AzTrials
AzTrials

PainNCT06196502

The Effect of Gentle Human Touch and Kangaroo Care on Pain and Crying Physiological Parameters During Hepatitis-B Vaccination in a Newborn

A study testing Gentle Human Touch (GHT), Kangaroo Care and Lactation in people with Pain, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Many short- and long-term consequences, including altered physiological parameters, issues with feeding and sleep, chronic pain syndrome, difficulty focusing, anxiety, cognitive behavioral disorders, adjustment disorders, and growth retardation, have been linked to pain in neonates. Read more about this study

Who is it for?
Ages 1 day to 2 daysHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
Gentle Human Touch (GHT), Kangaroo Care and Lactation
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2024to 30 Aug 2024
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 1 day to 2 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Gestational week between 38-42,
  • Born at 38 weeks or above and with a body weight of >2500 grams,
  • Apgar score 1st and 5th 7 and above per minute,
  • Mothers who speak and speak Turkish

Who cannot join

  • Congenital anomaly
  • Hospitalization of the baby in the neonatal intensive care unit after birth
  • Mothers with hepatitis B vaccine refusal
  • Mothers who do not have kangaroo care

Trial locations and contacts

1 site in 1 country.

Elif Tuba KOÇ, 1 contact

+905063057819

elif.koc@ahievran.edu.tr

Turkey (Türkiye)1 site
  • Kirsehir Ahi Evran University

    Kırşehir, Kırşehir, 40100

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Gentle Human Touch and Kangaroo Care Applied During Hepatitis-B Vaccination in Newborns on Pain, Crying Duration and Physiological Parameters: Randomized Controlled Study

Many short- and long-term consequences, including altered physiological parameters, issues with feeding and sleep, chronic pain syndrome, difficulty focusing, anxiety, cognitive behavioral disorders, adjustment disorders, and growth retardation, have been linked to pain in neonates. Each and every newborn is entitled to pain relief and reduction. Avoiding painful interventions is the most crucial tactic in the management of newborn pain. However, it is impossible to ignore the necessity of therapeutic and diagnostic interventions. As such, pain reduction and elimination are crucial. Non-pharmacological techniques used on infants undergoing invasive operations have been shown in studies to be successful in reducing discomfort, pain, and restlessness while also enhancing comfort.

Numerous non-invasive, non-pharmacological techniques are employed for this goal. Among the non-invasive, non-pharmacological techniques include breastfeeding, nursing, therapeutic touch, skin-to-skin contact, wrapping, swaddling, music therapy, and white noise. The Hepatitis-B vaccine is among the first invasive therapies administered to infants. Research indicates that pain scores are positively impacted by canopy touch. Skin-to-skin contact is achieved by a number of techniques. The most popular is kangaroo care, which is given to mothers nude on their chests. Gentle human touch is another technique used to lessen pain during invasive operations (GHT). GHT is a soothing tactile stimulation that doesn't involve touching or rubbing. Several research have examined GHT's impact and discovered that it effectively reduces pain.

The purpose of this study was to ascertain how GHT and Kangaroo care affected the newborn's pain, length of crying, and physiological parameters while the Hepatitis-B vaccine was being administered. The researchers at the Kirsehir Training and Research Hospital in Turkey will apply their findings to healthy newborns who are placed adjacent to their moms in the postpartum ward. The researchers have experience in neonatal critical care nursing and are qualified in therapeutic touch.

Read the detailed description

After birth, the fetus undergoes a process of transformation from its diverse physiological and anatomical state during the intrauterine period. During the first 28 days of life, every newborn's bodily systems and functions continue to evolve in an effort to adjust to the extrauterine world.

With the right treatment, extrauterine adaption can be ensured for the newborn during this dangerous time. Many invasive procedures for diagnosis and prevention are part of healthy newborn care, and they are crucial for maintaining health once early extrauterine adaption is achieved. These invasive procedures include blood sugar testing, intramuscular injections, heel blood collection, and blood collection from peripheral veins.

Contrary to popular assumption, neonates have more sensitive pain perception, and it is well recognized that discomfort in newborns can lead to a variety of issues. The American Academy of Pediatrics states that pain is an unpleasant emotional and sensory experience brought on by actual or anticipated texture.

Infants experience pain to the same extent as adults do. So much so that pain in babies has been linked to a wide range of both immediate and long-term consequences, including altered physiological parameters, issues with nutrition and sleep, chronic pain syndrome, difficulty focusing, anxiety, cognitive behavioral disorders, adjustment disorder, and growth retardation. Each and every newborn is entitled to pain relief and reduction.

