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Effectiveness of using sand bag and ice pack on hematoma and pain in post-percutaneous coronary intervention patients with femoral sheath

Effectiveness of using sand bag and ice pack on hematoma and pain in post-percutaneous coronary intervention patients with femoral sheath

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001448437
Enrollment
60
Registered
2025-12-19
Start date
2025-08-20
Completion date
2025-12-10
Last updated
2026-01-12

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

Conditions

None listed

Brief summary

The purpose of this study was to determine the effectiveness of using sand bag and ice pack on reducing hematoma and pain in post PCI patients with femoral sheath at hospital in Banda Aceh. This study used a randomized controlled trial (RCT) design that compared the incidence of hematoma and pain in post PCI patients with femoral sheath in three intervention groups. Group one was patient who used sand bag and ice pack, group two was patient who used sand bag, and group three was patient who used ice pack. Researchers used total sampling, namely all post PCI patients who were attached to the femoral sheath during the two-month study period, with an average of 60 PCI patients with femoral sheath. Data collection tools include sociodemographic forms, Numeric Rating Scale (NRS), and recording hematoma diameter measurements (mm). Data will be analyzed using descriptive analysis, one-way ANOVA, and repeated measured ANOVA.

Interventions

The procedure used in this study was that enumerators introduced themselves to prospective respondents, explained the purpose of the study, and obtained informed consent from them. After providing an explanation, enumerators asked prospective respondents to read the informed consent form. If they agreed to participate, they were asked to sign the informed consent form. After the signation the informed consent form, the enumerator began to fill demographic data including; age, gender, education,

The procedure used in this study was that enumerators introduced themselves to prospective respondents, explained the purpose of the study, and obtained informed consent from them. After providing an explanation, enumerators asked prospective respondents to read the informed consent form. If they agreed to participate, they were asked to sign the informed consent form. After the signation the informed consent form, the enumerator began to fill demographic data including; age, gender, education, occupation, marital status, percutaneous coronary intervention experience, body mass index, and hemodynamic measurements. After that, the enumerator looked at the data in the medical records related to sheath size and coagulant therapy. In group 1, before performing the intervention, the enumerator measured the hematoma and pain. The first measurement was taken 0 minutes after the removal of the femoral sheath or before the puncture area was covered with gauze. Then, the enumerator took an ice pack from the medical refrigerator. The ice pack was placed in the medical refrigerator at a temperature of 18-20°C at least 2 hours before the procedure. The average temperature of the ice pack was 18.1°C at 0 minutes, 19.2°C at 10 minutes, and 19.5°C at 20 minutes. The ice pack is placed on top of the dressing and two gauze bandages after removal of the femoral sheath. After that, the enumerator prepared a 2.1 kg sandbag that had been prepared in each Intensive Cardiovascular Care Unit, cardiovascular ward, High Care Unit for Surgical, and High Care Unit for Medical room and placed it on top of the ice pack. The sandbag and ice pack were used simultaneously for 20 minutes. After 20 minutes, the dressing is removed to measure the hematoma and pain for the second time. After the measurement is complete, the puncture area is closed again using gauze and the ice pack is removed. Next, the puncture area is pressed using a sandbag for 1 hour and 40 minutes, or a total of 2 hours. The ice pack that is no longer in use is cleaned with disinfectant and returned to the refrigerator for storage. After 2 hours, the third measurement of hematoma and pain is taken. After the measurement is complete, the puncture area is not covered again with gauze. After use, the sandbag is also cleaned with disinfectant before being stored in the equipment cabinet. The same steps are taken for groups 2 and 3. The difference is that group 2 only uses the sand bag for 2 hours and group 3 only uses the ice pack for 20 minutes. To ensure that all respondents followed the procedures in accordance with the standards operating procedure in this research, direct observation was conducted and reported on the observation sheet. After collecting the data, the researcher or enumerator checks the completeness and accuracy of the questionnaire. The researcher or enumerator concludes the interview by expressing gratitude for the willingness to participate in the research, providing a towel, and provides a reward in the form of education about coronary heart disease and the prevention of bleeding using a leaflet has been designed specifically for this study. Leaflet reference from Ministry of Health the Republic of Indonesia. The intervention is conducted face-to-face and individually and this study is conducted in a hospital. Each intervention is performed once, with the following details: Group 1 receives an ice pack for 20 minutes and a sandbag for 2 hours. Group 2 receives a sandbag for 2 hours, and Group 3 receives an ice pack for 20 minutes.

Sponsors

Mrs Eka Tlaga Herawati - Faculty of Nursing, Universitas Syiah Kuala
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
17 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Patients aged 17 to 70 years. Patients after PCI who have a femoral sheath inserted. Patients experiencing hematoma and complaining of pain after aff sheath femoral. No blood coagulation abnormalities based on laboratory test results. Heparin use below or equal to 10,000 IU during PCI. Patients in a calm condition according to the psychological status assessment on the initial integrated assessment form for inpatients at hospital

Exclusion criteria

Patients who received integrilin therapy after PCI. Patients who received analgesic therapy such as paracetamol and ibuprofen. Patients who had cold allergies in intervention groups 1 and 3 using allergy history assessment on the integrated initial assessment form for inpatients in Hospital.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026