Clinical trial NCT06727526: Acupressure's Impact on Pain and Physiological Parameters in Infants Undergoing Cardiac Catheterization
Official title: The Effect of Acupressure on Pain and Physiological Parameters in Infants Before and After Cardiac Catheterization: a Randomized Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Catheterization
Keywords: cardiac catheterization
congenital heart disease
Acupressure
nursing care
pain
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 35
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain
timeFrame: 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 outcomes:
measure: Heart Rate
timeFrame: 30 minutes after the first procedure, 30 minutes after the second procedure, 2 hours after the second procedure, 24 hours after the second procedure
measure: Saturation
timeFrame: 30 minutes after the first procedure, 30 minutes after the second procedure, 2 hours after the second procedure, 24 hours after the second procedure
Other outcomes:
Locations:
Study officials:
References:
citation: Koc Ozkan T, Balci S. The Effect of Acupressure on Acute Pain During Venipuncture in Children: Implications for Evidence-Based Practice. Worldviews Evid Based Nurs. 2020 Jun;17(3):221-228. doi: 10.1111/wvn.12437. Epub 2020 Apr 22.
citation: Bastani F, Khosravi M, Borimnejad L, Arbabi N. The effect of acupressure on cancer-related fatigue among school-aged children with acute lymphoblastic leukemia. Iran J Nurs Midwifery Res. 2015 Sep-Oct;20(5):545-51. doi: 10.4103/1735-9066.164508.
citation: American Academy of Pediatrics, Committee on Pediatric Emergency Medicine; American College of Emergency Physicians, Pediatric Committee; Emergency Nurses Association, Pediatric Committee. Joint policy statement--guidelines for care of children in the emergency department. J Emerg Nurs. 2013 Mar;39(2):116-31. doi: 10.1016/j.jen.2013.01.003.
citation: Alakhfash AA, Jelly A, Almesned A, Alqwaiee A, Almutairi M, Salah S, Hasan M, Almuhaya M, Alnajjar A, Mofeed M, Nasser B. Cardiac Catheterisation Interventions in Neonates and Infants Less Than Three Months. J Saudi Heart Assoc. 2020 May 12;32(2):149-156. doi: 10.37616/2212-5043.1051. eCollection 2020.