improve the quality of health services for children and families, to increase the satisfaction of families and health professionals, and to ensure the effective use of personnel.
Accordingly, this thesis study was planned in a randomized controlled experimental design type in order to determine the importance of family-centered care model and parents' participation in the procedures and the effect of gentle touch method applied by mothers during bloodletting on preterm pain level, physiological parameters, crying time and anxiety level of the mother.
Detailed description
June December 2021-Dec 2021, the universe of the research will consist of preterm infants and mothers admitted to Istanbul Zeynep Kamil Women and Children's Diseases Training and Research Hospital Neonatal Outpatient Clinic. The sample will be composed of mothers and preterm infants who have undergone bloodletting between these dates, who meet the sample selection criteria, and who volunteer to participate in the study Dec. At the beginning of the data collection phase, power analysis will be performed to determine the number of samples. Groups of babies will be determined using simple randomization method in computer environment.
Data Collection Process After obtaining the permissions of the ethics committee and the institution of the research, the subject and purpose of the research will be explained to all medical personnel working in the neonatal outpatient clinic of the hospital where the research will be conducted, and the methods to be applied in the research will be explained. After the parents of the babies who meet the case selection criteria are informed about the research, their oral and written consents will be obtained through the "Informed Consent Form". It will be determined by computerized simple randomization method which mothers and their babies who are willing to participate in the research and who meet the sample selection criteria will be included in which group (www.randomizer.org ). The experimental group and the control group will be fitted with a pulse oximeter device 5 minutes before the start of the blood collection procedure and it will be ensured that it is attached until 5 minutes after the procedure. 5 Minutes before the procedure, the procedure sequence and 5 minutes after the procedure, the baby's pain score, the number of heart beats, the oxygen saturation value and the mother's anxiety level will be recorded. The crying time will be recorded as the time elapsed from the moment the baby starts crying until the crying ends. All measurements will be measured by two independent observers and recorded in the observation form. The blood collection procedure will be performed by the same nurse in each of the 2 groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Preterm babies who apply to the blood collection room to draw blood, will be included in the experimental and control group. Randomization was done at www.randomizer.org.
| Arm | Type | Receives |
|---|---|---|
| gentle human touch | Experimental | Other: gentle human touchIn the study, after the mother in the experimental group was dressed in a clean apron, she was allowed to wash and disinfect her hands. When the temperature of the mother's hand was measured with a non-contact thermometer, it was allowed to warm it under a radiant heater until it reached 34 ºC. The mother, who was informed about the method before, was allowed to place the palm of one hand on the baby's crown, with her fingertips touching the eyebrow line. She placed her other hand on her lower abdomen, encircling the baby's waist and hips. It has been provided to perform sensitive touch operation without pressure and massage. The mother started the gentle touch method 5 minutes before the blood draw, and continued to do the touching during the blood draw and 5 minutes after the blood draw was finished. |
| Control group | No intervention | –The standard procedure of the clinic was applied to preterm infants in the control group. In the standard procedure of the clinic, the mother was with her baby in the blood collection room and did not perform any procedure. IN ALL BABIES IN THE CONTROL AND EXPERIMENTAL GROUP., Before the procedure, 5 minutes after the procedure and 20 minutes after the procedure, the mother filled out the STAI-I form. The NIPS scale to measure the infant's pain was scored by two independent observers before, during, and five minutes after the procedure. KTA, SPO2 values of the baby were recorded before, during and five minutes after the procedure. The baby's crying time was started when the crying started, and stopped when the crying stopped. |
Who may qualify
- Ages
- 32 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Between 32 and 37 gestational weeks,
- The first blood collection attempt is successful,
- Health follow-ups performed after childbirth are considered healthy by the physician,
Key exclusion criteria (2 listed)
- Analgesic given up to 6 hours before the procedure,
- With a congenital anomaly, • With any disease,
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 touchAlso: yokMother will apply gentle human touch touch technique during venous blood collection from preterm babies between 32-37 weeks of gestation | Other | gentle human touch |
Primary outcome
PRETERM PAİN
Time frame: AT THE FIRST MINUTE OF VENİPUNCTURE
Neonatal Infant Pain Scale
MOTHER'S ANXIETY
Time frame: FIVE MINUTES AFTER VENIPUNCTURE
State-Trait Anxiety Scale
3 secondary outcomes
HEART RATE
Time frame: AT THE FIRST MINUTE OF VENİPUNCTURE
OXYGEN SATURATION
Time frame: AT THE FIRST MINUTE OF VENİPUNCTURE
CRYING TIME
Time frame: METER STARTED WHEN BABY CRYING DURING THE PROCEDURE, STOPPED WHEN CRYING STOPPED
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 14 Feb 2023.
- Results publication: 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.
- Results publicationAkcan, E., & Polat, S. (2017). The role of the nurse in pain and pain management in newborns. Acıbadem University Journal of Health Sciences, (2), 64-69.
- Results publication: 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.
- Results publication: PubMed 32601011Dur S, Caglar S, Yildiz NU, Dogan P, Guney Varal I. The effect of Yakson and Gentle Human Touch methods on pain and physiological parameters in preterm infants during heel lancing. Intensive Crit Care Nurs. 2020 Dec;61:102886. doi: 10.1016/j.iccn.2020.102886. Epub 2020 Jun 27.
- Results publication: PubMed 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.
- Results publication: 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.
- Results publication: PubMed 22001561Liaw JJ, Yang L, Katherine Wang KW, Chen CM, Chang YC, Yin T. Non-nutritive sucking and facilitated tucking relieve preterm infant pain during heel-stick procedures: a prospective, randomised controlled crossover trial. Int J Nurs Stud. 2012 Mar;49(3):300-9. doi: 10.1016/j.ijnurstu.2011.09.017. Epub 2011 Oct 14.
- Results publicationMayfield, A. (2019). Effects of Kangaroo Mother Care on Mother-Infant Interaction: Infant Behaviors (Doctoral dissertation, Southeast Missouri State University).
- Results publication: 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.
- Results publication: PubMed 20926970Morrow C, Hidinger A, Wilkinson-Faulk D. Reducing neonatal pain during routine heel lance procedures. MCN Am J Matern Child Nurs. 2010 Nov-Dec;35(6):346-54; quiz 354-6. doi: 10.1097/NMC.0b013e3181f4fc53.
- Results publicationYilmaz, O. E., & Gözen, D. (2019). The Importance of Family Centered Care in Pediatric Nursing and Its Value in Improving the Quality of Care. Turkiye Klinikleri Child Health and Diseases Nursing-Special Topics, 5(2), 5-11.
- Results publication: PubMed 18978004Zempsky WT. Optimizing the management of peripheral venous access pain in children: evidence, impact, and implementation. Pediatrics. 2008 Nov;122 Suppl 3:S121-4. doi: 10.1542/peds.2008-1055c. No abstract available.
- 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 KILINÇ, 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 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 3 inclusion and 2 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 14 Feb 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 PAİN (time frame: AT THE FIRST MINUTE OF VENİPUNCTURE). 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 NCT05727631, which also lists 13 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 14 Feb 2023.