The Effects of Acupressure and Paternal Holding on Pain and Physiological Parameters During Heel Lancing

December 13, 2024 updated by: Ilcim Ercan Koyuncu, Baskent University

The Effects of Acupressure and Paternal Holding on Pain and Physiological Parameters in Infants During Heel Lancing: a Randomized Controlled Trial

Neonatal heel blood collection is a common medical procedure to obtain blood samples from newborns for diagnostic purposes. Although necessary for clinical evaluation, this procedure causes discomfort and distress in infants. The pain experienced during heel prick is a major concern and warrants exploration of effective and compassionate interventions to alleviate associated discomfort and reduce crying time. Non-pharmacological approaches, such as acupressure and cuddling, are thought to have important contributions to improving the overall experience of newborns undergoing this procedure. . The aim of this study was to evaluate the efficacy of acupressure and paternal hugging interventions in relieving pain and reducing crying time during neonatal heel haemorrhage. The choice of these interventions was based on their potential to offer non-invasive and holistic approaches to pain management by addressing not only the physical but also the emotional dimensions of the neonatal experience.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Neonatal heel prick blood collection is a common medical procedure performed to obtain blood samples from newborns for diagnostic purposes. Neonatal heel prick plays an important role in the diagnosis of genetic and metabolic diseases such as hypothyroidism and phenylketonuria. Although necessary for clinical evaluation, this procedure causes discomfort and distress in infants. Pain during heel prick is a major concern and warrants exploration of effective and compassionate interventions to alleviate the associated discomfort and reduce crying time. In this sense, there are studies on both heel prick instruments and interventions applied to the infant during heel prick. Non-pharmacological approaches such as acupressure and hugging are thought to have important contributions to improving the overall experience of newborns undergoing this procedure. It is known that one of the most important determinants of attachment in the postnatal period is touch, hugging and skin-to-skin contact. The neonatal period is a critical developmental stage characterised by rapid physiological and neurological changes. It is thought that the sensitivity of newborns to pain and early painful experiences may have potential long-term effects. There are studies suggesting that painful procedures may be effective in mother-baby or father-baby attachment. While there are studies in the literature on mother's hug, no study on father's hug was found. Due to the role of the presence of fathers in paediatric pain management, the potential to provide emotional support, the father's hug as a form of comforting touch, contributing to the release of oxytocin, a hormone associated with attachment and stress reduction, and the emotional bond established through hugging may act as a buffer against distress associated with painful procedures and promote a sense of security and assurance in the infant, it was considered appropriate to use it in this study. Acupressure, derived from traditional Chinese medicine, involves applying manual pressure to specific points on the body to promote healing and relieve pain. Similarly, emotional support provided by a carer, such as a father, through cuddling is thought to have the potential to reduce stress and improve the infant's emotional well-being. In this study, investigators aimed to evaluate the effectiveness of acupressure and paternal hug interventions in relieving pain and reducing crying time during neonatal heel haemorrhage. The choice of these interventions was based on their potential to offer non-invasive and holistic approaches to pain management by addressing not only the physical but also the emotional dimensions of the neonatal experience.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Baskent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being a term newborn
  • A healthy newborn with its mother by its side
  • Not taking any analgesic/sedative medication within 24 hours
  • The baby has not undergone invasive procedures other than routine interventions

Exclusion Criteria:

  • Preterm-postterm newborn
  • Having a systemic disease
  • Taking analgesic/sedative medication in the last 24 hours
  • Invasive procedures other than routine interventions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Experimental: Acupressure
Other: Acupressure
Acupressure will be applied to the foreheads of the babies in this group starting two minutes before the heel prick. Acupressure application will be finished when heel prick blood collection is finished.
Experimental: Paternal Holding
Other: Father's Lap
Infants in this group will be placed on the father's lap two minutes before heel prick blood collection. They will remain on the father's lap during the heel prick procedure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: pre-intervention, immediately after the intervention
Pain will be assessed using the Neonatal Pain, Agitation, Sedation Scale. The minimum score of the scale is 0 and the maximum score is 10. Four points and below is considered as mild pain, five points and above is considered as moderate and severe pain.
pre-intervention, immediately after the intervention
Pulse value
Time Frame: pre-intervention, immediately after the intervention
Pulse value will be assessed using the infant pulse oximeter.
pre-intervention, immediately after the intervention
Crying time
Time Frame: During the intervention
Crying time will be recorded throughout the procedure.
During the intervention
Saturation value
Time Frame: pre-intervention, immediately after the intervention
Saturation value will be assessed using the infant pulse oximeter.
pre-intervention, immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baskent University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mersin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Heel Lancing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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