Acupressure's Impact on Pain and Physiological Parameters in Infants Undergoing Cardiac Catheterization

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

The Effect of Acupressure on Pain and Physiological Parameters in Infants Before and After Cardiac Catheterization: a Randomized Placebo Controlled Trial

Acupressure, one of the traditional Chinese medicine practices dating back approximately 5,000 years, is a mind-body technique that can be independently applied by nurses. This practice involves applying pressure to specific points on the body to reduce pain. The pressure stimulates the release of substances such as endorphins, acetylcholine, norepinephrine, and dopamine, resulting in muscle relaxation, regulated blood circulation, and blocked pain signals at nerve endings, effectively reducing the sensation of pain. The aim of acupressure is to alleviate patient discomfort and improve quality of life by reducing the need for analgesics. Acupressure, which falls under the category of therapeutic massage, can be applied using the fingers and palms. According to its core philosophy, illness arises when the balance of energy flowing through body channels, called "meridians," is disrupted. Because acupressure does not involve needles, it is a safe, effective, and economical technique that is easy to learn and apply. The World Health Organization (WHO) classifies acupressure as a supportive treatment within its list of "treatable conditions." The technique involves applying pressure to the same point for 2-5 minutes. Stimulating specific points promotes the release of cytokines, such as endorphins, which play a role in pain reduction by blocking certain receptors on sensory nerve endings and thus preventing pain perception. Additionally, stimulating acupoints helps establish sympathetic and parasympathetic balance, supporting healthy homeostasis. Studies in the literature have investigated acupressure's positive effects on children's preoperative anxiety, postoperative pain severity, chemotherapy side effects, fatigue, sleep quality, asthma symptoms, and physical stress. In a study examining the impact of acupressure on procedural pain in infants prior to parenteral vaccinations, infants who received acupressure experienced lower pain levels and shorter crying durations. Similarly, a study investigating the effect of acupressure on acute pain during venous catheter insertion in children found that pain severity was lower among children who received acupressure. A systematic review examining the effects of acupressure on child health determined that acupressure is effective in alleviating procedural pain in children. The review emphasized that nurses should incorporate acupressure, a non-pharmacological method, into care practices for effective pain management in children. Despite evidence in the literature supporting acupressure's positive effects on pediatric health, no study has specifically examined its impact on pain and physiological parameters in children undergoing cardiac catheterization. Therefore, this thesis aims to investigate the effects of acupressure, applied before and after cardiac catheterization, on pain levels and physiological parameters in infants.

Study Overview

Status

Status

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Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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Interventional

Enrollment (Estimated)

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.
35

Phase

Phase

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  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

  • Name: Duygu Gözen, Prof. Dr.

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Infants between 1 month and 12 months
  • Infants with congenital heart disease
  • Infants undergoing cardiac catheterization for the first time
  • Infants undergoing planned cardiac catheterization
  • Infants without acupressure experience
  • Infants whose parents volunteered to participate in the study

Exclusion Criteria:

  • Infants with complications during catheterization
  • Infants followed up in the intensive care unit after catheterization
  • Infants with any deformity or lesion in the acupressure area
  • Infants who have not received analgesics after catheterization
  • Infants who were not given analgesics within six hours before catheterization
  • Infants with neurodevelopmental disorders
  • Infants whose parents did not volunteer to participate in the study

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: Single

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.
Experimental: Acupressure Group
Infants in this group will undergo acupressure both before and after cardiac catheterization. The initial session will be administered by the researcher 30 minutes prior to the procedure. Acupressure will target three specific points: the seventh point of the heart meridian (HT7), the fourth point of the large intestine meridian (LI4), and the sixth point of the pericardial meridian (PC6). The areas will be warmed for approximately 20 seconds to minimize tissue sensitivity, avoiding direct pressure on the acupressure points. Each point will receive 12 minutes of treatment, comprising 10 seconds of compression followed by 2 seconds of relaxation, applied symmetrically. After this initial session, the infant will undergo cardiac catheterization. Upon return to the ward post-catheterization, a second acupressure session will be conducted one hour after the administration of the final dose of ketamine hydrochloride.
Other: Acupressure
The literature found that acupressure positively affects child health, but no study was found to determine the effect of acupressure on pain and physiological parameters in children undergoing cardiac catheterization. Therefore, this study was designed to determine the effect of acupressure applied before and after cardiac catheterization on infants' pain levels and physiological parameters.
Placebo Comparator: Plasebo
Infants in this group will receive placebo acupressure before and after cardiac catheterization. The initial session will be administered 30 minutes before the procedure, targeting areas approximately 1-1.5 cm away from HT7, LI4, and PC6 points, where meridians do not pass. The areas will be warmed for 20 seconds to minimize tissue sensitivity, avoiding direct pressure on acupressure points. Each site will receive 12 minutes of treatment, alternating 10 seconds of compression and 2 seconds of relaxation, applied symmetrically. Post-catheterization, a second placebo session will be conducted an hour after the last dose of ketamine hydrochloride.
Other: Placebo acupressure
In health sciences, placebo refers to an inactive intervention used to relax the patient and assess treatment efficacy. It may involve inert substances (e.g., sugar tablets, saline) or non-therapeutic interventions (e.g., artificial electrical stimulation or conversations). Expectancy theory often explains The placebo effect, which suggests that treatment expectations can induce physiological changes. Factors like age, cognitive development, and previous pain experiences influence children's responses to placebo. Parental belief in an intervention's efficacy can reduce a child's pain expectations and positively influence their perception of pain. Although the sample included young children, our study incorporated the placebo group to account for this effect, especially since the parents evaluated pain scores.
No Intervention: Control Group
Infants in this group will not receive any specific intervention and will be provided routine care in the ward.

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
Time Frame: 30 minutes after the first procedure, 30 minutes after the second procedure, 2 hours after the second procedure, 24 hours after the second procedure
The Face, Legs, Activity, Cry, Consolability (FLACC) scale will assess the pain. The FLACC scale is a measurement used to assess pain for children between the ages of 1 month and 7 years or individuals who are unable to communicate their pain. The scale is scored in a range of 0-10, with 0 representing no pain. As the score increases, the patient's pain increases.
30 minutes after the first procedure, 30 minutes after the second procedure, 2 hours after the second procedure, 24 hours after the second procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: 30 minutes after the first procedure, 30 minutes after the second procedure, 2 hours after the second procedure, 24 hours after the second procedure
Maintaining or normalizing heart rate within normal range (100-160)
30 minutes after the first procedure, 30 minutes after the second procedure, 2 hours after the second procedure, 24 hours after the second procedure
Saturation
Time Frame: 30 minutes after the first procedure, 30 minutes after the second procedure, 2 hours after the second procedure, 24 hours after the second procedure
Normalizing or maintaining saturation rate within the normal range according to the child.
30 minutes after the first procedure, 30 minutes after the second procedure, 2 hours after the second procedure, 24 hours after the second procedure

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

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

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.
December 30, 2024

Primary Completion (Estimated)

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.
December 31, 2024

Study Completion (Estimated)

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.
December 30, 2025

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).
December 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.
December 9, 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.
December 11, 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.
December 1, 2024

More Information

Terms related to this study

Keywords

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.
  • Acupressure in Infants

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

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