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Procedural PainNCT06111534

Paternal vs Maternal Holding-Cuddling for Procedural Pain in Healthy Term Neonates

A study testing Holding in people with Procedural Pain, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigated the effect of maternal holding-cuddling (MHC) and paternal holding-cuddling (PHC) on heel prick pain and crying duration in healthy term neonates Read more about this study

Who is it for?
Ages 38 to 42 weeksHealthy volunteers can take part
Conditions the study is for
Procedural Pain
What is being tested?
Holding
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteTurkey (Türkiye)
Study dates
4 Feb 2016to 30 Sep 2016
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 38 to 42 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • healthy term neonates
  • birth weight between 2500 and 4000 g
  • 38-42 gestational week
  • postnatal age of 48-72 hours
  • a 5-minute APGAR score of ≥8,
  • having had no experience of any painful interventions other than vitamin K and hepatitis B vaccine at birth
Show all 10Show fewer
  • fed between 30 and 60 min before the procedure
  • undergoing heel prick only once
  • blood collection for the Guthrie test
  • willing to hold their babies during the procedure

Who cannot join

  • sleeping during the procedure
  • receiving analgesics up to 24 hours before the procedure

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Medeniyet University

    Istanbul, Kadıköy, 34720

Other trials in Turkey (Türkiye)

About this study

Official title: Paternal vs Maternal Holding-Cuddling for Procedural Pain in Healthy Term Neonates: A Quasi-experimental Study

This study investigated the effect of maternal holding-cuddling (MHC) and paternal holding-cuddling (PHC) on heel prick pain and crying duration in healthy term neonates

Read the detailed description

Newborns undergo many painful procedures. The heel prick, or heel lancing, is a painful procedure used for newborn screening tests. It is a more painful procedure than other venipuncture procedures. All pediatricians and healthcare professionals working with neonates should focus on pain management during heel pricks for two reasons. First, they are under an ethical obligation to help neonates experience as little pain as possible during medical procedures. Second, repeated painful exposure has harmful consequences. The International Guide to Pediatric Anesthesia (Good Practice in Postoperative and Procedural Pain) also recommends pharmacological and non-pharmacological methods to prevent and effectively manage acute procedural pain in children. However, pharmacological methods for pain management in neonates may have some side effects. On the other hand, non-pharmacological methods are easy to use, affordable, and time-effective methods with no side effects. Healthcare professionals do not use non-pharmacological methods that are expensive, hard to apply, and time-consuming. Therefore, this study focused on maternal holding-cuddling and paternal holding-cuddling as alternative non-pharmacological methods to prevent procedural pain in neonates during heel pricks. Holding-cuddling is an effective non-pharmacological method for reducing procedural pain.

Conditions
Procedural Pain
Being tested
Holding
Keywords
Healthy infant, Parent participation, Procedural pain
Medical subject headings
Pain, Procedural

What participants receive

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

  • HoldingBehavioural

    Holding is an effective non-pharmacological method for reducing procedural pain. Minor painful procedures, such as heel pricks, are easy to use, practical, non-invasive, and affordable procedures when performed when the neonate is held/cuddled by one of its parents. Neonates held/cuddled by their mothers are likely to experience less pain and cry less during heel pricks. The MHC and PHC methods help neonates experience tactile, auditory, visual, and olfactory sensory inputs that can enhance analgesic effects. These multisensory methods can alleviate the pain experienced by the infant during minor painful procedures and shorten the crying time. This type of analgesia may be mediated by multisensory stimulation associated with the mother/father-infant attachment.

Study groups in NCT06111534
Study groupRoleWhat they receive
MHC groupExperimentalEach MHC group participant (n=30) was brought to the procedure room by its mother. The mother sat in a comfortable chair with back support. She held her baby close to her chest, with the baby's head in a crossed position so that it could see its mother. The same nurse collected the blood sample. The mother communicated with the baby verbally and made eye contact with it to calm it down during the procedure. She was holding the baby both during and after the procedure.
Receives: Behavioral: Holding
PHC groupExperimentalEach PHC group participant (n=30) was brought to the procedure room by its father. The father sat in a comfortable chair with back support. He held his baby close to his chest, with the baby's head in a crossed position so that it could see its father. The same nurse collected the blood sample. The father communicated with the baby verbally and made eye contact with it to calm it down during the procedure. He was holding the baby both during and after the procedure.
Receives: Behavioral: Holding
Control groupNo interventionThe control group participants (n=32) underwent the procedure according to the routine clinical practice. Either parent brought the baby into the procedure room and laid it on the procedure table in the supine position. The nurse collected the blood sample. The parent was present in the room and communicated with the baby only verbally during the procedure. The parent picked up the baby after the procedure.

What is being measured

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

  1. Neonatal Infant Pain Scale (NIPS)

    The scale is used to assess procedural pain in neonates. It is a behavioral scale assessing five behavioral indicators (facial expression, cry, arms, legs, and state of alertness) and one physiological indicator (breathing patterns). Five items (facial expression, breathing pattern, arms, legs, and state of alertness) are scored as 0 (Good) or 1 (Bad), while one item (crying) is scored as 0 (Good), 1, or 2 (Bad). The total scale score ranges from 0 to 7, with higher scores indicating more pain.

    Measured: Through painful procedure completion, an average of 10 minutes

Secondary outcomes (2)

  1. Crying time during the procedure

    The duration of total crying time during the procedure is between when the heel is pricked and the injection site is covered with a cotton pad.

    Measured: Through painful procedure completion, an average of 2 minutes

  2. Crying time after the procedure

    The total crying time after the procedure is between when the procedure is completed and the baby calms down.

    Measured: Through painful procedure completion, an average of 2 minutes

Timeline

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

  1. First posted1 Nov 2023
  2. Study start4 Feb 2016
  3. Primary completion20 Aug 2016
  4. Study completion30 Sep 2016

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
Non-randomised
Intervention model
Sequential
Model description
Participants were recruited using random sampling. The group assignment was determined using the closed envelope method. Therefore, data were collected first from the MHC group, followed by the PHC and control groups.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06111534
Sponsor's protocol ID
2016/13173
Other IDs
2016
Status last verified
Oct 2023
First submitted
27 Oct 2023
Last updated
1 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It will be shared after the article is published.

Publications

  • Perry M, Tan Z, Chen J, Weidig T, Xu W, Cong XS. Neonatal Pain: Perceptions and Current Practice. Crit Care Nurs Clin North Am. 2018 Dec;30(4):549-561. doi: 10.1016/j.cnc.2018.07.013.

    PubMed 30447813

  • 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

  • Johnston CC, Campbell-Yeo M, Filion F. Paternal vs maternal kangaroo care for procedural pain in preterm neonates: a randomized crossover trial. Arch Pediatr Adolesc Med. 2011 Sep;165(9):792-6. doi: 10.1001/archpediatrics.2011.130.

    PubMed 21893645

  • Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.

    PubMed 8413140

  • Kucukoglu S, Aytekin A, Celebioglu A, Celebi A, Caner I, Maden R. Effect of White Noise in Relieving Vaccination Pain in Premature Infants. Pain Manag Nurs. 2016 Dec;17(6):392-400. doi: 10.1016/j.pmn.2016.08.006. Epub 2016 Oct 15.

    PubMed 27751753

Questions about this trial

What is this clinical trial studying?

A study testing Holding in people with Procedural Pain, run by Istanbul Medeniyet 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 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 1 Nov 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?

Neonatal Infant Pain Scale (NIPS) (time frame: Through painful procedure completion, an average of 10 minutes). 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 NCT06111534, 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 1 Nov 2023.

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