Avoiding painful interventions is the most crucial tactic in the management of newborn pain. It is impossible to avoid the necessity for therapeutic and diagnostic procedures, though. As such, pain reduction and elimination are crucial. According to studies, non-pharmacological techniques used on infants undergoing invasive operations are successful in reducing discomfort, pain, and restlessness while enhancing comfort. Numerous non-invasive, non-pharmacological techniques are employed for this goal. Among the non-invasive, non-pharmacological techniques include breastfeeding, nursing, therapeutic touch, skin-to-skin contact, wrapping, swaddling, music therapy, and white noise.

The Hepatitis-B vaccine is among the first invasive therapies administered to infants. Research indicates that pain scores are positively impacted by canopy touch. Skin-to-skin contact is achieved by a number of techniques. The most popular is kangaroo care, which is given to mothers nude on their chests.Gentle human touch is another technique used to lessen pain during invasive operations (GHT). GHT is a soothing tactile stimulation that doesn't involve touching or rubbing. Numerous research have examined GHT's impact and discovered that it effectively reduces pain.

In order to ensure patients' comfort and minimize the harmful effects of uncomfortable treatments, nurses play a crucial role. supplemental medical attention Basic nursing procedures have built-in techniques that help lessen the discomfort of intrusive interventions. Thus, the purpose of this study was to compare the effects of the two applications and assess the impact of kangaroo care and GHT on pain, duration of crying, and physiological parameters during the administration of the Hepatitis-B vaccine to neonates.Research Design: This study was designed as a randomized controlled experimental design to assess the impact of GHT and kangaroo care on newborn infants' pain, length of crying, and physiological parameters during the administration of the Hepatitis-B vaccine. Location and Study Features: The Gynecology and Obstetrics Service of the Kırşehir Training and Research Hospital in Turkey will be the site of this research. The ward has twelve nurses and twenty-eight beds. Every year, on average, 1000 people are born. The universe and study sample: To decide how many newborns should be in the research sample, a power analysis will be done at the start of the study. Upon reviewing the pertinent literature, it becomes evident that comparable research have utilized samples.Analyzing the pertinent literature reveals that research with similar designs have sampled between 30-35 groups. Research will be assessed in relation to the comparable research sample. The G*power tool will then be used by a statistician to do a power analysis. Study Universe and Sample: The number of newborn newborns to be included in the research sample will be determined at the outset of the study through a power analysis. Analyzing the pertinent literature reveals that research with similar designs have sampled between 30-35 groups. Research will be assessed in relation to the comparable research sample. The G*power tool will then be used by a statistician to do a power analysis.

At least thirty babies will be included in each of the three groups that will be randomly assigned, along with a control group. The sample group will be randomly assigned numbers ranging from 1 to 90 using the web software www.randomizer.org to identify the groups to which the newborns will be placed.A statistician will conduct post-power analysis once there are ninety samples.

Data collecting Form is the first data collecting tool. 1. The researcher scanned the literature to generate this form. It asks about the parents' sociodemographic details as well as the newborn's birth weight, height, head circumference, first and fifth Apgar scores, gestational week, and gender.

  1. The NIPS (Neonatal Infant Pain Scale) 3. Registration Form for Application This form is used to record the groups' physiological parameters and NIPS score before, during, and after the hepatitis-B vaccination procedure.

Methods and Approach to Be Used Mothers who are calm before giving birth will be invited to participate in the study. Mothers who volunteer to participate in the research and meet the eligibility requirements will have their written consent obtained.

Both the mother and the child are expected to be stable following delivery. Prior to the surgery, the newborns' physiological parameters (heart rate and SpO2) will be monitored by attaching a neonatal probe to the pulse oximetry.

Next, the groups selected by randomization will receive GHT with Gentle Human Touch (Group 1), Kangaroo Care (Group 2), and Control Group (Group 3). Without affecting the control group, the researcher will conduct the GHT and provide kangaroo care with the moms of the infants. The same nurse will give each baby the hepatitis-B vaccination. A neonatal nurse will use a stopwatch to monitor the newborn's screaming times during the process.

Conditions
Pain
Being tested
Gentle Human Touch (GHT), Kangaroo Care, Lactation
Keywords
newborn, pain, intervention, pediatric nursing, vaccination
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gentle Human Touch (GHT)Other

    Gentle touch is a touch technique that provides a kind of relaxation in premature babies, reduces behavioral stress and motor activities of babies and is effective in their positive behavior. GHT Hepatitis-B vaccine will start 5 minutes before the application and continue during and after the procedure. It is planned to take 10 minutes in total. The researcher will place one hand on the baby's head and the other hand on the baby's lower abdomen, covering the waist and hips, for 10 minutes.

