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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06727526
Enrollment
35
Registered
2024-12-11
Start date
2024-12-30
Completion date
2025-12-30
Last updated
2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Catheterization

Keywords

cardiac catheterization, congenital heart disease, Acupressure, nursing care, pain

Brief summary

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.

Interventions

OTHERAcupressure

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.

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.

Sponsors

Baskent University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Months to 12 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain30 minutes after the first procedure, 30 minutes after the second procedure, 2 hours after the second procedure, 24 hours after the second procedureThe 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.

Secondary

MeasureTime frameDescription
Heart Rate30 minutes after the first procedure, 30 minutes after the second procedure, 2 hours after the second procedure, 24 hours after the second procedureMaintaining or normalizing heart rate within normal range (100-160)
Saturation30 minutes after the first procedure, 30 minutes after the second procedure, 2 hours after the second procedure, 24 hours after the second procedureNormalizing or maintaining saturation rate within the normal range according to the child.

Contacts

Primary Contactİlçim Ercan
ilcimercan@hotmail.com05534700629
Backup ContactDuygu Gözen, Prof. Dr.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026