Cardiac CatheterizationNCT06727526
Acupressure's Impact on Pain and Physiological Parameters in Infants Undergoing Cardiac Catheterization
A study testing Acupressure in people with Cardiac Catheterization, run by Baskent University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Cardiac Catheterization
- What is being tested?
- Acupressure
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Duygu Gözen, Prof. Dr. contact
About this study
Official title: 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.
- Conditions
- Cardiac Catheterization
- Being tested
- Acupressure, Placebo acupressure
- Keywords
- cardiac catheterization, congenital heart disease, Acupressure, nursing care, pain
- Medical subject headings
- Heart Defects, Congenital, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
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 acupressureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure Group | Experimental | 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. Receives: Other: Acupressure |
| Plasebo | Placebo comparator | 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. Receives: Other: Placebo acupressure |
| Control Group | No intervention | Infants in this group will not receive any specific intervention and will be provided routine care in the ward. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
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.
Measured: 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 (2)
Heart Rate
Maintaining or normalizing heart rate within normal range (100-160)
Measured: 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
Normalizing or maintaining saturation rate within the normal range according to the child.
Measured: 30 minutes after the first procedure, 30 minutes after the second procedure, 2 hours after the second procedure, 24 hours after the second procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start30 Dec 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilcim Ercan Koyuncu, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727526
- Sponsor's protocol ID
- Acupressure in Infants
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32320139Bastani 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.
PubMed 26457090American 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.
PubMed 23498882Alakhfash 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.
PubMed 33154909
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure on Pain and Physiological Parameters in Infants Before and After Cardiac Catheterization: a Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT06727526
- Acronym / sponsor ID
- Acupressure in Infants
- Conditions
- Cardiac Catheterization
- Keywords
- cardiac catheterization, congenital heart disease, Acupressure, nursing care, pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupressure Group | Experimental | Other: AcupressureInfants 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. |
| Plasebo | Placebo comparator | Other: Placebo acupressureInfants 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. |
| Control Group | No intervention | –Infants in this group will not receive any specific intervention and will be provided routine care in the ward. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupressureThe 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. | Other | Acupressure Group |
| Placebo acupressureIn 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. | Other | Plasebo |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Results publication: PubMed 32320139Koc 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.
- Results publication: PubMed 26457090Bastani 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.
- Results publication: PubMed 23498882American 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.
- Results publication: PubMed 33154909Alakhfash 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Duygu Gözen, Prof. Dr. contact
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Cardiac Catheterization, run by Baskent University.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İlçim Ercan (05534700629, ilcimercan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT06727526, which also lists 4 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 17 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.