  • Kangaroo CareOther

    Kangaroo care will be provided to randomly selected volunteer moms in their own gynecological ward rooms, where they will have skin-to-skin contact with their babies while maintaining their privacy. Kangaroo care is a strategy that promotes bonding and engagement between a mother and her infant by allowing skin-to-skin contact with the newborn's face facing the mother and only the diaper remaining.

    The infant is positioned such that his or her shoulders are totally on the mother's chest, ensuring the baby's airway is open. To avoid heat loss while the baby is in skin-to-skin contact with his mother, a tiny blanket will be placed on his back and a beanie will be placed on his head. Kangaroo care will begin 5 minutes before the Hepatitis-B vaccine is administered and will continue throughout the operation. It is estimated that it will take 10 minutes in total.

  • LactationOther

    Breastfeeding will become standard medical practice. Breastfeeding will start as soon as the baby is given the vaccination and continue throughout the process.

Study groups in NCT06196502
Study groupRoleWhat they receive
Gentle human touch (GHT)ExperimentalExperimental: Gentle human touch (GHT) Group 1: Gentle touch is a touch technique that provides a kind of relaxation in premature babies, reduces behavioral stress and motor activities of babies and is effective in their positive behavior.
Receives: Other: Gentle Human Touch (GHT)
Kangaroo CareActive comparatorExperimental: Kangaroo Care Group 2: Kangaroo care is a comforting technique that strengthens and bonds the baby and parent, increases the production of milk by the mother, and lessens the stress and anxiety of both parties. Kangaroo care between parent and baby is a method that regulates vital values, reduces the possibility of hypoglycemia and prevents hypothermia.
Receives: Other: Kangaroo Care
LactationActive comparatorBreastfeeding will begin 5 minutes before the Hepatitis-B vaccine administration and will continue during and after the procedure. It is planned to last 10 minutes in total.
Receives: Other: Lactation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain level

    The newborn's pain assessment will be measured by NIPS. In the scale, the baby's facial expression (0-1 point), crying (0-2 points), breathing pattern (0-1 point), arm movements (0-1 point), leg movements (0-1 point) and alertness ( Scores between 0-7 are given according to 0-1 points). An increase in the score on the scale indicates a higher severity of pain.

    Measured: before vaccination/ immediately after vaccination

Secondary outcomes (4)
  1. newborn crying duration

    The newborn's crying duration will be measured and recorded with a stopwatch

    Measured: immediately after vaccination

  2. Saturation

    A portable pulse oximeter device will be used. saturation will be recorded and evaluated.

    Measured: before vaccination/ immediately after vaccination

  3. Heart rate

    A portable pulse oximeter device will be used.

    Measured: before vaccination/ immediately after vaccination

  4. Respiratory rate

    A portable pulse oximeter device will be used.

    Measured: before vaccination/ immediately after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2024
  2. Study start1 Feb 2024 (estimated)
  3. Primary completion30 Jul 2024 (estimated)
  4. Study completion30 Aug 2024 (estimated)

Resources

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
Model description
There are three sections to it, and they will all be finished simultaneously. This is not a study of drugs or devices. The three arms of the study are the breastfeeding (standard care), kangaroo care, and gentle human touch groups.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06196502
Sponsor's protocol ID
AhiEvranU-UTubaKOÇ-001
Status last verified
Dec 2023
First submitted
16 Nov 2023
Last updated
9 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Uematsu H, Sobue I. Effect of music (Brahms lullaby) and non-nutritive sucking on heel lance in preterm infants: A randomized controlled crossover trial. Paediatr Child Health. 2019 Feb;24(1):e33-e39. doi: 10.1093/pch/pxy072. Epub 2018 Jul 24.

    PubMed 30792607
  • Im H, Kim E. Effect of Yakson and Gentle Human Touch versus usual care on urine stress hormones and behaviors in preterm infants: a quasi-experimental study. Int J Nurs Stud. 2009 Apr;46(4):450-8. doi: 10.1016/j.ijnurstu.2008.01.009. Epub 2008 Mar 18.

    PubMed 18353332
  • Dur 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 32601011
  • Huang Q, Lai X, Liao J, Tan Y. Effect of non-pharmacological interventions on sleep in preterm infants in the neonatal intensive care unit: A protocol for systematic review and network meta-analysis. Medicine (Baltimore). 2021 Oct 29;100(43):e27587. doi: 10.1097/MD.0000000000027587.

    PubMed 34713833
  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Gentle Human Touch (GHT), Kangaroo Care and Lactation in people with Pain, run by Kirsehir Ahi Evran Universitesi 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 4 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: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Elif Tuba KOÇ, 1 (+905063057819, elif.koc@ahievran.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain level (time frame: before vaccination/ immediately after vaccination). 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 NCT06196502, which also lists 5 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 9 Jan 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in